SPECIAL REPORT DECEMBER 2011

DRUG DELIVERY Review and Outlook i n d u s t r y g r o w t h t o c o n t i n u e t h r o u g h n e w technologies

The worldwide drug-delivery arena is growing each year as the increasing aging population is in need of improved methods of administration for products and therapies. Drug-delivery industry growth is being led by the United States as well as emerging markets.

Oral forms remain the preferred method of drug-delivery administration. Gaining in popularity are parenteral, inhalation and implantable systems. Elements impacting the development of drug-delivery systems include reimbursement, environmental factors, and regulatory processes.

Product developers are coming up with better ways to improve therapy performance and safety as patients become more involved in their treatments in an effort to cut down on costs. New electronic technologies for reusable systems and disposable devices are leading to improved sales of auto-injectors. Microneedle technology is on the rise so that medicine can be precisely delivered to areas in need of treatment. UBM Canon DATA PRODUCTS Table of contents 828B Newtown-Yardley Road, Suite B Drug-Delivery Industry Overview ...... Page 3 Newtown, PA 18940 Drug-Delivery Company Overview ...... 8 United States Phone: +1 .215 .944 .9800 Drug-Delivery Prescription Products Fax: +1 .215 .867 .0053 Website: PharmaLive .com Awaiting Approval ...... 26 Steve Corrick Phase III ...... 29 VP and Executive Director UBM Canon Publishing Phase II/III ...... 36 steve .corrick@ubm .com Phase II ...... 37 Roger Burg Phase I/II ...... 46 VP, Operations Publications Division Phase I ...... 47 roger .burg@ubm .com +1 .310 .445 .4221 Preclinical Development ...... 50 Glenn Glasberg Companies ...... 52 Circulation and Marketing Director glenn .glasberg@ubm .com Drug-Delivery Medical Devices +1 .215 .944 .9810 Class I Devices – General Controls – 510(k) Exempt ...... 61 Sandra Baker Class II Devices – General Controls and Special Controls – 510(k) . . . . . 66 Data Products Manager sandra .baker@ubm .com Class III Devices – General Controls and Special Controls – 510(k) ...... 78 +1 .215 .944 .9836 Unclassified Devices – 510(k) ...... 79 Amanda Wells Assistant Marketing Manager Companies ...... 80 amanda .wells@ubm .com +1 .215 .944 .9840 Brandon Materazzi Marketing Assistant brandon .materazzi@ubm com. Review the most recent Special Reports at: www .PharmaLive .com/SpecialReports +1 .215 .944 .9809 Andrew Humphreys See these and other topics: Editor In Chief, Data Products andrew .humphreys@ubm .com POM Quarterly +1 .215 .944 .9812 Top 50 Specialty Companies Stefanie Fedder Global Contract Manufacturing Companies: Pharmaceutical and Biotechnology Manager, Data and Content stefanie .fedder@ubm .com Nutraceuticals and Vitamins Review and Outlook +1 .215 .944 .9807 Top 50 Pharmaceutical Companies and Their Pipelines John King Market Analyst/Editor john .king@ubm .com +1 .215 .944 .9820 eKnowledgeBase - searchable pipeline and business-information database for the world’s pharma & biotech companies . Request a trial at: www .PharmaLive .com/newEKB Silvia Arriola Data Specialist silvia .arriola@ubm .com +1 .215 .944 .9803 MDRWeb.com - searchable database of global medical device companies and Diane Strohm their products . Learn more at: www MDRWeb. .com - enter promo code SRTRIAL for Data Specialist diane .strohm@ubm .com free two-week trial access . +1 .215 .944 .9828 Andrew Ellison For more information on these products contact: Data Specialist andrew .ellison@ubm .com Sandra .Baker@ubm .com or call: +1-215-944-9836 +1 .215 .944 .9826

Stacey Miller Contributing editor editorial advisors for Special Reports Kim Stannard Jay Carter, SVP Director of Strategy Services, AbelsonTaylor Production assistant Sander Flaum, President, Flaum Partners Mark Havenhand, MBA, Ph D. ., Novartis Pharma AG, Global Head, UBM Ltd. Corporate Head Office Ludgate House Business Strategy & Planning Clinical Medical Services 245 Blackfriars Road Boaz Mendzelevski, VP of Cardiology & Chief Medical Officer, London, SE1 9UY, United Kingdom Medifacts International Phone: +44 (0) 20 7921 5000 Website: ubm .com Steven Michaelson, Managing Partner, RosettaWishbone Mike Myers, President, Palio UBM Canon Headquarters 11444 W . Olympic Blvd . David M. Oakley, R .Ph ., Ph D. ., Director of Technical Development, Los Angeles, CA 90064 AAIPharma United States Deborah Schnell, President, Sales and Strategic Planning, Phone: +1 .310 .445 .4200 Fax: +1 .310 .445 .4299 Healthy Advice Networks Website: ubmcanon .com Marc Weiner, Managing Partner, Ogilvy CommonHealth Worldwide

2 Drug Delivery Review and Outlook

The global drug-delivery market is ex- “There can be a cost benefit when health informatics in new patient-cen- periencing annual growth in the mid-to- transitioning health-care provision from tered systems,” he adds. high single digits. The rising global popu- the hospital environment to the home In the field of auto-injectors, sophisti- lation and the need for more convenient environment or other health-care facili- cated use of electronics in reusable sys- drug-administration methods have creat- ties,” he states. “Effective drug-delivery tems and disposable devices is causing ed more opportunities for manufacturers devices and systems that enable a patient growth, Mr. Reynolds says. to produce additional drug-delivery sys- to self-inject can aid this transition. For “There are also trends toward en- tems and therapies. example, it is now possible to transition hanced manual systems, including er- The U.S. drug-delivery market is an- from hospital IV to home-administered gonomic features designed to improve ticipated to generate 10 percent yearly subcutaneous injection through the use an impaired patient’s ability to deliv- growth during 2011 and 2012, according of an electronic patch injector or auto- er a dose from a prefilled syringe,” he to industry experts. injector.” states. “There are several well-estab- The worldwide pharma market was Auto-injectors are becoming more lished companies in this space offering projected to grow about 5-7% during commonly used to deliver medications device technologies, and increasing em- 2011 compared to 4-5% growth generat- that treat a variety of therapeutic areas phasis on new and merging players offer- ed in 2010. U.S. pharma sales were pre- such as rheumatoid arthritis, oncology, ing improved patient convenience, and dicted to be up slightly during 2011 com- diabetes, and multiple sclerosis. As a re- integration between the device and the pared to 2010. sult, mass production will be required to container.” The industry will continue to grow support the demand for auto-injectors through more sophisticated drug-deliv- and in turn stimulate various industrial Microneedle Technology ery systems, says Graham Reynolds, VP activities to support the manufacturing of Marketing/Innovation, Pharmaceutical processes required for development. In the realm of new technologies, a small Delivery Systems, West Pharmaceutical Worldwide sales of advanced drug-de- band of device-development companies Services Inc. “There will be an increase livery systems – inhalers, injections and have been attempting to commercialize in self-administration of therapies,” he infusion pumps – are projected to grow drug-delivery products based on arrays shares. “For novel devices, look for con- from a value of $139 billion in 2009 to of microneedles. By establishing chan- tinued trends toward safety and a strong $197 billion in 2014, according to Cam- nels in the outer most layer of the epi- focus on the needs of the patient.” bridge Design Partnership LLP experts. dermis, these devices were expected to West Pharmaceutical has developed Cambridge Design Partnership is a con- deliver therapeutic drugs across the skin innovative delivery systems such as the sulting company that develops drug-de- and into the dermal layers, according to ConfiDose auto-injector system and livery devices in the United Kingdom. Greystone Research Associates. the SmartDose electronic patch injec- Matt Schuman, senior partner at Cam- Greystone analysts say after years of tor. These systems offer a range of op- bridge Design Partnership, advises man- prototyping unique array designs, a few tions for dose volume, injection time and ufacturers to learn from other industries development programs have migrated electronic control/feedback. They are de- that focus on creating differentiation and toward improving the performance of signed to meet the challenges of innova- gaining competitive advantage through existing delivery methods. The market tive drug products. innovations in branding, usability and availability of microneedle drug-delivery Oral forms are expected to remain the shelf appeal. devices such as the Sanofi Pasteur’s In- largest drug-delivery category. Parenter- “We think, in the future, patients are tanza influenza vaccine, which is based al, inhalation and implantable systems going to be much more involved in their on Becton, Dickinson and Co.’s (BD) are on the quickest growth pace. Indus- own treatments to reduce costs and Soluvia syringe-mounted microneedle try analysts expect parenteral formula- smart drug-delivery technologies are part array device, is considered a milestone tions will eventually surpass oral dosag- of what is going to enable this change in the transition of microneedle drug de- es as the largest segment. safely,” says Tom Oakley, Head of Drug livery from development to market. Influencing drug-delivery systems de- Delivery at Cambridge Design Partner- Microneedle technology is anticipated velopment will be reimbursement, envi- ship. “As device developers, we are going to affect healthcare by enabling precise ronmental factors and regulatory path- to have to think of new ways to increase injection of therapeutic agents to pre- ways, Mr. Reynolds says. “In addition, the performance and safety of therapies scribed areas below the skin. Micronee- understanding the importance of the at lower cost. dle technology is generating commercial drug container as it relates to the inte- “We expect healthcare systems in- viability at a time when drug developers gration into the overall drug-delivery sys- creasingly to make drug choices based are dealing with new challenges as they tem will continue to be a key factor.” on calculations of the total cost of a pa- assess ways to admi1nister a new class of Manufacturers are also accounting tient’s disease, and devices that can con- compounds with important therapeutic for patients’ ability and desire to care tribute to reducing overall costs could potential, according to Greystone. for themselves, or have a family mem- have significant commercial value. This Radius Health Inc. of Cambridge, ber care for them, in the comfort of their means looking at system-level solutions Mass., and 3M Drug Delivery Systems own home, Mr. Reynolds notes. integrating drug delivery, diagnostics and of St. Paul, Minn., during 2011 agreed 3 to collaborate together in the micronee- than 35 transdermal patch products cluding: therapy restriction of local ef- dle realm to deliver osteoporosis therapy. have been approved for marketing. Ex- fects in the oral cavity (for example those The BA058 Microneedle Patch will use amples include the nicotine patch that indicated by local lesions); effects in the 3M’s patented Microstructured Trans- helps people quit smoking, the lidocaine entire oral cavity, such as mouth refresh- dermal System microneedle technology patch for relieving pain, and a patch con- ment or disinfection; swift systemic ef- to administer BA058 through the skin, taining hormone derivatives for prevent- fects after absorption via the oral mu- as an alternative to subcutaneous injec- ing pregnancy. cosae; discreet and easy application (no tion. The patch is expected to combine LTS Lohmann Therapie-Systeme is additional water needed); buccal absorp- the ease, convenience, and self-adminis- one of the world’s leading suppliers of tion that bypasses hepatic first path me- tration attributes of a transdermal patch transdermal and oral systems for the in- tabolism; and improved bioavailability, with the speed and efficiency of a tradi- ternational pharmaceutical industry. Us- enabling lower doses. tional injection. Terms of the agreement ing the company’s advanced oral medical 3M continues to be a major player were not disclosed. wafers, LTS provides flat, film or wafer- in transdermal drug-delivery technolo- Radius’ BA058 Microneedle Patch like medication for application in the oral gy. For decades, the company has pio- product is undergoing Phase 1 clinical cavity. This oral wafer medication sys- neered several advancements, includ- studies. The company’s concluded Phase tems uses the mouth as a site of both ap- ing drug-in-adhesive (DIA) technology 2 human testing of an injectable form of plication and drug action. that has become the industry standard BA058 showed that BA058 significantly The Andernach, Germany-based for passive delivery. increased bone mineral density (BMD) company offers three different oral wa- The 3M DIA system is a versatile plat- after six months of therapy. fer medication systems to provide the form that provides compatibility with a ideal solution for patients’ specific re- wide variety of drugs. This type of patch Transdermal Systems quirements. Depending on the type of is less likely to deliver too much medica- oral medical wafer, it is possible to gen- tion. Continued advancements allow this Transdermal patches – medicated adhe- erate different pharmacokinetic profiles, system to deliver more than one drug in sive pads placed on the skin that release and avoid undesirable side effects in the a single patch, resulting in added patient drugs gradually for up to a week – have gastrointestinal tract. convenience. been available in the United States for There are three types of LTS oral med- Because the adhesive layer not only more than 20 years. ical wafers: flash-release wafer; mucoad- serves to adhere the patch layers togeth- The first transdermal patch, approved hesive melt-away wafer; and mucoadhe- er and to the skin, but also contains the by the U.S. Food and Drug Administra- sive sustained-release wafer. drug, DIA systems offer advantages in tion in 1979, delivered scopolamine to According to LTS, oral medication wa- reduced size and thickness as well as treat motion sickness. Since then, more fer systems offer many advantages in- improved conformability to the appli-

Source: Acrux

4 cation site. This process helps drive pa- patient bedsides in a variety of medical “The design and manufacturing flexi- tient preference. applications. bility of a polymeric drug container, com- Delivery of drugs through skin has be- Researchers report an important ben- bined with the ability to create patient- come a popular mechanism for deliver- efit of the new patches is that they are friendly devices designed with human ing long-term, controlled dosages of vari- painless – the nanotubes’ diameter is too factors engineering, enables the design ous compounds. A drug is mixed with an small for nerves in the skin to detect. of more innovative overall delivery sys- adhesive and cast into a patch, which is Industry experts believe that drugs can tems that may aid in patient compliance then applied to the skin. be delivered more effectively via nano- through ease of use and enhanced tech- Acrux Ltd. of Melbourne, Australia tubes than through current microneedle nology,” he explains. has developed a revolutionary Metered or traditional patch technologies because Cyclic olefin polymers such as the Dose Transdermal System (MDTS) that the sea of nanotubes in the skin patches Daikyo Crystal Zenith polymer provide enables transdermal delivery of small- can be dosed and designed for optimal a transparent, break-resistant alternative molecule drugs without the use of skin effectiveness, efficiently delivering drugs to glass that is also silicone-oil free. patches. The technology is based upon across the densest layers of the skin. Another trend expanding in the drug- absorption enhancers used for more than delivery device industry is the increase 20 years in sunscreens, which the com- Material Issues of combination products, and drug-de- pany has applied to treatments that are vice combinations in particular. in clinical testing. These include estro- There has been a great deal of innova- “Many pharmaceutical companies gen, testosterone and a pain-manage- tion in terms of drug-container materi- are gaining interest in drug-delivery de- ment compound. als used within devices. vice technologies and the accompany- Acrux’s business strategy involves “Although glass has been the tradi- ing containment materials at a very early taking off-patent or soon to be off-pat- tional material of choice for drug con- stage of drug development,” Mr. Reynolds ent drugs and developing them for trans- tainment, it has significant limitations in- says. “Companies are finding that incor- dermal delivery. Acrux has entered into cluding breakage, glass particulate, visual porating the overall drug-delivery system collaborations with major pharmaceuti- quality and functional performance,” Mr. earlier in their development process en- cal companies such as Pharmacia (now Reynolds said. “Many glass systems re- ables a potentially faster route through part of Pfizer Inc.). Acrux agreed to part- quire siliconization to enable mechani- the compliance process and thus to mar- ner in March 2002 for the development cal performance, and this material can ket. This creates increased interest in de- of transdermal applications for Pharma- interact with drug products.” vices at an early stage. cia compounds. FDA is becoming increasingly aware However, Mr. Reynolds warns, the One innovative way to deliver drugs of glass-related quality issues, including FDA is placing extra scrutiny on the area transdermally comes from a partner- breakage, cracks, contamination and of combination products. ship between the California Institute of particulates (often formed over time due “There is uncertainty about how this Technology (Caltech) of Pasadena, Ca- to interaction between the glass and the may impact the drug-development pro- lif., in partnership with Zcube Srl, a re- drug) and there has been a tremendous cess,” he says. “Clearly, regulatory fac- search venture of the Italian pharmaceu- increase in the number of recalls related tors will continue to have a key impact tical company Zambon. The two entities to glass issues, Mr. Reynolds reports. on the future development of delivery inked an exclusive research and option “High-profile recalls have been initi- systems.” agreement to develop and commercialize ated for drugs that have had issues be- Any automated process runs the risk skin patches that contain embedded car- tween the container closure system and that the system does not function effec- bon nanotubes for delivering drugs. The the device,” he explains. “For example, if tively, which in this case means the dose patches will first be developed to pain- a glass prefilled syringe is used in an au- cannot be delivered. Risks include fail- lessly administer drugs through the skin; to-injector, there is a possibility of break- ure of the device and failure of the de- other applications are envisioned for fu- age due to the force used to activate the vice-container combination. ture use. system. It has also been demonstrated “In either case, the system would not A key aspect of the new skin patches that glass syringes within an auto-injec- be able to deliver the drug effectively to is an innovative technique that partial- tor may fracture or break if subjected to the patient,” Mr. Reynolds says. “Under- ly embeds the nanotubes into the flex- a sudden force, and this may not be vi- standing how the device and container ible materials in which they are grown. sually detectable. Other issues, such as integrate and interact to ensure effective This embedding technique allows one uneven siliconization, may result in in- operation is a critical part of ensuring end of each nanotube to be anchored complete injections, and there have been that the overall drug delivery is effective to the patch. The other end protrudes recalls for potential loss of sterility due and safe for the end user.” from the patch to deliver drugs to the to cracks in glass syringes.” skin. This technique, which allows for Recent developments around the use 3M’s novel dry-powder the anchoring and alignment of the nano- of polymeric materials for drug contain- inhaler technology tubes, neatly overcomes a previous tech- ment have allowed delivery-system com- nological shortcoming and will enable panies to work closely with drug man- 3M Drug Delivery Systems provides ef- new methods of drug delivery. This ap- ufacturers to develop novel systems ficient delivery systems for pharmaceu- proach is anticipated to help these ther- designed specifically to meet patient tical companies that develop inhalation apeutic nanotubes make their way to needs, Mr. Reynolds says. therapy. In a clinical study, 3M Drug 5 Delivery Systems found its Conix Dry injectors and pen devices. The Ewing, Diabetes Drug Delivery Powder Inhaler (DPI) achieved bron- N.J.-based company received patent pro- chodilator efficacy comparable toGlaxo - tection in 2011 for one of its devices to Among the various drug-delivery seg- SmithKline Plc.’s blockbuster brand Ad- deliver treatment for rheumatoid arthri- ments that will continue on a growth tra- vair Diskus (fluticasone propionate and tis. The VIBEX platform of needle-assist- jectory for years to come is diabetes. salmeterol inhalation powder) while pa- ed jet injection devices was granted pat- Since the early 1920s, injectable insu- tients with asthma use less drug. ent protection until 2027. lin has saved the lives of millions of peo- The study compared Conix DPI with The VIBEX platform is the basis for ple living with diabetes worldwide. With Advair Diskus 100/50 in the delivery of several products in development by An- more people being diagnosed with dia- a combination therapy (fluticasone pro- tares, including VIBEX MTX. This is the betes each year – in 2011, the CDC re- pionate and salmeterol xinafoate). Sev- first auto-injector in development to po- ported 25.8 million Americans are now enteen patients with mild-to-moderate tentially enable rheumatoid arthritis pa- living with the disease – the market for asthma received two treatments separat- tients to comfortably and safely self-in- insulin is steadily growing. ed by 7 to 16 days, according to a ran- ject methotrexate at home. Worldwide insulin sales have quadru- domized, two-period crossover design. Antares CEO Paul Wooton, Ph.D., says, pled in the past decade, exceeding $15 Results of the study showed that Conix “Independent market research commis- billion. The Danish drug company Novo DPI achieved a similar improvement in sioned by Antares with 200 rheumatol- Nordisk A/S, the world’s largest insu- pulmonary function as compared with ogists has confirmed that physicians, lin maker, sold $7.1 billion of insulin in Advair Diskus. Additionally, the study if offered a reliable and patient-friend- 2010. Those sales could climb by a dou- demonstrated pulmonary delivery of a ly method for self-injection, would like ble-digit percentage annually in 2011 combination formulation from the Conix to switch many patients to an injectable and beyond. DPI device was safe and well tolerated. form of methotrexate, potentially pro- Additionally, spending for therapies to Patients reported that the Conix DPI de- viding reproducible absorption, reduced treat diabetes could account for up to 7% vice was easy to use. side effects and a better therapeutic re- of all pharma expenditure in 2015. Conix DPI is designed to deliver a sponse. Since rheumatoid arthritis pa- A current treatment for diabetic retin- higher respirable (more efficient) dose tients are often already prescribed meth- opathy is laser therapy, which has side and a smaller non-respirable (less swal- otrexate in combination with injectable effects such as laser burns and the loss lowed) dose to patients. The dry pow- biological products, VIBEX MTX may of peripheral or night vision. Anti-cancer der inhaler works by using an innova- represent a significant revenue oppor- drugs may also be used to treat the dis- tive reverse-flow cyclone technology to tunity for Antares, potentially as early ease. However, these compounds clear deagglomerate and aerosolize drug parti- as in 2013, as we continue to focus on quickly from the bloodstream so high cles. The inhaler’s design allows formula- our product based strategy.” dosages are required, thus exposing oth- tion flexibility and protection from mois- er tissues to toxicity. ture ingress. The design is engineered Future growth anticipated for One novel device in the works is a de- to increase the effectiveness of energy drug-delivery market vice that can be implanted behind the transfer from patients’ inspiration to the eye for controlled and on-demand re- drug formulation. The marketplace for drug-delivery sys- lease of drugs to treat retinal damage Conix DPI is available for use with tems and their manufacturers is expect- caused by diabetes. marketed molecules as well as new ed to continue growing for many years Key to the innovation, developed chemical entities. to come. at the University of British Columbia “Growth trends in key areas, specifi- in Canada, is the ability to trigger the Anatares gains long-term cally diabetes, will continue,” Mr. Reyn- drug-delivery system through an exter- patent protection olds says. “Watch for growth in areas nal magnetic field. The research team ac- such as auto-immune disease as well as complished this by sealing the reservoir Antares Pharma Inc. is a leading U.S. sophisticated vaccines. Novel systems to of the implantable device – no larger than developer of novel and advanced self-in- enable the effective treatment of chronic the head of a pin – with an elastic mag- jection products, including needle-free conditions such as high cholesterol and netic polydimethylsiloxane (silicone) allergies will also grow. membrane. A magnetic field causes the “Pharmaceutical and biotech compa- membrane to deform and discharge a nies are working closely with drug-de- specific amount of the drug, similar to livery device manufacturers at an early squeezing water out of a flexible bottle. stage to ensure that there is efficient de- In a series of lab tests, the UBC re- velopment of an overall system to enable searchers loaded the implantable device cost-effective drug delivery. Cost factors with the drug docetaxel and triggered the may include the ability to move the prod- drug release at a dosage suitable for treat- Antares’ proprietary injection technologies include VIBEX, a pressure- uct to market as quickly and effectively ing diabetic retinopathy. The research- assisted, mini-needle jet-injector that as possible; reducing in-process rejects ers found the implantable device kept offers comfort and versatility. due to breakage or lack of function; and its integrity with negligible leakage for the overall cost of quality, which has to 35 days. Source: Antares Pharma be built into a system from the start.” Researchers also monitored the drug’s 6 biological effectiveness over a given peri- lease for injectable suspension). A regu- stitute, feels confident that this program od, testing it against two types of cultured latory decision is set for early 2012. If can make a positive impact to help im- cancer cells, including those found in the approved, the drug will be the first once- prove patient outcomes. prostate. They found that they were able weekly treatment for diabetes. When asked why J&J became in- to achieve reliable release rates. Becton Dickinson, a leading global volved in diabetes education, Dr. Hor- The device offers improvements upon medical technology company based in witz responded, “People traditionally existing implantable devices for drug de- Franklin Lakes, N.J., made great strides didn’t think of J&J as a diabetes com- livery, says Mu Chiao, Ph.D. “Technol- in 2011 with the development of BD pany, although we are among the glob- ogies available now are either battery Nano, the world’s smallest pen needle. al leaders in our glucose monitoring and operated and are too large for treat- “BD is committed to helping improve pump products. We decided we wanted ing the eye, or they rely on diffusion, the injection experience for the millions to make a difference ‘in the trenches,’ which means drug release rates cannot of people who live with diabetes, as dem- using the best practices of adult educa- be stopped once the device is implanted onstrated by our long history of innova- tion to train diabetes educators how to – a problem when patients’ conditions tive firsts – the first insulin syringe in change behaviors and motivate their pa- change.” 1924, the first 5 mm pen needle in 1999 tients.” The UBC device will not be ready for and the now the world’s first 4 mm pen Indianapolis-based Roche Diagnostics patient use for several years. Team mem- needle, the BD Nano,” said Linda Thar- U.S., with its business unit Roche Diabe- bers are working to pinpoint all the possi- by, president of BD Medical – Diabetes tes Care, continues its tradition as a lead- ble medical applications for their device Care. “We are confident this tiny needle er in blood glucose monitoring and insu- so that they can tailor the mechanical can have a big impact by easing diabetes lin delivery systems by partnering with design to particular diseases. patients’ transition and ongoing adher- DexCom. The two companies signed a After nearly a decade-long partner- ence to injectable drug therapy regimens research and development agreement in ship, San Diego-based Amylin Pharma- – a key element in helping to reduce the 2011 to integrate DexCom’s next-gener- ceuticals Inc. and Eli Lilly and Co. of disease’s deadly, debilitating and costly ation CGM system with the next gener- Indianapolis ended their relationship in complications.” ation of Accu-Chek insulin delivery sys- 2011 to deliver Byetta to people living Animas Corp. and LifeScan Inc., both tems targeted at the U.S. market. with diabetes. Amylin agreed to pay Lil- of West Chester, Pa., and members of In the future, users of an Accu-Chek ly $250 million to assume responsibility the Johnson & Johnson Family of Di- insulin pump in the U.S. will not only to develop and market the drug to con- abetes Companies, continues to build be able to view their blood glucose data trol low blood sugar. upon their existing collaborative efforts and insulin information on their wireless Under the alliance, Byetta (exenatide) to co-develop and market innovative new handheld, but also continuous glucose was launched in 2005 and has been used products and tools for people living with monitoring readings and trends. This by nearly 1.8 million patients worldwide. diabetes. would enable the user to make therapy During October 2011, the U.S. Food and The two companies joined forces to adjustments from the palm of his hand Drug Administration approved Byetta as co-develop the OneTouch Ping Glucose while operating the pump. an add-on therapy to insulin glargine, Management System. This is the first Beyond the traditional leading phar- with or without metformin and/or a thi- full-feature insulin pump that wireless- ma regions, Russia is growing into a sig- azolidinedione (TZD), in conjunction ly communicates with a blood glucose nificant diabetes market. During the next with diet and exercise for adults with meter remote. few years, the Russian diabetes market is type 2 diabetes who are not achieving Other products include the OneTouch projected to grow more than 7% annual- adequate glycemic control on insulin Verio Meter and Test Strip platform, ly during the next few years. This growth glargine alone. which received FDA clearance, paving will result from the market launch of sev- According to John Buse, M.D., Ph.D., the way for a new portfolio of self-mon- eral premium-priced diabetes medicines professor of medicine and director of the itoring of blood glucose products in the and the rising use of glucagon-like pep- Diabetes Care Center and chief of the Di- United States. tide 1 (GLP-1) analogs, dipeptidyl pepti- vision of Endocrinology at the Universi- Continuous glucose monitoring (CGM) dase (DPP-IV) inhibitors and insulin an- ty of North Carolina School of Medicine is one of the latest advancements in dia- alog mixes. in Chapel Hill, “Byetta is well-suited for betes management, Animas is partnering Two pipeline products belonging to a use with insulin glargine, offering a sim- with DexCom Inc. to develop a continu- novel class of sodium glucose cotrans- ple fixed-dose regimen that can help im- ous glucose monitoring-enabled insulin porter (SGLT)-2 inhibitors are anticipat- prove control of blood sugar overall and pump and CGM system. This integrates ed to have a strong market impact: Bris- after meals. In a clinical trial, patients us- a DexCom continuous glucose monitor- tol-Myers Squibb Co./AstraZeneca Plc.’s ing Byetta with insulin glargine achieved ing sensor with an Animas insulin pump. dapagliflozin and J&J’s canagliflozin. better glycemic control, without weight The system has been filed for CE Mark The government reimbursement pol- gain or an increased risk of hypoglyce- approval in Europe. icy in Russia, which encompasses treat- mia, compared to patients using insulin Johnson & Johnson expanded its ment with most insulins – including the glargine alone.” realm of diabetes care by developing premium-priced long-acting insulin ana- Amylin is awaiting word from the FDA the Diabetes Institute. David L. Horwitz, logs – is expected to increase use of rap- on whether the regulatory agency will ap- M.D., Ph.D., FACP, chief medical officer id-acting and long-acting branded insu- prove Bydureon (exenatide extended-re- of the Johnson & Johnson Diabetes In- lin analogs. 7 Drug Delivery Companies REVIEW This section of the report profiles some of the world’s leading companies AS WELL AS UP-AND-COMERS IN THE AREA OF Drug Delivery; some companies were already detailed within the preceding pages of this report.

Hospira Inc. is a generic version of Merck & Co.’s Pri- to patients, new treatment approaches to maxin, which generated 2010 U.S. sales physicians and better outcomes to man- Hospira is a global specialty pharmaceuti- of $140 million. Hospira also sells imipen- aged-care providers. cal and medication delivery company lo- em-cilastatin in Europe, Japan and sever- In 2011 the Pennsylvania-based cated in Lake Forest, Ill. Behind proven al other countries. company relocated headquarters from leadership and experience, Hospira pro- During 2010, Hospira launched mero- Chadds Ford to Malvern and acquired vides solutions to help improve the pro- penem, the first generic carbapenem on American Medical Systems. AMS is a di- ductivity, safety and effectiveness of pa- the U.S. market. Carbapenem antibiotics versified supplier of medical devices and tient care. have a U.S. market value of about $600 procedures to treat incontinence, erec- As a result of the lower-than-expected million. tile dysfunction, benign prostatic hyper- third-quarter results for 2011, the compa- Hospira’s specialty injectable pharma- plasia (BPH), pelvic floor prolapse and ny projected net sales for full-year 2011 to ceuticals (SIP) offering includes roughly other pelvic disorders in men and wom- increase 1% to 2% on a constant-currency 200 generic injectable drugs in many dos- en. American Medical Systems’ products basis. On a reported basis, the company ages and formulations. Many of the compa- were used to treat 340,000 patients in expected full-year 2011 net sales growth ny’s products are available in popular dif- 2010. of 2% to 3%. ferentiated presentations, several of which Endo’s total revenue during the third For full-year 2010, net sales were $3.9 are proprietary, such as the ADD-Vantage quarter of 2011 increased 71% to $759.1 billion. Projections for cash flow in 2011 drug-delivery system and iSecure prefilled million, compared with $444.1 million in were between $650 million and $700 mil- syringes. Therapeutic areas include anal- the same quarter of 2010. Net income lion. gesia, anesthesia, anti-infectives, cardio- for the three-month period ended Sept. As the world’s leading provider of in- vascular, oncology, emergency and other 30, 2011, was $40.6 million, versus $54.2 jectable drugs and infusion technologies, areas. Hospira also has robust pipelines of million in the comparable 2010 period. Hospira in 2011 launched imipenem-cilas- generic and biosimilar drugs. Endo’s devices and services sales, tatin for injection I.V. This is the first ge- driven by the acquisition of AMS, to- neric version of this key antibiotic to be- Endo Pharmaceuticals taled $185.6 million for the third quar- come available in the United States. The Holdings Inc. ter of 2011, an increase of 259% over the medication – a carbapenem that belongs prior year’s same period. Men’s Health, to the beta-lactam class of antibiotics – Endo is expanding to bring new therapies led by strong sales of the AMS 800 Ar- tificial Urinary Sphincter, grew 21% on a pro-forma basis in the third quarter of HOSPIRA 2011 year over year. In early September 2011, an FDA ad- visory panel met to discuss the use of surgical mesh products in the repair of pelvic organ prolapse and stress urinary incontinence, which Endo believes led to reduced procedural volumes during the third quarter. However, the company be- lieves that the advisory panel addressed the questions raised and that a recov- ery in procedural volumes will emerge in the near term. Endo Pharmaceuticals is evaluating new drug-delivery technologies to cre- ate innovative new medicines. During December 2011, Endo received FDA marketing approval for a new formula- tion of Opana ER designed to be crush- resistant. Endo is dedicated to executing a seamless transition during 2012 from the original formulation to the new for- mulation of Opana ER, which uses the proprietary INTAC technology owned Source: Hospira by Grunenthal, a partner in the devel- 8 opment of the product. The new for- Aiming to convey “the benefits of Ipsen Group mulation will remain named Opana ER transdermal patches” to patients world- with the same dosage strengths, color wide, the centers work together to en- Paris-based Ipsen is a global specialty- and packaging and similar tablet size gage in R&D of transdermal drug deliv- driven pharma company with total sales and shape. The FDA clearance signifies ery system (TDDS) products in a wide exceeding 1.1 billion euros in 2010 and that there is no significant difference in range of the therapeutic fields. nearly 4,500 employees. Ipsen’s ambi- the rate and extent of absorption of the Among Hisamitsu’s leading products tion is to become a leader in specialty therapeutic ingredient between this new is Salonpas brand patches, which were healthcare solutions for targeted debil- formulation and the original version of first introduced in 1934, According to itating diseases. The company’s devel- Opana ER. the company, their outright efficacy pro- opment strategy is supported by four pelled Hisamitsu to the position of mar- franchises: neurology/Dysport, endocri- Hisamitsu Pharmaceutical ket leadership currently held. Salonpas nology/Somatuline, uro-oncology/Deca- Co. Inc. was developed through the application of peptyl and hemophilia. Asahi Mankinko, the prototype therapeu- The Ipsen Group has an active policy Japan’s Hisamitsu has organized effective tic patch launched during 1903. Since of partnerships. R&D is focused on in- research & development systems, with then, Hisamitsu has striven to develop novative and differentiated technologi- four major centers that enable prompt fa- and refine therapeutic patches that are cal patient-driven platforms, peptides cilitation of R&D activities. Three of the safe and easy to use. and toxins. During 2010, R&D expendi- centers are based in Japan: Tosu Labo- For Hisamitsu’s fiscal 2012 second ture totaled more than 220 million eu- ratories, Tsukuba Laboratories, and the quarter ended Sept. 30, 2011, the com- ros, representing more than 20% of group Tokyo headquarters. The fourth center pany reported net sales of 69,160 mil- sales. is Miami-based Noven Pharmaceuticals lion yen, down 2% year over year. R&D For the company’s first nine months of Inc., which serves as Hisamitsu’s U.S. spending for 2Q fiscal 2012 advanced 2011, consolidated group sales reached growth platform for prescription phar- 28% to 7,487 million yen compared to 864 million euros, up 2.6% year over maceuticals. second-period fiscal 2011. year. Discounting a stocking effect in

Source: Hisamitsu Pharmaceutical

9 Source: Ipsen

Russia during 2010, Ipsen’s consolidat- structuring the company, Consort Med- a range of product launches during the ed sales improved 3.9% versus January- ical is optimistic for the future with next few years. September 2010. The 2011 sales im- expectations to see benefits in its in- “Our strategy of diversification reduc- provement was led by the endocrinology vestment in research and development es the risk of being exposed to any sin- franchise and in particular Somatuline, through the economic downturn with gle market and in the past two years we which generated a 12.6% year-on-year sales increase (12.8% excluding foreign exchange impacts). Based on Ipsen’s solid performance during the first three quarters of 2011, for the full year management expected e to deliver on: – Specialty Care drug sales growth close to 8.0% year-on-year – Primary Care drug sales decrease of 3.0% to 5.0% year-on-year – A recurring adjusted operating in- come in the upper range of 190 million euros to 200 million euros.

Consort Medical Plc.

Consort Medical is a healthcare company in the United Kingdom focused on med- ical device technologies for drug deliv- ery and hospital products for the man- Note: Period = May-October 2011 agement of patient airways. Source: Consort Medical After a challenging three years of re- 10 have positioned ourselves to benefit from cept to full-scale manufacturing. op and market pharmaceutical products higher growth markets such as biologic For Consort Medical’s six-month fi- that focus on urology and sexual health. drug delivery by autoinjector and Point- nancial period ended Oct. 31, 2011, reve- The company is based in Malvern, Pa. of-Care diagnostics,” says Toby Wool- nue from products and services increased For the third quarter of 2011, Auxili- rych, group finance director. “We have 5% to £68.8 million (May-October 2010: um reported net revenue of $66.7 million been pleased in the past year also to take £65.6 million). During the 2011 period compared to $53.6 million during third- advantage of low interest rate swap rates ended in October, two new nasal devel- quarter 2010. The net loss for July-Sep- and to fix substantially the whole of the opment contracts were inked that diver- tember 2011 was $4.1 million or 8 cents Group’s borrowings until the end of 2013 sify Bespak into new drug delivery mar- per share, versus a net loss of $12.8 mil- at a rate of between 1.48% and 1.78% plus kets. Also, Consort Medical signed a new lion or 27 cents per share for 3Q 2010. bank margin.” medicinal nicotine delivery device devel- Driving the company’s growth are two Production milestones for 2011 in- opment contract (please see the visual medications: Testim, a gel used to treat cluded manufacturing of the 500 mil- on page 10 for more details). adult men who have low or no testos- lionth Diskus and 1 billionth HFA valve “We are pleased to report a record set terone, and XIAFLEX, the only FDA-ap- manufactured and development of the of of results in what can only be described proved nonsurgical treatment for adults OTS Autoinjector. as a challenging and uncertain glob- with Dupuytren’s Contracture with a pal- Consort Medical’s Bespak unit has al economic environment,” noted CEO pable cord. comprehensive scientific capabilities, Jon Glenn. “Our strategy to deliver sus- Worldwide net revenue for XIAFLEX regulatory expertise as well as world- tainable organic growth is now delivering amounted to $13.1 million for the third class facilities to support the develop- ahead of expectations and we are confi- quarter of 2011, up 130% versus same- ment and production of metered-dose dent for the outlook for the rest of the time 2010. Global revenue for Testim to- inhaler valves, actuators and dose-coun- year and beyond.” taled $53.6 million, advancing 12% over ters. Bespak offers complete device de- the third quarter of 2010, with $52.9 mil- velopment services, with the design and Auxilium Pharmaceuticals Inc. lion of revenue generated in the Unit- engineering expertise to manage medical ed States. device development programs from con- Auxilium was founded in 1999 to devel- “We believe that the progress we

Source: Auxilium Pharmaceuticals

11 made in the third quarter of 2011 will taneous implants. Acino supplies leading ny’s results during the first six months of drive long term shareholder value. XIAF- pharmaceutical companies worldwide. the year. According to the company, with LEX revenues showed sequential growth The company offers the pharma arena no euro currency recovery on the hori- over the second quarter of 2011, despite a comprehensive array of services rang- zon the CHF/EUR exchange rate will in a slight decrease in overall Dupuytren’s ing from product development and reg- all likelihood leave its marks on Acino’s procedure volumes, and new XIAFLEX istration to sourcing, contract manufac- full-year 2011 result, primarily by limit- data were well received by physicians at- turing, packaging and logistics. ing operational margin improvements. tending the American Society for Sur- The Acino Group generated annu- Assuming a continued strength of the gery of the Hand meeting. We remain en- al net revenues of 128 million euros in CHF at current levels, Acino expects a couraged by the physician and patient 2010. For first-half 2011, the group re- positive full-year 2011 net result slight- success stories and believe that XIAF- ported top-line growth of 6% to EUR 65.2 ly above the year’s half-year level. LEX will become the standard of care for million. Dupuytren’s contracture,” commented The company is in the process of a tran- SkyePharma Plc. Armando Anido, CEO and president of sition in 2011 and 2012 via building on Auxilium. “Testim continued to perform its established business-to-business (B2B) SkyePharma is a specialist drug-delivery well, despite continuing competition in with pharma specialties and generics. company developing oral and inhalation the testosterone replacement market, Acino intends to strengthen its tech- products. The SkyePharma portfolio in- with prescriptions posting growth over nology competence and aims at intensi- cludes a wide range of patented and prov- the third quarter of 2010 and over the fying company partnerships with the re- en technologies to improve medicines. second quarter 2011.” search-driven pharma industry. On this The European-based company’s R&D basis, Acino expects to further enlarge facilities are located in Switzerland and Acino Holding Ltd. its pipeline of own and original custom- manufacturing operations are based in er products. France. SkyePharma partners with a Acino is a Basel, Switzerland-based com- The group intends to take its product wide range of companies from Big Phar- pany that develops and manufactures ge- portfolio under the Acino brand into new ma (GlaxoSmithKline, Novartis AG, neric and innovative pharmaceuticals us- selected emerging markets that have a Sanofi SA, AstraZeneca and F. Hoff- ing advanced drug-delivery technologies. demand for high quality Swiss/German- mann-La Roche Ltd.) to a range of small- Acino is concentrated on sophisticated made pharmaceuticals. er speciality pharmaceutical entities. oral dosage forms with modified release Acino anticipates delivering a steady SkyePharma’s proprietary drug-delivery of active ingredients, transdermal thera- revenue growth and EBITDA-margin dur- technologies enable the development of peutic patches and biodegradable subcu- ing full-year 2011 similar to the compa- new formulations of existing products as

Source: Acino Holding

12 well as new chemical entities to provide million, or $0.04 per share, during the erate/severe COPD exacerbation; and re- a clinical benefit to patients. third quarter of 2010. duced incidence of hospitalizations. Fur- SkyePharma’s Geomatrix and Geoclo- “Today, Depomed is a growing com- ther clinical data is under way. ck technologies allow for controlled-re- mercial business and has a strong bal- Another drug to treat COPD, QVA149, lease or timed-release versions of imme- ance sheet with over $150 million in is on track for a European launch in diate-release products to be developed cash that can facilitate transactions to 2013. providing advantages to both partner accelerate our growth,” noted Jim Schoe- According to Chief Executive Chris companies and patients. neck, Depomed’s president and CEO, Blackwell regarding Vectura’s six-month The group’s inhalation technologies upon the announcement of the compa- results ended Sept. 30, 2011, “Vectura’s include formulation as well as device ny’s 3Q 2011 performance. “I believe De- results demonstrate continued financial technologies. They encompass metered- pomed’s future as an integrated special- strength, with a profit after tax and cash dose inhalers and dry-powder inhalers. ty pharma company is very bright, and in excess of £80m. This strong finan- SkyePharma revenue in the first half that we are well-positioned to execute cial performance was underpinned by of 2011 totaled £22.1 million, down 25% our strategies,” two important new collaboration agree- compared with the first half of 2010 ments concerning VR315 and the filing (£29.3 million). This decrease was pri- Vectura Group Plc. of NVA237 in Europe. We look forward marily due to substantial manufacturing to the launch of NVA237 in Europe in revenues in the first half of 2010 relat- Vectura is a Chippenham, UK–based 2012 as well as additional Phase III clini- ed to non-recurring volumes to support company that specializes in developing cal data for both NVA237 and QVA149. regulatory and commercial activities, the inhaled therapies, principally for the “Looking ahead, we will focus on company reports. treatment of respiratory diseases. building our pipeline whilst looking for For the first half of 2011, company new partnering opportunities to main- Depomed Inc. revenue was recorded ahead of expecta- tain the growth prospects of the Com- tions at £21.1 million, down from £26.3 pany.” Depomed is a specialty pharmaceutical million during same-time 2010. company located in Menlo Park, Calif. Vectura experienced several opera- Columbia Laboratories Inc. Depomed has two approved and mar- tional highlights in 2011. NVA237 for keted products. Gralise (gabapentin) the treatment of COPD is on track for Livingston, N.J.-located Columbia Lab- is a once-daily treatment approved for European launch in 2012. The compa- oratories develops drugs that improve the management of postherpetic neu- ny successfully filed a European Market- treatment options for women’s reproduc- ralgia (PHN). Glumetza (metformin hy- ing Authorization Application, triggering tive healthcare. This is done by using Co- drochloride extended-release tablets) is a $5 million milestone receipt from No- lumbia’s novel bioadhesive delivery tech- approved for use in adults with type 2 di- vartis. nologies, which optimize drug delivery in abetes and promoted by Santarus Inc. in Phase III data presented at the Europe- a controlled, sustained manner. the United States. an Respiratory Symposium (ERS) found Total net revenue for Columbia for the The company’s third-quarter 2011 the drug increased lung function with third quarter of 2011 totaled $4.9 mil- results reflect a new commercialization fast onset of action; improved exercise lion, compared to $14.2 million for the agreement for Glumetza entered into endurance; delay to onset of first mod- third quarter of 2010. The 2010 quarter with Santarus in August 2011. Under terms of the agreement, Santarus began booking Glumetza product sales in Sep- tember 2011 while paying Depomed a royalty on net sales of 26.5% for the re- mainder of 2011 with the rate increasing to 29.5% during 2012, 32% in 2013 and 2014, and 34.5% in 2015 and beyond. Total revenue for the 2011 third quar- ter amounted to $16.5 million com- pared to $20.1 million for July-Septem- ber 2010. Revenue for 3Q 2011 included two months of Glumetza product sales and one month of royalties on Glumetza product sales made by Santarus. Third- period 2011 revenue included the one- time recognition of $6 million in mile- stone payments under development and license arrangements with Janssen Phar- maceutica and Covidien. Net loss for the quarter was $8.6 million, or $0.15 per Source: Vectura Group share, compared to net income of $1.9 13 included $8.5 million of the amortization In 2011, Antares received patent ap- the devices release their drug for months of the $34 million gain on the sale of the proval from the U.S. Patent and Trade- and years. progesterone assets in July 2010 to Wat- mark Office covering technology used in pSivida has a worldwide collabora- son Pharmaceuticals Inc. the company’s VIBEX platform of needle- tive R&D agreement with Pfizer to de- Third-quarter 2011 net revenue from assisted jet injection devices. The patent velop a long-term sustained-release im- Merck Serono for international sales of provides protection for the VIBEX tech- plant to deliver latanoprost for patients CRINONE (progesterone gel) increased nology until 2027. with ocular hypertension and glaucoma. 56% on a 60% volume increase year over “During the third quarter, Antares This collaboration is focused on develop- year. Net revenue from Watson for do- continued to make significant progress ing a bioerodible version of pSivida’s pro- mestic CRINONE grew 92% on a 41% vol- across all of our key development pro- prietary Durasert technology, designed ume increase compared to third-period grams,” says Paul K. Wotton, PhD, pres- to be injected into the subconjunctival 2010 levels. The higher dollar increase ident and Chief Executive Officer. “In space of the eye. in Watson net product revenue over vol- addition to generating strong and grow- Revenue for the company’s first quar- umes represents a pass-through of costs ing revenues, we continued to make sub- ter of 2011 ended Sept. 30 totaled $1.7 due to higher exchange rates. stantial headway on our wholly-owned million compared to $476,000 one year The PREGNANT study, Columbia’s VIBEX MTX auto injector product, a po- earlier. This result primarily reflected pivotal clinical trial of progesterone vag- tentially significant opportunity in the recognition of deferred collaborative re- inal gel 8% to reduce the risk of preterm large rheumatoid arthritis market. We search and development revenue from birth in women with premature cervi- also received development revenues from the amended and restated Pfizer agree- cal shortening, was published in the July our marketing partner Watson Pharma- ment in June 2011 and the termination 2011 issue of Ultrasound in Obstetrics ceuticals, triggered by our advances to- of a 2008 field-of-use license by Intrin- and Gynecology. wards commercial manufacturing read- siq in July 2011. “We are very pleased with the strong iness for Anturol.” pSivida reported a net loss of $2.4 mil- growth of CRINONE by Watson in the lion, or $0.12 per share, for its first quar- U.S. and Merck Serono internationally,” Lohmann Therapie-Systeme AG ter ended Sept. 30, 2011, compared to commented Frank Condella, Columbia’s a net loss of $3.1 million, or $0.17 per president and CEO. “We look forward to LTS of Germany is a global leader in the share, for July-September 2010. further revenue growth from our part- development and manufacturing of trans- “We have a very full plate with three ners going forward. dermal systems and oral thin films. The clinical-stage product candidates for the “During the third quarter of 2011, we products developed by LTS comprise a treatment of back-of-the-eye diseases,” continued to work closely with the U.S. multitude of innovations, including the noted Dr. Paul Ashton, pSivida president Food and Drug Administration (FDA) world’s first nicotine patch as well as the and CEO. “Most advanced is ILUVIEN to ensure a thorough review of the New only patch against Parkinson’s and Rest- for diabetic macular edema (DME) being Drug Application (NDA) for progester- less-Legs-Syndrome. developed by our licensee Alimera Sci- one vaginal gel 8% to reduce the risk of The innovation capability of LTS led ences, for which Alimera has resubmit- preterm birth in women with premature the way for oral thin film products on ted a New Drug Application and is await- cervical shortening. Our PDUFA date is the market with the introduction of List- ing a response from the FDA. We are also February 26, 2012. If the FDA approves erine Pocketpaks, which dominate the independently developing a product to this product for the preterm birth indi- North American market. West Caldwell, treat uveitis affecting the posterior seg- cation, we plan to supply sufficient quan- N.J.-based LTS Corp. has produced more ment of the eye (posterior uveitis) and tities to Watson for a timely commercial than one billion strips in the first three a product to treat glaucoma and ocular launch.” years after market launch. hypertension in collaboration with Pfiz- Columbia Laboratories expected to More than 5,000 patents reinforce LTS’ er.” be operating at a slight loss in the fourth top position in development of transder- The product pSivida is developing for quarter of 2011, but still maintain a net mal technologies. Since the end of the treating posterior uveitis uses the same profit for the full year. 1990s, LTS has been the principal share- micro insert (with a different inserter) as holder of CRS Clinical Research Servic- ILUVIEN for DME. The company’s col- Antares Pharma Inc. es, which conducts Phase I through IV laboration agreement with Alimera al- clinical trials. LTS offers the entire ser- lows pSivida to reference the ILUVIEN Antares develops jet-injectors, auto-in- vice spectrum: starting with develop- for DME regulatory filings, which pro- jectors and pen injectors to accommo- ment, continuing to clinical trials and vides the potential for an abbreviated date patients’ increasing use of self-in- production, up to final packaging. clinical development and regulatory ap- jectable medicines. proval process for the posterior uveitis The Ewing, N.J.-based company re- pSivida Inc. product. corded revenue of $3.9 million for the Posterior uveitis is an inflammato- third quarter of 2011 and $11.0 mil- pSivida is a leader in the development ry condition that can be extremely se- lion for the year-to-date period, with in- of miniaturized, injectable drug-delivery rious. In the United States, this disease creased quarter and YTD product rev- systems. Small in size, the company’s de- has been estimated to affect 175,000 peo- enue of 33% and 41% compared to the vices are FDA-approved to be adminis- ple and is responsible for 30,000 cases of same periods in 2010. tered into the eye. Once administered, blindness. An investigator-sponsored tri- 14 al in posterior uveitis opened during Sep- customers during late 2010, Molly fea- company generated sales of goods and tember 2011. tures compact size, permanently hidden services totaling CHF 122.8 million. The pSivida’s proposed product to treat needle, locking needle shield as well as a 6.6% year-over-year decrease from CHF glaucoma is an injectable, bioerodible two-step operation with integrated safe- 131.5 million was due to the currency sustained-release insert delivering la- ty features. effect and lower levels of remuneration tanoprost. The product is undergoing a According to the company, although for R&D services. Company reps say the dose-ranging study. pSivida granted Pfiz- the commercial applications of the Mol- strong Swiss franc had a negative impact er an exclusive option under various cir- ly auto injector will depend on the cor- on sales of goods totaling to CHF 6.9 mil- cumstances to license the development responding biopharmaceutical customer, lion. After adjustments for currency ef- and commercialization globally of this it is likely to be intended for therapeu- fects, sales represented an increase in insert for human ophthalmic disease oth- tic areas that require frequent injections the current reporting year of about CHF er than uveitis. either at home or in a clinical environ- 1.5 million (+1.3 %) year-on-year. pSivida is continuing to advance its ment. This will result in high-volume de- According to the company, in Germa- Tethadur system (based on BioSilicon mands. ny as many as one in three new patients technology), which is designed to deliv- or patients moving to a new pump sys- er large biologic molecules – including Owen Mumford Ltd. tem are opting for mylife OmniPod insu- peptides and proteins – on a sustained lin patch pump. The tubing-free insulin basis. Owen Mumford designs and manufac- pump is especially popular with women tures a range of medical devices and (55 %) and patients aged between 30 and SHL Group disposables that are used by healthcare 50 (39 %), Ypsomed officials noted. professionals and consumers worldwide. In 2012, Ypsomed will be launching SHL (Scandinavian Health Ltd.) is the The Oxford, England, company focuses a new, second-generation pod that has world’s largest privately owned design- on manufacturing devices for drug deliv- undergone further development. Accord- er, developer and manufacturer of ad- ery, sexual health, capillary blood sam- ing to Ypsomed, the new pod is not only vanced drug-delivery systems. Based in pling and neuropathy screening. significantly smaller and flatter, but also Sweden, SHL manufactures devices in- The company’s advanced automatic consumes less energy. cluding pen injectors, auto injectors and injection devices and pen needles offer For the second half of the company’s inhaler systems. maximum comfort. The product range fiscal year ending March 31, 2012, Yp- In 2011, SHL Group expanded oper- includes Autopen, Unifine Pentips, Au- somed expects turnover and operational ations with an expansion to its plant in toject 2, Autodrop, and Autosqueeze. profit margin to be slightly higher com- Taiwan. Frank Isaksson, GM for Taiwan, pared to the first half of the year based commented, “Demand for auto injec- Ypsomed Holding AG on current exchange rates. tors continues to rise as the number of biologics coming to market steadily in- Ypsomed is a worldwide leading indepen- Nektar Therapeutics creases. The simple fact is that SHL will dent developer and manufacturer of injec- continue to expand our production capa- tion systems for custom-made self-admin- Nektar Therapeutics is a leading biophar- bilities over the next few years and will istration as well as supplier of pen needles maceutical company developing a robust also find new ways to enhance our utili- for treating diabetes, growth disorders or pipeline of novel therapeutics based on zation of current machinery, people and infertility, and other therapeutic areas. Yp- its advanced polymer conjugate chem- resources. Several of our biotechnology somed is based in Burgdorf, Switzerland. istry technology platform. Nektar also and pharmaceutical customers are now Ypsomed has well-established part- partners with top biopharmaceutical working with us on multiple projects. nerships with numerous leading pharma- companies to bring new products to mar- “With continued expansion in Taiwan, ceutical and biotech companies such as ket. Nektar’s technology and drug-devel- our new facility in the USA and future ex- Sanofi, Eli Lilly, Pfizer, Roche, Genen- opment expertise have resulted in seven pansion in Europe we will have the depth tech Inc., Merck Serono, Amylin, and approved products for partners, includ- of capabilities and resources needed to NPS. ing leading biopharmaceutical players. maintain our leadership position in the In November 2011 Ypsomed acquired The San Francisco-based company re- auto injector market, including produc- ICU Medical Inc., one of few indepen- ported a drop in revenue for the third tion of other drug delivery devices such dent manufacturers of diabetes infusion quarter of 2011 to $27.1 million com- as pen injectors and inhalers systems,” sets operating in the very competitive pared to $37.9 million during the third he says. and patent-protected market for insu- quarter of 2010. The 3Q 2010 revenue, During 2011 SHL Group received cer- lin-pump accessories. Through this ac- however, was partially the result of the tification for the Good Design Award for quisition, Ypsomed secures ownership of completion as of December 31, 2010, of its revolutionary auto injector Molly. ICU’s diabetes infusion set patents. Pre- the amortization of a $125.0 million up- This award recognizes outstanding de- viously, Ypsomed had been acting as a front payment received in 2009 from As- signs that can further advance lifestyle trading partner for ICU Medical, selling traZeneca for the NKTR-118 and NKTR- and industrial activity, both of which are its Orbit infusion set under the name of 119 license agreement. embraced by Molly’s innovative design mylife Roto. “Nektar is highly focused on continu- and related business model. In the first half of Ypsomed’s 2011/2012 ing to advance our important proprietary Officially introduced to biopharma business year ended Sept. 30, 2011, the drug candidates in pain and cancer,” said 15 Source: Nektar Therapeutics

Howard W. Robin, president and CEO to $27.7 million for the same period in for the treatment of acute migraine and of Nektar. “AstraZeneca’s Phase 3 KO- 2010. General and administrative ex- cluster headaches. DIAC program for NKTR-118 for opioid- pense totaled $12.4 million in the third The company’s net loss for the third induced constipation is continuing on- quarter of 2011 as compared to $10.2 quarter of 2011 was $2.4 million, or $0.01 track with AZ targeting regulatory filing million for the third quarter of 2010. per share, compared with net income of in 2013. We are targeting the start of the $1.3 million, or $0.01 per share, for the Phase 3 BEACON study for NKTR-102 Aradigm Corp. third quarter of 2010. Net income for the in metastatic breast cancer before year- third period of 2010 was derived from the end. NKTR-181, our novel opioid can- Aradigm is an emerging specialty phar- non-cash gain on the extinguishment of didate to treat chronic pain, is moving maceutical company developing and debt from the Novo Nordisk equity for rapidly through Phase 1 clinical develop- commercializing a portfolio of drugs de- debt transaction. ment and we plan to announce top-line livered by inhalation for the treatment Total operating expenses for the third data before year-end. Finally, we plan to of severe respiratory disease. quarter of 2011 were $2.3 million, com- file an IND forNKTR-192 , our new clin- Bolstered by its depth of expertise in pared with total operating expenses of ical candidate to treat acute pain, in the pulmonary drug delivery and an exten- $3.3 million for the third quarter of 2010. first quarter of 2012.” sive intellectual property portfolio, the The decrease in operating expenses was Total operating costs and expenses in company is uniquely positioned to fulfill primarily due to expense-reduction ef- the third quarter of 2011 were $48.4 mil- unmet needs in pulmonary medicine. forts and lower clinical and manufactur- lion, an increase compared to $44.2 mil- Total revenue for the Hayward, Ca- ing costs for the inhaled ciprofloxacin lion in the third quarter of 2010. The lif., company was $0.2 million for the program versus the prior-year period. increase is primarily a result of higher third quarter of 2011, compared with development expenses related to the ad- the same amount for the third quarter of 3M Drug Delivery Systems vancement of multiple programs in clini- 2010. Revenue for both periods reflects cal development. Research and develop- the quarterly royalty payment from Zo- 3M, based in St. Paul, Minn., is a diver- ment expense increased to $31.0 million genix Inc. for product sales of SUMAV- sified technology company serving cus- in the third quarter of 2011 as compared EL DosePro needle-free delivery system tomers and communities with innova- 16 tive products and services. According ments was Health Care, which improved components, which are manufactured to 3M, the company captures a culture 10.9 percent. and sold in more than 60 countries and of creative collaboration that inspires a The company reported year-on-year six continents. never-ending stream of powerful tech- sales increases in all geographic regions. “We are pleased to have Jim step into nologies that make life better. 3M says Sales in local currencies grew 11.2 per- this new role within 3M,” commented it is the innovation company that nev- cent in Latin America/Canada, 9.2 per- Brad Sauer, executive VP of 3M Health er stops inventing. With $27 billion in cent in the United States, 5.9 percent Care Business. “Jim’s depth of knowledge sales, 3M employs about 80,000 people in Europe and 2.1 percent in Asia Pacif- and understanding of the pharmaceuti- worldwide and has operations in more ic. Excluding optical, Asia-Pacific sales cal industry equip him with outstanding than 65 countries. increased 11.3 percent in local curren- tools to cultivate the innovation that 3M Third-quarter sales for 2011 were cies. Drug Delivery Systems is known for. came in at about $7.5 billion, up 9.6 per- Taking into account the third-quar- Mr. Ingebrand’s previous positions cent year-on-year. The company report- ter performance, 3M updated its 2011 within the 3M Drug Delivery Systems ed third-quarter worldwide sales growth full-year performance expectations. The Division include roles as a key account of 9.6 percent, of which 3.7 percent came company expected earnings to be in the manager in the United Kingdom, an inha- from acquisitions, 3.1 percent stemmed range of $5.85 to $5.95 per share versus a lation program manager and a Six Sigma from foreign exchange impacts, 1.9 per- prior expected range of $6.10 to $6.25. Black Belt. Mr. Ingebrand most recently cent derived from organic volume growth Along with innovation, 3M Drug De- served as the global business director for and 0.9 percent came from higher year- livery Systems welcomed new leadership 3M Dental. He has worked in several oth- on-year selling prices. Organic volume in 2011. New Vice President and General er health-care divisions of 3M, including growth was below recent trend levels, re- Manager James Ingebrand replaced the 3M Infection Prevention and 3M Health flecting weakness across the electronics retiring James Vaughan in October. Care Specialties. market along with generally slowing eco- Mr. Ingebrand has a 27-year career nomic growth in the developed world. 3M at 3M, giving him significant insight into Aptalis Pharma Inc. also noted that a number of its customers the pharmaceutical and health-care in- reduced inventories during the quarter dustries. On February 11, 2011, Axcan completed in anticipation of slowing demand. As VP and general manager, Mr. In- the acquisition of Eurand N.V., a global Excluding the positive impact of cur- gebrand assumed responsibility for the specialty pharmaceutical company with rency, five of the company’s six busi- strategic direction of 3M Drug Delivery operating units in the United States and ness segments expanded sales in the Systems’ inhalation, transdermal, topi- Europe. The new company began its third quarter of 2011. One of the seg- cal and oral drug delivery devices and combined operations on February 14,

FLAMEL’S MEDUSA

Source: Flamel Technologies

17 2011, and took on the new name Ap- the previous year’s period. License and monary and Nasal Development, stated, talis as of May 4, 2011. Headquarters is research revenues amounted to $2.7 mil- “We have a strong history in inhalation based in Bridgewater, N.J. Other offices lion compared to $4.1 million during the built around our talented team of scien- are located in Alabama, Ohio and Penn- third quarter of 2010. Product sales and tists, who have experience gained from sylvania. services during 3Q 2011 were $5.2 mil- supporting numerous inhaled products Aptalis is a leading international spe- lion, and included the impact of the sup- and dosage forms available on the mar- cialty pharmaceutical company that de- ply agreement with an effective date of ket today. It is this talent and experi- velops, manufactures, markets and distrib- January 1, 2011, versus $1.8 million in ence we hope to share with the industry utes cystic fibrosis and gastroenterology the third quarter 2010. Other revenues at large for the advancement of patient products and therapeutic treatments. during the third quarter of 2011, com- treatments through active participation Another major milestone during 2011 posed primarily of royalties on the sale in IPAC-RS.” came with the Food and Drug Admin- of Coreg CR to GlaxoSmithKline, were istration’s decision to approve a new $2.5 million versus $2.1 million in the Cima Labs Inc. strength of ZENPEP (pancrelipase) De- prior-year period. layed-Release Capsules. Stephen H. Willard, Flamel’s chief CIMA specializes in orally disintegrating The new formulation is offered in executive officer, commented, “We are tablet, oral transmucosal and oral pow- 25,000 units of lipase, the highest strength very pleased to have come to an agree- der drug-delivery technologies. In addi- approved by the Food and Drug Admin- ment with GSK on a new Coreg CR mi- tion, CIMA has expertise in taste-mask- istration. The 25,000-unit strength gives croparticle supply contract. While the ing and customized release profiles. physicians another option in dosing pa- negotiations were lengthy, we believe we CIMA has functioned as an indepen- tients with exocrine pancreatic insuffi- achieved an excellent result for both par- dent business unit of Cephalon Inc. ciency (EPI) caused by cystic fibrosis or ties. This agreement was a primary driv- Cephalon is an international biophar- other conditions, and could potentially er of our profitability this past quarter maceutical company dedicated to the reduce pill burden. and increases our expectations for the discovery, development, and market- “Added to the recent FDA approval of continued sales of this product.” ing of innovative products to treat hu- the 3,000-unit dose, ZENPEP offers phy- man diseases. Cephalon focuses on four sicians and their patients the broadest Catalent Pharma core therapeutic areas: central nervous range of dosing options, including the Solutions Inc. system disorders, pain, cancer, and ad- lowest and highest doses available, of diction. During 2011, Cephalon was ac- any FDA-approved pancreatic enzyme Catalent Pharma Solutions serves thou- quired by Teva Pharmaceutical Indus- product,” said Frank Verwiel, M.D., pres- sands of large and small innovators in tries Ltd. ident and CEO of Aptalis Pharma. He more than 100 markets, including 36 of CIMA has commercialized more than noted ZENPEP is the only pancreatic the top 50 biotech companies and 49 of 20 products in 70-plus countries around enzyme offered in six dosage strengths the leading 50 pharma companies. Its in- the world. The company is based in – 3,000, 5,000, 10,000, 15,000, 20,000 tellectual property in oral, injectable, and Brooklyn Park, Minn. and 25,000 units of lipase – reflecting the respiratory dosage forms and advanced company’s strong emphasis on research drug packaging includes more than 1,200 Sagent Pharmaceuticals Inc. and development. “We believe the broad patents and patent applications. range of ZENPEP strengths can provide From drug and biologic development Sagent Pharmaceuticals of Schaumburg, added convenience by helping patients services to delivery technologies to sup- Ill., experienced a productive 2011. In reduce the number of capsules they take ply solutions, Catalent Pharma Solutions the third quarter, the company launched with every meal, while the precise dos- has 75 years of experience in the indus- six new products including generic levo- ing can aid in the management of their try. Catalent helps clients get more mol- floxacin in pre-mixed bags, gemcitabi- EPI.” ecules to market faster, enhance prod- ne at patent expiration and paclitaxel, uct performance, and provide superior, a critical oncology product on the FDA Flamel Technologies S.A. reliable manufacturing and packaging so- drug shortage list. lutions. Such product launches increased rev- Flamel Technologies is a leading drug- For its fiscal-year 2011 the company enue 94% to $41.3 million. Gross profit delivery company. Flamel is focused on generated more than $1.6 billion in rev- increased to $6.9 million. the goal of developing safer, more effica- enue. Also during 2011, Somerset, N.J.- Sagent received the 2011 North Amer- cious formulations of drugs to tackle un- based Flamel became a new member of ican Frost & Sullivan Award for Product met medical needs. The company’s de- the International Pharmaceutical Aero- Quality Leadership for Sagent’s Preven- velopment pipeline includes biological sol Consortium on Regulation and Sci- tIV Measures (SM) packaging and label- and chemical drugs formulated with its ence (IPAC-RS). This is the industry’s ing system used in the heparin product proprietary platforms Medusa and Mi- leading scientific consortium for the de- line. cropump. velopment of standards and regulations “I am very pleased with the growth we The Lyon, France-based company to enhance the availability of quality, achieved during the quarter, nearly dou- reported financial gains in 2011. Third- safe and efficacious drug products for bling our gross margin percentage from quarter 2011 revenue gains were report- patients. the second quarter,” said Jeffrey M. Yor- ed at $10.4 million, versus $8.0 million in Dean McKinney, Catalent’s VP of Pul- don, CEO, founder, and chairman of the 18 board of Sagent. “We expect to continue leader Santen Pharmaceutical Co. Ltd. or inspiratory capacity (IC) compared to our revenue and gross margin momen- and Novagali Pharma announced Sant- Spiriva HandiHaler. tum in the fourth quarter, while focusing en’s acquisition of 50.55% of Novagali PT003 is an inhaled, fixed-dose com- on the launch of 40 additional products, Pharma’s capital. As a result of this ac- bination bronchodilator product com- which are represented by 75 ANDAs quisition, Santen will table a mandato- prising a long-acting muscarinic antag- that have been recently approved or are ry takeover bid with the AMF for the re- onist (LAMA) and a long-acting beta-2 pending approval by the FDA.” maining shares and securities it does not agonist (LABA) delivered via a metered- yet hold. This offer would be followed dose inhaler (HFA MDI). The company Novagali Pharma SA by the delisting of the remaining Nova- additionally is developing a triple-combi- gali Pharma shares, assuming that Sant- nation product that combines the LAMA Founded in 2000, Novagali of Evry, en holds at least 95% of Novagali Phar- and LABA components of PT003 with an France, is a pharmaceutical company ma’s capital and voting rights after the inhaled corticosteroid (ICS) for twice- that develops ophthalmic innovative takeover offer. daily administration from an HFA MDI products for all segments of the eye. Due for the treatment of severe COPD. to Novagali’s three proprietary technol- Pearl Therapeutics Inc. Both products are being developed us- ogy platforms, the company has an ad- ing Pearl’s proprietary porous particle co- vanced portfolio of highly innovative Pearl Therapeutics is developing unique suspension technology. This technology products. One of them is on the market dual and triple combination products for allows the formulation of multiple prod- and two are undergoing Phase III clini- the treatment of widely prevalent respi- ucts in the MDI format, with highly sta- cal trials. ratory diseases, including chronic ob- ble, robust and aerodynamically efficient For the 3rd quarter of 2011, Novaga- structive pulmonary disease. Pearl’s cur- drug delivery. li Pharma’s earnings – reflecting sales rent focus is on making advanced inhaled of Cationorm – totaled 199,000 euros, therapies available to broad patient pop- Acura Pharmaceuticals Inc. up more than 24% compared to the 3rd ulations via familiar and accepted me- quarter of 2010. This pursuance in sales tered dose inhalers. Palatine, Ill.-based Acura is a specialty growth is associated with the upramping The privately held company based pharma company focused on the R&D of sales in countries where the product in Redwood City, Calif., is finding pos- and commercialization of product can- was already marketed. Total revenue was itive results with its Phase IIb study didates meant to address medication use 636,000 euros over the prior-year same (NCT01085045) demonstrating that the and misuse via its AVERSION and IM- quarter, an increase of 3.8%. dual bronchodilator combination prod- PEDE technologies. During June 211, In October Japanese pharmaceutical uct PT003 (GFF MDI) provides superi- FDA cleared for marketing the first prod-

Source: Novagali Pharma

19 uct using the AVERSION technology. BioDelivery Sciences to higher placebo effects, accounted for Acura also has a development pipeline International Inc. nearly two-thirds of the total study popu- of other AVERSION technology products lation. When we eliminate the BEMA Bu- such as additional opioids, stimulants, BioDelivery Sciences is a specialty phar- prenorphine starting dose from the anal- and benzodiazepines along with the IM- maceutical company that is leveraging ysis, where the greatest placebo response PEDE technology for pseudoephedrine its novel and proprietary patented drug- occurred, particularly in the opioid na- hydrochloride products. delivery technologies to develop and ive group, we achieved a pain score dif- The company reported a net loss of commercialize, either on its own or in ference between BEMA Buprenorphine $2.1 million for the third quarter of 2011, partnerships with third parties, new ap- and placebo that approached statistical compared to a net loss of $2.6 million the plications of proven therapeutics. BDSI significance (p=0.066). This starting previous year’s third quarter. The com- is focusing on developing products to dose ‘phenomenon’ is not dissimilar to pany generated $20.5 million in reve- meet unmet patient needs in the areas what has been observed with other ap- nue for the first nine months of 2011, of pain management and oncology sup- proved opioids.” an increase from the first nine months portive care. “While there is disappointment over in 2010. Acura attributes the gains to a In 2011, BDSI completed a Phase III missing the primary efficacy endpoint of $20 million payment from Pfizer as a re- clinical study of BEMA Buprenorphine this study, the many positive findings we sult of the FDA’s approval of a new drug for the treatment of moderate-to-severe observed gives us great confidence in our application for OXECTA. chronic pain in a mixed opioid naive and ability to ultimately bring this product to “We are making progress in our strat- opioid experienced population. market for the treatment of chronic pain egy to leverage Acura’s proprietary tech- “We witnessed a high placebo re- in a variety of patient types,” adds Dr. nology platforms to develop products in- sponse in the opioid naive segment Mark A. Sirgo, president and chief execu- tended to address medication abuse and of our patient population, particular- tive officer of Raleigh, N.C.-based BDSI. misuse,” says Bob Jones, president and ly at our starting dose, which account- BDSI’s ONSOLIS (fentanyl buccal CEO. “The abuse and misuse of opioids ed for the overall lack of efficacy that soluble film) is approved in the Unit- and other medications is a serious pub- was observed in this trial,” explains An- ed States, Canada, and the European lic health and safety issue and we believe drew Finn, Ph.D., executive vice presi- Union (where the product is market- that the products developed through our dent of product development at BDSI. ed as BREAKYL) for the management AVERSION and IMPEDE technology plat- “This group of patients, who are not ac- of breakthrough pain in opioid-tolerant forms can be part of the solution.” customed to taking opioids and prone adult patients with cancer.

Source: BioDelivery Sciences International

20 Dusa Pharmaceuticals Inc. astick in Korea and other Asia-Pacif- Access made significant progress in in- ic countries. The termination resulted creasing reimbursement for MuGard. Dusa is a dermatology company that is in the recognition of $1.4 million of de- MuGard continued receiving reimburse- developing and marketing Levulan Pho- ferred revenues and $1.3 million in in- ment from many networks of leading in- todynamic Therapy (PDT) and other come from operations, which positive- surance companies and pharmacy ben- products focused on patients with com- ly impacted both the company’s GAAP efit managers, including Group Health mon skin conditions. Dusa is based in and non-GAAP results for the third quar- Inc. (GHI), TRICARE, Harvard Pilgrim, Wilmington, Mass. ter of 2011. Humana and Express Scripts. Reim- Total product revenues for the compa- bursement has more than doubled and ny’s nine-month period ended Septem- Access Pharmaceuticals Inc. now includes several more payers. ber 30, 2011, were $30.3 million, an in- Clinicians prescribing MuGard con- crease of $4.9 million, or 19%, from $25.4 Access Pharmaceuticals is a biopharma- tinue to provide feedback and anecdotal million in the comparable prior-year pe- ceutical company based in Dallas lever- evidence of positive clinical experiences. riod. PDT revenues totaled $30.0 mil- aging its proprietary drug-delivery plat- More than 700 clinicians have prescribed lion, an increase of $5.5 million, or 22%, forms to develop treatments in the areas MuGard for their patients and over 75% from $24.5 million for the comparable of oncology, cancer supportive care and of these doctors are recurring prescrib- 2010 period. The increase in PDT rev- diabetes. ers. enues was attributable to a $5.3 million Access’ products include MuGard, increase in Kerastick revenues. which received FDA marketing clearance Acrux Ltd. Levulan Kerastick for topical solution for the management of patients with mu- plus Dusa’s BLU-U Blue Light Photody- cositis; ProLindac, a second-generation Acrux is an Australian drug-delivery namic Therapy Illuminator is approved DACH Platinum in Phase II clinical test- company developing and commercializ- for the treatment of minimally to mod- ing of patients with ovarian cancer; and ing a range of patient-preferred, patented erately thick actinic keratoses of the face Thiarabine, a novel nucleoside analog pharmaceutical products for global mar- or scalp. Dusa also sells other dermatolo- that has demonstrated both pre-clinical kets. The company uses its innovative gy products, including ClindaReach. and clinical activity in certain cancers. technology to administer drugs through During the third quarter of 2011, the Thiarabine is undergoing a Phase I/IIa the skin. company terminated its agreement with clinical trial in hematological malignan- For Acrux’s fiscal year ended June 30, Daewoong Pharmaceutical Co. Ltd. and cies at the M.D. Anderson Cancer Cen- 2011, the company recorded a profit of DNC Daewoong Derma & Plastic Sur- ter in Houston. $57 million, resulting in earnings of 35 gery Network Co. for the Levulan Ker- Throughout the third quarter of 2011, cents per share, up from 29 cents in the

Source: Acrux

21 prior year. The result was driven by reve- ment of breakthrough cancer pain. Fen- conditions specifically focused on cen- nue of $93 million, including a milestone tanyl TAIFUN is a fast-acting fentanyl for- tral nervous system (CNS) disorders payment of $87 million from Eli Lilly af- mulation delivered using the company’s such as schizophrenia, addiction and ter the FDA issued a marketing authori- TAIFUN multi-dose dry-powder inhaler depression. zation for Axiron in November 2010. platform. Akela’s pipeline also includes The Dublin, Ireland-based company In April 2011, Acrux paid a special a growth hormone releasing hormone boasts a product portfolio that includes dividend to shareholders of 60 cents per (GHRH), which is being developed for more than 20 products on the market; share, or approximately $100 million. Af- frailty and wasting in chronic renal dis- five key commercial products to treat ter distributing surplus cash in the spe- ease. MS, schizophrenia, bipolar disorder, cial dividend, Acrux retained cash re- Its pharmaceutical contract manu- opioid dependence, and type 2 diabe- serves of $33 million as of June 30, 2011. facturing business, PharmaForm, has tes; and a substantial and growing pipe- The testosterone therapy market in the accounted for much of the company’s line of product candidates in clinical de- United States continues to grow strong- success in the past year. PharmaForm velopment. ly, with sales in 2010 up 29% versus the enabled Akela to become profitable in In September 2011, Alkermes merged prior year to $1.3 billion. 2010 and has continued to grow prof- with Elan Drug Technologies. As of Sept. Axiron was launched into the mar- itably, quarter over quarter, generating 30, 2011, Alkermes had $1.5 billion in to- ket by Lilly in April 2011. Uptake by pa- nearly $1 million in net income during tal assets – reflecting the combination of tients has been strong; four months af- the first quarter of 2011. Alkermes and Elan – compared with to- ter launch, Axiron’s share had grown to Akela intends to focus on Pharma- tal assets of Alkermes Inc. on March 31, 22.3% of New to Brand Prescriptions and Form’s business through business-de- 2011, of $452.4 million. 6.1% of Total Prescriptions. velopment initiatives, the addition of For the company’s fiscal-year 2012, “Acrux is pleased to have delivered specialty commercial manufacturing which ends in March 2012, Alkermes ex- a profit of $57 million and a first divi- services, expansion of capacity and – as pects total revenues to range from $350 dend of 60 cents per share,” comment- opportunities arise – expansion through million to $380 million, up from a pre- ed Acrux CEO Richard Treagus. “We are targeted acquisitions of niche, formula- vious range of $205 million to $229 mil- encouraged by the uptake of Axiron so tion and manufacturing businesses. lion. far in the United States and look forward In 2011, Akela also regained the prod- “This quarter marks the beginning of to continuing to deliver shareholder val- uct rights to Fentanyl TAIFUN in Japan a new phase of growth for Alkermes, as ue.” from Teikoku Seiyaku Co. Akela will no we begin to realize the financially trans- longer invest in the Fentanyl TAIFUN formative effects of the EDT transac- Acusphere Inc. program and is actively seeking buyers tion,” comments Richard Pops, CEO of for the project. Alkermes. “We are now fully executing Acusphere is a specialty pharmaceutical on our strategy to build Alkermes for company primarily focused on the devel- Alkermes Inc. growth in both the near- and long-term. opment of Imagify, a cardiovascular drug In the near-term, we will see the growth for the detection of coronary artery dis- Alkermes is a leader in innovative medi- in revenues from the expansion of our ease. Acusphere is in the process of seek- cines that address the unmet needs and portfolio of commercial products. Over ing regulatory approval of Imagify in Eu- challenges of people living with debilitat- the long-term, we will realize the value rope, and negotiating a Special Protocol ing diseases. The company is designing of our advancing pipeline of new drug Assessment with FDA for an additional innovative treatments for major clinical candidates. clinical trial required for U.S. approval. In 2010, the Lexington, Mass.-based company secured $10 million in financ- ing to develop Imagify. In 2011, Acus- phere worked with the FDA on a design for its Phase III clinical study of the drug. The study will compare stress ultrasound with Imagify to stress ultrasound without Imagify for the detection of coronary ar- tery disease. The company expects the study to cost $15 million and take two years to complete, based upon enrollment of 900 patients.

Akela Pharma Inc.

Akela Pharma is a drug-development company with its lead product Fentanyl Source: AlphaRx TAIFUN being developed for the treat- 22 “We are committed to our vision of building Alkermes plc as a global leader in the development of innovative prod- ucts for a broad range of CNS diseases for the benefit of patients and healthcare systems around the world.”

AlphaRx Inc.

AlphaRx is a specialty pharmaceutical company dedicated to developing prov- en therapies by reformulating marketed drugs. Through application of the compa- ny’s proprietary site-specific nano drug- delivery technology, the reformulated products offer improved medical bene- fits and a potential for significant com- mercial product development. AlphaRx of Hong Kong, China, is de- veloping and commercializing Inda- flex and ARX8203 internally for the pain market. With Indaflex, the compa- ny takes in royalties of $10,000 month- Source: QLT ly, which is increasing to $15,000. The company is reviewing options to make over the same prior year-ago time period. through the first nine months of 2011 the product available in Europe, which Our significant revenue growth resulted were $15.6 million. it projects will bring in an additional $12 from the shipment of the remaining ad- The Vancouver, Canada-based compa- million. ditional one-time orders to Merck Serono ny is working on drug-delivery systems ARX8203 is a therapy for gout. The and increased sales to Merial. In addi- for glaucoma, age-related retinal diseases company is looking to conduct an effica- tion, both operating and net income were and hereditary blindness as well as oth- cy and safety trial on 90 gout patients. positive for the third quarter of 2011 as er conditions. Another potential blockbuster is GAI- compared to the negative results of the 122 for the Chinese market. China re- prior year-ago time period.” Novo Nordisk A/S portedly has more patients with stroke “However, these positive results are than anywhere else in the world. The to- only temporary. There are no addition- Novo Nordisk is a global healthcare com- tal market potential for GAI-122 in China al Serono orders to fill. The increased pany with 88 years of innovation and is $1.68 billion. GAI-122 is being devel- Merial orders for their launch have been leadership in diabetes care. With head- oped by AlphaRx’s partner, Gaia BioP- met, and Merial’s order forecast is dra- quarters in Denmark, Novo Nordisk mar- harma, under a licensing agreement. matically lower.” kets products in 179 countries. The company’s sales growth of 11% Bioject Medical QLT Inc. during January-September 2011 was at- Technologies Inc. tributed to the diabetes drugs Victoza, QLT is an ocular-focused company. QLT NovoRapid and Levemir. Sales in North Bioject Medical Technologies is a devel- is dedicated to the development and America increased 17% in the first nine oper of needle-free drug-delivery systems commercialization of innovative ocular months of 2011. Sales in International based out of Portland, Ore. products that address the unmet medical Operations grew 16%. Bioject reported third-quarter 2011 needs of patients and clinicians world- Novo Nordisk expects to end 2011 revenue of $3.1 million, compared to rev- wide. with sales growth of 10-11% (previously enue of $1.5 million in the comparable For the third quarter, total revenue of projected at 9-11%), and operating profit 2010 period. For the nine-month period $9.6 million was up 11.6% from the third growth measured in local currencies was ended September 30, 2011, Bioject re- quarter of 2010, primarily because the anticipated to be 17-19% (previously fore- ported revenue of $7.3 million compared quarter included $2 million related to a casted at 15-19%). to revenue of $3.9 million in the compa- shipment of Visudyne for the treatment The preliminary outlook for 2012 in- rable period of 2010. However, projected of wet age-related macular degeneration dicates high single-digit sales growth and revenues for the company were not opti- to Novartis. operating profit growth of close to 10%. mistic, according to management. QLT expected annual U.S. Visudyne The outlook is associated with unusu- “Unfortunately we have to report a sales to be in the range of $20 million to al uncertainty given the challenging fi- mixed message,” stated Ralph Makar, $22 million, compared with the original nancial situation in major countries Bioject’s president and CEO. “Third 2011 guidance of $23 million to $26 mil- around the world. The outlook for op- quarter 2011 revenue increased 107% lion. Visudyne sales in the United States erating profit furthermore reflects costs 23 to submit the New Drug Application in the first half of 2012,” according to James E. Brown, D.V.M., president and CEO of Durect. “In July, as a culmination of a multi-year feasibility effort with Zogenix, DURECT added an antipsychotic devel- opment program to our pipeline. In ad- dition, we continue to support an expe- rienced team at Pfizer in resolving the remaining issues related to REMOXY.”

NovaDel Pharma Inc.

NovaDel is a specialty pharmaceutical company that is developing oral spray formulations for a broad range of mar- keted therapeutics. The company’s No- vaMist technology enables rapid deliv- ery of drugs into the bloodstream, which results in faster onset of action and po- tential patient benefits in compliance, convenience and safety. NovaDel’s most Source: Durect advanced candidates target angina, in- somnia and nausea. related to the expected market launch diseases and may in the future enable The Bridgewater, N.J., company re- of Degludec. biotechnology drugs to reach the mar- corded total revenue of $0.4 million for Lars Rebien Sørensen, president and ketplace in a superior dosage form. the first nine months of 2011, compared CEO of Novo Nordisk, stated, “We are As of September 30, 2011, the Cuper- to $0.3 million for the first nine months pleased to see our key products, No- tino, Calif.-based company had cash and of 2010. voRapid, Levemir and Victoza, continue investments of $35.1 million, compared NovaDel Pharma expects current and to drive strong underlying sales growth. to cash and investments of $37.5 million anticipated cash and cash equivalents to The filing of our new-generation insu- as of June 30, 2011, and $49.6 million at fund operations through December 31, lins, ultra-long-acting Degludec and De- December 31, 2010. 2011. The company is actively seeking gludecPlus, in the US and Europe is a “We completed enrollment in our piv- additional funding through equity fi- major milestone in the expansion of our otal Phase III trial for POSIDUR (BESST) nancing, strategic alternatives or simi- leadership in diabetes care.” in the third quarter, expect to have top- lar transactions. However, the company line data in the fourth quarter of this year cannot assure it will be able to obtain ad- Durect Corp. and, assuming positive data, we expect ditional funding.

Durect is a drug-delivery technology company focused on developing propri- etary products in chronic care areas. Du- rect’s approach minimizes development risk and maximizes speed to market to expand technology platforms through in- ternal work and acquisitions, and opti- mizes and enables the development of biotech products. Durect’s injectable, implantable and micro-catheter-based technologies allow for site-specific delivery of drugs while re- ducing drug degradation, a current obsta- cle with the delivery of protein and pep- tides. Additionally, Durect has acquired technologies to expand the breadth of its drug-delivery capabilities into injectable, transdermal and oral dosage forms. Du- rect believes that its technologies have the potential to make significant impacts in the treatment of chronic debilitating Source: A.P. Pharma 24 A.P. Pharma Inc.

A.P. Pharma is a specialty pharmaceu- tical company that is developing prod- ucts using its proprietary Biochronomer polymer-based drug-delivery technolo- gy. The company’s primary focus is on A.P. Pharma’s lead product candidate APF530, which is intended for the pre- vention of chemotherapy-induced nau- sea and vomiting (CINV). The Redwood City, Calif., company reported a net loss for the second quar- ter of 2011 at $1.9 million, compared with a net loss of $3.6 million for the Source: Emisphere Technologies second quarter of 2010. The net loss was lower in the fiscal third quarter primar- ily due to expenses related to the resig- use its bioerodible injectable and im- Pharma AG), and oral GLP-1 and GLP- nation of the company’s former chief ex- plantable delivery systems. 1 analogs for Type 2 diabetes (with part- ecutive officer during the second quarter ner Novo Nordisk). of 2010 and $0.6 million of lower spend- Emisphere Technologies Inc. Emisphere is developing an oral for- ing in the fiscal third quarter related to mulation of Eligen B12 (1,000 mcg) for the New Drug Application (NDA) resub- Emisphere Technologies develops oral use by B12-deficient individuals. On Au- mission. forms of injectable drugs or poorly ab- gust 5, 2011, Emisphere received notice In May 2011, A.P. Pharma received sorbed compounds. from the U.S. Patent Office that the U.S. notice of termination from Merial Ltd. re- For the first nine months of 2011, patent application directed to the oral lated to an agreement covering a product Emisphere of Cedar Knolls, N.J., report- Eligen B12 formulation was allowed. This under development in the animal health ed a net loss of $4.8 million. For the third new patent provides intellectual proper- care market. As a result, all remaining quarter of the year, Emisphere reported ty protection for Eligen B12 in the Unit- deferred revenues under this agreement a net loss of $17.6 million. ed States through 2029. were substantially recognized in the cur- Promising marquee products in the Results of the product’s clinical trials rent fiscal quarter. pipeline include an improved formula- and market research are being evaluat- A.P. Pharma has additional clinical tion of oral Vitamin B12, oral calcitonin ed and the company is exploring alter- and preclinical stage programs in the for osteoarthritis and osteoporosis (in native development and commercializa- area of pain management, all of which Phase III development with Novartis tion options.

25 Awaiting Approval — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Abstral Sublingual fentanyl Abstral is intended for the Narcotic analgesic Africa NewBridge treatment of breakthrough Pharmaceuticals cancer pain . Afrezza Insulin Afrezza is intended for the Insulin United States MannKind Corp . treatment of type 1 diabetes . Afrezza Insulin Afrezza is intended for the Insulin United States MannKind Corp . treatment of type 2 diabetes . Androderm 2nd Testosterone Androderm 2nd Generation Hormone therapy United States Watson Pharmaceuticals Generation is intended for testosterone Inc . replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, such as primary hypogonadism and secondary hypogonadism . Anturol Oxybutynin Anturol is intended for the — United States Watson Pharmaceuticals treatment of overactive bladder . Inc . APF530 Granisetron APF530 is intended for the 5-HT3 receptor antagonist United States A .P . Pharma Inc . prevention of acute and delayed chemotherapy- induced vomiting . Bio-T-Gel — Bio-T-Gel is intended for the Hormone therapy United States BioSante Pharmaceuticals treatment of hypogonadism in Inc . men . Bonalfa (TV-02H) Tacalcitol monohydrate Bonalfa (TV-02H) is intended for Active vitamin D3 Japan Teijin Ltd . the treatment of psoriasis vulgaris . Bronchitol Mannitol Bronchitol is intended for the Osmotic diuretic European Union Pharmaxis Ltd . treatment of cystic fibrosis in adults aged 18 years old or older as an add-on therapy to best standard of care . Bydureon Exenatide Bydureon is intended for the Glucagon-like peptide-1 United States Developer: Amylin treatment of type 2 diabetes . receptor agonist Pharmaceuticals Inc ,. Eli Lilly and Co ,. and Alkermes plc ;. Marketer: Amylin Pharmaceuticals Inc . and Eli Lilly and Co . Ciclesonide Nasal Aerosol Ciclesonide Ciclesonide Nasal Aerosol HFA Glucocorticosteroid United States Sunovion HFA is intended for the treatment of Pharmaceuticals Inc . perennial allergic rhinitis in adult and adolescent patients 12 years old or older . Ciclesonide Nasal Aerosol Ciclesonide Ciclesonide Nasal Aerosol HFA Glucocorticosteroid United States Sunovion HFA is intended for the treatment of Pharmaceuticals Inc . seasonal allergic rhinitis in adult and adolescent patients 12 years old or older . Concerta Methylphenidate Concerta is intended for the Central nervous system European Union Developer: Johnson & hydrochloride treatment of attention deficit stimulant Johnson Pharmaceutical hyperactivity disorder in adults . Research & Development; Marketer: McNeil Pediatrics Contrave Bupropion and naltrexone Contrave is intended for the Dopamine and United States Developer/Marketer: treatment of obesity . norepinephrine reuptake Orexigen Therapeutics inhibitor and opioid Inc . and Takeda antagonist Pharmaceuticals North America Inc . Duac Low Dose Clindamycin phosphate Duac Low Dose is intended for Oxidizing agent United States Stiefel and benzoyl peroxide the topical treatment of acne vulgaris . Dulera Momestasone furoate Dulera is intended for the Beta 2 adrenergic agonist United States Merck & Co . and formoterol fumarate treatment of chronic obstructive and corticosteroid pulmonary disease . Excellarate — Excellarate is intended for the — United States Tissue Repair Co . treatment of non-healing, neuropathic diabetic foot ulcers . Extended Release Carbinoxamine Extended Release Antihistamine United States Tris Pharma Carbinoxamine Oral Carbinoxamine Oral Suspension Suspension is intended for the treatment of allergies in children 2 years old or older .

Source: eKnowledgeBase.com 26 Awaiting Approval — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Eylea Aflibercept Eylea is intended for the Vascular endothelial United States Developer: Regeneron treatment of wet age-related growth factor Pharmaceuticals Inc . macular degeneration . and Bayer HealthCare Pharmaceuticals Inc ;. Marketer: Regeneron Pharmaceuticals Inc . Eylea Aflibercept Eylea is intended for the Vascular endothelial European Union Developer: Regeneron treatment of wet age-related growth factor Pharmaceuticals Inc . macular degeneration . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial Japan Developer: Regeneron treatment of wet age-related growth factor Pharmaceuticals Inc . macular degeneration and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Fentanyl SL Spray Fentanyl Fentanyl SL Spray is intended for — United States Insys Therapeutics Inc . the treatment of breakthrough cancer pain . Fluenz Live attenuated influenza Fluenz is intended for the Preventive vaccine European Union AstraZeneca Plc . vaccine prevention of seasonal influenza in children 24 months to less that 18 years old . Flutiform Formoterol and Flutiform is intended for the — United States SkyePharma Plc . fluticasone treatment of asthma in patients 12 years old or older . Flutiform Formoterol and Flutiform is intended for the — European Union Mundipharma fluticasone treatment of asthma . International Ltd . Horizant Gabapentin enacarbil Horizant is intended for the Voltage-gated calcium United States GlaxoSmithKline Inc . management of post-herpetic channel modulator neuralgia in adults . Iluvien Fluocinolone acetonide Iluvien is intended for the Corticosteroid United States Developer/Marketer: treatment of diabetic macular Alimera Sciences Inc . and edema . pSivida Ltd . Iluvien Fluocinolone acetonide Iluvien is intended for the Corticosteroid European Union Developer/Marketer: treatment of diabetic macular Alimera Sciences Inc . and edema . pSivida Ltd . Imiquimod Imiquimod Imiquimod is intended for the — Japan Mochida Pharmaceutical treatment of actinic keratosis . Co . Immediate Release Oxycodone Immediate Release Oxycodone Mu-type opioid receptor United States Pfizer Inc . Oxycodone with Aversion hydrochloride with Aversion Technology (with (MOR-1) agonist Technology (with Niacin) Niacin) is intended for the treatment of moderate to severe pain . Intermezzo Zolpidem tartrate Intermezzo is intended for the Imidazopyridine United States Developer: Transcept treatment of insomnia in patients Pharmaceuticals Inc ;. who awaken in the middle of Marketer: Purdue Pharma the night and have difficulty LP returning to sleep . Ivermectin Ivermectin Ivermectin is intended for the Pediculicide United States Topaz Pharmaceuticals treatment of head lice . LLC Janumet XR Sitagliptin phosphate and Janumet XR is intended for the Dipeptidyl peptidase-4 United States Merck & Co . metformin hydrochloride treatment of type 2 diabetes . inhibitor and biguanide Komboglyze Saxagliptin hydrochloride Komboglyze is intended as an Dipeptidyl peptidase IV European Union Developer/Marketer: and metformin adjunct to diet and exercise, for inhibitor and biguanide Bristol-Myers Squibb Co . the treatment of type 2 diabetes and AstraZeneca Plc . in adults who are not adequately controlled on metformin or those already being treated with the combination of saxagliptin and metformin as separate tablets . KW-0761 Mogamulizumab KW-0761 is intended for the Anti-CCR4 humanized Japan Kyowa Hakko Kirin treatment of adult T-cell monoclonal antibody Pharma Inc . leukemia-lymphoma .

Source: eKnowledgeBase.com 27 Awaiting Approval — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Levadex Dihydroergotamine Levadex is intended for the — United States Developer: MAP mesylate treatment of acute migraine Pharmaceuticals headaches . Inc ;. Marketer: MAP Pharmaceuticals Inc . and Allergan Inc . Lodotra Prednisone Lodotra is intended for the Circadian cytokine United States Horizon Pharma Inc . treatment of rheumatoid arthritis . modulator Long-Acting Oxymorphone Oxymorphone Long-Acting Oxymorphone HCI is Narcotic analgesic United States Endo Pharmaceuticals HCI hydrochloride intended for the relief of chronic Inc . pain . Lucentis Ranibizumab Lucentis is intended for the Human antibody European Union Novartis Ophthalmics Inc . treatment of retinal vein fragment occlusion . Mechlorethamine Mechlorethamine Mechlorethamine is intended — United States Yaupon Therapeutics Inc . for the treatment of early-stage cutaneous T-cell lymphoma . MoxDuoIR Morphine and MoxDuoIR is intended for the Opioid analgesic United States QRxPharma Pty Ltd . oxycodone treatment of moderate to severe acute pain . MQX-503 Nitroglycerin MQX-503 is intended for the Vasodilator United States MediQuest Therapeutics treatment and prevention of Inc . Raynaud phenomenon disease . MuGard — MuGard is intended for the — China Developer: Access treatment of oral mucositis in Pharmaceuticals Inc ;. cancer patients . Marketer: Milestone Biosciences LLC Neupro Rotigotine Neupro is intended as adjunctive Dopamine D2 receptor United States UCB Inc . therapy with levodopa for agonist the treatment of adults with advanced Parkinson’s disease . Neupro Rotigotine Neupro is intended for the Dopamine D2 receptor United States UCB Inc . treatment of moderate-to- agonist severe restless legs syndrome . NVA237 Glycopyrronium bromide NVA237 is intended for the Long acting muscarinic European Union Novartis Pharma AG treatment of chronic obstructive antagonist pulmonary disease . Ocriplasmin Microplasmin Ocriplasmin is intended for Thrombolytic agent European Union ThromboGenics Ltd . the non-surgical treatment of vitreomacular adhesion . Ondansetron RapidFilm Ondansetron Ondansetron RapidFilm is Serotonin 5-HT3 receptor China SciClone intended for the prevention of antagonist Pharmaceuticals Inc . nausea and vomiting caused by chemotherapy, radiotherapy and surgery . Ondansetron RapidFilm Ondansetron Ondansetron RapidFilm is Serotonin 5-HT3 receptor Vietnam SciClone intended for the prevention of antagonist Pharmaceuticals Inc . nausea and vomiting caused by chemotherapy, radiotherapy and surgery . Pancrecarb Pancrelipase Pancrecarb is intended for Enzyme United States Digestive Care Inc . the treatment of exocrine pancreatic insufficiency . Prochieve Progesterone Prochieve is intended to reduce Progestin United States Watson Pharmaceuticals the risk of preterm birth in women Inc . with a cervical length between 10 and 20 mm as measured by transvaginal ultrasound at mid- pregnancy . QNASL Beclomethasone QNASL is intended for the Corticosteroid United States Teva Pharmaceutical diproprionate treatment of perennial allergic Industries Ltd . hydrofluroalkane rhinitis . QNASL Beclomethasone QNASL is intended for the Corticosteroid United States Teva Pharmaceutical diproprionate treatment of seasonal allergic Industries Ltd . hydrofluroalkane rhinitis . Qnexa Phentermine and Qnexa is intended for the — United States Vivus Inc . topiramate treatment of obesity . Qnexa Phentermine and Qnexa is intended for the — European Union Vivus Inc . topiramate treatment of obesity .

Source: eKnowledgeBase.com 28 Awaiting Approval — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Remoxy Oxycodone Remoxy is intended for the Mu-type opioid receptor United States Pfizer Inc . treatment of moderate-to-severe (MOR-1) agonist chronic pain . Sancuso Granisetron Sancuso is intended for the 5-HT3 receptor antagonist European Union ProStrakan Group Plc . prevention of side-effects of nausea and vomiting in patients undergoing chemotherapy . Sitavir Acyclovir Sitavir is intended for the — European Union BioAlliance Pharma SA treatment of oral herpes (labial herpes) . Sublivac — Sublivac is intended for the Therapeutic vaccine Germany HAL Allergy Group treatment of allergic asthma . Sublivac — Sublivac is intended for Therapeutic vaccine Germany HAL Allergy Group the treatment of allergic conjunctivitis . Sublivac — Sublivac is intended for the Therapeutic vaccine Germany HAL Allergy Group treatment of allergic rhinitis . Tazarotene Tazarotene Tazarotene is intended for the Retinoid United States Developer: Stiefel; treatment of acne vulgaris in Marketer: Allergan Inc . patients 12 years old or older . and Stiefel Tobi Podhaler Tobramycin Tobi Podhaler is intended for Aminoglycoside antibiotic European Union Novartis Pharma AG the treatment of pseudomonas aeruginosa infections in patients with cystic fibrosis 6 years old or older . Vitaros Alprostadil Vitaros is intended for the Prostaglandin E1 United States Apricus Biosciences Inc . treatment of erectile dysfunction . vasodilator Vitaros Alprostadil Vitaros is intended for the Prostaglandin E1 European Union Apricus Biosciences Inc . treatment of erectile dysfunction . vasodilator Xerclear Chlorhexidine Xerclear is intended for the Antiviral South Korea Developer: Medivir AB; treatment of labial herpes (cold Marketer: Daewoong sores) . Pharmaceutical Co . Zelrix Sumatriptan Zelrix is intended for the — United States NuPathe Inc . treatment of acute migraine . Zyclara Imiquimod Zyclara is intended for the Toll-like receptor 7 agonist European Union Meda AB treatment of actinic keratosis .

Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Aeroquin Levofloxacin Aeroquin is intended for the Fluoroquinolone antibiotic United States Mpex Pharmaceuticals treatment of treatment of Inc . pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis . AG200-15 Levonorgestrel and AG200-15 is intended for the Contraceptives United States Agile Therapeutics Inc . ethinyl estradiol prevention of pregnancy . AGO178 Agomelatine AGO178 is intended for the Melatonin receptor (M1 United States Novartis Pharmaceuticals treatment of major depressive and M2) agonist and Corp . disorder . 5-HT2C antagonist AN2690 — AN2690 is intended for the Antifungal United States Anacor Pharmaceuticals treatment of onychomycosis Inc . infection . Arikace Liposomal amikacin Arikace is intended for the Antibiotic European Union Insmed Inc . treatment of Pseudomonas aeruginsa lung infections in children from birth to 18 years of age with cystic fibrosis . Aza Acid Foam — Aza Acid Foam is intended for — European Union Intendis GmbH the treatment of rosacea . Aztreonam Aztreonam Aztreonam is intended for the Monobactam antibiotic United States Gilead Sciences Inc . treatment of Burkholdemia cepacia infection in patients with cystic fibrosis .

Source: eKnowledgeBase.com 29 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer BEMA Buprenorphine Buprenorphine BEMA Buprenorphine is intended Partial mu-opiate United States BioDelivery Sciences for the treatment of moderate to receptor agonist International Inc . severe chronic pain . BromSite — BromSite is intended for the — United States InSite Vision Inc . treatment of pain and swelling associated with ocular surgery . Bronchitol Mannitol Bronchitol is intended for Osmotic diuretic United States Pharmaxis Ltd . facilitating mucus clearance in patients with cystic fibrosis . Bronchitol Mannitol Bronchitol is intended for the Osmotic diuretic United States Pharmaxis Ltd . treatment of bronchiectasis . Bronchitol Mannitol Bronchitol is intended for the Osmotic diuretic European Union Pharmaxis Ltd . treatment of bronchiectasis . CD07805/47 — CD07805/47 is intended for the — United States Galderma Laboratories LP treatment of rosacea . Ciclesonide HFA Ciclesonide Ciclesonide HFA is intended for Glucocorticosteroid European Union Nycomed Group the treatment of allergic rhinitis . Cogenzia Gentamicin Cogenzia is intended for the — United States Innocoll Inc . prevention of infection in diabetic foot ulcers . Cogenzia Gentamicin Cogenzia is intended for the — United States Innocoll Inc . treatment of infection in diabetic foot ulcers . COL-003 Oxycodone COL-003 is intended for the Opioid analgesic United States Collegium treatment of chronic low back Pharmaceutical Inc . pain . CollaRx Gentamicin Gentamicin CollaRx Gentamicin Surgical Aminoglycoside antibiotic United States Developer: Innocoll Surgical Implant Implant is intended for the Inc .; Marketer: Baxter prevention of surgical site Healthcare Corp . infections in patients who are at higher risk of infections . Crinone Progesterone Crinone is intended for the Progestin United States Watson Pharmaceuticals prevention of preterm birth . Inc . CVBT-141B — CVBT-141B is intended for the Human fibroblast growth United States CardioVascular treatment of ischemic diabetic factor-1 (FGF-1) BioTherapeutics Inc . wounds . Cyclokat Cyclosporine A Cyclokat is intended for the — United States Novagali Pharma treatment of moderate to severe dry eye syndrome . Cyclokat Cyclosporine A Cyclokat is intended for the — European Union Novagali Pharma treatment of moderate to severe dry eye syndrome . Cymbalta Duloxetine hydrochloride Cymbalta is intended for Serotonin and United States Eli Lilly and Co . the treatment of prediatric norepinephrine reuptake depression . inhibitor Duodopa Levodopa and Duodopa is intended for DOPA decarboxylase United States Abbott Laboratories carbidopa the treatment of advanced inhibitor and dopamine Parkinson’s disease . prodrug E6014 Glutamine E6014 is intended for the — United States Eisai Inc . treatment of oral mucositis in patients receiving mucotoxic cancer therapy . EGP-437 Dexamethasone EGP-437 is intended for the Corticosteroid United States EyeGate phosphate treatment of dry eye . Pharmaceuticals Inc . ELI-154 Oxycodone ELI-154 is intended for the Narcotic analgesic United States Elite Pharmaceuticals Inc . treatment of pain . ELI-216 Oxycodone ELI-216 is intended for the — United States Elite Pharmaceuticals Inc . hydrochloride treatment of opioid abuse . Elidel Pimecrolimus Elidel is intended for the Calcineurin inhibitor United States Developer: Novartis treatment of atopic dermatitis in Pharmaceuticals Corp .; infants under 2 years old . Marketer: Valeant Pharmaceuticals International Inc . Eralese Ingenol mebutate Eralese is intended for the topical — United States Leo Pharma Inc . treatment of actinic keratosis .

Source: eKnowledgeBase.com 30 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Eylea Aflibercept Eylea is intended for the Vascular endothelial United States Developer: Regeneron treatment of central retinal vein growth factor Pharmaceuticals Inc . occlusion . and Bayer HealthCare Pharmaceuticals Inc ;. Marketer: Regeneron Pharmaceuticals Inc . Eylea Aflibercept Eylea is intended for the Vascular endothelial European Union Developer: Regeneron treatment of central retinal vein growth factor Pharmaceuticals Inc . occlusion . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial European Union Developer: Regeneron treatment of diabetic macular growth factor Pharmaceuticals Inc . edema . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial Japan Developer: Regeneron treatment of diabetic macular growth factor Pharmaceuticals Inc . edema . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial Australia Developer: Regeneron treatment of diabetic macular growth factor Pharmaceuticals Inc . edema . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial European Union Developer: Regeneron treatment of myopic choroidal growth factor Pharmaceuticals Inc . neovascularization . and Bayer HealthCare Pharmaceuticals; Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial Japan Developer: Regeneron treatment of patients with growth factor Pharmaceuticals Inc . choroidal neovascularisation and Bayer HealthCare of the retina as a result of Pharmaceuticals; pathologic myopia . Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial China Developer: Regeneron treatment of patients with growth factor Pharmaceuticals Inc . choroidal neovascularisation and Bayer HealthCare of the retina as a result of Pharmaceuticals; pathologic myopia . Marketer: Bayer HealthCare Pharmaceuticals Eylea Aflibercept Eylea is intended for the Vascular endothelial Taiwan Developer: Regeneron treatment of patients with growth factor Pharmaceuticals Inc . choroidal neovascularisation and Bayer HealthCare of the retina as a result of Pharmaceuticals; pathologic myopia . Marketer: Bayer HealthCare Pharmaceuticals FC Patch Low Ethinyl estradiol and FC Patch Low is intended for the Contraceptives United States Bayer HealthCare gestodene prevention of pregnancy . Pharmaceuticals Inc . FC Patch Low Ethinyl estradiol and FC Patch Low is intended for the Contraceptives European Union Bayer HealthCare gestodene prevention of pregnancy . Pharmaceuticals Femprox Alprostadil Femprox is intended for the Prostaglandin E1 United States Apricus Biosciences Inc . treatment of female sexual vasodilator arousal disorder . Fentanyl Taifun Fentanyl Fentanyl Taifun is intended for Narcotic analgesic United States Akela Pharma Inc . the treatment of breakthrough cancer pain .

Source: eKnowledgeBase.com 31 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Fentos Tape Fentanyl citrate Fentos Tape is intended for the Narcotic analgesic Japan Developer: Kyowa Hakko relief of non-malignant chronic Kirin Co ;. Marketer: Kyowa pain . Hakko Kirin Co . and Hisamitsu Pharmaceutical Inc . Flagyl Metronidazole Flagyl 375 is intended for the Antiprotozoal Japan Shionogi & Co . treatment of bacteria vaginosis . FP 1097 — FP 1097 is intended for the — United States FemmePharma Global treatment of women suffering Healthcare Inc . from overactive bladder . FP 1097 — FP 1097 is intended for the — United States FemmePharma Global treatment of women suffering Healthcare Inc . from urinary incontinence . HOB-294 Oxybutynin hydrochloride HOB-294 is intended for the — Japan Hisamitsu Pharmaceutical treatment of overactive bladder . Inc . HTU-520 Terbinafine hydrochloride HTU-520 is intended for the — Japan Hisamitsu Pharmaceutical treatment of onychomycosis . Inc . IDP 108 — IDP 108 is intended for the — United States Valeant Pharmaceuticals treatment of fungal infection . International Inc . Intuniv Guanfacine Intuniv is intended for the Selective alpha-2A- European Union Shire Plc . hydrochloride treatment of attention deficit adrenergic receptor hyperactivity disorder . agonist Invega Paliperidone palmitate Invega is intended for the Benzisoxazole derivative European Union Developer: Johnson & treatment of schizophrenia in Johnson Pharmaceutical adolescent . Research & Development; Marketer: Janssen Pharmaceuticals Inc . IPX066 Carbidopa and IPX066 is intended for the — United States Impax Laboratories Inc . levodopa treatment of Parkinson’s disease . IPX066 Carbidopa and IPX066 is intended for the — European Union Developer: levodopa treatment of Parkinson’s disease . GlaxoSmithKline Plc . and Impax Laboratories Inc ;. Marketer: GlaxoSmithKline Plc . ITM-014 Lanreotide acetate ITM-014 is intended for the Somatostatin analog Japan Teijin Ltd . treatment of acromegaly . Ketotransdel Ketoprofen Ketotransdel is intended for the Non-steroidal anti- United States Transdel Pharmaceuticals treatment of acute pain . inflammatory drug Inc . KRP-108 — KRP-108 is intended for the Beta-3 agonist Japan Kyorin Pharmaceutical treatment of asthma . Co . KW-2246 Fentanyl citrate KW-2246 is intended for the Opioid receptor agonist Japan Kyowa Hakko Kirin Co . treatment of cancer pain . LCS — LCS is intended for prevention of Contraceptives European Union Bayer HealthCare pregnancy . Pharmaceuticals Levomilnacipran Levomilnacipran Levomilnacipran is intended for Norepinephrine and United States Forest Laboratories Inc . the treatment of depression . serotonin reuptake inhibitor Levomilnacipran Levomilnacipran Levomilnacipran is intended Norepinephrine and Canada Forest Laboratories Inc . for the treatment of major serotonin reuptake depressive disorder . inhibitor Lialda Mesalamine Lialda is intended for the Aminosalicylate United States Shire US Inc . treatment of diverticulitis . LibiGel Testosterone LibiGel is intended for the Hormone therapy United States BioSante Pharmaceuticals treatment of female sexual Inc . dysfunction, specifically hypoactive sexual desire disorder in naturally menopausal women and surgically menopausal women . LibiGel Testosterone LibiGel is intended for the Hormone therapy United States BioSante Pharmaceuticals treatment of myocardial Inc . infarction and stroke in women with female sexual dysfunction 50 years of age or older . Liraglutide Liraglutide Liraglutide is intended for the Glucagon-like peptide-1 European Union Novo Nordisk AS treatment of obesity in non- diabetic patients .

Source: eKnowledgeBase.com 32 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Livatag Doxorubicin Livatag is intended for the — European Union BioAlliance Pharma SA treatment of hepatocellular carcinoma . Lixiana Edoxaban Lixiana is intended for the Factor Xa inhibitor United States Daiichi Sankyo Inc . prevention of stroke in atrial fibrillation . Lixiana Edoxaban Lixiana is intended for the Factor Xa inhibitor European Union Daiichi Sankyo Co . prevention of stroke in atrial fibrillation . Lixiana Edoxaban Lixiana is intended for the Factor Xa inhibitor European Union Daiichi Sankyo Co . treatment and prevention of recurrent venous thromboembolism . Lixiana Edoxaban Lixiana is intended for the Factor Xa inhibitor Japan Daiichi Sankyo Co . treatment and prevention of recurrent venous thromboembolism . Locilex Pexiganan acetate Locilex is intended for the Antimicrobial peptide United States Dipexium treatment of diabetic foot ulcers . Pharmaceuticals LLC Marqibo Vincristine sulfate Marqibo is intended for the Vinca alkaloid United States Talon Therapeutics Inc . treatment of adult patients in relapsed Philadelphia chromosome negative acute lymphoblastic leukemia . MEDI-3250 Live, attenuated, MEDI-3250 is intended for the Preventive vaccine United States MedImmune Inc . influenza virus vaccine prevention of seasonal influenza . (quadrivalent) Melphalan Melphalan Melphalan is intended for Alkylating agent United States Delcath Systems Inc . the treatment of cutaneous melanoma . Melphalan Melphalan Melphalan is intended for the Alkylating agent United States Delcath Systems Inc . treatment of ocular melanoma metastatic to the liver . Mezavant Mesalazine Mezavant is intended for the 5-aminosalicylic acid European Union Shire Plc . treatment of diverticulitis . Midazolam Midazolam Midazolam is intended for the Benzodiazepine United States Upsher-Smith Laboratories treatment of epileptic patients Inc . who experience episodic seizure clusters, sometimes referred to as acute repetitive seizures . Misodel Misoprostol Misodel is intended for the — United States Cytokine induction of labor . PharmaSciences Inc . MK-0524A Niacin and laropiprant MK-0524A is intended for Niacin combined with a United States Merck & Co . treatment of atherosclerosis . novel flushing pathway inhibitor MK-3641 — MK-3641 is intended for the Therapeutic vaccine United States Merck & Co . treatment of ragweed allergies . MK-7243 Lyophilisate MK-7243 is intended for the Therapeutic vaccine United States Merck & Co . treatment of grass pollen allergies in children and adolescents aged 5 to 17 years old . MoxDuoIR Morphine and MoxDuoIR is intended for the Opioid analgesic European Union QRxPharma Pty Ltd . oxycodone treatment of moderate to severe pain . MoxDuoIR Morphine and MoxDuoIR is intended for the Opioid analgesic United States QRxPharma Pty Ltd . oxycodone treatment of moderate to severe postoperative pain in patients following total knee replacement surgery . Neupro Rotigotine Neupro is intended for the Dopamine D2 receptor Japan Otsuka Pharmaceutical treatment of Parkinson disease . agonist Co . Neupro Rotigotine Neupro is intended for the Dopamine D2 receptor Japan Otsuka Pharmaceutical treatment of restless legs agonist Co . syndrome . Nucynta ER Tapentadol hydrochloride Nucynta ER is intended for the Mu-opioid receptor United States Developer: Johnson & treatment of diabetic peripheral agonism and Johnson Pharmaceutical neuropathy . norepinephrine reuptake Research & Development inhibitor and Grunenthal GMBH; Marketer: Janssen Pharmaceuticals Inc .

Source: eKnowledgeBase.com 33 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer NVA237 Glycopyrronium bromide NVA237 is intended for the Long acting muscarinic United States Novartis Pharmaceuticals treatment of chronic obstructive antagonist Corp . pulmonary disease . NX-1207 — NX-1207 is intended for the — United States Nymox Pharmaceutical treatment of benign prostatic Corp . hyperplasia . NX-1207 — NX-1207 is intended for the — European Union Recordati SpA treatment of benign prostatic hyperplasia . Ocriplasmin Microplasmin Ocriplasmin is intended for Thrombolytic agent United States ThromboGenics Ltd . the non-surgical treatment of vitreomacular adhesion . Octreotide Implant Octreotide Octreotide Implant is intended Synthetic peptide United States Endo Pharmaceuticals for the treatment of acromegaly . Inc . Octreotide Implant Octreotide Octreotide Implant is intended Synthetic peptide European Union Endo Pharmaceuticals for the treatment of acromegaly . Inc . Oral Treprostinil Treprostinil sodium Oral Treprostinil is intended for the Prostacyclin analog United States United Therapeutics Corp . treatment of pulmonary arterial hypertension Oralair Grasses — Oralair Grasses is intended for Therapeutic vaccine United States Stallergenes the treatment of grass pollen allergies . Oral-lyn Insulin Oral-lyn is intended for the Insulin United States Generex Biotechnology treatment of type 1 diabetes Corp . mellitus . Oral-lyn Insulin Oral-lyn is intended for the Insulin European Union Generex Biotechnology treatment of type 1 diabetes Corp . mellitus . Oral-lyn Insulin Oral-lyn is intended for the Insulin Canada Generex Biotechnology treatment of type 1 diabetes Corp . mellitus . Oral-lyn Insulin Oral-lyn is intended for the Insulin Canada Generex Biotechnology treatment of type 2 diabetes . Corp . Ozurdex Dexamethasone Ozurdex is intended for the Synthetic adrenocortical United States Allergan Inc . treatment of diabetic macular steroid edema . PA32540 Aspirin and omeprazole PA32540 is intended for — United States Pozen Inc . secondary CV/stroke prevention . PA32540 Aspirin and omeprazole PA32540 is intended to reduce — United States Pozen Inc . gastrointestinal side effects and complications compared to a nonsteroidal anti-inflammatory drug or enteric coated aspirin taken alone . Probuphine Buprenorphine and Probuphine is intended for — United States Titan Pharmaceuticals ethylene vinyl acetate the treatment of opioid Inc . dependence . Progestin Only Patch — Progestin Only Patch is intended Contraceptives United States Watson Pharmaceuticals for the prevention of pregnancy . Inc . Provecta — Provecta is intended for the — Australia Provectus treatment of metastatic Pharmaceuticals Inc . melanoma . PSD502 Lidocaine and prilocaine PSD502 is intended for the — United States Developer: Shionogi Inc . treatment of premature and Plethora Solutions ejaculation . Holding Plc ;. Marketer: Shionogi Inc . PSD502 Lidocaine and prilocaine PSD502 is intended for the — European Union Developer: Shionogi Inc . treatment of premature and Plethora Solutions ejaculation . Holdings Plc ;. Marketer: Shionogi Inc . Qnaze Beclomethasone Qnaze is intended for the Corticosteroid United States Teva Pharmaceuticals dipropionate treatment of seasonal allergic USA Inc . rhinitis . Qutenza Capsaicin Qutenza is intended for the TRVR-1 channel agonist United States NeurogesX Inc . treatment of HIV-associated distal sensory polyneuropathy . QVA149 Indacaterol and QVA149 is intended for the Long-acting beta 2 United States Novartis Pharmaceuticals glycopyrronium bromide treatment of chronic obstructive agonist and long-acting Corp . pulmonary disease . muscarinic antagonist

Source: eKnowledgeBase.com 34 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Relovair Fluticasone furoate and Relovair is intended for the Glucocorticoid agonist United States Developer: vilanterol trifenatate treatment of chronic obstructive and long acting beta2 GlaxoSmithKline Inc . pulmonary disease . agonist and Theravance Inc ;. Marketer: GlaxoSmithKline Inc . Relovair Fluticasone furoate and Relovair is intended for the Glucocorticoid agonist European Union Developer: vilanterol trifenatate treatment of chronic obstructive and long acting beta2 GlaxoSmithKline Plc . pulmonary disease . agonist and Theravance Inc ;. Marketer: GlaxoSmithKline Plc . Remura Bromfenac Remura is intended for the Non-steroidal anti- United States Ista Pharmaceuticals Inc . treatment of dry eye disease . inflammatory drug RP103 Cysteamine bitartrate RP103 is intended for the — United States Raptor Pharmaceutical treatment of nephropathic Corp . cystinosis . RP103 Cysteamine bitartrate RP103 is intended for the — European Union Raptor Pharmaceutical treatment of nephropathic Corp . cystinosis . SAR1118 — SAR1118 is intended for the Leukocyte function- United States SARcode Corp . treatment of dry eye . associated antigen-1 inhibitor Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte European Union Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd . protoporphyria . Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte Australia Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd . protoporphyria . Ser-120 — Ser-120 intended for the — United States Allergan Inc . treatment of nocturia . Serada Gabapentin Serada is intended for the — United States DepoMed Inc . treatment of moderate to severe menopausal hot flashes . Sitavir Acyclovir Sitavir is intended for the — United States BioAlliance Pharma SA treatment of oral herpes (labial herpes) . SMC021 Salmon calcitonin SMC021 is intended for the Osteoclast activity United States Novartis Pharmaceuticals treatment of osteoporosis . inhibitor Corp . Somatuline Autogel Lanreotide acetate Somatuline Autogel is Somatostatin analog United States Developer: Ipsen Inc .; intended for the treatment of Marketer: Tercica Inc . neuroendocrine tumors . Somatuline Autogel Lanreotide acetate Somatuline Autogel is Somatostatin analog European Union Developer: Ipsen Inc .; intended for the treatment of Marketer: Tercica Inc . neuroendocrine tumors . SR-rhGH — SR-rhGH is intended for the — United States Developer: Biopartners treatment of growth hormone GmbH and LG Life deficiency in children and adults . Sciences Ltd ;. Marketer: Biopartners GmbH SR-rhGH — SR-rhGH is intended for the — European Union Developer: Biopartners treatment of growth hormone GmbH and LG Life deficiency in children and adults . Sciences Ltd ;. Marketer: Biopartners GmbH Stimuvax — Stimuvax is intended for the Therapeutic vaccine United States EMD Serono Inc . treatment of non-small cell lung cancer . Stimuvax — Stimuvax is intended for the Therapeutic vaccine European Union Merck Serono SA treatment of non-small cell lung cancer . TDT-067 Terbinafine TDT-067 is intended for the Antifungal United States Celtic Pharmaceutical treatment of onychomycosis . Holdings L .P . TDT-067 Terbinafine TDT-067 is intended for the Antifungal European Union Celtic Pharmaceutical treatment of onychomycosis . Holdings L .P . ThermoDox Doxorubicin ThermoDox, in combination — Japan Yakult Honsha Co . with radio-frequency ablation, is intended for the treatment of liver cancer . ThermoDox Doxorubicin ThermoDox, in combination — United States Celsion Corp . with radio-frequency ablation, is intended for the treatment of non-resectable liver cancer .

Source: eKnowledgeBase.com 35 Phase III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Tiotropium/Olodaterol Tiotropium bromide and Tiotropium/Olodaterol Long-acting muscarinic Germany Boehringer Ingelheim Combination olodaterol Combination is intended for the antagonist and Long- GmbH treatment of chronic obstructive acting beta-2 agonist pulmonary disease . Tobi Podhaler Tobramycin Tobi Podhaler is intended for Aminoglycoside antibiotic United States Novartis Pharmaceuticals the treatment of Pseudomonas Corp . aeruginosa infections infection in cystic fibrosis patients . Tofacitinib Topical Tofacitinib Tofacitinib is intended for the Janus kinase 3 inhibitor United States Pfizer Inc . treatment of psoriasis . Topiramate Topiramate Topiramate is intended as adjunctive treatment of patients 18 to 75 years old with refractory partial-onset seizures with or without secondary generalized seizures . — United States Upsher-Smith Laboratories Inc . Urocidin Mycobacterial cell wall- Urocidin is intended for the Biological response United States Endo Pharmaceuticals DNA complex treatment of refractory non- modifier Inc . muscle invasive bladder cancer . Urocidin Mycobacterial cell wall- Urocidin is intended for the Biological response Canada Endo Pharmaceuticals DNA complex treatment of refractory non- modifier Inc . muscle invasive bladder cancer . Vaginorm Dehydroepiandrosterone Vaginorm is intended for the — European Union Bayer HealthCare treatment of female sexual Pharmaceuticals dysfunction in postmenopausal women . Vaginorm Dehydroepiandrosterone Vaginorm is intended for the — European Union Bayer HealthCare treatment of female sexual Pharmaceuticals dysfunction in postmenopausal women . Varisolve — Varisolve is intended for the — United States BTG International Inc . treatment of vericose veins . Varisolve — Varisolve is intended for the — European Union BTG International Inc . treatment of vericose veins . Vekacia Cyclosporine A Vekacia is intended for Cyclosporine A cationic United States Novagali Pharma the treatment of vernal emulsion keratoconjunctivitis . Zaltrap Aflibercept Zaltrap, in combination with Vascular endothelial United States Developer/ 5-fluorouracil, leucovorin and growth factor Marketer: Regeneron irinotecan, is intended as second- Pharmaceuticals Inc . and line treatment for metastatic Sanofi colorectal cancer . Zaltrap Aflibercept Zaltrap, in combination with Vascular endothelial European Union Developer/ 5-fluorouracil, leucovorin and growth factor Marketer: Regeneron irinotecan, is intended as second- Pharmaceuticals Inc . and line treatment for metastatic Sanofi colorectal cancer . Zenhale Momestasone furoate Zenhale is intended for the Beta 2 adrenergic agonist European Union Merck & Co . and formoterol fumarate treatment of chronic obstructive and corticosteroid pulmonary disease . ZX002 Hydrocodone ZX002 is intended for the Narcotic analgesic United States Zogenix Inc . treatment of chronic pain .

Phase II/III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer ADS-5102 Amantadine ADS-5102 is intended for the — United States Adamas Pharmaceuticals hydrochloride treatment of levodopa induced Inc . dyskinesia in patients with Parkinson’s disease . Aerosolized AAT Alpha-1antitrypsin Aerosolized AAT is intended for Alpha 1 proteinase European Union Kamada Ltd . the treatment of patients with inhibitor alpha-1 antitrypsin deficiency .

Source: eKnowledgeBase.com 36 Phase II/III — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer DE-102 Betamethasone DE-102 is intended for the — Japan Developer: Santen treatment of diabetic macular Pharmaceutical Co . and edema . Oakwood Laboratories LLC; Marketer: Santen Pharmaceutical Co . Livatag Doxorubicin Livatag is intended for the — United States BioAlliance Pharma SA treatment of hepatocellular carcinoma . NVD-201 Sumatriptan succinate Sumatriptan Oral Spray is 5-HT receptor agonist United States NovaDel Pharma Inc . intended for the treatment of migraine headaches . Sufentanil Transdermal Sufentanil Sufentanil Transdermal Patch is — European Union Developer: Labtec GmbH Patch intended to provide extended and Hameln rds GmbH; chronic pain relief for several Marketer: Labtec GmbH days .

Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer 256066 — 256066 is intended for the Phosphodiesterase type United States GlaxoSmithKline Inc . treatment of chronic obstructive 4 inhibitor pulmonary disease . 705498 — 705498 is intended for the Transient receptor United States GlaxoSmithKline Inc . treatment of non-allergic rhinitis . potential vanilloid (TRPV1) antagonist 870086 — 870086 is intended for the Novel glucocorticoid United States GlaxoSmithKline Inc . treatment of asthma . agonist 870086 — 870086 is intended for the Novel glucocorticoid United States GlaxoSmithKline Inc . treatment of atopic dermatitis . agonist 961081 — 961081 is intended for the Muscarinic antagonist South Africa GlaxoSmithKline Inc . treatment of moderate to severe and beta2 agonist chronic obstructive pulmonary disease . AEN-100 Zinc AEN-100, in combination with — United States Adeona Pharmaceuticals AEN-200, is intended for the Inc . treatment of amyotrophic lateral sclerosis . Aerosolized AAT Alpha-1antitrypsin Aerosolized AAT is intended for Alpha 1 proteinase Israel Kamada Ltd . the treatment of bronchiectasis . inhibitor Aerosolized AAT Alpha-1antitrypsin Aerosolized AAT is intended for Alpha 1 proteinase European Union Kamada Ltd . the treatment of cystic fibrosis . inhibitor Aerovant — Aerovant is intended for the Recombinant human IL-4 United States Aerovance Inc . treatment of asthma . variant Aerovant — Aerovant is intended for the Recombinant human IL-4 European Union Aerovance Inc . treatment of asthma . variant Afimoxifene Afimoxifene Afimoxifene is intended for the — United States Developer: BHR Pharma treatment of cyclic breast pain, LLC; Marketer: Ascend also known as cyclical mastalgia . Therapeutics Inc . AG900 Progestin AG900 is intended for the Contraceptives United States Agile Therapeutics Inc . prevention of pregnancy in women desiring contraception who are breast-feeding . AG900 Progestin AG900 is intended for the Contraceptives United States Agile Therapeutics Inc . prevention of pregnancy in women where estrogen containing contraceptives are contraindicated, inappropriate or unwanted . ALN-RSV01 — ALN-RSV01 is intended for — United States Developer/Marketer: the treatment of adult lung- Alnylam Pharmaceuticals transplant patients naturally Inc . and Cubist infected with respiratory syncytial Pharmaceuticals Inc . virus .

37 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Amikacin Inhale Amikacin Amikacin Inhale is intended — United States Developer/Marketer: as adjunctive treatment of Nektar Therapeutics Gram-negative pneumonia in and Bayer HealthCare intubated and mechanically- Pharmaceuticals Inc . ventilated patients . Amikacin Inhale Amikacin Amikacin Inhale is intended — European Union Developer: Nektar as adjunctive treatment of Therapeutics and Gram-negative pneumonia in Bayer HealthCare intubated and mechanically- Pharmaceuticals; ventilated patients . Marketer: Bayer HealthCare Pharmaceuticals AmiKet Amitriptyline and AmiKet is intended for the relief Tricyclic antidepressant ketamine of pain associated with diabetic and dissociative peripheral neuropathy . anesthetic United States EpiCept Corp . AmiKet Amitriptyline and AmiKet is intended for the relief Tricyclic antidepressant ketamine of pain associated with neuralgia and dissociative due to of chemotherapy . anesthetic United States EpiCept Corp . AmiKet Amitriptyline and AmiKet is intended for the relief Tricyclic antidepressant ketamine of pain associated with post- and dissociative herpetic neuralgia . anesthetic United States EpiCept Corp . AN2728 — AN2728 is intended for the Phosphodiesterase 4 United States Anacor Pharmaceuticals treatment of mild to moderate enzyme inhibitor Inc . plaque type psoriasis . APF112 Mepivacaine APF 112 is intended for the relief Local anesthetic United States A .P . Pharma Inc . of postsurgical pain . Arbaclofen placarbil Arbaclofen placarbil Arbaclofen placarbil is intended — United States XenoPort Inc . for the adjunctive treatment of gastroesophageal reflux disease . ARC-4558 Clonidine hydrochloride ARC-4558 is intended for the — United States Arcion Therapeutics Inc . treatment of pain associated with painful diabetic neuropathy . Arikace Liposomal amikacin Arikace is intended for the Antibiotic European Union Insmed Inc . treatment of pseudomonas aeruginosa lung infections in cystic fibrosis patients . Arikace Liposomal amikacin Arikace is intended for the Antibiotic United States Insmed Inc . treatment of Pseudomonas aeruginsa lung infections in non-cystic fibrosis patients with bronchiectasis . ARX-01 — ARX-01 is intended for the Analgesic United States AcelRx Pharmaceuticals treatment of moderate-to-severe Inc . inpatient acute pain following knee replacement surgery . ARX-02 Sufentanil ARX-02 is intended for the Narcotic analgesic United States AcelRx Pharmaceuticals treatment of breakthrough Inc . cancer pain . ARX-03 Sufentanil and triazolam ARX-03 is intended to provide — United States AcelRx Pharmaceuticals sedation and analgesia for the Inc . treatment of procedural pain and anxiety . Asacol Mesalamine Asacol is intended for the — Japan Developer/Marketer: treatment of Crohn’s disease . Zeria Pharmaceutical Co . and Kyowa Hakko Kirin Co . ASC-J9 — ASC-J9 is intended for the Antiandrogen United States Developer: AndroScience treatment of acne vulgaris . Corp . and Orient Europharma Co .; Marketer: AndroScience Corp . ASC-J9 — ASC-J9 is intended for the Antiandrogen Taiwan Developer: AndroScience treatment of acne vulgaris . Corp . and Orient Europharma Co .; Marketer: Orient Europharma Co .

Source: eKnowledgeBase.com 38 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer ASM-024 — ASM-024 is intended for the — Canada Asmacure Ltee treatment of asthma . ASM8 — ASM8 is intended for the Inhaled anti-inflammatory Canada Pharmaxis Ltd . treatment of asthma . drug AZD3199 — AZD3199 is intended for the Inhaled long-acting United States AstraZeneca treatment of asthma . beta2 agonist Pharmaceuticals LP AZD3199 — AZD3199 is intended for the Inhaled long-acting European Union AstraZeneca treatment of asthma . beta2 agonist Pharmaceuticals LP AZD3199 — AZD3199 is intended for the Inhaled long-acting United States AstraZeneca treatment of chronic obstructive beta2 agonist Pharmaceuticals LP pulmonary disease . AZD3199 — AZD3199 is intended for the Inhaled long-acting European Union AstraZeneca treatment of chronic obstructive beta2 agonist Pharmaceuticals LP pulmonary disease . AZD5423 — AZD5423 is intended for the iSEGRA United States AstraZeneca treatment of chronic obstructive Pharmaceuticals LP pulmonary disease . AZD5423 — AZD5423 is intended for the iSEGRA European Union AstraZeneca treatment of chronic obstructive Pharmaceuticals LP pulmonary disease . Aztreonam Aztreonam Aztreonam is intended for the Monobactam antibiotic United States Gilead Sciences Inc . treatment of bronchiectasis BC-819 — BC-819 is intended for the — United States BioCancell Therapeutics treatment of pancreatic cancer . Inc . BC-819 — BC-819 is intended for the — United States BioCancell Therapeutics treatment of superficial bladder Inc . carcinoma . BC-819 — BC-819 is intended for the — Israel BioCancell Therapeutics treatment of superficial bladder Inc . carcinoma . Bepotastine Besilate Bepotastine Besilate Bepotastine Besilate is intended Histamine H1 receptor United States Ista Pharmaceuticals Inc . for the treatment of symptoms antagonist associated with seasonal allergic rhinitis . Beraprost-MR Beraprost Beraprost-MR is intended for the Prostacyclin receptor United States United Therapeutics Corp . treatment of pulmonary arterial stimulator hypertension Bimosiamose Bimosiamose Bimosiamose is intended for the Selectin antagonist European Union Revotar treatment of asthma . Biopharmaceuticals AG Bimosiamose Bimosiamose Bimosiamose is intended for the Selectin antagonist European Union Revotar treatment of chronic obstructive Biopharmaceuticals AG pulmonary disease . BIO-11006 — BIO-11006 is intended for the — United States BioMarck treatment of chronic obstructive Pharmaceuticals Ltd . pulmonary disease . Bremelanotide Bremelanotide Bremelanotide is intended for Melanocortin receptor United States Palatin Technologies Inc . the treatment of premenopausal agonist women with female sexual dysfunction . Catioprost Latanoprost Catioprost is intended for the — United States Novagali Pharma treatment of glaucoma . CB-03-01 — CB-03-01 is intended for the Androgen receptor United States Cosmo Pharmaceuticals treatment of acne . antagonist SpA CB-03-01 — CB-03-01 is intended for the Androgen receptor United States Cosmo Pharmaceuticals treatment of alopecia . antagonist SpA Cevira — Cevira is intended for the non- — United States PhotoCure ASA surgical treatment of cervical HPV infection and precancerous lesions of the cervix . Cevira — Cevira is intended for the non- — European Union PhotoCure ASA surgical treatment of cervical HPV infection and precancerous lesions of the cervix . Cipro Inhaler Ciprofloxacin Cipro Inhaler is intended for the

Source: eKnowledgeBase.com 39 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer treatment of chronic Quinolone antibiotic United States Developer: Bayer lung infection caused by HealthCare Pseudomonas aeruginosa Pharmaceuticals Inc . in cystic fibrosis patients . and Nektar Therapeutics; Marketer: Merck & Co . CPX-1 Irinotecan and floxuridine CPX-1 is intended for the — United States Celator Pharmaceuticals treatment of colorectal cancer . Inc . CPX-351 Cytarabine and CPX-351 is intended for the — United States Celator Pharmaceuticals danorubicin treatment of newly diagnosed Inc . acute myeloid leukemia in patients between 60 and 75 years old . CPX-351 Cytarabine and CPX-351 is intended for the — United States Celator Pharmaceuticals danorubicin treatment of patients up to 60 Inc . years old with acute myeloid leukemia in first relapse . CRLX101 Camptothecin CRLX101 is intended for the — United States Cerulean Pharma Inc . treatment of advanced cancer . CRLX101 Camptothecin CRLX101 is intended for the — United States Cerulean Pharma Inc . treatment of non-small cell lung cancer . CRLX101 Camptothecin CRLX101 is intended for the — United States Cerulean Pharma Inc . treatment of solid tumors . CT327 — CT327 is intended for the TrkA inhibitor Switzerland Creabilis SA treatment of atopic dermatitis . CT327 — CT327 is intended for the TrkA inhibitor Denmark Creabilis SA treatment of neuropathic pain . CT327 — CT327 is intended for the TrkA inhibitor United States Creabilis SA treatment of psoriasis . CT327 — CT327 is intended for the TrkA inhibitor European Union Creabilis SA treatment of psoriasis . Davunetide Davunetide Davunetide is intended for the — United States Allon Therapeutics Inc . treatment of Alzheimer’s disease . Davunetide Davunetide Davunetide is intended for the — United States Allon Therapeutics Inc . treatment of schizophrenia . Deovo — Deovo is intended for the — United States Hatchtech Pty Ltd treatment of head lice . Diabecell — Diabecell is intended for the Insulin secretion enhancer New Zealand Living Cell Technologies treatment of type 1 diabetes . Ltd Dipraglurant Dipraglurant Dipraglurant is intended for the Metabotropic glutamate European Union Addex Pharmaceuticals treatment of Parkinson’s disease receptor 5 negative SA levadopa induced dyskinesia . allosteric modulator E6005 — E6005 is intended for the Phosphodiesterase 4 European Union Eisai Co . treatment of atopic dermatitis . inhibitor EGP-437 Dexamethasone EGP-437 is intended for the — United States EyeGate phosphate treatment of anterior uveitis . Pharmaceuticals Inc . EISO — EISO is intended for the treatment — United States ViroXis Corp . of human papilloma virus skin warts . Eladur Bupivacaine Eladur is intended for the — United States Pfizer Inc . treatment of chronic lower back pain . Empatic SR Zonisamide Empatic SR is intended for the — United States Orexigen Therapeutics treatment of obesity . Inc . EndoTAG-1 — EndoTAG-1 is intended for the — United States MediGene AG treatment of pancreatic cancer . EndoTAG-1 — EndoTAG-1 is intended for the — European Union MediGene AG treatment of pancreatic cancer . EndoTAG-1 — EndoTAG-1 is intended for the — European Union MediGene AG treatment of triple receptor negative breast cancer . Enkephalin Enkephalin NP2 is intended for the treatment Gene therapy United States Diamyd Inc . of cancer pain . Eralese Ingenol mebutate Eralese is intended for the — United States Leo Pharma Inc . treatment of non-melanoma skin cancer .

Source: eKnowledgeBase.com 40 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Eylea Aflibercept Eylea is intended for the Vascular endothelial United States Developer: Regeneron treatment of diabetic macular growth factor Pharmaceuticals Inc . edema . and Bayer HealthCare Pharmaceuticals Inc ;. Marketer: Regeneron Pharmaceuticals Inc . FOV1101 Prednisolone and FOV1101 is intended for — United States Sanofi cyclosporine the treatment of allergic conjunctivitis . FOV1101 Prednisolone and FOV1101 is intended for — European Union Sanofi SA cyclosporine the treatment of allergic conjunctivitis . FOV2302 — FOV2302 is intended for the Plasma kallikrein inhibitor European Union Developer: Sanofi SA and treatment of retinal vein Dyax Corp ;. Marketer: occlusion induced macular Sanofi SA edema . HIV Vaccine — HIV Vaccine is intended for the Therapeutic vaccine United States Vical Inc . treatment of HIV infection . HP-3000 — HP-3000 is intended for the — Japan Hisamitsu Pharmaceutical treatment of Parkinson’s disease . Inc . HP802-247 — HP802-247 is intended for the — United States Healthpoint Ltd . treatment of venous leg ulcers . HTU-520 Terbinafine hydrochloride HTU-520 is intended for the — United States Hisamitsu Pharmaceutical treatment of onychomycosis . Inc . Iluvien Fluocinolone acetonide Iluvien is intended for the Corticosteroid United States Developer/Marketer: treatment of dry age-related Alimera Sciences Inc . and macular degeneration . pSivida Ltd . Iluvien Fluocinolone acetonide Iluvien is intended for the Corticosteroid United States Developer/Marketer: treatment of retinal vein Alimera Sciences Inc . and occlusion . pSivida Ltd . Iluvien Fluocinolone acetonide Iluvien is intended for the Corticosteroid United States Developer/Marketer: treatment of wet age-related Alimera Sciences Inc . and macular degeneration . pSivida Ltd . INO-8875 — INO-8875 is intended for the Adenosine A1 receptor United States Inotek Pharmaceuticals treatment of glaucoma . antagonist Corp . IOP Lowering SR — IOP Lowering SR is intended for — United States Allergan Inc . the treatment of glaucoma . ITCA 650 Exenatide ITCA 650 is intended for the Glucagon-like peptide-1 United States Developer: Intarcia treatment of type 2 diabetes . receptor agonist Therapeutics Inc . and Quintiles Laboratories Ltd ;. Marketer: Intarcia Therapeutics Inc . Jakafi Ruxolitinib Jakafi is intended for the JAK1/JAK2 inhibitor United States Incyte Corp . treatment of psoriasis . LAS100977 — LAS100977 is intended for the Long acting beta2 European Union Laboratorios Almirall S .A . treatment of asthma . agonist LAS100977 (LABA) — LAS100977 (LABA) is intended for Long acting beta2 United States Developer: Forest the treatment of asthma . agonist Laboratories Inc . and Laboratorios Almirall S .A ;. Marketer: Forest Laboratories Inc . LAS100977 (LABA) — LAS100977 is intended for the Long acting beta2 United States Developer: Forest treatment of chronic obstructive agonist Laboratories Inc . and pulmonary disease . Laboratorios Almirall S .A ;. Marketer: Forest Laboratories Inc . Lipoquin Ciprofloxacin Lipoquin is intended for the — United States Aradigm Corp . treatment of cystic fibrosis . Lipoquin Ciprofloxacin Lipoquin is intended for the — European Union Aradigm Corp . treatment of cystic fibrosis . Lipoquin Ciprofloxacin Lipoquin is intended for the — United States Aradigm Corp . treatment of patients with non- cystic fibrosis bronchiectasis . Locteron Alfa interferon Locteron is intended for the — United States Biolex Therapeutics Inc . treatment of chronic hepatitis C virus . Locteron Alfa interferon Locteron is intended for — European Union Biolex Therapeutics Inc . the treatment of previously untreated chronic hepatitis C .

Source: eKnowledgeBase.com 41 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Lodotra Prednisone Lodotra is intended for the Circadian cytokine United States Horizon Pharma Inc . treatment of polymyalgia modulator rheumatica . LT-02 Phosphatidylcholine LT-02 is intended for the — Germany Lipid Therapeutics GmbH treatment of mesalazine- refractory ulcerative colitis . Luliconazole Luliconazole Luliconazole is intended for the Imidiazole antifungal United States Topica Pharmaceuticals treatment of onychomycosis . Inc . MAP0005 — MAP0005 is intended for the Corticosteroid and long- United States MAP Pharmaceuticals treatment of asthma . acting beta 2 agonist Inc . MAP0005 — MAP0005 is intended for the Corticosteroid and long- United States MAP Pharmaceuticals treatment of chronic obstructive acting beta 2 agonist Inc . pulmonary disease . Marqibo Vincristine sulfate Marqibo is intended as front-line Vinca alkaloid United States Talon Therapeutics Inc . for the treatment of elderly patients with Philadelphia chromosome negative acute lymphoblastic leukemia . Marqibo Vincristine sulfate Marqibo is intended for the Vinca alkaloid United States Talon Therapeutics Inc . first-line treatment of aggressive non-Hodgkin’s lymphoma . Melphalan Melphalan Melphalan is intended for the Alkylating agent United States Delcath Systems Inc . treatment of unresectable liver cancer . MG01CI Metadoxine MG01CI is intended for the — Israel Developer: Teva treatment of adults with attention Pharmaceutical Industries deficit hyperactivity disorder . Ltd . and Alcobra Ltd ;. Marketer: Teva Pharmaceutical Industries Ltd . MQX-5902 Methotrexane MQX-5902 is intended for the — United Kingdom MediQuest Therapeutics treatment nail psoriasis . Inc . MRX-4 — MRX-4 is intended for the Anti-inflammatory European Union Morria treatment of allergic rhinitis . Biopharmaceuticals Plc . MRX6 — MRX6 is intended for the Anti-inflammatory Israel Morria treatment of contact dermatitis . Biopharmaceuticals Plc . Multaq Dronedarone Multaq is intended for the Calcium channel blocker Japan Sanofi SA treatment of patients with permanent atrial fibrillation . Naloxone Naloxone Naloxone is intended for the Short-lasting opioid Finland Lightlake Therapeutics treatment of binge eating in antagonist Inc . obese patients . Naloxone Naloxone Naloxone is intended for the Short-lasting opioid United Kingdom Lightlake Therapeutics treatment of bulimia nervosa . antagonist Inc . NanoDOX Doxycycline NanoDOX is intended for the — United States Nanotherapeutics Inc . treatment of dermal ulcers . NB-002 — NB-002 is intended for the — United States NanoBio Corp . treatment of onychomycosis . ND0801 — ND0801 is intended for the — Israel NeuroDerm Ltd . treatment of attention deficit disorder in adults . ND0801 — ND0801 is intended for the — Israel NeuroDerm Ltd . treatment of attention deficit hyperactivity disorder in adults . NestraGel Nestorone NestraGel, in combination with Contraceptives United States Antares Pharma Inc . estradiol, is intended for the prevention of pregnancy . Nexagon — Nexagon is intended for the Oligonucleotide United States CoDa Therapeutics Inc . treatment of patients with chronic venous leg ulcers . NGX-1998 Capsaicin NGX-1998 is intended for the — United States NeurogesX Inc . treatment of post-herpetic neuralgia . NH004 Tropicamide NH004 is intended for the Anticholinergic agent United States NeuroHealing treatment of sialorrhea in patients Pharmaceuticals Inc . with Parkinson disease . NKQ-01 Phentanyl NKQ-01 is intended for the relief Narcotic analgesic United States Nippon Kayaku Co . of cancer-related pain .

Source: eKnowledgeBase.com 42 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Norovirus VLP Vaccine — Norovirus VLP Vaccine Preventive vaccine United States LigoCyte Intranasal(Monovalent) Intranasal(Monovalent) is Pharmaceuticals Inc . intended for the prevention of Norovirus infection(stomach flu) . Novexatin — Novexatin is intended for the Antifungal United Kingdom NovaBiotics Ltd . treatment of nail fungus . NST-141 — NST-141 is intended for the — Japan Developer/Marketer: treatment of pruritus associated Nippon Shinyaku Co . and with atopic dermatitis . Taiho Pharmaceutical Co . NST-141 — NST-141 is intended for the — Japan Otsuka Pharmaceutical treatment of pruritus associated Co . with atopic dermatitis . NT-501 Ciliary neurotrophic factor NT-501 is intended for the Ciliary neurotrophic factor United States Neurotech USA Inc . treatment of retinitis pigmentosa . NT-501 Ciliary neurotrophic factor NT-501 is intended for the Ciliary neurotrophic factor United States Neurotech USA Inc . treatment of visual loss associated with the dry form of age related macular degeneration . NVC-422 — NVC-422 is intended for the Aganocide antimicrobial United States NovaBay prevention of urinary catheter Pharmaceuticals Inc . blockage and encrustation which is often a contributing factor to urinary tract infections in chronically catheterized patients . Ocriplasmin Microplasmin Ocriplasmin is intended for Thrombolytic agent United States ThromboGenics Ltd . induction of posterior vitreous detachment . Ocriplasmin Microplasmin Ocriplasmin is intended for — European Union ThromboGenics Ltd . the treatment of age-related macular degeneration . OncoGel Paclitaxel OncoGel is intended for the Taxane United States BTG International Inc . treatment of esophageal cancer . ONO-7165/ EMD531444 — ONO-7165/ EMD531444 is Therapeutic vaccine Japan Developer/Marketer: intended for the treatment of Merck Serono SA and non-small cell lung cancer . Ono Pharmaceutical Co . Oral Treprostinil Treprostinil sodium Oral Treprostinil is intended for the Prostacyclin analog United States United Therapeutics Corp . treatment of digital ulcers . Oral Treprostinil Treprostinil sodium Oral Treprostinil is intended for Prostacyclin analog United States United Therapeutics Corp . the treatment of pulmonary arterial hypertension in idiopathic pulmonary fibrosis . Pandemic Flu Vaccine — Pandemic Flu Vaccine Patch is Preventive vaccine United States Developer/Marketer: Patch intended for the prevention of Intercell AG and pandemic influenza . GlaxoSmithKline Inc . Pennsaid Diclofenac sodium Pennsaid is intended for the Nonsteroidal anti- United States Mallinckrodt treatment of pain, stiffness, inflammatory drug Pharmaceuticals and impaired physical function associated with osteoarthritis . PEP02 Irinotecan hydrochloride PEP02 is intended for second- — United States PharmaEngine Inc . line treatment of metastatic pancreatic cancer . PH94B — PH94B is intended for the Psychotropic United States Pherin Pharmaceuticals treatment of social phobia . vomeropherin Inc . ProLindac — ProLindac is intended for the DACH platinum polymer United States Access Pharmaceuticals treatment of ovarian cancer . Inc . ProLindac — ProLindac is intended for the DACH platinum polymer European Union Access Pharmaceuticals treatment of platinum sensitive Inc . ovarian cancer . ProLindac — ProLindac is intended for the DACH platinum polymer European Union Access Pharmaceuticals treatment of relapsed ovarian Inc . cancer . Provecta — Provecta is intended for the — United States Provectus treatment of Stage III and IV Pharmaceuticals Inc . metastatic melanoma . PT001 Glycopyrrolate PT001 is intended for the Long acting muscarinic United States Pearl Therapeutics Inc . hydrofluoroalkane treatment of chronic obstructive antagonist bronchodilator pulmonary disease .

Source: eKnowledgeBase.com 43 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer PT003 Glycopyrrolate and PT003 is intended for the — United States Pearl Therapeutics Inc . formoterol treatment of chronic obstructive pulmonary disease . PT005 Formoterol fumarate PT005 is intended for the — United States Pearl Therapeutics Inc . treatment of mild to severe chronic obstructive pulmonary disease . Pulmaquin Ciprofloxacin Ciprofloxacin is intended for the — United States Aradigm Corp . treatment of adult patients with non-cystic fibrosis bronchiectasis . Pulmaquin Ciprofloxacin Ciprofloxacin is intended for the — Australia Aradigm Corp . treatment of adult patients with non-cystic fibrosis bronchiectasis . PXL01 — PXL01 is intended for the — Sweden Pergamun AB prevention of post-surgical adhesions in patients undergoing hand surgery . QMF149 Indacaterol and QMF149 is intended for the Corticosteroid and long- United States Novartis Pharmaceuticals mometasone furoate treatment of asthma . acting beta 2 agonist Corp . QMF149 Indacaterol and QMF149 is intended for the Corticosteroid and long- United States Novartis Pharmaceuticals mometasone furoate treatment of chronic obstructive acting beta 2 agonist Corp . pulmonary disease . Qnexa Phentermine and Qnexa is intended for the — United States Vivus Inc . Topiramate treatment of type 2 diabetes . Reolysin — Reolysin, in combination with Therapeutic vaccine United States Oncolytics Biotech Inc . paclitaxel and carboplatin, is intended for the treatment of non-small cell lung cancer with K-RAS or EGFR-activated tumours . RGN-137 Thymosin beta4 RGN-137 is intended for the Synthetic peptide United States RegeneRx treatment of chronic pressure Biopharmaceuticals Inc . ulcers . RGN-137 Thymosin beta4 RGN-137 is intended for the Synthetic peptide United States RegeneRx treatment of epidermolysis Biopharmaceuticals Inc . bullosa . RGN-137 Thymosin beta4 RGN-137 is intended for the Synthetic peptide United States RegeneRx treatment of venous stasis ulcers . Biopharmaceuticals Inc . RPL554 — RPL554 is intended for the phosphodiesterase 3 and Netherlands Verona Pharma Plc . treatment of asthma . phosphodiesterase 4 enzyme inhibitors RT001 Botulinum toxin type A RT001 is intended for the — United States Revance Therapeutics treatment of lateral canthal lines Inc . (crow’s feet wrinkles) . RX-10045 — RX-10045 is intended for the Resolvin analog United States Celtic Therapeutics LLLC treatment of moderate to severe dry eye syndrome . Saber-Bupivacaine Bupivacaine Saber-Bupivacaine is intended Local anesthetic European Union Nycomed Group for the treatment of pain and incisional pain . Sativex Tetrahydrocannabinol Sativex is intended for the Cannabinoid United States Otsuka America and cannabidiol treatment of pain in patients with Pharmaceutical Inc . advanced cancer that has not been adequately relieved by opioid medications . Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte United States Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd . protoporphyria . Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte United States Clinuvel Pharmaceuticals treatment of nonsegmental stimulating hormone Ltd . vitiligo . Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte Europen Union Clinuvel Pharmaceuticals treatment of nonsegmental stimulating hormone Ltd . vitiligo . SKP-1041 — SKP-1041 is intended for the Non benzodiazepine United States Somnus Therapeutics Inc . treatment of sleep disorders . agent Synavive Dipyridamole and Synavive is intended for the Dissociated United States Zalicus Inc . prednisolone treatment of hand osteoarthritis . glucocorticoid

Source: eKnowledgeBase.com 44 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Synavive Dipyridamole and Synavive is intended for the Dissociated United States Zalicus Inc . prednisolone treatment of knee osteoarthritis . glucocorticoid Synavive Dipyridamole and Synavive is intended for the Dissociated United States Zalicus Inc . prednisolone treatment of rheumatoid arthritis . glucocorticoid Synavive Dipyridamole and Synavive is intended for the Dissociated European Union Zalicus Inc . prednisolone treatment of rheumatoid arthritis . glucocorticoid TAK-390MR Dexlansoprazole TAK-390MR is intended for healing Proton pump inhibitor Japan Takeda Pharmaceutical and mantenance treatment of Co . erosive esophagitis . TAK-390MR Dexlansoprazole TAK-390MR is intended for Proton pump inhibitor Japan Takeda Pharmaceutical the treatment of non-erosive Co . gastroesophageal reflux disease . Talactoferrin Talactoferrin alfa Talactoferrin is intended for the — United States Agennix Inc . treatment of diabetic ulcers . Topical Interferon Alpha-2b — Topical Interferon Alpha-2b is Antiviral United States Helix BioPharma Corp . intended for the treatment of low-grade cervical dysplasia . Topical Interferon Alpha-2b — Topical Interferon Alpha-2b is Antiviral Germany Helix BioPharma Corp . intended for the treatment of low-grade cervical dysplasia . TPM-02/Insulin — TPM-02/Insulin is intended for the Insulin United States Phosphagenics Ltd . treatment of type 1 diabetes . Transdur Sufentanil Transdur is intended for the Narcotic analgesic United States Durect Corp . treatment of chronic pain . Transdur Sufentanil Transdur is intended for the Narcotic analgesic European Union Durect Corp . treatment of chronic pain . TT-063 S-flurbiprofen TT-063 is intended for the — Japan Developer: Taisho treatment of myalgia . Pharmaceutical Co . and Tokuhon Corp ;. Marketer: Taisho Pharmaceutical Co . TT-063 S-flurbiprofen TT-063 is intended for the — Japan Developer: Taisho treatment of osteoarthritis pain . Pharmaceutical Co . and Tokuhon Corp ;. Marketer: Taisho Pharmaceutical Co . TT-063 S-flurbiprofen TT-063 is intended for the — Japan Developer: Taisho treatment of scapulohumeral Pharmaceutical Co . and periarthritis pain . Tokuhon Corp ;. Marketer: Taisho Pharmaceutical Co . V-101 — V-101 is intended for the — United States Vicept Therapeutics Inc . treatment of erythema in patients with rosacea . ViaDerm-hPTH (1-34) Calcitonin ViaDerm-hPTH (1-34) is intended — United States Eli Lilly and Co . for the treatment of osteoporosis . Vicinium — Vicinium is intended for the — United States Viventia Biotechnologies treatment of locally persistent Inc . non-invasive bladder cancer . Vicinium — Vicinium is intended for the — Canada Viventia Biotechnologies treatment of locally persistent Inc . non-invasive bladder cancer . Vismodegib Vismodegib Vismodegib is intended for the Hedgehog antagonist United States Genentech Inc . treatment of basal cell nevus syndrome (Gorlin syndrome) . VR496 — VR496 is intended for the — United States Vectura Group Plc . treatment of cystic fibrosis . VR496 — VR496 is intended for the — European Union Vectura Group Plc . treatment of cystic fibrosis . WBI-1001 — WBI-1001 is intended for the — Canada Welichem Biotech Inc . treatment of atopic dermatitis (type of eczema) . WBI-1001 — WBI-1001 is intended for the — Canada Welichem Biotech Inc . treatment of psoriasis . Xantryl — Xantryl is intended for the — United States Provectus treatment of atopic dermatitis . Pharmaceuticals Inc .

Source: eKnowledgeBase.com 45 Phase II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Xantryl — Xantryl is intended for the — United States Provectus treatment of psoriasis . Pharmaceuticals Inc . Xaracoll Bupivacaine Xaracoll is intended to provide — United States Innocoll Inc . pain control at the surgical site and thus reduce the level of additional analgesia required after surgery . Xaracoll Bupivacaine Xaracoll is intended to provide — European Union Innocoll Inc . pain control at the surgical site and thus reduce the level of additional analgesia required after surgery . XEN402 — XEN402 is intended for the — Canada Xenon Pharmaceuticals treatment of post herpetic Inc . neuralgia . XP21279 — XP21279 is intended for the — United States XenoPort Inc . treatment of Parkinson’s disease patients with motor fluctuations . Zaltrap Aflibercept Zaltrap, in combination with Vascular endothelial United States Developer/ 5-fluorouracil, leucovorin and growth factor Marketer: Regeneron oxaliplatin, is intended as first- Pharmaceuticals Inc . and line treatment for metastatic Sanofi colorectal cancer . Zoraxel — Zoraxel is intended for the — United States Rexahn Pharmaceuticals treatment of erectile dysfunction . Inc . ZP-PTH Teriparatide ZP-PTH is intended for the — United States Zosano Pharma Inc . treatment of osteoporosis .

Phase I/II — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer ARG101 Testosterone ARG101 is intended for the — United States arGentis Pharmaceuticals treatment of dry eye syndrome in Inc . menopausal women . BC-819 — BC-819 is intended for the — United States BioCancell Therapeutics treatment of ovarian cancer . Inc . Civamide Civamide Civamide is intended for the TRPV-1 receptor United States Winston Pharmaceuticals treatment of chronic post- modulator Inc . herpetic neuralgia . HGT-2310 Idursulfase-IT HGT-2310 is intended for the Human iduronate-2- United States Shire US Inc . treatment of Hunter syndrome sulfatase patients with significant central nervous system symptoms . IBI-20089 Triamcinolone acetonide IBI-20089 is intended for the — United States Icon Bioscience Inc . (IBI) treatment of cystoid macular edema . MP0112 — MP0112 is intended for the — Switzerland Allergan Inc . treatment of diabetic macular edema . MP0112 — MP0112 is intended for the — Switzerland Allergan Inc . treatment of wet age-related macular degeneration . ND0611 — ND0611 is intended for the — Israel NeuroDerm Ltd . treatment of Parkinson’s disease . OPB-2045G Gluconate olanexidin OPB-2045G is intended as — Japan Otsuka Pharmaceutical antiseptic in preoperative patients . Co . RPL554 — RPL554 is intended for the phosphodiesterase 3 and Netherlands Verona Pharma Plc . treatment of allergic rhinitis . phosphodiesterase 4 enzyme inhibitors RT001 Botulinum toxin type A RT001 is intended for the — United States Revance Therapeutics treatment of hyperhidrosis Inc . (excessive sweating) . ThermoDox Doxorubicin ThermoDox, in combination with — United States Celsion Corp . hyperthermia (heat), is intended for the treatment of recurrent chest wall breast cancer .

Source: eKnowledgeBase.com 46 Phase I — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer 610677 — 610677 is intended for the p38 kinase inhibitor United States GlaxoSmithKline Inc . treatment of chronic obstructive pulmonary disease . 705498 — 705498 is intended for the Transient receptor United States GlaxoSmithKline Inc . treatment of pruritis . potential vanilloid (TRPV1) antagonist ALKS 9070 Aripiprazole ALKS 9070 is intended for the Dopamine receptor United States Alkermes plc . treatment of schizophrenia . agonist and dopamine receptor antagonist Alocrest Vinorelbine tartrate Alocrest is intended for the Semi-synthetic vinca United States Talon Therapeutics Inc . treatment of advanced solid alkaloid tumors . AN2718 — AN2718 is intended for Antifungal United States Anacor Pharmaceuticals the treatment of skin and Inc . onychomycosis fungal infections . AN2728 — AN2728 is intended for the Phosphodiesterase 4 United States Anacor Pharmaceuticals treatment of atopic dermatitis . enzyme inhibitor Inc . AN2898 — AN2898 is intended for the Anti-inflammatory United States Anacor Pharmaceuticals treatment of atopic dermatitis . Inc . AN2898 — AN2898 is intended for the Anti-inflammatory United States Anacor Pharmaceuticals treatment of psoriasis . Inc . AP301 — AP301 is intended for the Synthetic peptide Austria Apeptico GmbH treatment of oedematous respiratory failure in patients suffering from lung infection, lung injury and lung transplantation . APD515 — APD515 is intended for the — United Kingdom Acacia Pharma Ltd . treatment of xerostomia (dry mouth) in advanced cancer patients . ARD-1600 Nicotine ARD-1600 is intended as an aid Nicotinic agonist United States Aradigm Corp . to smoking-cessation treatment . ATI355 — ATI355 is intended for the Anti NOGO-A mAb United States Novartis Pharmaceuticals treatment of spinal cord injury . Corp . AZ-003 Fentanyl AZ-003 is intended for the Analgesic United States Alexza Pharmaceuticals treatment of acute pain . Inc . BEMA Buprenorphine Buprenorphine BEMA Buprenorphine, in Partial mu-opiate United States BioDelivery Sciences combination with nalaxone, is receptor agonist International Inc . intended for the treatment of opioid dependence . BEMA Granisetron Granisetron BEMA Granisetron is intended for 5-HT3 receptor antagonist United States BioDelivery Sciences the prevention of nausea and International Inc . vomiting associated with cancer therapy . Bepotastine Nasal Bepotastine Besilate Bepotastine Nasal, in Histamine H1 receptor United States Ista Pharmaceuticals Inc . combination with Antihistamine antagonist and Steroid, is intended for the treatment of allergic rhinitis . Brakiva Topotecan Brakiva is intended for the — United States Talon Therapeutics Inc . treatment of ovarian cancer . Brakiva Topotecan Brakiva is intended for the — United States Talon Therapeutics Inc . treatment of small cell lung cancer . DermX — DermX is intended for the — United States ProCertus BioPharm Inc . prevention of radiodermatitis in post-surgical breast cancer . Diazepam Diazepam Diazepam is intended for the — United States Neurelis Inc . management of patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity . Dipraglurant Dipraglurant Dipraglurant is intended for the Metabotropic glutamate European Union Addex Pharmaceuticals treatment of dystonia . receptor 5 negative SA allosteric modulator DM-1992 Levodopa and DM-1992 is intended for the — Russia Depomed Inc . carbidopa treatment of Parkinson’s disease . EGP-437 Dexamethasone EGP-437 is intended for the — United States EyeGate phosphate treatment of scleritis . Pharmaceuticals Inc .

Source: eKnowledgeBase.com 47 Phase I — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Exenatide Nasal Spray Exenatide Exenatide Nasal Spray is Glucagon-like peptide-1 United States Developer: Amylin intended for the treatment of receptor agonist Pharmaceuticals Inc . and type 2 diabetes . MDRNA Inc ;. Marketer: Amylin Pharmaceuticals Inc . Exenatide Transdermal Exenatide Exenatide Transdermal Patch is Glucagon-like peptide-1 United States Developer/Marketer: Eli Patch intended for the treatment of receptor agonist Lilly and Co . and Amylin type 2 diabetes . Pharmaceuticals Inc . Extended-Release — Extended-Release Formulation Interferon beta 1a European Union Merck Serono SA Formulation of Interferon of Interferon Beta 1a is intended Beta 1a for the treatment of multiple sclerosis . GelVac Influenza Vaccine — GelVac Influenza Vaccine is Preventive vaccine United States Nanotherapeutics Inc . intended for the prevention of influenza . Hydromorphone (PF329) Hydromorphone Hydromorphone (PF329) is Narcotic analgesic United States PharmacoFore Inc . intended for the treatment of pain . iCo-007 — iCo-007 is intended for the c-Raf Kinase United States iCo Therapeutics Inc . treatment of diabetic macular edema . IDP 113 — IDP 113 is intended for the — United States Valeant Pharmaceuticals treatment of fungal infection . International Inc . IFNbeta-1a Extended — IFNbeta-1a Extended Release for IFNbeta-1a United States EMD Serono Inc . Release the treatment of relapsing forms of multiple sclerosis . INT0010 Dronabinol INT0010 is intended for the — Canada IntelGenx Corp . treatment of multiple sclerosis induced neuropathic pain . ISIS-SOD1 — ISIS-SOD1 is intended for the Antisense United States Isis Pharmaceuticals Inc . treatment of amyotrophic lateral sclerosis . ITCA 638 — ITCA 638 is intended for the Th1 cytokine United States Intarcia Therapeutics Inc . treatment of chronic hepatitis C . ITCA 880 — ITCA 880 is intended for the Endocrine peptide United States Intarcia Therapeutics Inc . treatment of obesity . ITCA 884 — ITCA 884 is intended for the Endocrine peptide United States Intarcia Therapeutics Inc . treatment of obesity . Lemuteporfin Lemuteporfin Lemuteporfin is intended for the — Canada Valocor Therapeutics Inc . treatment of acne . LiRIS Lidocaine LiRIS (Lidocaine Releasing — United States Taris Biomedical Inc . Intravesical System) is intended for the treatment of interstitial cystitis . Marqibo Vincristine sulfate Marqibo is intended for the Vinca alkaloid United States Talon Therapeutics Inc . treatment of cancer in children . MDT-637 — MDT-637 is intended for the Small molecule fusion United States Developer/Marketer: treatment of respiratory syncytial inhibitor MicroDose Therapeutx virus . Inc . and Gilead Sciences Inc . MEDI-534 — MEDI-534 is intended for the Preventive vaccine United States MedImmune Inc . prevention of parainfluenzavirus type 3 infection in young infants . Menadione Topical Lotion Menadione Menadione is intended for the — United States Talon Therapeutics Inc . treatment and prevention of skin rash associated with the use of epidermal growth factor receptor (EGFR) inhibitors in the treatment of certain cancers . MoxDuo CR Morphine and MoxDuo CR is intended for the Opioid analgesic United States QR Pharma Inc . oxycodone treatment of chronic pain . NanoBUP Buprenorphine and NanoBUP is intended for the — United States Nanotherapeutics Inc . naloxone treatment of opiate addiction . NanoDOX Doxycycline NanoDOX is intended for the — United States Nanotherapeutics Inc . treatment of trauma wounds . NB-003 — NB-003 is intended for the — United States NanoBio Corp . treatment of acne .

Source: eKnowledgeBase.com 48 Phase I — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer NB-1008 — NB-1008 is intended for the Therapeutic vaccine United States NanoBio Corp . treatment of influenza . NRI-ANA Lidocaine NRI-ANA is intended for the — United States Nuvo Research Inc . treatment of acute neuropathic pain . OTO-104 Dexamethasone OTO-104 is intended for the Steroid United States Otonomy Inc . treatment of Meniere’s disease . Probuphine Buprenorphine and Probuphine is intended for the — United States Titan Pharmaceuticals ethylene vinyl acetate treatment of chronic pain . Inc . Probuphine Buprenorphine and Probuphine is intended for the — United States Titan Pharmaceuticals ethylene vinyl acetate treatment of chronic pain . Inc . Prochieve 2nd Generation Progesterone Prochieve 2nd Generation is Progestin United States Watson Pharmaceuticals intended for the treatment Inc . of infertile women with progesterone deficiency . PUR118 — PUR118 is intended for the — United States Pulmatrix Inc . treatment of chronic obstructive pulmonary disease . PUR118 — PUR118 is intended for the — United States Pulmatrix Inc . treatment of cystic fibrosis . R343 — R343 is intended for the Syk kinase inhibitor United States Rigel Pharmaceuticals treatment of allergic asthma . Inc . Retinoic acid Retinoic acid Retinoic acid is intended for the Vitamin A derivative United States Phosphagenics Ltd . treatment of acne . S-524101 — S-524101 is intended for the Therapeutic vaccine Japan Shionogi & Co . treatment of allergies rhinitis caused by house dust mite allergen . Sancuso Granisetron Sancuso is intended for the 5-HT3 receptor antagonist Japan Solasia Pharma KK prevention of chemotherapy- induced nausea and vomiting . TPM/Oxycodone Oxycodone TPM/Oxycodone is intended for Narcotic analgesic United States Phosphagenics Ltd . the treatment of pain . Transmucosal Film Oxybutinin Transmucosal Film is intended — United States Auxilium Pharmaceuticals for the treatment of overactive Inc . bladder . UX001 Sialic acid UX001 is intended for the — United States Ultragenyx treatment of hereditary inclusion Pharmaceutical Inc . body myopathy (HIBM) . Vabicaserin Vabicaserin hydrochloride Vabicaserin is intended for the — United States Pfizer Inc . treatment of schizophrenia . VIAtab Insulin VIAtab is intended as an insulin — United States Biodel Inc . supplement for the treatment of early-stage type 2 diabetes . Vicodin 10/650 Hydrocodone bitartrate Vicodin 10/650 is intended for the Narcotic analgesic and United States Abbott Laboratories and acetaminophen treatment of moderate-to-severe antitussive chronic and acute pain . Zoenasa — Zoenasa is intended for the — United States Altheus Therapeutics Inc . treatment of adult patients with left-sided, or distal, ulcerative colitis . ZT-031 — ZT-031 is intended for the Parathyroid hormone United States Developer: Azelon treatment of osteoporosis . analog Pharmaceuticals Inc . and Aegis Therapeutics LLC; Marketer: Azelon Pharmaceuticals Inc . ZT-034 Teriparatide ZT-034 is intended for the Parathyroid hormone United States Azelon Pharmaceuticals treatment of osteoporosis . analog Inc .

Source: eKnowledgeBase.com 49 Preclinical Development — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer ALKS 7921 — ALKS 7921 is intended for the — United States Alkermes plc . treatment of schizophrenia . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor Alpha-1 proteinase United States Grifols Inc . Aerosol Aerosol is intended for the inhibitor treatment of chronic obstructive pulmonary disease . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor Alpha-1 proteinase United States Grifols Inc . Aerosol Aerosol is intended for the inhibitor treatment of congenital alpha1 antitrypsin deficiency . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor Aerosol Alpha-1 proteinase United States Grifols Inc . Aerosol is intended for the treatment of inhibitor cystic fibrosis . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor I V. . is Alpha-1 proteinase United States Grifols Inc . I .V . intended for the treatment of inhibitor chronic obstructive pulmonary disease . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor I V. . is Alpha-1 proteinase United States Grifols Inc . I .V . intended for the treatment of inhibitor congenital alpha1 antitrypsin deficiency . Alpha-1 Protease Inhibitor — Alpha-1 Protease Inhibitor I V. . is Alpha-1 proteinase United States Grifols Inc . I .V . intended for the treatment of inhibitor cystic fibrosis . AP301 — AP301 is intended for the Synthetic peptide United States Apeptico GmbH prevention of ischemia reperfusion injury in the lung during lung transplantation . AP301 — AP301 is intended for the Synthetic peptide Austria Apeptico GmbH treatment of acute lung injury . ARD-1100 Ciprofloxacin ARD-1100 is intended for the — United States Aradigm Corp . prevention of pulmonary anthrax infection . ARD-1100 Ciprofloxacin ARD-1100 is intended for the — United States Aradigm Corp . treatment of pulmonary anthrax infection . ARG102 Progesterone ARG102 is intended for the — United States arGentis Pharmaceuticals treatment of dry eye syndrome . Inc . Aricept Donepezil hydrochloride Aricept is intended for the Acetylcholinesterase Japan Developer: Teikoku treatment of Alzheimer’s disease . inhibitor Seiyaku Co . and Eisai Co ;. Marketer: Eisai Co . ATL1102 — ATL1102 is intended for the — United States Antisense Therapeutics treatment of asthma . Ltd . ATS907 — ATS907 is intended for the Rho kinase inhibitor United States Altheos Inc . treatment of glaucoma . BEMA Triptan — BEMA Triptan is intended for the — United States BioDelivery Sciences treatment of migraine . International Inc . COL-172 — COL-172 is intended for the Opioid analgesic United States Collegium treatment of moderate to severe Pharmaceutical Inc . pain in individuals who require around-the-clock opioid therapy for an extended period of time . CollaGuard Collagen CollaGuard is intended for the — Canada Merus Labs International prevention of postoperative Inc . adhesions following abdominal and pelvic surgery . Cutasil — Cutasil is intended for skin scarless — United States Sirnaomics Inc . wound healing . Duromist Sildenafil Duromist is intended for the — United States NovaDel Pharma Inc . treatment of erectile dysfunction . ETX1153a — ETX1153a is intended for the — United Kingdom e-Therapeutics Plc . treatment of hospital acquired resistant infections . EV-086 — EV-086 is intended for the Antifungal Switzerland Evolva Holding SA treatment of invasive and topical fungal infections . GelVac Typhoid Vaccine — GelVac Typhoid Vaccine is Preventive vaccine United States Nanotherapeutics Inc . intended for the prevention of norovirus infection .

Source: eKnowledgeBase.com 50 Preclinical Development — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer GelVac Typhoid Vaccine — GelVac Typhoid Vaccine is Preventive vaccine United States Nanotherapeutics Inc . intended for the prevention of typhoid fever . HB1345 — HB1345 is intended for the Lipohexapeptide United States Helix BioMedix Inc . treatment of acne . HB1345 — HB1345 is intended for the Lipohexapeptide United States Helix BioMedix Inc . treatment of dermatological infections . HBV Vaccine — HBV Vaccine is intended for the Therapeutic vaccine United States NanoBio Corp . treatment of hepatitis B virus infection . IXS312 — IXS312 is intended for the Antibody United States InNexus Biotechnology treatment of age-related Inc . macular degeneration . KRP-AB1102 Aclidinium bromide KRP-AB1102 is intended for the Long acting muscarinic Japan Kyorin Pharmaceutical treatment of chronic obstructive antagonist Co . pulmonary disease . LAS190792 — LAS190792 is intended for the Muscarinic antagonist Spain Laboratorios Almirall S .A . treatment of chronic obstructive pulmonary disease . Marqibo Vincristine sulfate Marqibo is intended for the Vinca alkaloid United States Talon Therapeutics Inc . treatment of multiple melanoma . MCD-386CR — MCD-386CR is intended for M1 selective muscarinic United States Mithridion Inc . the treatment of progressive agonist supranuclear palsy . N6022 Inhaled — N6022 Inhaled is intended for the — United States N30 Pharma Inc . treatment of asthma . N6022 Inhaled — N6022 Inhaled is intended for the — United States N30 Pharma Inc . treatment of chronic obstructive pulmonary disease . NanoFOVIR Cidofovir NanoFOVIR is intended for the — United States Nanotherapeutics Inc . treatment of respiratory infection . NanoGENT Gentamicin NanoGENT is intended to provide Antibiotic United States Nanotherapeutics Inc . early treatment for exposure to biological warfare agents, as well as tuberculosis and other respiratory infections . NVX-207 — NVX-207 is intended for the Small molecule sterol United States Novelix Pharmaceuticals treatment of actinic keratosis . analog Inc . OTO-201 — OTO-201 is intended for the Antibiotic United States Otonomy Inc . treatment of otitis media . PeptiClere — PeptiClere is intended for the — United States ProteoTech Inc . treatment of Alzheimer’s disease . PT010 Glycopyrrolate, PT010 is intended for the — United States Pearl Therapeutics Inc . formoterol fumarate and treatment of severe chronic an inhaled corticosteroid obstructive pulmonary disease . Pulmaquin Ciprofloxacin Ciprofloxacin is intended for the — United States Aradigm Corp . management of bronchiectasis . Relday Risperidone Relday is intended for the — United States Zogenix Inc . treatment of schizophrenia . RT001 Botulinum toxin type A RT001 is intended for the — United States Revance Therapeutics treatment of acne . Inc . Seala — Seala is intended for the Estrogen receptor-beta United States BioNovo Inc . treatment of postmenopausal agonist vaginal atrophy . Seala — Seala is intended for the Estrogen receptor-beta United States BioNovo Inc . treatment of vaginal dryness . agonist SGX203 — SGX203 is intended for the Corticosteroid United States Soligenix Inc . treatment of pediatric Crohn’s disease . Simplivir — Simplivir is intended for the — United States CytoGenix Inc . treatment of gerpes simplex virus . Teribone Teriparatide acetate Teribone is intended for the Synthetic human Japan Asahi Kasei Corp . treatment of osteoporosis . parathyroid hormone Topiramate Topiramate Topiramate is intended for the — United States Supernus treatment of epilepsy . Pharmaceuticals Inc .

Source: eKnowledgeBase.com 51 Preclinical Development — Drug-Delivery Prescription Products

Product name Chemical Indication Class of drug Region Developer/Marketer Transmucosal Film Oxybutinin Transmucosal Film is intended for — United States Auxilium Pharmaceuticals the treatment of pain . Inc . Veregen Polyphenol Veregen is intended for the Antiviral Canada Developer: MediGene treatment of genital warts . AG; Marketer: Triton Pharma Inc . Xerclear Chlorhexidine Xerclear is intended for the Antiviral China Developer: Medivir AB; treatment of labial herpes (cold Marketer: Daewoong sores) . Pharmaceutical Co . Xerclear Chlorhexidine Xerclear is intended for the Antiviral Hong Kong Developer: Medivir AB; treatment of labial herpes (cold Marketer: Daewoong sores) . Pharmaceutical Co . Xerese Acyclovir and Xerese is intended for the Purine nucleoside analog United States Meda Pharmaceuticals hydrocortisone treatment of genital herpes . Inc . Zenpep Pancrelipase Zenpep is intended for Pancreatic enzyme Russia Developer: Aptalis the treatment of exocrine product Pharma Inc .; Marketer: pancreatic insufficiency due Nycomed Group to cystic fibrosis and other conditions . Zolpimist Zolpidem tartrate Zolpimist is intended for the Imidazopyridine European Union Rechon Life Science AB treatment of insomnia . Zybrestat Fosbretabulin Zybrestat is intended for the Combretastatin-A4 United States Oxigene Inc . treatment of age-related phosphate macular degeneration .

Drug-Delivery Prescription-Product Companies

A.P. Pharma Inc. Adamas Pharmaceuticals Inc. Agennix Inc. 123 Saginaw Dr . 1900 Powell St ., Suite 1050 8 Greenway Plaza, Suite 910 Redwood City, CA 94063, United States Emeryville, CA 94608, United States Houston, TX 77046, United States Phone: 650-366-2626 Phone: 510-450-3500 Phone: 713-552-1091 Fax: 650-365-6490 Fax: 510-428-0519 Fax: 713-552-0795 Website: www.appharma.com Email: [email protected] Email: [email protected] Website: www.adamaspharma.com Website: www.agennix.com Abbott Laboratories Year established: 2002 Year established: 1993 100 Abbott Park Rd . Abbott Park, IL 60064-6400, United States Addex Pharmaceuticals SA Agile Therapeutics Inc. Phone: 847-937-6100 12, chemin des Aulx 366 Wall St ,. Princeton, NJ 08540, United States Fax: 847-937-1511 Geneva, Plan-les-Ouates 1228, Switzerland Phone: 609-683-1880 Email: [email protected] Phone: +41 22 884 15 55 Fax: 609-683-1855 Website: www.abbott.com Fax: +41 22 884 15 56 Email: [email protected] Year established: 1888 Email: [email protected] Website: www.agiletherapeutics.com Website: www.addexpharma.com Year established: 1997 Acacia Pharma Ltd. Harston Mill Adeona Pharmaceuticals Inc. Akela Pharma Inc. Cambridge, CB22 7GG, United Kingdom 3995 Research Park Drive, Suite 200 11501 Domain Drive, Suite 130 Phone: +44 1223 875130 Ann Arbor, MI 48108, United States Austin, TX 78758, United States Fax: +44 1223 875131 Phone: 734-332-7800 Phone: 512-834-0449 Website: www.acaciapharma.com Fax: 734-332-7878 Fax: 512-834-2105 Email: [email protected] Website: www.akelapharma.com Access Pharmaceuticals Inc. Website: www.adeonapharma.com Year established: 1998 2600 Stemmons Freeway, Suite 176 Year established: 2001 Dallas, TX 75207-2107, United States Alcobra Ltd. Phone: 214-905-5100 Aegis Therapeutics LLC 53 Hashalom Rd . Fax: 214-905-5101 16870 West Bernardo Dr ., Suite 390 Givatayim, Israel Email: [email protected] San Diego, CA 92127, United States Phone: +972 3 7326616 Website: www.accesspharma.com Phone: 858-618-1400 Year established: 2008 Year established: 1974 Fax: 858-618-1441 Email: [email protected] Alexza Pharmaceuticals Inc. AcelRx Pharmaceuticals Inc. Website: www.aegisthera.com 2091 Stierlin Court 575 Chesapeake Dr . Mountain View, CA 94043, United States Redwood City, CA 94063, United States Aerovance Inc. Phone: 650-944-7000 Phone: 650-216-3500 2929 Seventh St ., Suite 120 Fax: 650-944-7999 Fax: 650-216-6500 Berkeley, CA 94710, United States Email: [email protected] Email: [email protected] Phone: 510-549-5500 Website: www.alexza.com Website: www.acelrx.com Fax: 510-549-5501 Year established: 2000 Year established: 2005 Email: [email protected] Website: www.aerovance.com Alimera Sciences Inc. Year established: 2004 6120 Windward Pkwy ,. Suite 290 Alpharetta, GA 30005, United States Phone: 678-990-5740 Fax: 678-990-5744 Website: www.alimerasciences.com Year established: 2003

Source: eKnowledgeBase.com 52 Antisense Therapeutics Ltd. AstraZeneca Plc. Alkermes plc. Level 1, 10 Wallace Ave . 2 Kingdom Street, Paddington 852 Winter St . Toorak, Victoria 3142, Australia London, W2 6BD, United Kingdom Waltham, MA 02451, United States Phone: +61 3 9827 8999 Phone: +44 20 7604 8000 Phone: 781-609-6000 Fax: +61 3 9827 1166 Fax: +44 20 7604 8270 Email: [email protected] Website: www.antisense.com.au Email: [email protected] Website: www.alkermes.com Website: www.astrazeneca.com Year established: 1987 Apeptico GmbH Year established: 1999 Mariahilferstraße 136 Top 1 .15 Allergan Inc. Vienna, A-1150, Austria Auxilium Pharmaceuticals Inc. 2525 DuPont Dr ., PO Box 19534 Phone: +43 664 1432919 40 Valley Stream Pkwy . Irvine, CA 92612, United States Fax: +43 664 1477280 Malvern, PA 19355, United States Phone: 714-246-4500 Email: [email protected] Phone: 484-321-5900 Fax: 714-246-6987 Website: www.apeptico.com Fax: 484-321-5999 Email: [email protected] Website: www.auxilium.com Website: www.allergan.com Apricus Biosciences Inc. Year established: 1999 Year established: 1950 6330 Nancy Ridge Drive, Suite 103 San Diego, CA 92121, United States Azelon Pharmaceuticals Inc. Allon Therapeutics Inc. Phone: 858-222-8041 Four Tower Bridge, 200 Barr Harbor Dr . Suite 400 1168 Hamilton St ., Suite 506 Fax: 858-866-0482 West Conshohocken, PA 19428, United States Vancouver, BC V6B 2S2, Canada Email: [email protected] Phone: 610-260-6045 Phone: 604-736-0634 Website: www.apricusbio.com Website: www.azelon.com Fax: 604-736-1616 Year established: 1987 Year established: 2001 Email: [email protected] Website: www.allontherapeutics.com Aptalis Pharma Inc. Baxter Healthcare Corp. 597 Laurier Blvd . One Baxter Pkwy . Alnylam Pharmaceuticals Inc. Mont-Saint-Hilaire, QC J3H 6C4, Canada Deerfield, IL 60015, United States 300 Third St ., 3rd Floor Phone: 450-467-5138 Phone: 847-948-2000 Cambridge, MA 02142, United States Fax: 450-464-9979 Fax: 847-948-3642 Phone: 617-551-8200 Email: [email protected] Website: www.baxter.com Fax: 617-551-8101 Website: www.aptalispharma.com Website: www.alnylam.com Year established: 1982 Bayer HealthCare Pharmaceuticals Year established: 2002 Mueller Strasse 178 Aradigm Corp. Berlin, Mitte 13353, Germany Altheos Inc. 3929 Point Eden Way Phone: +49 3 04 681 111 601 Gateway Blvd ., Suite 250 Hayward, CA 94545, United States Fax: +49 3 04 681 5305 South San Francisco, CA 94080, United States Phone: 510-265-9000 Email: [email protected] Phone: 650-989-8570 Fax: 510-265-0277 Website: www.bayerscheringpharma.de Fax: 650-745-0676 Email: [email protected] Year established: 2006 Email: [email protected] Website: www.aradigm.com Website: altheos.net Year established: 1991 Bayer HealthCare Pharmaceuticals Inc. Year established: 2009 6 West Belt Rd . Arcion Therapeutics Inc. Wayne, NJ 07470, United States Altheus Therapeutics Inc. 2400 Boston St ., Suite 330 Phone: 973-694-4100 755 Research Pkwy ., Suite 435 Baltimore, MD 21224, United States Website: www.bayerhealthcare.com Oklahoma City, OK 73104, United States Phone: 410-522-8701 Year established: 2007 Phone: 405-319-8180 Email: [email protected] Fax: 408-319-8178 Website: www.arciontherapeutics.com BHR Pharma LLC Email: [email protected] 607 Herndon Pkwy ., Suite 110 Website: altheustherapeutics.com arGentis Pharmaceuticals Inc. Herndon, VA 20170, United States 1661 International Drive, Suite 400 Phone: 703-964-3033 Amylin Pharmaceuticals Inc. Memphis, TN 38120, United States Fax: 703-964-3044 9360 Towne Centre Dr ., Suite 110 Phone: 901-818-3262 Email: [email protected] San Diego, CA 92121, United States Fax: 866-460-8790 Website: www.bhr-pharma.com Phone: 858-552-2200 Email: [email protected] Year established: 2008 Fax: 858-552-2212 Website: www.argentisrx.com Email: [email protected] Year established: 2005 BioAlliance Pharma SA Website: www.amylin.com 49 Boulevard du General Martial Valin, 4th Floor Year established: 1987 Asahi Kasei Corp. Paris, 75015, France 1-105 Kanda Jinbocho, Chiyoda-ku Phone: +33 1 45 58 76 00 Anacor Pharmaceuticals Inc. Tokyo, Chiyoda-ku 101-8101, Japan Fax: +33 1 45 58 08 81 1020 E . Meadow Cir . Phone: +81 3 3507 2060 Email: [email protected] Palo Alto, CA 94303, United States Fax: +81 3 3507 2495 Website: www.bioalliancepharma.com Phone: 650-543-7500 Email: [email protected] Fax: 650-543-7660 Website: www.asahi-kasei.co.jp BioCancell Therapeutics Inc. Email: [email protected] Year established: 1931 8 Hartom St . Website: www.anacor.com Jerusalem, 97775, Israel Year established: 2002 Ascend Therapeutics Inc. Phone: +972 2 548 6555 607 Herndon Parkway, Suite 110 Fax: +972 2 548 6550 AndroScience Corp. Herndon, VA 20170, United States Email: [email protected] 11175 Flintkote Ave ., Suite F Phone: 703-471-4744 Website: www.biocancell.com San Diego, CA 92121, United States Fax: 703-478-0959 Year established: 2004 Phone: 858-638-7230 Email: [email protected] Email: [email protected] Website: www.ascendtherapeutics.com Biodel Inc. Website: www.androscience.com Year established: 2001 100 Saw Mill Rd . Year established: 2000 Danbury, CT 06810-7352, United States Asmacure Ltee Phone: 203-796-5000 Antares Pharma Inc. 2600 Blvd . Laurier, Suite 880 Fax: 203-796-5001 250 Phillips Blvd ,. Suite 290, Princeton Crossroads Quebec, QU G1V 4W2, Canada Email: [email protected] Corporate Center Phone: 418-780-4255 Website: www.biodel.com Ewing, NJ 08618, United States Fax: 418-781-0216 Phone: 609-359-3020 Website: www.asmacure.com BioDelivery Sciences International Inc. Fax: 609-359-3015 801 Corporate Center Drive, Suite 210 Email: [email protected] AstraZeneca Pharmaceuticals LP Raleigh, NC 27607, United States Website: www.antarespharma.com 1800 Concord Pike, PO Box 15437 Phone: 919-582-9050 Year established: 2001 Wilmington, DE 19850-5437, United States Fax: 919-582-9051 Phone: 302-886-3000 Email: [email protected] Website: www.astrazeneca-us.com Website: www.bdsi.com Year established: 1997

Source: eKnowledgeBase.com 53 Biolex Therapeutics Inc. Celtic Pharmaceutical Holdings L.P. Daewoong Pharmaceutical Co. 158 Credle St . 1 Victoria Street, 4th Floor 163-3 Samsung-dong, Kangnam-gu Pittsboro, NC 27312, United States Hamilton, HM 11, Bermuda Seoul, Korea Phone: 919-542-9901 Phone: +1 441 299 7440 Phone: +82 2 550 8259 Fax: 919-542-9910 Email: [email protected] Fax: +82 2 550 8249 Email: [email protected] Website: www.celticpharma.com Email: [email protected] Website: www.biolex.com Website: www.daewoong.com Year established: 1997 Celtic Therapeutics LLLC 34-35 Dronningens Gade, Hibsicus Alley Daiichi Sankyo Co. BioMarck Pharmaceuticals Ltd. St . Thomas, 00802, U .S . Virgin Islands 3-5-1 Nihombashi-honcho Westpark Corporate Center, 4364 South Alston Avenue Phone: 340-779-6908 Tokyo, Chuo-ku 103-8426, Japan Durham, NC 27713, United States Fax: 340-714-5192 Phone: +81 3 6225 1111 Email: [email protected] Email: [email protected] Website: www.daiichisankyo.co.jp Website: www.biomarck.com Website: www.celtictherapeutics.com Year established: 2005 Year established: 2007 BioNovo Inc. Daiichi Sankyo Inc. 5858 Horton St ., Suite 400 Cerulean Pharma Inc. Two Hilton Ct . Emeryville, CA 94608, United States 840 Memorial Drive, 5th Floor Parsippany, NJ 07054, United States Phone: 510-601-2000 Cambridge, MA 02139, United States Phone: 973-359-2600 Fax: 510-601-5050 Phone: 617-551-9600 Fax: 973-359-2645 Email: [email protected] Fax: 617-494-1544 Website: www.daiichisankyo-us.com Website: www.bionovo.com Email: [email protected] Year established: 2006 Year established: 1998 Website: www.ceruleanrx.com Delcath Systems Inc. Biopartners GmbH Clinuvel Pharmaceuticals Ltd. 810 Seventh Avenue, Suite 3505 Sihlbruggstrasse 3 330 Collins St ., Level 11 New York, NY 10019, United States Baar, 6340, Switzerland Melbourne, Victoria VIC 3000, Australia Phone: 212-489-2100 Phone: +41 41 766 20 80 Phone: +61 3 9660 4900 Fax: 212-498-2102 Fax: +41 41 766 20 81 Fax: +61 3 9660 4999 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.delcath.com Website: www.biopartners.ch Website: www.clinuvel.com Year established: 2000 Year established: 1999 Depomed Inc. 1360 O’Brien Dr . BioSante Pharmaceuticals Inc. CoDa Therapeutics Inc. Menlo Park, CA 94025-1436, United States 111 Barclay Blvd . 10505 Sorrento Valley Rd ., Suite 395 Phone: 650-462-5900 Lincolnshire, IL 60069, United States San Diego, CA 92121, United States Fax: 650-462-9993 Phone: 847-478-0500 Phone: 858-677-0474 Email: [email protected] Fax: 847-478-9152 Fax: 858-677-0475 Website: www.depomedinc.com Email: [email protected] Email: [email protected] Year established: 1995 Website: www.biosantepharma.com Website: www.codatherapeutics.com Diamyd Inc. Boehringer Ingelheim GmbH Collegium Pharmaceutical Inc. 2100 Wharton Street, Suite 701 Binger Strasse 173 400 Highland Corporate Dr . Pittsburgh, PA 15203, United States Ingelheim, 55216, Germany Cumberland, RI 02864, United States Phone: 412-488-0348 Phone: +49 6 13 277 0 Phone: 401-762-2000 Fax: 412-488-0349 Fax: +49 6 13 272 3000 Email: [email protected] Email: [email protected] Website: www.boehringer-ingelheim.com Website: www.collegiumpharma.com Website: www.diamyd.com Year established: 1885 Year established: 2002 Year established: 2005

Bristol-Myers Squibb Co. Cosmo Pharmaceuticals SpA Digestive Care Inc. 345 Park Ave . Via C . Colombo 1 1120 Win Dr . New York, NY 10154-0037, United States Lainate, I-20020, Italy Bethlehem, PA 18017-7059, United States Phone: 212-546-4000 Phone: +39 2 9333 7614 Phone: 610-882-5950 Fax: 212-546-4020 Fax: +39 2 9333 7663 Fax: 610-882-0349 Website: www.bms.com Email: [email protected] Email: [email protected] Year established: 1989 Website: www.cosmopharmaceuticals.com Website: www.digestivecare.com Year established: 1996 Year established: 1990 BTG International Inc. Five Tower Bridge Suite 800, 300 Barr Harbor Dr . Creabilis SA Dipexium Pharmaceuticals LLC West Conshohocken, PA 19428-2998, United States 15 Rue Edward Steichen 22 Camelot Ct . Phone: 610-278-1660 L-2540, Luxembourg White Plains, NY 10603-1552, United States Fax: 610-278-1605 Email: [email protected] Phone: 917-533-1469 Email: [email protected] Website: www.creabilis-sa.com Website: www.dipexiumpharmaceuticals.com Website: www.btgplc.com Year established: 2003 Durect Corp. CardioVascular BioTherapeutics Inc. Cubist Pharmaceuticals Inc. 2 Results Way 9500 Hillwood Drive, Suite 200 65 Hayden Ave . Cupertino, CA 95014-5962, United States Las Vegas, NV 89134, United States Lexington, MA 02421, United States Phone: 408-777-1417 Phone: 702-839-7200 Phone: 781-860-8660 Fax: 408-777-3577 Email: [email protected] Fax: 781-240-0256 Email: [email protected] Website: www.CVBT.com Email: [email protected] Website: www.durect.com Website: www.cubist.com Year established: 1998 Celator Pharmaceuticals Inc. Year established: 1992 303B College Rd . East Dyax Corp. Princeton, NJ 08540, United States CytoGenix Inc. 300 Technology Sq . Phone: 609-243-0123 New York, NY 77042, United States Cambridge, MA 02139, United States Fax: 609-243-0202 Phone: 830-632-5944 Phone: 617-225-2500 Email: [email protected] Fax: 830-632-5944 Fax: 617-225-2501 Website: www.celatorpharma.com Email: [email protected] Email: [email protected] Website: www.cytogenix.com Website: www.dyax.com Celsion Corp. Year established: 1989 10220-I Old Columbia Rd . Cytokine PharmaSciences Inc. Columbia, MD 21046-1705, United States Walnut Hill Plaza, 150 S . Warner Rd ,. Suite 420 Eisai Co. Phone: 410-290-5390 King of Prussia, PA 19406, United States 4-6-10 Koishikawa Fax: 410-290-5394 Phone: 610-687-1776 Tokyo, Bunkyo-ku 112-8088, Japan Email: [email protected] Fax: 610-687-4340 Phone: +81 3 3817 3700 Website: www.celsion.com Email: [email protected] Fax: +81 3 3811 3305 Website: www.cytokinepharmasciences.com Website: www.eisai.co.jp Year established: 1993 Year established: 1941

Source: eKnowledgeBase.com 54 Eisai Inc. Galderma Laboratories LP Healthpoint Ltd. 100 Tice Blvd . 14501 N . Freeway 3909 Hulen St . Woodcliff, NJ 07666, United States Fort Worth, TX 76177, United States Ft . Worth, TX 76107, United States Phone: 201-692-1100 Phone: 817-961-5000 Phone: 800-441-8227 Fax: 201-692-1804 Website: www.galdermausa.com Fax: 817-900-4100 Website: www.eisai.com Year established: 1961 Website: www.healthpoint.com Year established: 1995 Year established: 1992 Genentech Inc. Eli Lilly and Co. One DNA Way Helix BioMedix Inc. Lilly Corporate Center South San Francisco, CA 94080-4990, United States 22118 20th Ave . SE, Suite 204 Indianapolis, IN 46285, United States Phone: 650-225-1000 Bothell, WA 98021, United States Phone: 317-276-2000 Fax: 650-225-6000 Phone: 425-402-8400 Fax: 317-277-6429 Email: [email protected] Fax: 425-806-2999 Website: www.lilly.com Website: www.gene.com Website: www.helixbiomedix.com Year established: 1876 Year established: 1976 Helix BioPharma Corp. Elite Pharmaceuticals Inc. Generex Biotechnology Corp. 305 Industrial Pkwy . S ,. Unit 3 165 Ludlow Ave . 33 Harbour Square, Suite 202 Aurora, ON L4G 6X7, Canada Northvale, NJ 07647, United States Toronto, ON M5J 2G2, Canada Phone: 905-841-2300 Phone: 201-750-2646 Phone: 416-364-2551 Fax: 905-841-2244 Fax: 201-750-2755 Fax: 416-364-9363 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.helixbiopharma.com Website: www.elitepharma.com Website: www.generex.com Year established: 1995 Year established: 1990 Year established: 1983 Hisamitsu Pharmaceutical Inc. EMD Serono Inc. Gilead Sciences Inc. 408 Tashireo Daikan-machi One Technology Pl . 333 Lakeside Dr . Saga, Tosu-shi 841-0017, Japan Rockland, MA 02370, United States Foster City, CA 94404, United States Phone: +81 3 5293 1720 Phone: 781-681-2340 Phone: 650-574-3000 Fax: +81 3 5293 1724 Email: [email protected] Fax: 650-578-9264 Website: www.hisamitsu.co.jp/english/index.html Website: www.emdserono.com Email: [email protected] Year established: 1847 Year established: 2007 Website: www.gilead.com Year established: 1987 Horizon Pharma Inc. Endo Pharmaceuticals Inc. 1033 Skokie Blvd ,. Suite 355 100 Endo Blvd . GlaxoSmithKline Inc. Northbrook, IL 60062, United States Chadds Ford, PA 19317, United States 5 Moore Dr ., PO Box 13398 Phone: 224-383-3000 Phone: 610-558-9800 Research Triangle Park, NC 27709-0000, United States Fax: 224-383-3001 Fax: 610-558-8979 Phone: 888-825-5249 Website: www.horizonpharma.com Website: www.endo.com Fax: 919-248-2381 Year established: 2010 Email: [email protected] EpiCept Corp. Website: us.gsk.com iCo Therapeutics Inc. 777 Old Saw Mill River Rd . 760-777 Hornby St . Tarrytown, NY 10591, United States GlaxoSmithKline Plc. Vancouver, BC V6Z 1S4, Canada Phone: 914-606-3500 980 Great West Rd . Phone: 604-602-9414 Fax: 914-606-3501 Brentford, Middlesex TW8 9GS, United Kingdom Fax: 604-602-9699 Email: [email protected] Phone: +44 208 047 5000 Email: [email protected] Website: www.epicept.com Fax: +44 208 047 7897 Website: www.icotherapeutics.com Email: [email protected] Year established: 2005 e-Therapeutics Plc. Website: www.gsk.com Holland Park, Holland Dr . Year established: 2000 Icon Bioscience Inc. (IBI) New Castle-upon-Tyne, NE2 4LZ, United Kingdom 1253 Reamwood Ave . Website: www.etherapeutics.co.uk Grifols Inc. Sunnyvale, CA 94089, United States Year established: 2001 4101 Research Commons, 79 T . W . Alexander Dr ,. PO Website: www.iconbioscience.com Box 110526 Evolva Holding SA Research Triangle Park, NC 27709, United States Impax Laboratories Inc. Duggingerstrasse 23 Phone: 919-316-6300 30831 Huntwood Ave . Reinach, CH-4153, Switzerland Website: www.talecris.com Hayward, CA 94544, United States Phone: +41 61 485 2000 Year established: 2005 Phone: 510-476-2000 Fax: +41 61 485 2001 Fax: 510-471-3200 Email: [email protected] Grunenthal GmbH Email: [email protected] Website: www.evolva.com Pascalstrabe 6 Website: www.impaxlabs.com Aachen-Oberforstbach, 52076, Germany Year established: 1997 EyeGate Pharmaceuticals Inc. Phone: +49 2 41 569 1111 100 Beaver St . Fax: +49 2 41 569 1112 Incyte Corp. Waltham, MA 02453, United States Email: [email protected] Rt . 141 & Henry Clay Rd ., Building E336 Phone: 781-788-8869 Website: www.grunenthal.com Wilmington, DE 19880, United States Email: [email protected] Year established: 1946 Phone: 302-498-6700 Website: www.eyegatepharma.com Fax: 302-425-2750 Year established: 1998 HAL Allergy Group Email: [email protected] J .H . Oortweg 15-17 Website: www.incyte.com FemmePharma Global Healthcare Inc. Leiden, 2333 CH, Netherlands Year established: 1991 37 West Ave ., Second Floor Website: www.hal-allergy.com Wayne, PA 19087, United States Year established: 1959 InNexus Biotechnology Inc. Phone: 610-995-0801 1055 West Hastings St ., Suite 2200 Fax: 610-995-0825 Hameln rds GmbH Vancouver, BC V6E 2E9, Canada Email: [email protected] Langes Feld 13 Phone: 480-862-7500 Website: www.fpghc.com Hameln, 31789, Germany Fax: 480-657-8919 Year established: 2005 Phone: +49 5151 581 208 Email: [email protected] Website: www.hameln-rds.com Website: www.ixsbio.com Forest Laboratories Inc. Year established: 2001 909 Third Ave . Hatchtech Pty Ltd New York, NY 10022-4731, United States Level 9, 278 Collins Street Innocoll Inc. Phone: 212-421-7850 Victoria, 3000, Australia 42662 Kitchen Prim Ct . Email: [email protected] Phone: +61 400 673 938 Ashburn, VA 20148, United States Website: www.frx.com Email: [email protected] Email: [email protected] Year established: 1956 Website: hatchtech.com.au Website: www.innocollinc.com

Source: eKnowledgeBase.com 55 Inotek Pharmaceuticals Corp. Janssen Pharmaceuticals Inc. Lipid Therapeutics GmbH 100 Cummings Center, 4th Floor Titusville, NJ, United States Alte Glockengiesserei 9 Beverly, MA 01915, United States Website: www.janssenpharmaceuticalsinc.com Heidelberg, 69115, Germany Phone: 978-232-9660 Phone: +49 6221 33 50 58 0 Fax: 978-232-8975 Johnson & Johnson Pharmaceutical Research & Fax: +49 6221 33 50 58 9 Email: [email protected] Development Email: [email protected] Website: www.inotekcorp.com 920 Route 202, PO Box 300 Website: www.lipid-therapeutics.com Year established: 1996 Raritan, NJ 08869, United States Year established: 2008 Phone: 908-704-4000 InSite Vision Inc. Fax: 908-722-5867 Living Cell Technologies Ltd 965 Atlantic Ave . Email: [email protected] 70 Pitt St ,. Level 3, Suite 302, Alameda, CA 94501, United States Website: www.jnjpharmarnd.com Sydney, NSW 2000, Australia Phone: 510-865-8800 Year established: 1988 Phone: +61 3 0013 5875 Fax: 510-865-5700 Email: [email protected] Website: www.insitevision.com Kamada Ltd. Website: www.lctglobal.com Year established: 1986 Kiryat Weizmann, Science Park, 7 Sapir St ,. PO Box 4081 Year established: 1987 Ness Ziona, 74140, Israel Insmed Inc. Phone: +972 8 940 6472 Mallinckrodt Pharmaceuticals 8720 Stony Point Pkwy ., Suite 200 Fax: +972 8 940 6473 675 McDonnell Blvd ., PO Box 5840 Richmond, VA 23235, United States Email: [email protected] St . Louis, MO 63134, United States Phone: 804-565-3000 Website: www.kamada.com Phone: 800-325-8888 Fax: 804-565-3500 Year established: 1990 Website: www.mallinckrodt.com Email: [email protected] Website: www.insmed.com Kyorin Pharmaceutical Co. MannKind Corp. 5, Kanda Surugadai 2-chome 28903 N . Ave . Paine Insys Therapeutics Inc. Tokyo, Chiyoda-ku 101-8311, Japan Valencia, CA 91355, United States 10220 South 51st Street, Suite 2 Phone: +81 3 3293 3451 Phone: 661-775-5300 Phoenix, AZ 85044, United States Email: [email protected] Fax: 661-775-2081 Phone: 602-910-2617 Website: www.kyorin-gr.co.jp/e/index.html Website: www.mannkindcorp.com Fax: 602-910-2627 Year established: 1991 Email: [email protected] Kyowa Hakko Kirin Co. Website: www.insysrx.com Otemachi Building 5F 1-6-1 MAP Pharmaceuticals Inc. Tokyo, Chiyoda-ku 100-8185, Japan 2400 Bayshore Pkwy ., Suite 200 Intarcia Therapeutics Inc. Phone: +81 3 3282 0007 Mountain View, CA 94043, United States 24650 Industrial Blvd . Fax: +81 3 3284 1968 Phone: 650-386-3100 Hayward, CA 94545, United States Website: www.kyowa-kirin.co.jp Fax: 650-386-3101 Phone: 510-782-7800 Year established: 2008 Website: www.mappharma.com Fax: 510-782-7801 Year established: 2003 Website: www.intarcia.com Kyowa Hakko Kirin Pharma Inc. Year established: 1997 212 Carnegie Center, Suite 101 McNeil Pediatrics Princeton, NJ 08540, United States Boston, MA, United States IntelGenx Corp. Phone: 609-919-1100 Website: www.mcneilpediatrics.net 6425 Abrams Ville Website: www.kyowa-kirin-pharma.com St-Laurent, QC H4S 1X9, Canada MDRNA Inc. Phone: 514-331-7440 Laboratorios Almirall S.A. 3830 Monte Villa Pkwy . Fax: 514-331-0436 General Mitre 151 Bothell, WA 98021, United States Email: [email protected] Barcelona, 08022, Spain Phone: 425-908-3600 Website: www.intelgenx.com Phone: +34 93 291 30 00 Fax: 425-908-3650 Fax: +34 93 291 31 80 Email: [email protected] Intendis GmbH Email: [email protected] Website: www.mdrnainc.com Max-Dohrn-StraBe 10 Website: www.almirall.es Year established: 1993 Berlin, Mitte 10589, Germany Year established: 1943 Phone: +49 30 520075 660 Meda AB Email: [email protected] Labtec GmbH Pipers vag 2 A, Box 906, Solna, SE-170 09, Sweden Website: www.intendis.com Raiffeisenstrasse 4 Phone: +46 8 630 19 00 Year established: 2005 Langenfeld, 40764, Germany Fax: +46 8 630 1 9 50 Phone: +49 2173 9735 0 Email: [email protected] Intercell AG Fax: +49 2173 9735 35 Website: www.meda.se Campus Vienna Biocenter 3 Email: [email protected] Vienna, 1030, Austria Website: www.labtec-pharma.com Meda Pharmaceuticals Inc. Phone: +43 1 20620 Year established: 1990 265 Davidson Ave ,. Suite 300 Fax: +43 1 20620-800 Somerset, NJ 08873, United States Email: [email protected] Leo Pharma Inc. Phone: 732-564-2200 Website: www.intercell.com 1 Sylvan Way Website: www.medpointepharma.com Year established: 1998 Parsippany, NJ 07054, United States Year established: 2001 Phone: 973-637-1690 Ipsen Inc. Fax: 973-637-1682 MediGene AG 27 Maple St . Website: www.leo-pharma.com Lochhamer Strasse 11, Martinsried, 82152, Germany Milford, MA 01757-3650, United States Phone: +49 89 85 65 29 00 Phone: 774-396-6800 LG Life Sciences Ltd. Fax: +49 89 85 65 29 20 Fax: 508-473-3531 LG Twin Tower, 20, Youido-dong Email: [email protected] Email: [email protected] Seoul, Yongdungpo-gu 150-721, Korea Website: www.medigene.com Website: www.ipsen.com Phone: +82 23 773 1114 Year established: 1994 Year established: 1986 Fax: +82 23 773 7012 Website: www.lgls.co.kr/eng MedImmune Inc. Isis Pharmaceuticals Inc. Year established: 2002 One MedImmune Way 1896 Rutherford Rd . Gaithersburg, MD 20878, United States Carlsbad, CA 92008, United States Lightlake Therapeutics Inc. Phone: 301-398-0000 Phone: 760-931-9200 54 Baker Street Email: [email protected] Fax: 760-603-2700 London, W1U 7BU, United Kingdom Website: www.medimmune.com Email: [email protected] Website: www.lightlaketherapeutics.com Year established: 1988 Website: www.isispharm.com Year established: 1989 LigoCyte Pharmaceuticals Inc. MediQuest Therapeutics Inc. 2155 Analysis Dr . 22322 20th Ave . SE, Suite 100 Ista Pharmaceuticals Inc. Bozeman, MT 59718, United States Bothell, WA 98021, United States 15295 Alton Pkwy ., Irvine, CA 92618, United States Phone: 406-585-2733 Phone: 425-398-9580 Phone: 949-788-6000 Fax: 406-585-2766 Fax: 425-398-9590 Fax: 949-788-6010 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.ligocyte.com Website: www.mqti.com Website: www.istavision.com Year established: 1998 Year established: 1994

Source: eKnowledgeBase.com 56 Medivir AB N30 Pharma Inc. NovaBay Pharmaceuticals Inc. Lunastigen 7, PO Box 1086 885 Arapahoe Ave . 5980 Horton St ., Suite 550 Huddinge, SE-141 22, Sweden Boulder, CO 80302, United States Emeryville, CA 94608, United States Phone: +46 85 46 83 10 0 Phone: 720-565-4079 Phone: 510-899-8800 Fax: +46 85 46 83 19 9 Website: www.n30pharma.com Fax: 510-291-8811 Email: [email protected] Email: [email protected] Website: www.medivir.se NanoBio Corp. Website: www.novabaypharma.com Year established: 1988 2311 Green Rd ,. Suite A Ann Arbor, MI 48105, United States NovaBiotics Ltd. Merck & Co. Phone: 734-302-4000 Cruickshank Bldg ., Craibstone One Merck Dr ., PO Box 100 Fax: 734-302-9150 Aberdeen, AB21 9TR, United Kingdom Whitehouse Station, NJ 08889-0100, United States Email: [email protected] Phone: +44 1224 711377 Phone: 908-423-1000 Website: www.nanobio.com Fax: +44 1224 711370 Website: www.merck.com Year established: 2000 Email: [email protected] Year established: 1891 Website: www.novabiotics.co.uk Nanotherapeutics Inc. Year established: 2004 Merck Serono SA 13859 Progress Blvd ,. Suite 300 9 Chemin des Mines Alachua, FL 32615, United States NovaDel Pharma Inc. Geneva, CH-1211, Switzerland Phone: 386-462-9663 1200 Route 22 East, Suite 2000 Phone: +41 22 739 30 00 Fax: 386-462-2087 Bridgewater, NJ 08807, United States Fax: +41 22 739 21 79 Email: [email protected] Phone: 908-203-4640 Email: [email protected] Website: www.nanotherapeutics.com Fax: 908-203-4744 Website: www.merckserono.net Email: [email protected] Year established: 1906 Nektar Therapeutics Website: www.novadel.com 455 Mission Bay Boulevard South Year established: 1982 Merus Labs International Inc. San Francisco, CA 94158, United States 1177 W . Hastings St ., Suite 2007 Phone: 415-482-5300 Novagali Pharma Vancouver, BC V6E 2K3, Canada Fax: 415-339-5300 1 rue Pierre Fontaine, Genavenir IV Phone: 604-221-0595 Email: [email protected] Evry, Cedex F-91058, France Fax: 604-225-0588 Website: www.nektar.com Phone: +33 1 69 87 40 20 Email: [email protected] Year established: 1990 Fax: +33 1 69 87 40 30 Website: www.meruslabs.com Email: [email protected] Neurelis Inc. Website: www.novagali.com MicroDose Therapeutx Inc. San Diego, CA, United States Year established: 2000 4262 U .S . Route 1 Website: www.neurelis.com Monmouth Junction, NJ 08852, United States Novartis Ophthalmics Inc. Phone: 732-355-2100 NeuroDerm Ltd. Basel, CH 4002, Switzerland Fax: 732-355-2101 Weizmann Science Park Phone: +41 61 324 1111 Website: mdtx.com Ness Ziona, Israel Fax: +41 61 324 8001 Year established: 1998 Email: [email protected] Website: www.novartisophthalmics.com Website: www.neuroderm.com Year established: 1996 Milestone Biosciences LLC 200 Via De Lago, Suite B NeurogesX Inc. Novartis Pharma AG Altamonte Springs, FL 32701, United States 2215 Bridgepointe Parkway, Suite 200 Forum 1, Novartis Campus Fax: 407-977-2247 San Mateo, CA 94404, United States Basel, CH-4056, Switzerland Email: [email protected] Phone: 650-358-3300 Phone: +41 61 324 11 11 Website: www.milestonebio.com Fax: 650-649-1798 Fax: +41 61 324 80 01 Year established: 2007 Email: [email protected] Website: www.novartis.com Website: www.neurogesx.com Year established: 1996 Mithridion Inc. Year established: 2000 505 Science Dr ., Suite C Novartis Pharmaceuticals Corp. Madison, WI 53711, United States NeuroHealing Pharmaceuticals Inc. One Health Plaza, 59 Route 10 Phone: 608-443-2432 50 Undine Rd ., Unit #1 East Hanover, NJ 07936-1080, United States Fax: 608-443-2434 Newton, MA 02135, United States Phone: 862-778-8300 Email: [email protected] Phone: 617-331-4111 Fax: 888-644-8585 Website: www.mithridion.com Email: [email protected] Email: [email protected] Year established: 2006 Website: www.NeuroHealing.com Website: www.pharma.us.novartis.com

Mochida Pharmaceutical Co. Neurotech USA Inc. Novelix Pharmaceuticals Inc. 7, Yotsuya 1-chome 701 George Washington Hwy . 8008 Girard Avenue, Suite 330 Tokyo, Shinjuku-ku 160-8515, Japan Lincoln, RI 02865, United States La Jolla, CA 92037, United States Phone: +81 3 3358 7211 Phone: 401-333-3880 Phone: 858-454-3245 Fax: +81 3 3358 7887 Fax: 401-495-2420 Fax: 858-729-0465 Website: www.mochida.co.jp Email: [email protected] Email: [email protected] Year established: 1913 Website: www.neurotechusa.com Website: www.novelix.com

Morria Biopharmaceuticals Plc. NewBridge Pharmaceuticals Novo Nordisk AS 53 Davies St . Business Central Tower A, Office #2405, Dubai Internet Novo Alle, Krogshoe JVEJ41 London, Mayfair W1K5JH, United Kingdom City, PO Box 500618 Bagsvaerd, DK-2880, Denmark Phone: +44 207 152 6341 Dubai, United Arab Emirates Phone: +45 44 44 88 88 Fax: +44 207 152 6342 Phone: +971 4 429 8700 Fax: +45 44 49 05 55 Email: [email protected] Fax: +971 4 429 8676 Website: www.novonordisk.com Website: www.morria.com Email: [email protected] Year established: 1989 Website: www.nbpharma.com Mpex Pharmaceuticals Inc. NuPathe Inc. 11535 Sorrento Valley Rd . Nippon Kayaku Co. 375 East Elm St ., Suite 110 San Diego, CA 92109, United States Tokyo Fujimi Building,11-2, Fujimi 1-Chome Conshohocken, PA 19428, United States Phone: 858-875-2840 Chiyoda-ku, Tokyo, Chiyoda-ku 102-8172, Japan Phone: 484-567-0130 Fax: 858-875-2851 Phone: +81 3 3237 5046 Fax: 484-567-0136 Email: [email protected] Website: www.nipponkayaku.co.jp Email: [email protected] Website: www.mpexpharma.com Year established: 1916 Website: www.nupathe.com

Mundipharma International Ltd. Nippon Shinyaku Co. Nuvo Research Inc. Milton Rd ., Cambridge Science Park, Unit 220 14, Kisshoin Nishinosho-Monguchicho Kisshoin, Minami-ku 7560 Airport Rd ., Unit 10 Cambridge, CB4 0GW, United Kingdom Kyoto, Minami-ku 601-8550, Japan Mississauga, ON L4T 4H4, Canada Phone: +44 1223 424 211 Phone: +81 7 5321 1111 Phone: 905-673-6980 Fax: +44 1223 426 626 Fax: +81 7 5321 0678 Fax: 905-673-1842 Website: www.mundipharma.co.uk Email: [email protected] Email: [email protected] Website: www.nippon-shinyaku.co.jp Website: www.nuvoresearch.com Year established: 1919 Year established: 1990

Source: eKnowledgeBase.com 57 Nycomed Group Palatin Technologies Inc. Plethora Solutions Holdings Plc. Thurgauerstrasse 130, PO Box 88 4-C Cedar Brook Dr ., Cedar Brook Corporate Center 233 High Holborn, 4th Floor Zurich, 8152, Switzerland Cranbury, NJ 08512, United States London, Covent Garden WC1V 7DN, United Kingdom Phone: +41 44 555 10 00 Phone: 609-495-2200 Phone: +44 20 3077 5400 Fax: +41 44 555 10 01 Fax: 609-495-2201 Fax: +44 20 3077 5440 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.nycomed.com Website: www.palatin.com Website: www.plethorasolutions.co.uk Year established: 1874 Year established: 1986 Year established: 2003

Nymox Pharmaceutical Corp. Pearl Therapeutics Inc. Pozen Inc. 9900 Cavendish Blvd ., Suite 306 200 Saginaw Dr . 1414 Raleigh Rd ,. Suite 400 Saint-Laurent, QC H4M 2V2, Canada Redwood City, CA 94063, United States Chapel Hill, NC 27517, United States Phone: 800-936-9669 Phone: 650-305-2600 Phone: 919-913-1030 Fax: 514-332-2227 Fax: 650-568-1804 Fax: 919-913-1039 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.nymox.com Website: www.pearltherapeutics.com Website: www.pozen.com Year established: 1989 Year established: 2006 ProCertus BioPharm Inc. Oakwood Laboratories LLC Pergamun AB 510 Charmany Dr ., Suite 175 B 7670 First Place, Suite A Banvaktsvagen 12 Madison, WI 53719, United States Oakwood Village, OH 44146, United States Solna, SE-171 48, Sweden Phone: 608-277-7950 Phone: 440-359-0000 Phone: +468 470 37 40 Fax: 608-277-8041 Fax: 440-359-0001 Website: www.pergamum.com Website: www.procertus.com Email: [email protected] Year established: 2005 Year established: 1997 Website: www.oakwoodlabs.com Year established: 1997 Pfizer Inc. ProStrakan Group Plc. 235 East 42nd St . Galabank Business Park Oncolytics Biotech Inc. New York, NY 10017-5755, United States Galashiels, Scotland TD1 1QH, United Kingdom 1167 Kensington Crescent NW, Suite 210 Phone: 212-733-2323 Phone: +44 189 666 4000 Calgary, AB T2N 1X7, Canada Fax: 212-733-7851 Fax: +44 189 666 4001 Phone: 403-670-7377 Email: [email protected] Email: [email protected] Fax: 403-283-0858 Website: www.pfizer.com Website: www.prostrakan.com Email: [email protected] Year established: 1849 Year established: 1995 Website: www.oncolyticsbiotech.com Year established: 1998 PharmacoFore Inc. ProteoTech Inc. 75 Shoreway Rd ., Suite D 12040 115th N E. . Ave . Ono Pharmaceutical Co. San Carlos, CA 94070, United States Kirkland, WA 98034, United States 8-2 Kyutaromachi, 1-chome Phone: 650-331-4000 Phone: 425-825-0400 Osaka, Chuo-ku 541-8526, Japan Fax: 650-331-4050 Fax: 425-823-8505 Phone: +81 6 6263 5670 Email: [email protected] Email: [email protected] Website: www.ono.co.jp Website: www.pharmacofore.com Website: www.proteotech.com Year established: 1717 Year established: 1996 PharmaEngine Inc. Orexigen Therapeutics Inc. 16F, 237 Sung-Chiang Rd . Provectus Pharmaceuticals Inc. 3344 N . Torrey Pines Court, Suite 200 Taipei, 104, Taiwan 7327 Oak Ridge Hwy ., Suite A La Jolla, CA 92037, United States Phone: +886 2 25158228 Knoxville, TN 37931, United States Phone: 858-875-8600 Fax: +886 2 25157558 Phone: 866-594-5999 Fax: 858-875-8650 Email: [email protected] Fax: 866-998-0005 Email: [email protected] Website: www.pharmaengine.com Email: [email protected] Website: www.orexigen.com Year established: 2003 Website: www.pvct.com Year established: 2002 Pharmaxis Ltd. pSivida Ltd. Orient Europharma Co. 20 Rodborough Rd . 400 Pleasant Street 7F No . 368, SEC 1, Fu Hsing S . Rd . Frenchs Forest, New South Wales 2086, Australia Watertown, 02472, United States Taipei, Taiwan Phone: +61 2 9454 7200 Phone: 617-926-5000 Phone: +886 2 2755 4881 Fax: +61 2 9451 3622 Fax: 617-926-5050 Fax: +886 2 2702 4324 Email: [email protected] Website: www.psivida.com Email: [email protected] Website: www.pharmaxis.com.au Website: www.oep.com.tw Year established: 1998 Pulmatrix Inc. Year established: 1982 99 Hayden Ave ., Suite 390 Pherin Pharmaceuticals Inc. Lexington, MA 02421, United States Otonomy Inc. 4962 El Camino Real, Suite 223 Phone: 781-357-2333 5626 Oberlin Dr ., Suite 100 Los Altos, CA 94022, United States Fax: 781-357-2399 San Diego, CA 92121, United States Phone: 650-961-2703 Email: [email protected] Phone: 858-768-7823 Fax: 650-568-1671 Website: www.pulmatrix.com Fax: 858-200-0821 Website: www.pherin.com Year established: 2003 Website: www.otonomy.com Year established: 1991 Purdue Pharma LP Otsuka America Pharmaceutical Inc. Phosphagenics Ltd. One Stamford Forum, 201 Tresser Blvd . 2440 Research Blvd . 2/90 William St . Stamford, CT 06901-3431, United States Rockville, MD 20850, United States Melbourne, VIC 3000, Australia Phone: 203-588-8000 Phone: 301-990-0030 Phone: +61 3 9605 5916 Fax: 203-588-8850 Fax: 301-212-8647 Fax: +61 3 9605 5999 Website: www.purduepharma.com Website: www.otsuka-us.com Email: [email protected] Year established: 1892 Year established: 1989 Website: www.phosphagenics.com Year established: 1999 QR Pharma Inc. Otsuka Pharmaceutical Co. 259 Radnor Chester Rd ., Suite 205 2-9 Kanda-Tsukasamachi PhotoCure ASA Radnor, PA 19087, United States Tokyo, Chiyoda-ku 101-8535, Japan Hoffsveien 48 Phone: 484-253-2296 Phone: +81 3 3292 0021 Oslo, NO-0377, Norway Fax: 484-253-2288 Fax: +81 3 3295 2058 Phone: +47 22 06 2210 Email: [email protected] Website: www.otsuka.com/en Fax: +47 22 06 2218 Website: www.qrpharma.com Year established: 1964 Email: [email protected] Website: www.photocure.com QRxPharma Pty Ltd. Oxigene Inc. Year established: 1993 1/194 Miller Street 701 Gateway Blvd ., Suite 210 North Sydney, NSW 2060, Australia South San Francisco, CA 94080, United States Phone: +61 2 9492 8021 Phone: 650-635-7000 Fax: +61 2 8920 0314 Fax: 650-635-7001 Website: www.qrxpharma.com Website: www.oxigene.com Year established: 2002

Source: eKnowledgeBase.com 58 Quintiles Laboratories Ltd. Sanofi SA Soligenix Inc. 610 Oakmont Ln . 174 Avenue de France 29 Emmons Drive, Suite C-10 Westmont, IL 60559, United States Paris, Cedex 13 75635, France Princeton, NJ 08540, United States Phone: 630-789-1233 Phone: +33 1 53 77 40 00 Phone: 609-538-8200 Website: www.quintiles.com Fax: +33 1 53 77 42 96 Fax: 609-452-6467 Email: [email protected] Email: [email protected] Raptor Pharmaceutical Corp. Website: www.sanofi.com Website: www.soligenix.com 9 Commercial Blvd ., Suite 200 Year established: 2004 Year established: 1985 Novato, CA 94949, United States Phone: 415-382-8111 Santen Pharmaceutical Co. Somnus Therapeutics Inc. Fax: 415-382-1368 9-19, Shimoshinjo 3-chome 135 Route 202/206, Suite 4 Email: [email protected] Osaka, Higashiyodogawa-ku 533-8651, Japan Bedminster, NJ 07921, United States Website: www.raptorpharma.com Phone: +81 6 6321 7000 Phone: 908-901-0300 Year established: 2006 Fax: +81 6 6328 5082 Website: www.somnusthera.com Email: [email protected] Year established: 2007 Rechon Life Science AB Soldattorpsvägen 5 [email protected] Stallergenes Limhamn, Sweden Website: www santen. co. jp. 6, rue Alexis de Tocqueville Phone: +46 40 36 10 10 Year established: 1890 Antony Cedex, 92183, France Email: [email protected] Phone: +33 1 55 59 20 00 Website: www.rechon.com SARcode Corp. Fax: +33 1 55 59 20 02 343 Sansome St ., Suite 505 Website: www.stallergenes.com Recordati SpA San Francisco, CA 94104-5622, United States Via Matteo Civitali, 1 Email: [email protected] Stiefel Milan, 20148, Italy Website: www.sarcode.com 20 T .W . Alexander Drive Phone: +39 2 4878 71 Year established: 2006 Research Triangle Park, NC 27709-4910, United States Fax: +39 2 4007 3747 Phone: 919-990-6000 Email: [email protected] SciClone Pharmaceuticals Inc. Website: www.stiefel.com Website: www.recordati.com 950 Tower Lane, Suite 900 Year established: 1847 Year established: 1926 Foster City, CA 94404-2125, United States Phone: 650-358-3456 Sunovion Pharmaceuticals Inc. Regeneron Pharmaceuticals Inc. Fax: 650-358-3469 84 Waterford Dr . 777 Old Saw Mill River Rd . Email: [email protected] Marlborough, MA 01752-7010, United States Tarrytown, NY 10591-6707, United States Website: www.sciclone.com Phone: 508-481-6700 Phone: 914-345-7400 Year established: 1989 Fax: 508-357-7499 Email: [email protected] Email: [email protected] Website: www.regeneron.com Shionogi & Co. Website: www.sunovion.com Year established: 1988 1-8, Doshomachi 3-chome Year established: 1984 Osaka, Chuo-Ku 541-0045, Japan RegeneRx Biopharmaceuticals Inc. Phone: +81 6 6202 2161 Supernus Pharmaceuticals Inc. 15245 Shady Grove Rd ., Suite 470 Fax: +81 6 6229 9596 1550 East Gude Dr ., Rockville, MD 20850, United States Rockville, MD 20850, United States Website: www.shionogi.co.jp Phone: 301-838-2500 Phone: 301-208-9191 Year established: 1878 Fax: 301-838-2501 Email: [email protected] Website: www.supernuspharma.com Website: www.regenerx.com Shionogi Inc. Year established: 1982 100 Campus Dr . Taiho Pharmaceutical Co. Florham Park, NJ 07932, United States 1-27, Kanda danishiki-cho Revance Therapeutics Inc. Phone: 973-966-6900 Tokyo, Chiyoda-ku 101-8444, Japan 2400 Bayshore Pkwy ., Suite 100 Email: [email protected] Phone: +81 3 3294 4527 Mountain View, CA 94043, United States Website: www.shionogiusa.com Fax: +81 3 3233 4057 Phone: 650-230-4500 Year established: 2001 Website: www.taiho.co.jp/english/index.html Fax: 650-230-4501 Year established: 1963 Email: [email protected] Shire Plc. Website: www.revance.com 5 Riverwalk, Citywest Business Campus Taisho Pharmaceutical Co. Dublin, Hampshire 24, Ireland 3-24-1, Takada, Toshima-ku Revotar Biopharmaceuticals AG Phone: +44 125 689 4000 Tokyo, Toshima-ku 170-8633, Japan Neuendorfstrasse 24a Fax: +44 125 689 4708 Phone: +81 3 3985 1111 Hennigsdorf, 16761, Germany Email: [email protected] Fax: +81 3 3985 0716 Phone: +49 3 30 2202 5010 Website: www.shire.com Website: www.taisho.co.jp Fax: +49 3 30 2202 5011 Year established: 1986 Year established: 1912 Email: [email protected] Website: www.revotar.de Shire US Inc. Takeda Pharmaceutical Co. 725 Chesterbrook Blvd ., Wayne, PA 19087, United States 1-1, Doshomachi 4-chome Rexahn Pharmaceuticals Inc. Phone: 484-595-8800 Osaka, Chuo-ku 540-8645, Japan 15245 Shady Grove Rd ., Suite 455 Fax: 484-595-8200 Phone: +81 6 6204 2111 Rockville, MD 20850, United States Website: www.shire.com Fax: +81 6 6204 2880 Phone: 240-268-5300 Website: www.takeda.com Fax: 240-268-5310 Sirnaomics Inc. Year established: 1781 Email: [email protected] 401 Professional Dr ., Suite 130 Website: www.rexahn.com Gaithersburg, MD 20879, United States Takeda Pharmaceuticals North America Inc. Year established: 2001 Phone: 301-740-1730 One Takeda Pkwy ,. Deerfield, IL 60015, United States Email: [email protected] Phone: 224-554-6500 Rigel Pharmaceuticals Inc. Website: www.sirnaomics.com Website: www.tpna.com 1180 Veterans Blvd . Year established: 2007 Year established: 1998 South San Francisco, CA 94080, United States Phone: 650-624-1100 SkyePharma Plc. Talon Therapeutics Inc. Fax: 650-624-1101 46-48 Grosvenor Gardens 400 Oyster Point Blvd ., Suite 215 Email: [email protected] London, SW1W 0EB, United Kingdom South San Francisco, CA 94080, United States Website: www.rigel.com Phone: +44 207 881 0524 Phone: 650-588-6404 Fax: +44 207 881 1199 Fax: 650-588-2787 Sanofi Website: www.skyepharma.com Email: [email protected] 55 Corporate Dr ., PO Box 6800 Year established: 1996 Website: www.talontx.com Bridgewater, NJ 08807-2854, United States Phone: 800-981-2491 Solasia Pharma KK Taris Biomedical Inc. Email: [email protected] 3F Shiodome Bldg ,. 1-2-20 Kaigan, Minato-ku 99 Hayden Ave ., Suite 100 Website: en.sanofi.com Tokyo, 105-0022, Japan Lexington, MA 02421, United States Phone: +81 3 6721 8332 Phone: 781-676-7750 Fax: +81 3 6721 2020 Fax: 781-676-7788 Website: www.solasia.co.jp/en Email: [email protected] Year established: 2006 Website: www.tarisbiomedical.com

Source: eKnowledgeBase.com 59 Teijin Ltd. Topica Pharmaceuticals Inc. Verona Pharma Plc. 6-7, Minami-hommachi, 1-chome 435 Tasso St ., Suite 325 100 Borough High St ., Suite 21 - Alpha House Osaka, Chuo-ku 541-8587, Japan Palo Alto, CA 94301, United States London, SE1 1LB, United Kingdom Phone: +81 6 6268 21312 Phone: 650-473-3800 Phone: +44 20 7863 3300 Website: www.teijin.co.jp Fax: 650-473-3805 Fax: +44 20 7863 3314 Year established: 1918 Website: www.topicapharma.com Email: [email protected] Website: www.veronapharma.com Teikoku Seiyaku Co. Transcept Pharmaceuticals Inc. 567 Sanbonmatsu, Higashikagawa 1003 W . Cutting Blvd ., Suite 110 Vical Inc. Kagawa, 769-2695, Japan Pt . Richmond, CA 94804, United States 10390 Pacific Center Ct . Phone: +81 879 25 2221 Phone: 510-215-3500 San Diego, CA 92121-4340, United States Fax: +81 879 24 1555 Fax: 510-215-3535 Phone: 858-646-1100 Website: www.teikoku.co.jp/english_v/e_index.html Email: [email protected] Fax: 858-646-1150 Year established: 1848 Website: www.transcept-pharma.com Email: [email protected] Website: www.vical.com Tercica Inc. Transdel Pharmaceuticals Inc. Year established: 1987 2000 Sierra Point Pkwy ., Suite 400 4225 Executive Square, Suite 485 Brisbane, CA 94005, United States La Jolla, CA 92037, United States Vicept Therapeutics Inc. Phone: 650-624-4900 Phone: 858-457-5300 101 Lindenwood Drive, Suite 430 Fax: 650-243-5111 Email: [email protected] Malvern, PA 19355, United States Email: [email protected] Website: www.transdelpharma.com Phone: 484-324-2930 Website: www.tercica.com Fax: 484-324-2988 Year established: 2001 Tris Pharma Email: [email protected] 2033 Route 130, Brunswick Business Park, Suite D Website: www.vicepttx.com Teva Pharmaceutical Industries Ltd. Monmouth Junction, NJ 08852, United States Year established: 2009 5 Basel St . Phone: 732-940-2800 Petach Tikva, 49131, Israel Fax: 732-940-2855 ViroXis Corp. Phone: +972 3 926 72 67 Website: www.trispharma.com 12621 Silicon Dr ., Suite 100 Fax: +972 3 923 40 50 San Antonio, TX 78249, United States Website: www.tevapharm.com Triton Pharma Inc. Phone: 210-558-8896 Year established: 1901 665 Milway Ave ,. Suite 31B Fax: 210-694-9466 Concord, ON L4K 3T8, Canada Email: [email protected] Teva Pharmaceuticals USA Inc. Phone: 866-429-9707 Website: www.viroxis.com 1090 Horsham Rd ., PO Box 1090 Email: [email protected] Year established: 2006 North Wales, PA 19454-1090, United States Website: www.tritonpharma.ca Phone: 215-591-3000 Year established: 2005 Viventia Biotechnologies Inc. Fax: 215-591-8600 7895 Tranmere Drive, Suite 204 Email: [email protected] UCB Inc. Mississauga, ON L5S 1V9, Canada Website: www.tevapharmusa.com 1950 Lake Park Dr . Phone: 905-362-2973 Year established: 1996 Smyrna, GA 30080, United States Fax: 905-362-2981 Phone: 770-970-7500 Email: [email protected] Theravance Inc. Fax: 770-970-8917 Website: www.viventia.com 901 Gateway Blvd . Website: www.ucb-group.com Year established: 1983 South San Francisco, CA 94080, United States Phone: 650-808-6000 Ultragenyx Pharmaceutical Inc. Vivus Inc. Email: [email protected] 77 Digital Dr ., Suite 210 1172 Castro St . Website: www.theravance.com Novato, CA 94949, United States Mountain View, CA 94040, United States Year established: 1996 Phone: 415-884-0223 Phone: 650-934-5200 Fax: 415-884-0562 Fax: 650-934-5357 ThromboGenics Ltd. Email: [email protected] Email: [email protected] 14 Bridgecourt Office Park, Walkinstown Ave . Website: www.ultragenyx.com Website: www.vivus.com Dublin, 12, Ireland Year established: 2010 Year established: 1991 Phone: +353 1 409 7757 Fax: +353 1 409 8180 United Therapeutics Corp. Watson Pharmaceuticals Inc. Email: [email protected] 1110 Spring St . Morris Corporate Center III, 400 Interpace Pkwy . Website: www.thrombogenics.com Silver Spring, MD 20910, United States Parsippany, NJ 07054, United States Year established: 1998 Phone: 301-608-9292 Phone: 862-261-7000 Fax: 301-608-9291 Website: www.watson.com Tissue Repair Co. Email: [email protected] Year established: 1985 6740 Top Gun St . Website: www.unither.com San Diego, CA 92121, United States Year established: 1996 Welichem Biotech Inc. Phone: 858-793-6641 316-4475 Wayburne Dr . Fax: 858-793-7243 Upsher-Smith Laboratories Inc. Burnaby, BC V5G 3L1, Canada Email: [email protected] 6701 Evenstad Dr . Phone: 604-432-1703 Website: www.t-r-co.com Maple Grove, MN 55369, United States Fax: 604-432-1704 Phone: 763-315-2000 Email: [email protected] Titan Pharmaceuticals Inc. Email: [email protected] Website: www.welichem.com 400 Oyster Point Blvd ., Suite 505 Website: www.upsher-smith.com South San Francisco, CA 94080, United States Year established: 1919 Winston Pharmaceuticals Inc. Phone: 650-244-4990 100 North Fairway Dr ., Suite 134 Fax: 650-244-4956 Valeant Pharmaceuticals International Inc. Vernon Hills, IL 60061, United States Email: [email protected] 7150 Mississauga Rd . Phone: 847-362-8200 Website: www.titanpharm.com Mississauga, ON L5N 8M5, Canada Fax: 847-362-8394 Year established: 1992 Phone: 905-286-3000 Email: [email protected] Fax: 905-286-3050 Website: www.winstonlabs.com Tokuhon Corp. Website: www.valeant.com Shiba 2 Chome Bldg . 13F, 2-28-8 Chiba Year established: 1994 Xenon Pharmaceuticals Inc. Tokyo, Minato-ku 105-0014, Japan 3650 Gilmore Way, Phone: +81 3 5439 2100 Valocor Therapeutics Inc. Burnaby, BC V5G 4W8, Canada Fax: +81 3 5439 2500 777 Dunsmuir St ., Suite 1300 Phone: 604-484-3300 Email: [email protected] Vancouver, BC V7Y 1K2, Canada Fax: 604-484-3450 Website: www.tokuhon.co.jp/english Website: www.valocor.com Email: [email protected] Year established: 1901 Website: www.xenon-pharma.com Vectura Group Plc. Topaz Pharmaceuticals LLC One Prospect W . 500 Office Center Dr ., Suite 400 Chippenham, SN14 6FH, United Kingdom Fort Washington, PA 19034, United States Phone: +44 124 966 7700 Website: www.topazpharma.com Fax: +44 124 966 7701 Website: www.vectura.com Year established: 1997

Source: eKnowledgeBase.com 60 XenoPort Inc. Zalicus Inc. Zogenix Inc. 3410 Central Expressway 245 First St ., Third Floor 11682 El Camino Real, Suite 320 Santa Clara, CA 95051, United States Cambridge, MA 02142, United States San Diego, CA 92130, United States Phone: 408-616-7200 Phone: 617-301-7000 Phone: 858-259-1165 Fax: 408-616-7210 Fax: 617-301-7010 Fax: 858-259-1166 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.xenoport.com Website: www.zalicus.com Website: www.zogenix.com Year established: 1999 Year established: 2000 Zosano Pharma Inc. Yakult Honsha Co. Zeria Pharmaceutical Co. 34790 Ardentech Ct . 1-19 Higashi-Shinbashi 1-Chome Minato-Ku 10-11 Nihonbashi- Kobuna-cho Fremont, CA 94555, United States Tokyo, 105-8660, Japan Tokyo, Chuo-ku 103-8351, Japan Phone: 510-745-1200 Phone: +81 3 3574 8960 Phone: +81 3 3663 2351 Website: www.zosanopharma.com Website: www.yakult.co.jp Website: www.zeria.co.jp/english/index.html Year established: 2006 Year established: 1935 Year established: 1955

Yaupon Therapeutics Inc. 259 North Radnor-Chester Rd . Radnor, PA 19087, United States Phone: 610-975-9290 Fax: 610-975-9012 Website: www.yaupontherapeutics.com

Source: eKnowledgeBase.com

Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Board, Arm (With Cover), Sterile BTX 878 3910. Alimed, Inc . Board, Arm (With Cover), Sterile BTX Arm boards for a variety of surgical procedures . 878 3910. Bryton Corp . Board, Arm (With Cover), Sterile BTX Neonatal limb board immobilizes I V. . site . 878 3910. Cas Medical Systems, Inc . Board, Arm (With Cover), Sterile BTX DALE Bendable Armboard . Large #650 fits most 878 3910. Dale Medical Products, Inc . adults . Medium #651 fits pediatrics . Small # 652 fits infant . Board, Arm (With Cover), Sterile BTX Reusable armboard strap . 878 3910. Fpp, Inc . Board, Arm (With Cover), Sterile BTX 878 3910. Hausmann Industries, Inc . Board, Arm (With Cover), Sterile BTX TKO Multi-Position Armboard, used with virtually any rail 878 3910. Health Supply Company Inc ., The clamp; when used with the Midkiff GEOSTATIC Clamp, greater positioning flexibility and allocation is achieved . Board, Arm (With Cover), Sterile BTX 878 3910. J . T . Posey Co . Board, Arm (With Cover), Sterile BTX Ameritus Neonatal and Pediatric limb boards designed to 878 3910. Kentec Medical Inc . stabilize the hand and foot for IV securement and other applications . Board, Arm (With Cover), Sterile BTX Arm board . 878 3910. Kentron Health Care, Inc . Board, Arm (With Cover), Sterile BTX Vinyl covered foam . Disposable/reusable . Item no . 1012 . 878 3910. Lundy Medical Product, Llc Board, Arm (With Cover), Sterile BTX 878 3910. Medrecon, Inc . Board, Arm (With Cover), Sterile BTX Lateral, pivoting & surgical (radiolucent) . 878 3910. Mizuho Osi Board, Arm (With Cover), Sterile BTX Premie, newborn, neonatal to adult models, disposable or 878 3910. Morrison Medical reusable: 1x4, 1 5x3,. 2x4, 2x6, 2x9, 3x6, 3x9, 3x12, 3x18, 4x9, & 4x18in . Board, Arm (With Cover), Sterile BTX Arm rest boards 878 3910. Peaktop Ltd . Board, Arm (With Cover), Sterile BTX PEDI-BOARD $2 .52 to $6 90. for 3, 4, 6, 8, and 15 in . sizes . 878 3910. Pedicraft, Inc . Board, Arm (With Cover), Sterile BTX 878 3910. Philips Medical Systems North America Board, Arm (With Cover), Sterile BTX (wtih cover), non-sterile - TARRY ARM BOARD; TARRY ARM 878 3910. Tarry Manufacturing BOARD SLEEVES; TARRY BOARD Board, Arm (With Cover), Sterile BTX TELOS anesthesia/general purpose radiolucent arm board . 878 3910. Telos Medical Equipment (Austin Fits any Clark Socket and may be used for hand and shoulder & Assoc ., Inc .) surgery . Stand, Infusion FOX Infusion stand . 880 6990. Ac Healthcare Supply, Inc . Stand, Infusion FOX SAF-T-POLE I V. ,. pole and irrigation tower for arthroscopy, TURP 880 6990. Advanced Medical Innovations, and hysteroscopy . Saves money and the practitioner’s back . Inc . Stand, Infusion FOX 880 6990. Alimed, Inc . Stand, Infusion FOX Easy Irrigation Tower - Four independently adjustable hooks 880 6990. Allen Medical Systems, Inc . each safely support up to 10,000cc of fluid . Comfortable, quick-release knobs permit vertical adjustment of hangers from 51⁄2 to 81⁄2 . (167 .5 cm x 259 cm) This nurse- friendly design m

Source: MDRWeb.com 61 Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Stand, Infusion FOX 880 6990. American Medical Mfg ., Inc . Stand, Infusion FOX 880 6990. Armstrong Medical Industries, Inc . Stand, Infusion FOX 880 6990. Atd-American Co . Stand, Infusion FOX 880 6990. B . Braun Medical, Inc . Stand, Infusion FOX Stainless steel and chrome IV Stands with four, five and six leg 880 6990. Blickman bases . Five different height adjustment mechanisms- foot- operated, twist lock, friction knob,thumb control, trigger lock . Stand, Infusion FOX IV poles, many varieties . 880 6990. Brandt Industries, Inc . Stand, Infusion FOX 880 6990. Brenner Metal Products Stand, Infusion FOX 880 6990. Brewer Company, The Stand, Infusion FOX 880 6990. Cameron-Miller, Inc . Stand, Infusion FOX Stand infusion, intravenous . 880 6990. Camtec Stand, Infusion FOX 880 6990. Cardinal Health 200, Inc Stand, Infusion FOX 880 6990. Clinimed, Incorporated Stand, Infusion FOX Various configurations of iv poles . 880 6990. Conmed Integrated Systems (Cmis) Stand, Infusion FOX Various styles & sizes of wall brackets, dispensers, etc . 880 6990. Covidien Lp, Formerly Registered As Kendall Stand, Infusion FOX 880 6990. Covidien Lp, Formerly Registered As Kendall Stand, Infusion FOX I .V . stands and accessories . 880 6990. Crest Healthcare Supply Stand, Infusion FOX 880 6990. Depuy Mitek, Inc . Stand, Infusion FOX Infusion stand . 880 6990. Ekos Corp . Stand, Infusion FOX 880 6990. Ethicon, Inc . Stand, Infusion FOX $50 .00 for aluminum I V. . pole for ambulance gurney . 880 6990. Farley Inc ., W .T . Stand, Infusion FOX 880 6990. Galaxy Medical Manufacturing Co . Stand, Infusion FOX IV securement device . IV Protector is an FDA - Class 1 excemst 880 6990. Glo Touch Corporation infusion set accessory device -(Anchor joint)- disposable for IV line safety so as to avoid strain, disconnection from patient while in transport . Stand, Infusion FOX Various . 880 6990. Health Care Logistics, Inc . Stand, Infusion FOX 880 6990. Hill-Rom Holdings, Inc . Stand, Infusion FOX Infusion stands and accessories . 880 6990. Hill-Rom, Inc . Stand, Infusion FOX 880 6990. Homak Manufacturing Company Inc . Stand, Infusion FOX Hospira IV stand 880 6990. Hospira Inc . Stand, Infusion FOX I .v . stand . 880 6990. I .V . League Medical Stand, Infusion FOX I .v . stand and accessories . 880 6990. Icu Medical (Ut), Inc Stand, Infusion FOX Infusion stand . 880 6990. Innovative Medical Designs Stand, Infusion FOX 880 6990. Instrument Specialists, Inc . Stand, Infusion FOX 880 6990. Integra Lifesciences Of Ohio Stand, Infusion FOX Infusion pump stand i v. . pole . 880 6990. Iradimed Corporation Stand, Infusion FOX 880 6990. Jedmed Instruments Co . Stand, Infusion FOX Cart, walker . 880 6990. Livengood Engineering Inc . Stand, Infusion FOX 880 6990. Maquet, Inc . Stand, Infusion FOX Various models of infusion stands and poles . 880 6990. Maquet, Inc . Stand, Infusion FOX Iv pole . 880 6990. Medical Depot Stand, Infusion FOX 880 6990. Medi-Crush Company Stand, Infusion FOX 880 6990. Medtronic Navigation, Inc . Stand, Infusion FOX Heavy duty, stainless steel IV poles and accessories . 880 6990. Medved Products, Inc . Stand, Infusion FOX “The Messerli Connection” Adjustable connector for IV 880 6990. MEI Corporation poles and adjustable receiver for wheelchairs, beds, and gurneys . Takes 3-5 seconds to make the switch .

Source: MDRWeb.com 62 Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Stand, Infusion FOX Infusion pump stands . 880 6990. Modular Services Company Stand, Infusion FOX 880 6990. Ohmeda Medical Stand, Infusion FOX 880 6990. Omni Medical Supply Inc . Stand, Infusion FOX Stainless steel or chrome: pump, gravity feed, hand or foot 880 6990. Pedigo Products operated . Stand, Infusion FOX $190 .00 per IV floor stand . 880 6990. Phelan Manufacturing Corp . Stand, Infusion FOX Infusion stand 880 6990. Provita Gmbh Medizintechnik Stand, Infusion FOX A broad and deep variety of standard and custom IV stands 880 6990. Pryor Products are available . These products are designed to work safely and effectively in their intended patinet care areas . Stand, Infusion FOX I .v . stand, i .v . pole . 880 6990. Quality Control Corp . Stand, Infusion FOX 880 6990. Quest Medical, Inc . Stand, Infusion FOX 880 6990. Radiation Products Design, Inc . Stand, Infusion FOX 880 6990. Sharps Compliance Corp . Stand, Infusion FOX 880 6990. Steelcraft, Inc . Stand, Infusion FOX 880 6990. The After Market Group Stand, Infusion FOX INFUSION CART 880 6990. Wells Johnson Co . Stand, Infusion FOX No common name listed 880 6990. Wisap Gesellschaft Fur Wissenschaftl . App . Bau Mbh Shield, Eye, Ophthalmic (Including HOY (including sunlamp protective eyewear and post-mydriatic 886 4750. Alcon Research, Ltd . Sunlamp Protective Eyewear and eyewear) - CLEAR EYE SHIELD Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Alimed, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Alphaprotech, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Altomed Opthalmic Products Sunlamp Protective Eyewear and Ltd . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Opthalmic eye shield 886 4750. Amann Medizintechnik Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various models of shield, eye, ophthalmic 886 4750. Amarco Medizintechnik Gmbh Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Ophthalmic eye shield . To be used primarily by children with 886 4750. Anissa’s Fun Patches Sunlamp Protective Eyewear and lazy eye, or to conceal the eye after surgery, etc . for adults as Post-mydriatic Eyewear) well as children . Shield, Eye, Ophthalmic (Including HOY Architectures 886 4750. Architectures Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Shield, eye, ophthalmic (including sunlamp protective eye) . 886 4750. Astron International Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST- 886 4750. Avedro, Inc . Sunlamp Protective Eyewear and MYDRIATIC EYEWEAR) - Vibex Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various types of shields . 886 4750. B . Graczyk, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye shield 886 4750. Baur Und Haselbarth-Chirurg Sunlamp Protective Eyewear and Gmbh Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Bausch & Lomb Surgical Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Anti-fog coated shields for surgical and face masks . 886 4750. Brady Precision Converting, Llc Sunlamp Protective Eyewear and Post-mydriatic Eyewear)

Source: MDRWeb.com 63 Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Shield, Eye, Ophthalmic (Including HOY Various types of safety shields and spectacle frame mounted 886 4750. Ctp Coil Inc . Sunlamp Protective Eyewear and occulars . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Eagle Laboratories Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Edge i-wear corp . 886 4750. Edge I-Wear Corp . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Ferguson Production, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Ophthalmic eye shield . 886 4750. Fresnel Prism & Lens Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Spectacle frames and sunglasses 886 4750. Fukui Koki Co . Ltd . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Gargoyles Eyewear Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. General Scientific Safety Sunlamp Protective Eyewear and Equipment Co . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Genesis Biosystems, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. George Tiemann & Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Safety glasses 886 4750. Greattec Vision S .A . De C .V . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Gulden Ophthalmics Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye protector convex/flat 886 4750. Gustav Ehinger Gmbh & Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye shield, light shield . 886 4750. Hurricane Medical Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye shield 886 4750. Indo German Surgical Corp . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Sun goggles 886 4750. Intercos Gmbh Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Sunglasses 886 4750. Izumi Optical Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye mask 886 4750. J E. .M . Sales Ltd . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Jardon Eye Prosthetics, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Jedmed Instruments Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. K Medical Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST- 886 4750. Kbd, Inc . Sunlamp Protective Eyewear and MYDRIATIC EYEWEAR) Post-mydriatic Eyewear)

Source: MDRWeb.com 64 Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Shield, Eye, Ophthalmic (Including HOY No common name listed 886 4750. Leonids Traders Pvt . Ltd . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Tanning booth eyewear . 886 4750. Lt Acquisition, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Ablatable mask . 886 4750. Maverick Technologies, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY SAFE-CHOICE Disposable . 886 4750. Medegen Medical Products, Llc Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various . 886 4750. Medone Surgical, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY E-Z CLEAN eye shield . 886 4750. Megadyne Medical Products, Sunlamp Protective Eyewear and Inc . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various 886 4750. Model Eye Industry Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY NEOSHADES: Phototherapy Eye Shields . Cute phototherapy 886 4750. Neotech Products, Inc . Sunlamp Protective Eyewear and mask with sunglasses printed on one side . Fun for parents, Post-mydriatic Eyewear) patients and staff . Shield, Eye, Ophthalmic (Including HOY Spectacle frame, sunglassess 886 4750. One Optical Co ., Ltd . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye shield 886 4750. Paul Instruments (India) Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Safety shields . 886 4750. Perioptix, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY $47 .30 per box of 50 pcs . of PRO-SHIELDS . 886 4750. Pro-Optics, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Radiation filtering glasses . 886 4750. Protech Leaded Eyewear Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Hematocrit control . 886 4750. Richmond Products, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye shield, ophthalmic 886 4750. Rz Medizintechnik Gmbh Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Sharn, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various 886 4750. Sofard Co ., Ltd . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. Sperian Eye & Face Protection Sunlamp Protective Eyewear and Inc . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Eye protector . 886 4750. Sun-Med Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Pediatric & Adult Eye Shields . 886 4750. Total Molding Services, Inc . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY SAFE-EDGE malleable ophthalmic aluminum eyeshield and 886 4750. Trident Medical Products Sunlamp Protective Eyewear and Universal Polycarbonate plastic eyeshield with U V. . additive . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY 886 4750. U .V . Vision Corp . Sunlamp Protective Eyewear and Post-mydriatic Eyewear)

Source: MDRWeb.com 65 Drug-Delivery Class I Devices – General Controls – 510(k) Exempt

Product Regulation Product name code Product description number Company name Shield, Eye, Ophthalmic (Including HOY ULTRACELL PVA corneal light shields and LASIK shields . 886 4750. Ultracell Medical Technologies, Sunlamp Protective Eyewear and Inc . Post-mydriatic Eyewear) Shield, Eye, Ophthalmic (Including HOY Various 886 4750. Woosung Industry Co . Sunlamp Protective Eyewear and Post-mydriatic Eyewear) Infusor, Pressure, For IV Bags KZD 880 5420. Armstrong Medical Industries, Inc . Infusor, Pressure, For IV Bags KZD Various pressure infusors and accessories . 880 5420. Baxter Healthcare Corp ,. Renal Division Infusor, Pressure, For IV Bags KZD Pressure infusor . 880 5420. Circulatory Technology, Inc . Infusor, Pressure, For IV Bags KZD $65 00. to $68 00. each; volumes: 500mL and 1000mL (units used 880 5420. Clark Company Inc ., David to administer fluids under pressure) . Infusor, Pressure, For IV Bags KZD Pressure Infusor Irrigator 880 5420. Covidien Infusor, Pressure, For IV Bags KZD BLOOD TRANSFUSION PRESSURE BAG; I V. . FLUID 880 5420. Cw Medical, Inc . Infusor, Pressure, For IV Bags KZD Pressure infusor . 880 5420. David Clark Company, Inc . Infusor, Pressure, For IV Bags KZD Infuser bag . 880 5420. Ethox International Infusor, Pressure, For IV Bags KZD Pressure infusor for use with BLOOD PACK units and transfer 880 5420. Fenwal Inc . packs . Infusor, Pressure, For IV Bags KZD Pressure infusor 880 5420. Fujinomiya Factory Of Terumo Corporation Infusor, Pressure, For IV Bags KZD Infusion device for IV fluid administration . 880 5420. Health Care Logistics, Inc . Infusor, Pressure, For IV Bags KZD Various types . 880 5420. Icu Medical (Ut), Inc Infusor, Pressure, For IV Bags KZD Piv system, various models . 880 5420. Mfg One, Llc Infusor, Pressure, For IV Bags KZD Pressure infusor/irrigator 880 5420. Mmj S A. . De C .V . Infusor, Pressure, For IV Bags KZD 880 5420. Mobile I V. . Systems, Llc Infusor, Pressure, For IV Bags KZD I .V .; MULTIPLE MODELS; REPROCESSED PRESSURE INFUSER 880 5420. ReNu Medical Inc . Infusor, Pressure, For IV Bags KZD Automated pressure infusor for I .V . fluid therapy . 880 5420. Smiths Medical Asd, Inc . Infusor, Pressure, For IV Bags KZD INFU-SURG 880 5420. Sts Division Of Ethox International Infusor, Pressure, For IV Bags KZD Pressure infusion bag . 880 5420. Ventlab Corp . Infusor, Pressure, For IV Bags KZD Infusor inflating device . 880 5420. Vital Signs Mn, Inc . Infusor, Pressure, For IV Bags KZD 880 5420. Vital Signs, Inc . Infusor, Pressure, For IV Bags KZD 880 5420. Zoll Medical Corp .

Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Flowmeter, Blood, Cardiovascular DPW Hemosonic 100 non-invasive transesophageal hemodynamic 870 2100. Arrow International, Inc . monitor . Flowmeter, Blood, Cardiovascular DPW Vascular probe . 870 2100. Cardinal Healthcare 209, Inc . Flowmeter, Blood, Cardiovascular DPW $6,900 00. for FM501D electromagnetic flowmeter for research 870 2100. Carolina Medical, Inc . use . $7,595 .00 for FM701D CLINIFLOW II for operating room use . Flowmeter, Blood, Cardiovascular DPW Doppler vascular access monitor . 870 2100. Escalon Trek Medical Flowmeter, Blood, Cardiovascular DPW Tissue perfusion monitoring system 870 2100. Hemedex Incorporated Flowmeter, Blood, Cardiovascular DPW 870 2100. Koven Technology, Inc . Flowmeter, Blood, Cardiovascular DPW Laser doppler perfusion imager 870 2100. Lisca Ab Flowmeter, Blood, Cardiovascular DPW Medical blood volume flowmeter 870 2100. Medi-Stim A/S Flowmeter, Blood, Cardiovascular DPW 870 2100. Terumo Cardiovascular Systems, Corp Flowmeter, Blood, Cardiovascular DPW Doppler, instrument monitor . 870 2100. Volcano Corporation Patch, Pledget And Intracardiac, DXZ 870 3470. Bard Peripheral Vascular, Inc . PETP, PTFE, Polypropylene

Source: MDRWeb.com 66 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Patch, Pledget And Intracardiac, DXZ Fabrics,grafts,pledgets . 870 3470. Bard Shannon Limited PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch . 870 3470. Bridger Biomed, Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch kit (sterile) . 870 3470. Chase Medical, Lp PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ CorMatrix ECM for Pericardial Closure; CorMatrix ECM for 870 3470. CorMatrix Cardiovascular Inc . PETP, PTFE, Polypropylene Cardiac Tissue Repair Patch, Pledget And Intracardiac, DXZ Ptfe pledget . 870 3470. Covidien Lp, Formerly Registered PETP, PTFE, Polypropylene As United States Surgical Patch, Pledget And Intracardiac, DXZ CryoPatch SG Pulm . Human Cardia 870 3470. Cryolife, Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Various, cardiovascular patch . 870 3470. Deroyal Surgical - Rose Hill PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ 870 3470. Ethicon, Inc PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ 870 3470. Ethicon, Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Sterile teflon pledgets . 870 3470. Ethicon, Llc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ HEMASHIELD 870 3470. Maquet Cardiovascular LLC PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Intracardiac patch or pledget . 870 3470. Mast Biosurgery Usa Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Patch . 870 3470. Shelhigh, Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ CorRestore(TM) System; Bovine pericardial patch system 870 3470. Somanetics Corp . PETP, PTFE, Polypropylene uniquely designed for cardiac repair and reconstruction and especially well-suited for Surgical Ventricular Restoration (SVR) . Patch, Pledget And Intracardiac, DXZ Peri-Guard Cardiovascular Patch; Supple Peri-Guard; Vascu- 870 3470. Synovis Life Technologies, Inc PETP, PTFE, Polypropylene Guard Patch, Pledget And Intracardiac, DXZ 870 3470. Tuzik Boston PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Teflon pledget 870 3470. Tyco Healthcare Uk Ltd . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ 870 3470. Ussc Puerto Rico, Inc . PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch . 870 3470. W .L . Gore & Associates,Inc PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Patch “sterile” . 870 3470. Yama, Inc . PETP, PTFE, Polypropylene System, Dialysate Delivery, Sealed FII 876 5860. Fresenius Usa, Inc . System, Dialysate Delivery, Single FIL 876 5820. Fresenius Usa, Inc . Pass System, Dialysate Delivery, Single FKP 876 5820. B . Braun Medical Inc ,. Renal Patient Therapies Div . System, Dialysate Delivery, Single FKP Sps single patient system . 876 5820. Baxter Healthcare Corp ,. Renal Patient Division System, Dialysate Delivery, Single FKP Chf systems 100 . 876 5820. Chf Solutions, Inc . Patient System, Dialysate Delivery, Single FKP 876 5820. Fresenius Usa, Inc . Patient System, Dialysate Delivery, Single FKP No common name listed 876 5820. Fuji Medical Instr Mfg ., Co . Ltd . Patient System, Dialysate Delivery, Single FKP Sodium bicarbonate mixing & delivery system, mixes and 876 5820. G .E M. . Water Systems, Int’L ., Llc Patient monitors sodium bicarbonate solution and delivers it to the dialysis patients . System, Dialysate Delivery, Single FKP Watercheck 2 reagent strip, chloramine test strips . 876 5820. Integrated Biomedical Patient Technology, Inc . System, Dialysate Delivery, Single FKP No common name listed 876 5820. Nikkiso Co . Ltd . Patient

Source: MDRWeb.com 67 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name System, Dialysate Delivery, Single FKP Hemodialysis accessory . 876 5820. Nxstage Medical, Inc . Patient System, Dialysate Delivery, Central FKQ Diacide . 876 5820. Alden Medical Llc Multiple Patient System, Dialysate Delivery, Central FKQ CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) 876 5820. Fresenius Medical Care North Multiple Patient America System, Dialysate Delivery, Central FKQ CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) 876 5820. Fresenius Medical Care North Multiple Patient America System, Dialysate Delivery, Central FKQ CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) 876 5820. Fresenius Medical Care North Multiple Patient America System, Dialysate Delivery, Central FKQ CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) 876 5820. Fresenius Medical Care North Multiple Patient America System, Dialysate Delivery, Central FKQ CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) 876 5820. Fresenius Medical Care North Multiple Patient America System, Dialysate Delivery, Central FKQ O3Z OZONE SYSTEM 876 5820. Mar Cor Purification Multiple Patient System, Dialysate Delivery, Central FKQ RENAPAK ;. Acetate Concentrate; Acid Concentrate; 876 5820. Minntech Corporation Multiple Patient Bicarbonate Concentrate; Conductivity Meter;; Conductivity Meter System, Dialysate Delivery, Central FKQ Dialysate delivery systems, sigle and multi stations 876 5820. Rismed Oncology Systems Multiple Patient System, Dialysate Delivery, Sorbent FKT Model 1000; Allient Sorbent Hemodialysis System; Model 1500; 876 5600. Renal Solutions Inc . Regenerated 2008 Hemodialysis Sorbent System System, Dialysate Delivery, Sorbent FKT Sorbent cartridges . 876 5600. Sorb Technology, Inc . Regenerated Stopcock, I .V . Set FMG Plastic disposable non-sterile stop cock . 880 5440. Ac Healthcare Supply, Inc . Stopcock, I .V . Set FMG multiple 880 5440. Arrow International, Inc . Stopcock, I .V . Set FMG Similar models of stopcocks 880 5440. B . Braun Medical Ag Stopcock, I .V . Set FMG OTHER; DISCOFIX 880 5440. B . Braun Medical, Inc . Stopcock, I .V . Set FMG 880 5440. B . Braun Oem Division, B . Braun Medical Inc . Stopcock, I .V . Set FMG Iv set stopcock . 880 5440. B . Braun Of Puerto Rico, Inc . Stopcock, I .V . Set FMG Stopcock, various types 880 5440. Baur Und Haselbarth-Chirurg Gmbh Stopcock, I .V . Set FMG I .V . SET - Multi-Port Manifold; Stopcock Manifold Gangs; 880 5440. Baxter Healthcare Corporation, Medication Delivery Stopcock, I .V . Set FMG 880 5440. Baxter Healthcare Corporporation, Alternate Care And Channel Team Stopcock, I .V . Set FMG Various stopcocks . 880 5440. Baxter Healthcare S .A . Stopcock, I .V . Set FMG Various designs & combinations of plastic stopcocks 880 5440. Baxter Productos Medicos, Ltda . Stopcock, I .V . Set FMG PTFs, various types & sizes 880 5440. Berghof/America Stopcock, I .V . Set FMG Metal stopcocks in 30 sizes . 880 5440. Cadence Science Inc . Stopcock, I .V . Set FMG i .v . set - Various 880 5440. Cardinal Health 303,Inc . Stopcock, I .V . Set FMG 880 5440. Churchill Medical Systems, Inc . Stopcock, I .V . Set FMG 880 5440. Cook Inc . Stopcock, I .V . Set FMG I .V . SET - Plas . Stck . w/extension tube/steril; MULTIPLE 880 5440. Covidien Stopcock, I .V . Set FMG 880 5440. Covidien Lp Stopcock, I .V . Set FMG 880 5440. David Scott Company Stopcock, I .V . Set FMG 880 5440. Directmed, Inc . Stopcock, I .V . Set FMG Stopcock, i .v . set . 880 5440. Edwards Lifesciences Technology Sarl Stopcock, I .V . Set FMG 880 5440. Elcam Medical, Inc . Stopcock, I .V . Set FMG 880 5440. Ernst Flow Industries Stopcock, I .V . Set FMG No common name listed 880 5440. Farmatap S A. . De C .V . Stopcock, I .V . Set FMG i .v . set - Robertsite 4 Way Stopcock 880 5440. Halkey-Roberts Corp . Stopcock, I .V . Set FMG MULTIPLE 880 5440. Hospira Inc .

Source: MDRWeb.com 68 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Stopcock, I .V . Set FMG INTRALOCK disposable stopcock . 880 5440. Hospira, Inc . Stopcock, I .V . Set FMG Intravascular administrtion set . 880 5440. Icu Medical (Ut), Inc Stopcock, I .V . Set FMG Intravascular administration set . 880 5440. Icu Medical, Inc . Stopcock, I .V . Set FMG Ultraconcentrator manifold with extension set . Graft delivery 880 5440. Interpore Cross International syringe . Disposable system for intraoperative collection of autologous growth factors . Stopcock, I .V . Set FMG Stopcocks and iv sets . 880 5440. Kentron Health Care, Inc . Stopcock, I .V . Set FMG 880 5440. Kontes Glass Co . Stopcock, I .V . Set FMG Various types of stopcocks with luer lock adapters . 880 5440. Merit Medical Systems, Inc . Stopcock, I .V . Set FMG 880 5440. Microgroup Stopcock, I .V . Set FMG 880 5440. Mps Acacia Stopcock, I .V . Set FMG 880 5440. Novosci Corp . Stopcock, I .V . Set FMG 880 5440. S4j Manufacturing Services, Inc . Stopcock, I .V . Set FMG No common name listed 880 5440. Schad Medical Instruments Gmbh Stopcock, I .V . Set FMG HYPERAL stopcock, extension sets and T-connector . 880 5440. Smiths Medical OEM Stopcock, I .V . Set FMG 880 5440. Sorin Group Usa Stopcock, I .V . Set FMG Three way stopcock . 880 5440. Terumo Medical Corporation Stopcock, I .V . Set FMG Stopcock and stopcock adapter . 880 5440. Unimed S .A . Stopcock, I .V . Set FMG Disposable stopcocks . 880 5440. Vygon Corp . Stopcock, I .V . Set FMG Sterile stopcocks 880 5440. Vygon S A Catheter, Intravascular, Therapeutic, FOZ Various models of orthodontic products . 880 5200. All Star Orthodontics, Llc Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various central lines sterile . 880 5200. Alsius Corp . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Flush syringes . 880 5200. Amsino Medical Usa Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Central catheter, central venous catheter, kit & tray . 880 5200. Argon Medical Devices Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Intravascular catheter . 880 5200. Arkray Factory Usa, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various intravascular catheters 880 5200. Arrow Internacional De Mexico, Short-term Less Than 30 Days S .A . De C .V . Catheter, Intravascular, Therapeutic, FOZ multiple 880 5200. Arrow International, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various 880 5200. As Advanced Medical Systems Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. B . Braun Medical Inc ,. Renal Short-term Less Than 30 Days Therapies Div . Catheter, Intravascular, Therapeutic, FOZ MULTIPLE 880 5200. Bard Access Systems, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various 880 5200. Bard Reynosa S .A . De C .V . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 0 .9% SODIUM CHLORIDE INJECTION ; BD Posiflush Saline 880 5200. Becton Dickinson And Co . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 0 .9% SODIUM CHLORIDE INJECTION ; BD Posiflush Saline 880 5200. Becton Dickinson And Company Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. Becton Dickinson And Company Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ multiple 880 5200. Becton Dickinson Infusion Short-term Less Than 30 Days Therapy Systems, Inc . Catheter, Intravascular, Therapeutic, FOZ Catheter, intravascular, short term ;. BD Preefil Flush Syringe; BD 880 5200. Becton Dickinson Medical Short-term Less Than 30 Days Posiflush Heparin Systems Catheter, Intravascular, Therapeutic, FOZ Infusion catheter . 880 5200. Bentec Medical, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Multiple 880 5200. Catalent Pharma Solutions Short-term Less Than 30 Days

Source: MDRWeb.com 69 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Catheter, Intravascular, Therapeutic, FOZ 880 5200. Catheter Research, Inc . (Cri) Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. Centurion Medical Products Short-term Less Than 30 Days Corp . Catheter, Intravascular, Therapeutic, FOZ 880 5200. Centurion Medical Products Short-term Less Than 30 Days Corporation Catheter, Intravascular, Therapeutic, FOZ 880 5200. Cook Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. Covidien Lp Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ SUNDER CENTRAL VENOUS CATHETER KIT 880 5200. Cw Medical, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Custom design and manufacturing of catheters and specialty 880 5200. Diablo Sales & Marketing, Inc . Short-term Less Than 30 Days guidewires . Guiding catheters; stent delivery and drug delivery systems . Catheter, Intravascular, Therapeutic, FOZ Central venous catheter kit . 880 5200. Edwards Lifesciences Technology Short-term Less Than 30 Days Sarl Catheter, Intravascular, Therapeutic, FOZ Therapeutic, short-term (less than 30 days) ;. MULTIPLE 880 5200. Edwards Lifesciences, Llc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various types of sterile infusion catheter & accessories . 880 5200. Ev3 Neurovascular Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Pre-filled saline flush syringe . 880 5200. Excelsior Medical Corp . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Needle 880 5200. Haemonetics Corp . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Multiple 880 5200. Hospira Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. Hospira, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various 880 5200. Johnson & Johnson De Short-term Less Than 30 Days Monterrey, Sa De Cv Catheter, Intravascular, Therapeutic, FOZ Various 880 5200. Kofu Factory Of Terumo Corp . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Catheter, iv, therapeutic, short-term less than 30 days . 880 5200. Kollsut Scientific Corporation Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Normal Saline & Heparin I . V . Flush Syringe (in diff . volumes) - 880 5200. Medefil, Inc . Short-term Less Than 30 Days prefilled syringe for single use Catheter, Intravascular, Therapeutic, FOZ 880 5200. Millar Instruments, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Peripherally inserted central catheters and placement kits . 880 5200. Navilyst Medical Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Intravenous silicone catheter . 880 5200. Neo Medical Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Neonatal, dual lumen umbilical catheter; pediatric PICC and 880 5200. Neo-Care Arrow International Short-term Less Than 30 Days umbilical catheterization kit . Catheter, Intravascular, Therapeutic, FOZ 880 5200. Patton Medical Devices Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Vents (self sealing) for IV Cathether 880 5200. Porex Technologies Gmbh Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ VANISHPOINT I .V . CATHETER 880 5200. Retractable Technologies, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Jelco; Optiva 880 5200. Smiths Medical Asd, Inc . Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Introducer needle . 880 5200. Stryker Instruments, Instruments Short-term Less Than 30 Days Div . Catheter, Intravascular, Therapeutic, FOZ Intravascular catheter . 880 5200. Terumo Medical Corporation Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880 5200. Tfx Medical Oem Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Over-the-needle catheter . 880 5200. Thomas Medical Products, Inc . Short-term Less Than 30 Days

Source: MDRWeb.com 70 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Catheter, Intravascular, Therapeutic, FOZ Mudicut intrvenous cannula, (various sizes) 880 5200. Tyco Healthcare Ireland Limited Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Sterile short iv cannula 880 5200. Vygon S A Short-term Less Than 30 Days Set, Administration, Intravenous FPA Various sizes of IV administration sets (sterile) . 880 5440. Abbott Diagnostics Intl, Biotechnology Ltd Set, Administration, Intravenous FPA Complete line of IV administration sets . 880 5440. Accellent El Paso Set, Administration, Intravenous FPA AMSINO I V. . administration set is available in a variety of spikes, 880 5440. Amsino International, Inc . chambers, tubing lengths, and diameters . Set, Administration, Intravenous FPA Convenience kit . 880 5440. Aplicare, Inc . Set, Administration, Intravenous FPA IV Transfer Spike 880 5440. App Pharmaceuticals, Llc Set, Administration, Intravenous FPA Hyperbaric kit . 880 5440. Argon Medical Devices Inc . Set, Administration, Intravenous FPA Sterile subcutaneous infusion set . 880 5440. Arkray Factory Usa, Inc . Set, Administration, Intravenous FPA Multiple 880 5440. Arrow Internacional De Mexico, S .A . De C .V . Set, Administration, Intravenous FPA High flow solution administration set . 880 5440. Arrow International, Inc . Set, Administration, Intravenous FPA Solution administration set 880 5440. Ashitaka Factory Of Terumo Corporation Set, Administration, Intravenous FPA No common name listed 880 5440. B . Braun Celsa Set, Administration, Intravenous FPA 880 5440. B . Braun Oem Division, B . Braun Medical Inc . Set, Administration, Intravenous FPA Iv administration set . 880 5440. B . Braun Of Puerto Rico, Inc . Set, Administration, Intravenous FPA Various 880 5440. Bard Reynosa S .A . De C .V . Set, Administration, Intravenous FPA Various sterile sets with/without filters . 880 5440. Baxter Healthcare Corp ,. Renal Division Set, Administration, Intravenous FPA Basic solution . Blood sets . Interlink Access System . 880 5440. Baxter Healthcare Corporporation, Alternate Care And Channel Team Set, Administration, Intravenous FPA Various sterile sets with/without filters . 880 5440. Baxter Healthcare S .A . Set, Administration, Intravenous FPA Various sterile sets with and without filters 880 5440. Baxter Productos Medicos, Ltda . Set, Administration, Intravenous FPA I V. . start kits and accessories . 880 5440. Becton Dickinson Infusion Therapy Systems, Inc . Set, Administration, Intravenous FPA Infusion sets . 880 5440. Becton, Dickinson & Co ., (Bd) Preanalytical System Set, Administration, Intravenous FPA Shielded needle connector assembly . 880 5440. Beech Medical Products, Inc . Set, Administration, Intravenous FPA SELEC-3 is a multi-drip I V. . administration set . Choose between 880 5440. Biomedix, Inc . a 10, 15, or 60-drop/cc-volume setting without breaking the line . Each set has two “Y” port connections and a built-in extension set, with a backflow prevention device . Custom sets availab Set, Administration, Intravenous FPA Iv administration set 880 5440. Block Medical De Mexico S A. . De C .V . Set, Administration, Intravenous FPA Scalp vein set 880 5440. Boin Medica Co . Ltd . Set, Administration, Intravenous FPA multiple 880 5440. Cardinal Health 200, Inc Set, Administration, Intravenous FPA Various administration sets & accessories . 880 5440. Cardinal Health 303,Inc . Set, Administration, Intravenous FPA Intravascular fluid transfer & administration set 880 5440. Carmel Pharma Ab . Set, Administration, Intravenous FPA Needle-free valved connector and cap . 880 5440. Catheter Innovations, Inc . Set, Administration, Intravenous FPA 880 5440. Centurion Medical Products Corp . Set, Administration, Intravenous FPA 880 5440. Centurion Medical Products Corporation Set, Administration, Intravenous FPA Various sizes of i .v . administration set, infusion set 880 5440. Changchun Kangda Medical Supply Co ., Ltd . Set, Administration, Intravenous FPA Administration sets . 880 5440. Clinical Pharmacies, Inc . Set, Administration, Intravenous FPA 880 5440. Codan Us Corporation Set, Administration, Intravenous FPA 880 5440. Coeur Inc ,. Sheboygan Set, Administration, Intravenous FPA MASTERFLOW IV rate controller which controls rate of solution 880 5440. Conmed Corporation flow economically .

Source: MDRWeb.com 71 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Set, Administration, Intravenous FPA 880 5440. Csl Behring Set, Administration, Intravenous FPA 880 5440. Custom Healthcare Systems, Inc . Set, Administration, Intravenous FPA VARIOUS MODELS OF INFUSION SET 880 5440. Cw Medical, Inc . Set, Administration, Intravenous FPA Various intravascular administration sets, sterile and non-sterile . 880 5440. Deroyal Surgical - Rose Hill Set, Administration, Intravenous FPA Decanting devices . 880 5440. Deuteronomy Management Services,Inc . Set, Administration, Intravenous FPA 880 5440. Directmed, Inc . Set, Administration, Intravenous FPA Fluid transfer spike, i .v . administration . 880 5440. Edwards Lifesciences Research Medical Set, Administration, Intravenous FPA Set, administration, intravascular . 880 5440. Edwards Lifesciences Technology Sarl Set, Administration, Intravenous FPA Extension sets . 880 5440. Entracare, Llc Set, Administration, Intravenous FPA I .v . administration 880 5440. Erika De Reynosa, S .A . De C .V . Set, Administration, Intravenous FPA Infusion set (winged) . 880 5440. Evans Medical Inc . Set, Administration, Intravenous FPA Microbore extension set . 880 5440. Excelsior Medical Corp . Set, Administration, Intravenous FPA Huber infusion sets . EXEL I .V . Administration Set . 880 5440. Exelint International Co . Set, Administration, Intravenous FPA 880 5440. Filtrona Extrusion, Inc /Pexco®. Medical Products Div . Set, Administration, Intravenous FPA Lure lock, luer slip; with/without needle; various sizes;also include 880 5440. Global Healthcare injection site and burette Set, Administration, Intravenous FPA I V. . administration sets, available with y-injection sites and 880 5440. Globe Medical Tech, Inc . flashback bulbs . Set, Administration, Intravenous FPA Blood collection needle 880 5440. Greiner Bio-One Gmbh Set, Administration, Intravenous FPA No common name listed 880 5440. Haemotronic, S P. A. . Advanced Medical Technologies Set, Administration, Intravenous FPA Infusion set 880 5440. Halex Istar Industria Farmaceutica Ltda . Set, Administration, Intravenous FPA OEM and private-labeled infusion disposables, including infusion 880 5440. Harmac Medical Products, Inc . bags and sets, extension sets, heparin traps, T-connectors, roller clamps, latex-free injection sites, and infusion components . Set, Administration, Intravenous FPA Icoset i .v . solution administration set, disposable 880 5440. Hatu’- Ico S .P .A . Set, Administration, Intravenous FPA Various leukocyte reduction filters sets . 880 5440. Hemerus Medical, Llc . Set, Administration, Intravenous FPA 880 5440. Hospira, Inc . Set, Administration, Intravenous FPA Various sizes of iv administration sets (sterile) . 880 5440. Hospira, Inc . Set, Administration, Intravenous FPA Various . 880 5440. Icu Medical (Ut), Inc Set, Administration, Intravenous FPA Intravascular administration set . 880 5440. Icu Medical, Inc . Set, Administration, Intravenous FPA Set, administration, intravascular 880 5440. Imp Group Ltd . Set, Administration, Intravenous FPA 880 5440. Integra Biotechnical Llc Set, Administration, Intravenous FPA 880 5440. International Medical Industries Set, Administration, Intravenous FPA Infusion pump administration sets . 880 5440. Iradimed Corporation Set, Administration, Intravenous FPA Cardioplegia cooling/administration set . 880 5440. Jostra Bentley, Inc . Set, Administration, Intravenous FPA 880 5440. Kawasumi Laboratories America, Inc . Set, Administration, Intravenous FPA Infusion plug w/wo filter needle 880 5440. Kelsar, S .A . Set, Administration, Intravenous FPA Infusion set 880 5440. Kofu Factory Of Terumo Corp . Set, Administration, Intravenous FPA Various types of i .v . solution administration sets 880 5440. Labomed Sre Set, Administration, Intravenous FPA Various . 880 5440. Lexamed Set, Administration, Intravenous FPA IV Set, Buret Set, Extension Set; Lifeline IV & Buret Sets; disposable . 880 5440. Lifemed Of California Set, Administration, Intravenous FPA 880 5440. Lucomed Inc . Set, Administration, Intravenous FPA Dual flow divider 880 5440. Macosta S .N C. . Set, Administration, Intravenous FPA Various 880 5440. Medex Medical Ltd . Set, Administration, Intravenous FPA I .V . line securing device . 880 5440. Medical Action Industries, Inc . Set, Administration, Intravenous FPA Multi lumen extension set . 880 5440. Medical Technologies Of Georgia, Inc .

Source: MDRWeb.com 72 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Set, Administration, Intravenous FPA Tubing clamp 880 5440. Medivice Systems, Ltd . Set, Administration, Intravenous FPA Injection cap . 880 5440. Medron, Inc . Set, Administration, Intravenous FPA 880 5440. Medtronic Minimed Set, Administration, Intravenous FPA 880 5440. Merit Medical Systems Inc . Set, Administration, Intravenous FPA Fluid administration sets . 880 5440. Merit Medical Systems, Inc . Set, Administration, Intravenous FPA Various types of angiography kits eg digital subtraction . 880 5440. Merit Medical Systems, Inc . Set, Administration, Intravenous FPA 880 5440. Merlyn Pharmaceuticals, Inc . Set, Administration, Intravenous FPA Safety blood collection and infusion sets . IV administration sets . 880 5440. Myco Medical Specialty anesthesia trays and kits . Set, Administration, Intravenous FPA Fluid delivery sets . 880 5440. Navilyst Medical Set, Administration, Intravenous FPA Various macro and microbore, extension sets, filter sets, sterile . 880 5440. Nexus Medical, Llc Set, Administration, Intravenous FPA Infusion set . 880 5440. Nipro Diabetes Systems, Inc . Set, Administration, Intravenous FPA Plastic IV check valves, plastic IV hooks, custom plastic set 880 5440. Np Medical, Inc . components . Set, Administration, Intravenous FPA 880 5440. Omni Medical Supply Inc . Set, Administration, Intravenous FPA 880 5440. Primrose Medical, Inc . Set, Administration, Intravenous FPA I .V . administration sets, infusion set, I V. . tubing . 880 5440. Prizm Medical, Inc . Set, Administration, Intravenous FPA Various sterile sets with and without filters . 880 5440. Rd Medical Mfg . Inc . Set, Administration, Intravenous FPA Various . 880 5440. Rymed Technologies, Inc . Set, Administration, Intravenous FPA 880 5440. Smiths Medical OEM Set, Administration, Intravenous FPA LiftLoc Safety Infusion Set . LiftLoc is a safety Huber needle 880 5440. Specialized Health Products designed to reduce the risk of accidental needlesticks by International, Inc . shielding the needle after use . LiftLoc’s low profile and small footprint make dressing the site easy . Set, Administration, Intravenous FPA 880 5440. State Trading Corporation Of India, Ltd . Set, Administration, Intravenous FPA Iv administration set . 880 5440. Terumo Cardiovascular Systems (Tcvs) Set, Administration, Intravenous FPA Intravascular administration set . 880 5440. Terumo Medical Corporation Set, Administration, Intravenous FPA Various sizes of infusion set 880 5440. Tianjin Hanaco Medical Co .,Ltd . Set, Administration, Intravenous FPA Various . 880 5440. Venetec International ., Inc . Set, Administration, Intravenous FPA Technegas patient administration set 880 5440. Vita Medical Ltd . Set, Administration, Intravenous FPA Set, administration, intravascular . 880 5440. Vital Signs Mn, Inc . Set, Administration, Intravenous FPA Shielded needle connector . 880 5440. Vlv Associates, Inc . Set, Administration, Intravenous FPA Intravenous accessories . 880 5440. Vygon Corp . Set, Administration, Intravenous FPA Various types of sterile infusion tubing sets . 880 5440. Walkmed Infusion Llc Set, Administration, Intravenous FPA Various configurations of amsino i .v . sets 880 5440. Zhejiang Kindly Medical Devices And Plastics Co ., Tubing, Fluid Delivery FPK ACE Extension Tubes ; with and without Medication Sites 880 5440. Ace Surgical Supply Co ., Inc . Tubing, Fluid Delivery FPK Empower Transfer Set 880 5440. Acist Medical Systems, Inc . Tubing, Fluid Delivery FPK 880 5440. Apothecary Products, Inc . Tubing, Fluid Delivery FPK 880 5440. B . Braun Oem Division, B . Braun Medical Inc . Tubing, Fluid Delivery FPK Liquid delivery systems and oral liquid tube sets . 880 5440. Baxa Corporation Tubing, Fluid Delivery FPK MICRO-VOLUME Infusion Sets, Solution Sets, Extension Sets, IV 880 5440. Baxter Healthcare Filtration Sets . Corporporation, Alternate Care And Channel Team Tubing, Fluid Delivery FPK Filtration sets . 880 5440. Codan Us Corporation Tubing, Fluid Delivery FPK Tubing, fluid delivery . 880 5440. Edwards Lifesciences Technology Sarl Tubing, Fluid Delivery FPK 880 5440. Filtrona Extrusion, Inc /Pexco®. Medical Products Div . Tubing, Fluid Delivery FPK Various accessories for fluid delivery tubing . 880 5440. Health Care Logistics, Inc . Tubing, Fluid Delivery FPK Multiple 880 5440. Hospira Inc . Tubing, Fluid Delivery FPK Tubing, extension set . 880 5440. Hurricane Medical

Source: MDRWeb.com 73 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Tubing, Fluid Delivery FPK Various types of arterial pressure tubing . 880 5440. Icu Medical (Ut), Inc Tubing, Fluid Delivery FPK Fluid transfer set . 880 5440. Integra Lifesciences Corp . Tubing, Fluid Delivery FPK I .V . extension sets . 880 5440. Marquette Medical, Inc . Tubing, Fluid Delivery FPK Sof-set Micro QR MMT-324; Sof-set Micro QR MMT-325 880 5440. Medtronic Minimed Tubing, Fluid Delivery FPK High-pressure tubing with SHERLOCK connectors . 880 5440. Merit Medical Systems, Inc . Tubing, Fluid Delivery FPK Cytostraw . 880 5440. Monogen, Inc . Tubing, Fluid Delivery FPK 880 5440. Mps Acacia Tubing, Fluid Delivery FPK NALGENE clear PVC, low-density polyethylene, polyproplylene, 880 5440. Nalge Nunc International FEP, PFA, PVDF, PUR and platinum-cured silicone available . Tubing, Fluid Delivery FPK Drug delivery catheter system i .v . 880 5440. Norfolk Medical Products, Inc . Tubing, Fluid Delivery FPK 880 5440. Quest Medical, Inc . Tubing, Fluid Delivery FPK TYGON tubing represents a broad range of materials and 880 5440. Saint-Gobain Performance formulations to meet specific application requirements . Plastics--Akron Tubing, Fluid Delivery FPK 880 5440. Spectra Medical Devices, Inc . Tubing, Fluid Delivery FPK Irrigation tubing . 880 5440. Stryker Puerto Rico, Ltd . Tubing, Fluid Delivery FPK Funneled, co-extrusion, multi-lumen, striped, radiopaque, 880 5440. Sunlite Plastics, Inc . coiled and cut-to-length . PVC, polyetheylene, nylon and other thermoplastics . Custom and standard tubing . Tubing, Fluid Delivery FPK 880 5440. Tfx Medical Oem Tubing, Fluid Delivery FPK Custom contract manufacturer . 880 5440. The Metrix Co . Tubing, Fluid Delivery FPK Tubing set . 880 5440. Thomas Medical Products, Inc . Tubing, Fluid Delivery FPK Silicone rubber tubing & molded components . 880 5440. Tss Hudson Pump, Infusion FRN 880 5700. 3m Co . Pump, Infusion FRN Volumetric pump features selection dial that simplifies the user 880 5700. Abbott Laboratories interface and a mode button for switching from primary to secondary fluid administration . Pump, Infusion FRN Quantum Enteral Nutrition Pump 880 5700. Abbott Laboratories Pump, Infusion FRN Infusion pump . 880 5700. Acist Medical Systems, Inc . Pump, Infusion FRN Specialized repair services for leading infusion pumps . AC 880 5700. Aiv, Inc . (Formerly American Iv) Adapters, batteries, power cords and other service parts also available for sale . Pump, Infusion FRN ENTERAL - 880 5700. Altron, Inc . Pump, Infusion FRN The pneumo-hydraulic capillary infusion system . 880 5700. Arndorfer Medical Specialties Pump, Infusion FRN Arthroscopy pump and various types of tubing (sterile) . 880 5700. Arthrex, Inc . Pump, Infusion FRN Multipurpose wound drain, multilumen drain allowing lavage 880 5700. Axiom Medical, Inc . and topical applications while continuing evacuation . Relocation/repositioning made easy . Multiple sizes . Pump, Infusion FRN MULTIPLE 880 5700. B . Braun Medical, Inc . Pump, Infusion FRN 880 5700. B . Braun Oem Division, B . Braun Medical Inc . Pump, Infusion FRN Syringe pump for microfilter/min perfusions . For use with 880 5700. Basi (Bioanalytical Systems, Inc .) research animals only-- not for for humans . Pump, Infusion FRN MICRO FUSE, Dual Rate Infuser: 13-oz, portable, battery- 880 5700. Baxa Corporation operated syringe infuser with two selectable rates of flow . Custom infusers are available .; InFuse T10 Pump, Infusion FRN Various infusion pumps . 880 5700. Baxter Healthcare Corporation Pump, Infusion FRN APII . INFUSO .R . INTERMATE system . INFUS O. .R . 880 5700. Baxter Healthcare Corporporation, Alternate Care And Channel Team Pump, Infusion FRN Infusion pump with Warmer FMS 2000 fluid-management system 880 5700. Belmont Instrument Corp . for rapid infusion of warmed fluid, including blood products, up to 750 ml/min, with monitoring for air bubbles, line pressure, temperature, and volume infused . Pump, Infusion FRN Ambulatory infusion pump . 880 5700. Bionica, Inc . Pump, Infusion FRN Infusion pump 880 5700. Block Medical De Mexico S A. . De C .V . Pump, Infusion FRN 880 5700. Braemar, Inc . Pump, Infusion FRN 880 5700. Brandel

Source: MDRWeb.com 74 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Pump, Infusion FRN Multi-infusion . 880 5700. Breg, Inc ,. An Orthofix Company Pump, Infusion FRN Infiltration system - automatic and syringe delivery . AUTOFUSE 880 5700. Byron Medical 10c multiple injection system . Also available, BIG BAG 3000 and PSI-TEC syringe pump . Pump, Infusion FRN Finesse Insulin Delivery System 880 5700. Calibra Medical Inc . Pump, Infusion FRN Navigator Delivery System 880 5700. Carticept Medical, Inc Pump, Infusion FRN Infusion pump 880 5700. Changchun Kangda Medical Supply Co ., Ltd . Pump, Infusion FRN Design and development of fluid management systems . 880 5700. Cmt, Inc . Pump, Infusion FRN 880 5700. Conmed Linvatec Pump, Infusion FRN 880 5700. Corpak Medsystems, Inc . Pump, Infusion FRN 880 5700. Covidien Lp, Formerly Registered As Kendall Pump, Infusion FRN IV EXPRES, CHRONOPUMP infusion pump for hospital and 880 5700. Debiotech Sa ambulatory use, multi mode (PCA, TPN, DOSE, Continuous, Secondary) Pump, Infusion FRN 880 5700. Dma Med-Chem Corporation Pump, Infusion FRN Mechanical infusion pump . 880 5700. Ethox International Pump, Infusion FRN Syringe pump . 880 5700. Excelsior Medical Corp . Pump, Infusion FRN Centrifuge and Diaphragm Pumps . 880 5700. Graymills Corp . Pump, Infusion FRN Peristaltic . 880 5700. Greylor Co . Pump, Infusion FRN OEM and private-labeled infusion bags and administration 880 5700. Harmac Medical Products, Inc . sets . Contract manufacturer of custom infusion disposables . Pump, Infusion FRN Microprocessor controlled . 880 5700. Harvard Apparatus, Inc . Pump, Infusion FRN Multiple 880 5700. Hospira Inc . Pump, Infusion FRN MULTIPLE 880 5700. Hospira, Inc . Pump, Infusion FRN Various types of infusion pumps (non-sterile) . 880 5700. Icu Medical (Ut), Inc Pump, Infusion FRN Pargwtaral infusor pump 880 5700. Infusion Medix, Ltd . Pump, Infusion FRN Sterile empty pca syringe . 880 5700. International Medication Systems, Ltd . Pump, Infusion FRN Infusion pump and accessories . 880 5700. Iradimed Corporation Pump, Infusion FRN Enteral feeding pumps and accessories 880 5700. Kelsar, S .A . Pump, Infusion FRN Infusion pump . 880 5700. Kmi Kolster Methods, Inc . Pump, Infusion FRN INSULIN - Symphony Meter Remote 880 5700. Lifescan, Inc . Pump, Infusion FRN MTP 1001 $2,375 for general use peristaltic infusion pump . 880 5700. Medical Technology Products, Inc . Pump, Infusion FRN 880 5700. Mediq/Prn Pump, Infusion FRN Various models of portable infusion pumps 880 5700. Medis S R. .L . Pump, Infusion FRN MicroMed MMT-407C; Paradigm Reservoir; MMT-103 Reservoir; 880 5700. Medtronic Minimed MMT-326 Paradigm Reservoir Pump, Infusion FRN 880 5700. Mentor Texas, Inc . Pump, Infusion FRN SILBERG TISSUE PREPARATION SYSTEM: consists of a peristaltic 880 5700. Mettler Electronics Corp . pump to infuse saline subcutaneously and disperse the saline into deeper tissues using ultrasound, $15,000 . Pump, Infusion FRN COMPUFLO 880 5700. Milestone Scientific Inc . Pump, Infusion FRN MULTIPLE 880 5700. Moog Inc . Pump, Infusion FRN No common name listed 880 5700. Nikkiso Co . Ltd . Pump, Infusion FRN Rental of equipment . 880 5700. Omni Medical Supply Inc . Pump, Infusion FRN $207 .00 for pole mounted drug pump; $444 .00 for ICU pump; 880 5700. Razel Scientific Instruments, Inc . also, oxytocin flow rate chart optional . Pump, Infusion FRN CardioGen-82 Infusion System 880 5700. Rbm Services, Llc . Pump, Infusion FRN 880 5700. Sigma International, Llc . Pump, Infusion FRN SMISSON-CARTLEDGE TIS-120; ThermaCor 1200; TIS-1200 Thermal 880 5700. Smisson-Cartledge Biomedical Infusion System

Source: MDRWeb.com 75 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Pump, Infusion FRN Infusion pump and accessories . 880 5700. Smith & Nephew Inc ,. Endoscopy Div . Pump, Infusion FRN 880 5700. Smith & Nephew, Inc ,. Endoscopy Division Pump, Infusion FRN 880 5700. Smith & Nephew, Inc ,. Endoscopy Division Pump, Infusion FRN 880 5700. Sparton Corporation Pump, Infusion FRN Peristaltic . 880 5700. Specialty Manufacturing Co ,. The Pump, Infusion FRN Peristaltic pumps: routine lab use and chromatography 880 5700. Spectrum Laboratories, Inc . applications . Pump, Infusion FRN 880 5700. Spencer Italia S .R .L . Pump, Infusion FRN Various models of infusion pumps and accessories . 880 5700. Stryker Instruments, Instruments Div . Pump, Infusion FRN Infusion pump . 880 5700. Stryker Puerto Rico, Ltd . Pump, Infusion FRN SURGI-PRESS PRESSURE INFUSION; MULTIPLE 880 5700. Sts Division Of Ethox International Pump, Infusion FRN SMART peristaltic pump, non influsion . 1,2,3 or 4 channel with 8 880 5700. Tecan Systems rollers . Pump, Infusion FRN 880 5700. Terumo Cardiovascular Systems, Corp Pump, Infusion FRN Ambulatory infusion pump . 880 5700. Universal Medical Technologies Pump, Infusion FRN Infusion pump . 880 5700. Valeritas, Llc Pump, Infusion FRN Various models of infusion pumps . 880 5700. Walkmed Infusion Llc Pump, Infusion FRN 880 5700. Wells Johnson Co . Pump, Infusion FRN 880 5700. World Precision Instruments (W .P .I ),. Inc . Container, IV KPE 880 5000. Advance Medical Designs, Inc . Container, IV KPE Tamper evident seal . 880 5000. App Pharmaceuticals, Llc Container, IV KPE 880 5000. App Pharmaceuticals, Llc Container, IV KPE 880 5000. App Pharmaceuticals, Llc Container, IV KPE Vitalmix plus empty i v. . container . 880 5000. Avail Medical Products Container, IV KPE Dual-chambered container to store both drug and diluent . 880 5000. B . Braun Oem Division, B . Braun Medical Inc . Container, IV KPE Various types of sterile iv mixing containers/bags and 880 5000. B . Braun Of Puerto Rico, Inc . accessories . Container, IV KPE QUICK MIX Container . 880 5000. Baxter Healthcare Corporation Nutrition Container, IV KPE Large and small volume parenterals, premix medications, 880 5000. Baxter Healthcare Corporation, VIAFLEX containers, evacuated glass containers . Global Drug Delivery Container, IV KPE Evacuated Container; I V. . GENERAL HOSPITAL; Vialfex 880 5000. Baxter Healthcare Corporation, Container; Additive Cap; IntraVia Container Empty; All-In-One Medication Delivery Container; Container, IV KPE Various sterile empty solution containers . 880 5000. Baxter Healthcare S .A . Container, IV KPE Iva seal ii . 880 5000. Covidien Lp, Formerly Registered As Ludlow Container, IV KPE Iva seal ii . 880 5000. Covidien Lp, Formerly Registered As Tyco Healthcare Container, IV KPE Tamper evident seal . 880 5000. Custom Tape Company Container, IV KPE Decanting device . 880 5000. Deuteronomy Management Services,Inc . Container, IV KPE STERI-SPOUTS 880 5000. Durden Enterprises Container, IV KPE Mix container with attached transfer set . 880 5000. Entracare, Llc Container, IV KPE Various . 880 5000. Health Care Logistics, Inc . Container, IV KPE Multiple 880 5000. Hospira Inc . Container, IV KPE multiple 880 5000. Hospira, Inc . Container, IV KPE 880 5000. Jorgensen Laboratories Container, IV KPE 880 5000. Lucomed Inc .

Source: MDRWeb.com 76 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Container, IV KPE 880 5000. Medi-Dose, Inc . Container, IV KPE INFUSIO JUTURUM 2000 Wide range of IV bags for infusion, 880 5000. Medistad Medical Bv irrigation, blood collection, etc . Container, IV KPE Intravenous solution bags . 880 5000. Millipore Corporation Container, IV KPE Empty solution transfer container for total parenteral nutrition 880 5000. Plasco, Inc . Container, IV KPE SECURE Total parenteral nutrition bags, 250ml . through 4000ml . 880 5000. The Metrix Co . (available in plastic also) . Container, IV KPE Calibrated cylinders used as I .V . chambers . 880 5000. Tulox Plastics Corp . Container, IV KPE Various types of sterile reservoir bags . 880 5000. Walkmed Infusion Llc Container, IV KPE Pharmaceutical containers . 880 5000. West Pharmaceutical Services, Inc . System, Dialysate Delivery, Semi- KPF Renal therapy clinical data management software . 876 5630. Baxter Healthcare Corp ,. Renal Automatic, Peritoneal Division System, Dialysate Delivery, Semi- KPF 876 5630. Fresenius Usa, Inc . Automatic, Peritoneal Set, IV Fluid Transfer LHI Fluid transfer sets and spikes . 880 5440. Accellent El Paso Set, IV Fluid Transfer LHI Maxifill Transfer Set 880 5440. App Pharmaceuticals, Llc Set, IV Fluid Transfer LHI 880 5440. App Pharmaceuticals, Llc Set, IV Fluid Transfer LHI Transfer set . 880 5440. Avail Medical Products Set, IV Fluid Transfer LHI HYPERFORMER COMPOUNDER 880 5440. B . Braun Medical, Inc . Set, IV Fluid Transfer LHI 880 5440. B . Braun Oem Division, B . Braun Medical Inc . Set, IV Fluid Transfer LHI Iv sets 880 5440. B . Braun Of Dominican Republic Set, IV Fluid Transfer LHI Various dispensing pins/connectors and fluid transfer sets . 880 5440. B . Braun Of Puerto Rico, Inc . Set, IV Fluid Transfer LHI 880 5440. Baxa Corporation Set, IV Fluid Transfer LHI Solution transfer sets . 880 5440. Baxter Healthcare Corporation Nutrition Set, IV Fluid Transfer LHI CHEMO-AIDE DISPENSING PIN; VIAL-MATE RECONSTITUTION 880 5440. Baxter Healthcare Corporation, DEVICE; Medication Delivery Set, IV Fluid Transfer LHI Solution transfer sets . 880 5440. Baxter Healthcare Corporporation, Alternate Care And Channel Team Set, IV Fluid Transfer LHI Chemotherapy dispensing pin . 880 5440. Baxter Healthcare S .A . Set, IV Fluid Transfer LHI Single dose dispensing pin . 880 5440. Cardinal Health 303,Inc . Set, IV Fluid Transfer LHI 880 5440. Churchill Medical Systems, Inc . Set, IV Fluid Transfer LHI Pharmacy compounding systems . 880 5440. Covidien Lp, Formerly Registered As Ludlow Set, IV Fluid Transfer LHI Various contrast saver sets, intravascular administration sets . 880 5440. Deroyal Surgical - Rose Hill Set, IV Fluid Transfer LHI I .v .sets . 880 5440. Deroyal Wound Care Set, IV Fluid Transfer LHI 880 5440. Directmed, Inc . Set, IV Fluid Transfer LHI Emergency infusion . 880 5440. Ethox International Set, IV Fluid Transfer LHI Set in fluid transfer 880 5440. Eurospital S .P .A . Set, IV Fluid Transfer LHI Dispensing pump tubing . 880 5440. Excelsior Medical Corp . Set, IV Fluid Transfer LHI Various . 880 5440. Health Care Logistics, Inc . Set, IV Fluid Transfer LHI Multiple 880 5440. Hospira Inc . Set, IV Fluid Transfer LHI I .v . decanter-flexible . 880 5440. Inrad Set, IV Fluid Transfer LHI Tubing set for therapeutic phlebotomy . 880 5440. Kawasumi Laboratories America, Inc . Set, IV Fluid Transfer LHI INSTAFIL, Transfer unit, high flow or gravity . 880 5440. Lifemed Of California Set, IV Fluid Transfer LHI I .V . extension sets . 880 5440. Medikmark Inc . Set, IV Fluid Transfer LHI 880 5440. Mps Acacia Set, IV Fluid Transfer LHI Vial Adapter 880 5440. Novo Nordisk Pharmaceuticals, Inc . Set, IV Fluid Transfer LHI QTMicro System; SafeFill Vial Adaptors; QTJunior System; 880 5440. Q .I . Medical, Inc . QuickTest System

Source: MDRWeb.com 77 Drug-Delivery Class II Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Set, IV Fluid Transfer LHI 880 5440. Smiths Medical OEM Set, IV Fluid Transfer LHI I .V . safety connector . 880 5440. Venetec International ., Inc . Set, IV Fluid Transfer LHI Fluid transfer set . 880 5440. West Pharmaceutical Services, Inc . Set, IV Fluid Transfer LHI multiple 880 5440. West Pharmaceutical Services, Inc . - Lititz, Pa Pump, Infusion, PCA MEA 880 5700. Abbott Laboratories Pump, Infusion, PCA MEA Specialized repair services for leading PCA pumps . AC 880 5700. Aiv, Inc . (Formerly American Iv) Adapters available for sale as well . Pump, Infusion, PCA MEA 880 5700. Ardus Medical, Inc . Pump, Infusion, PCA MEA Pca infusor, basal-bolus, pca infusor .; MULTIPLE 880 5700. Baxter Healthcare Corporation, Medication Delivery Pump, Infusion, PCA MEA 880 5700. Hospira, Inc . Pump, Infusion, PCA MEA Verifuse . 880 5700. Integra Lifesciences Corp . Pump, Infusion, PCA MEA 880 5700. Mps Acacia Pump, Infusion, PCA MEA 880 5700. Smiths Medical Asd, Inc . Pump, Infusion, PCA MEA Infusion pump . 880 5700. Stryker Instruments, Instruments Div . Pump, Infusion, PCA MEA Various models of PCA infusion pumps . 880 5700. Walkmed Infusion Llc Pump, Infusion, Elastomeric MEB Elastomeric infusion pump . 880 5700. Advanced Infusion, Inc . Pump, Infusion, Elastomeric MEB Solace Post-Operative Pain Relief Infusion System 880 5700. Apex Medical Technologies, Inc . Pump, Infusion, Elastomeric MEB Infusor, elastomeric infusion pump . 880 5700. Baxter Healthcare Corporation, Medication Delivery Pump, Infusion, Elastomeric MEB Various types of infusion pumps . 880 5700. Biomet, Inc . Pump, Infusion, Elastomeric MEB Various 880 5700. Block Medical De Mexico S A. . De C .V . Pump, Infusion, Elastomeric MEB Pain care 2000 . 880 5700. Breg, Inc ,. An Orthofix Company Pump, Infusion, Elastomeric MEB Multiple 880 5700. I-Flow Corporation Pump, Infusion, Elastomeric MEB Various models of infusion pumps, and accessories . 880 5700. Stryker Instruments, Instruments Div . Pump, Infusion, Elastomeric MEB Disposable infusion pump kit . 880 5700. Symbios Medical Products, Llc Pump, Infusion, Elastomeric MEB Innsion pump, various sterile disposables and non-sterile non- 880 5700. Tandem Medical, Inc . disposables . Pump, Infusion, Elastomeric MEB Disposable ambulatory infuser . 880 5700. Walkmed Infusion Llc Pump, Infusion, Elastomeric MEB MULTIPLE 880 5700. Zevex Incorporated Vessel Guard or Cover, To facilitate MFX Patch, cardiovascular . 870 3470. Medtronic Cardiovascular revision surgeries Surgery, The Heart Valve Div . Vessel Guard or Cover, To facilitate MFX Patch cardiovascular . 870 3470. Medtronic Heart Valves revision surgeries Vessel Guard or Cover, To facilitate MFX Surgical membrane . 870 3470. W .L . Gore & Associates,Inc revision surgeries

Drug-Delivery Class III Devices – General Controls and Special Controls - 510(k)

Product Regulation Product name code Product description number Company name Silicone, Liquid, Injectable KGM Sterile silicone oil for use as a prolonged retinal tamponade . Therapeutic Silicone Technologies, Inc . Agent, Bulking, Injectable For LNM Uretheral bulking agent . Bioform Medical, Inc . Gastro-Urology Use Agent, Bulking, Injectable For LNM MACROPLASTIQUE IMPLANTS Uroplasty, Inc . Gastro-Urology Use Agent, Injectable, Embolic MFE Injectable bulking agent . Carbon Medical Technologies, Inc . Agent, Injectable, Embolic MFE Liquid embolic agent . Cordis Neurovascular, Inc .

Source: MDRWeb.com 78 Drug-Delivery Class III Devices – General Controls and Special Controls – 510(k)

Product Regulation Product name code Product description number Company name Agent, Injectable, Embolic MFE Injectable embolic agent . Ev3 Neurovascular Intravascular Radiation Delivery MOU Various types of vascular brachytherapy systems including Best Vascular, Inc . System sterile catheters and . Intravascular Radiation Delivery MOU Source delivery unit . Guidant Corporation System

Drug-Delivery Unclassified Devices – 510(k)

Product name Product Product description Regulation Company name code number System, Delivery, Allergen And LDH Allergy prick test needle . Alkaline Corp . Vaccine System, Delivery, Allergen And LDH ASTRAL Inoculation System--1- and 10-uL inoculation loop Bio Plas, Inc . Vaccine system; streaking needles; Clone-Piks . System, Delivery, Allergen And LDH Hill top chamber r . Hill Top Research Corp Vaccine System, Delivery, Allergen And LDH QUINTEST and QUINTIP skin test devices (sterile)for allergy testing . Hollister-Stier Laboratories, Llc Vaccine System, Delivery, Allergen And LDH Injectable vaccines and Medical Supply Insource, Inc . Vaccine System, Delivery, Allergen And LDH Skin prick test . Panatrex, Inc . Vaccine System, Delivery, Allergen And LDH Allergy skin test device-sterile . Q .T .I . Corp . Vaccine Controller, Infusion, Intravascular LDR Csl Behring Controller, Infusion, Intravascular LDR Deka Research & Development Corp . Kit, IV Start LRS Audina Hearing Instruments, Inc . Kit, IV Start LRS Becton Dickinson Infusion Therapy Systems, Inc . Kit, IV Start LRS Centurion Medical Products Corp . Kit, IV Start LRS Centurion Medical Products Corporation Kit, IV Start LRS Cotran Corp . Kit, IV Start LRS Crest Healthcare Supply Kit, IV Start LRS I .v . prep kit ryder . Customed, Inc . Kit, IV Start LRS Features include tourniquet, alcohol prep pad, PVP ointment, Cypress Medical Products PVP prep pad or ampule swab, 2x2 gauze sponges, 3/4in . surgical tape and patient ID label . Other components available . Kit, IV Start LRS Primary gravity IV sets (84-120”) for use in oncology centers and Kawasumi Laboratories America, ambulatory surgical suite . Inc . Kit, IV Start LRS Various Types & Configurations including Chloraprep . Price Lsl Industries, Inc . Range mostly $50 to $147 Kit, IV Start LRS ChloraPrep Medikmark Inc . Kit, IV Start LRS nfusion Kit for NovoSeven RT; Test Medium Reconstitution Kit for Novo Nordisk Pharmaceuticals, Training Inc . Kit, IV Start LRS I .v . set Nypro Singapore Pte . Ltd . Kit, IV Start LRS Various types of iv start kits . Rd Medical Mfg . Inc . Kit, IV Start LRS Various Servo-Med Industries Pvt . Ltd . Labor and Delivery Kit MLS Armstrong Medical Industries, Inc . Labor and Delivery Kit MLS The Placental Triage Kit (PTK) . The PTK is designed to help Bio-Logics Products, Inc . improve how placentas are handled in the birthing room . It standardizes placental triage, making it quicker, more efficient and low cost while optimizing documentation and information on placen

79 Drug-Delivery Unclassified Devices – 510(k)

Product name Product Product description Regulation Company name code number Labor and Delivery Kit MLS Centurion Medical Products Corp . Labor and Delivery Kit MLS Centurion Medical Products Corporation Labor and Delivery Kit MLS OB KITS, Kit obstetrical, disposable for birthing and delivery of Morrison Medical babies in emergency situations . Available with many various components to meet your expectations or regulations . Labor and Delivery Kit MLS Rockford Medical & Safety Co . Labor and Delivery Kit MLS Utah Medical Products, Inc .

Drug-Delivery Medical-Device Companies

Abbott Diagnostics Intl, Biotechnology Ltd Advanced Medical Innovations, Inc. Alphaprotech, Inc. Road #2 KM . 58 .0 , PO Box 278, Cruce Davila 9410 De Soto Avenue,, Building J 1287 West Fairway Dr . Barceloneta, PR 00617, United States Chatsworth, CA 91311, CA 91311, United States Nogales, AZ 85621, United States Phone: 787-846-3500 Phone: 818-701-7180 Phone: 229-242-1931 Email: [email protected] Fax: 818-701-9708 Website: www.abbott.com Email: [email protected] Alsius Corp. Website: www.amiwelisten.com 15770 Laguna Canyon, Suite 150 Abbott Laboratories Year established: 1995 Irvine, CA 92618, United States 100 Abbott Park Rd . Phone: 949-453-0150 Abbott Park, IL 60064-3500, United States Aiv, Inc. (Formerly American Iv) Fax: 949-453-9702 Phone: 847-937-6100 7485 Shipley Avenue Email: [email protected] Fax: 847-935-3969 Harmans, MD 21077, United States Website: www.alsius.com Email: [email protected] Phone: 410-787-1300 Website: www.abbott.com Fax: 410-787-1337 Altomed Opthalmic Products Ltd. Year established: 1888 Email: [email protected] 2 Witney Way, Boldon Business Park Website: www.aiv-inc.com Boldon Colliery, NE35 9PE, United Kingdom Abbott Laboratories Phone: 191/519-0111 1033 Kingsmill Pkwy ., Columbus, OH 43229, United States Alcon Research, Ltd. Fax: 191/519-0283 Phone: 614-624-7677 6201 South Fwy . Email: [email protected] Fax: 614-227-3244 Fort Worth, TX 76134-2001, United States Website: www.altomed.com Website: www.ross.com Phone: 817-293-0450 Year established: 1976 Fax: 800-241-0677 Ac Healthcare Supply, Inc. Email: [email protected] Altron, Inc. 116-51 230th St . Website: www.alconlabs.com 6700 Bunker Lake Blvd . N .W . Cambria Heights, NY 11411, United States Year established: 1945 Minneapolis, MN 55303-5852, United States Phone: 905-448-4706 Phone: 763-427-7735 Alden Medical Llc Fax: 763-427-3773 Accellent El Paso 360 Cold Spring Ave . Email: [email protected] 31C Butterfield Trail West Springfield, MA 01089, United States Website: www.altronmfg.com El Paso, TX 79906, United States Phone: 413-747-9717 Year established: 1974 Phone: 915-771-9112 Fax: 915-771-9107 Alimed, Inc. Amann Medizintechnik Email: [email protected] 297 High St . Neuhauser Str . 43 Website: www.accellent.com Dedham, MA 02026-2844, United States Emmingen-Liptingen, 78576, Germany Phone: 781-329-2900 Phone: 49-746-59267 Ace Surgical Supply Co., Inc. Fax: 781-329-8392 1034 Pearl St . Email: [email protected] Amarco Medizintechnik Gmbh Brockton, MA 02301, United States Website: www.alimed.com Finkenstr . 8 Phone: 508-588-3100 Year established: 1970 Tuttlingen, 78532, Germany Fax: 508-583-3140 Phone: 74-61-9 21 1 Email: [email protected] Alkaline Corp. Website: www.acesurgical.com 20 Meridian Road #9 American Medical Mfg., Inc. Eatontown, NJ 07724, United States 9410 Desoto Ave ,. Unit J Acist Medical Systems, Inc. Phone: 732-531-7830 Chatsworth, CA 91311, United States 7905 Fuller Road Fax: 732-531-7830 Phone: 818-701-7171 Eden Prairie, MN 55344, United States Email: [email protected] Fax: 818-701-9708 Phone: 952-995-9300 Website: www.allergyhelp.com Email: [email protected] Fax: 952-941-4648 Website: www.amiwelisten.com All Star Orthodontics, Llc Year established: 1990 Advance Medical Designs, Inc. 4570 Progress Dr . 1241 Atlanta Industrial Drive Columbus, IN 47201, United States Amsino International, Inc. Marietta, GA 30066, United States Phone: 812-314-0804 855 Towne Center Drive, Pomona, CA 91767, United States Phone: 770-422-3125 Phone: 909-626-5888 Fax: 770-429-2471 Allen Medical Systems, Inc. Fax: 909-626-3888 Email: [email protected] 1 Post Office Square Email: [email protected] Website: www.advancemedicaldesigns.com Acton, MA 01720, United States Website: www.amsino.com Year established: 1984 Phone: 978-263-5401 Year established: 1993 Fax: 978-263-8846 Advanced Infusion, Inc. Email: [email protected] Amsino Medical Usa 466 West Arrow Hwy ., Unit H Website: www.allenmedical.com 5209 Linbar Dr ., Suite 640 San Dimas, CA 91773, United States Nashville, TN 37211, United States Phone: 909-305-9857 Phone: 615-332-9959

Source: MDRWeb.com 80 Anissa’s Fun Patches Arndorfer Medical Specialties B. Braun Medical Ag P .O . Box 455 5656 Grove Terrace Postfach 176 Chuckey, TN 37641, United States Greendale, WI 53129, United States Escholzmatt, 6182, Switzerland Phone: 423-234-3404 Phone: 414-425-1661 Phone: 495-661-710 Fax: 423-234-3404 Email: [email protected] Arrow Internacional De Mexico, S.A. De C.V. B. Braun Medical Inc., Renal Therapies Div. Website: www.anissasfunpatches.com Modulo 1, Circuito 5, Parque Industrias De America 824 Twelfth Avenue Year established: 2002 Col . Panamericana, Chihuahua, Mexico Bethlehem, PA 18018, United States Phone: 610-378-0131 Phone: 610-691-5400 Apex Medical Technologies, Inc. Fax: 610-691-1547 10064 Mesa Ridge Ct ., Suite 202 Arrow International, Inc. Email: [email protected] San Diego, CA 92121-2948, United States 9 Plymouth St . Website: www.bbraunusa.com Phone: 858-535-0012 Everett, MA 02149, United States Year established: 1979 Fax: 858-535-9715 Phone: 610-655-8522 Email: [email protected] Website: www.arrowintl.com B. Braun Medical, Inc. Website: www.apexmedtech.com Year established: 1975 901 Marcon Blvd . Year established: 1985 Allentown, PA 18109, United States Arrow International, Inc. Phone: 610-596-2536 Aplicare, Inc. 2 Berry Dr Website: www.bbraunusa.com 550 Research Parkway Mount Holly, NJ 08060, United States Meriden, CT 06450, United States Phone: 610-655-8522 B. Braun Medical, Inc. Phone: 203-630-0500 Website: www.arrowintl.com 1601 Wallace Dr ., Suite 150 Fax: 203-630-4876 Year established: 1975 Carrollton, TX 75006, United States Email: [email protected] Phone: 610-596-2536 Website: www.aplicare.com Arthrex, Inc. Year established: 1983 1370 Creekside Blvd . B. Braun Oem Division, B. Braun Medical Inc. Naples, FL 34108, United States 824 Twelfth Avenue Apothecary Products, Inc. Phone: 239-643-5553 Bethlehem, PA 18018-3524, United States 11750 12th Avenue S . Fax: 800-643-9310 Phone: 610-691-6785 Burnsville, MN 55337-1295, United States Website: www.arthrex.com Fax: 610-691-1785 Phone: 888-770-8767 Year established: 1984 Email: [email protected] Fax: 800-328-1584 Website: www.bbraunoem.com Email: [email protected] As Advanced Medical Systems Year established: 1979 Website: www.apothecaryproducts.com Werdauer Str . 51 Year established: 1975 Fraureuth, 8427, Germany B. Braun Of Dominican Republic Phone: 614-889-2220 Km No . 22, Las Americas Hwy . App Pharmaceuticals, Llc Parque Las Americas, Dominican Republic 3159 Staley Rd . Ashitaka Factory Of Terumo Corporation Phone: 610-691-5400 Grand Island, NY 14072, United States 150 Maimaiki-Cho Phone: 847-330-3953 Fujinomiya, 418-0015, Japan B. Braun Of Puerto Rico, Inc. Email: [email protected] Phone: 011-81-33374 215 7. Insular Rd . Website: www.apppharma.com Sabana Grande, PR 00637, United States Astron International Inc. Phone: 610-691-5400 App Pharmaceuticals, Llc 3410 Westview Dr . 2020 N . Ruby St . Naples, FL 34104, United States B. Graczyk, Inc. Melrose Park, IL 60160, United States Phone: 239-435-0136 27826 Burmax Court Phone: (708) 345-6170 Dowagiac, MI 49047, United States Fax: (708) 450-7563 Atd-American Co. Phone: 269-782-2100 135 Greenwood Ave . App Pharmaceuticals, Llc Wyncote, PA 19095-1337, United States Bard Access Systems, Inc. 1501 E . Woodfield Rd ., Suite 300e Phone: 215-576-1000 605 N . 5600 West Schaumburg, IL 60173, United States Fax: 215-576-1827 Salt Lake City, UT 84116, United States Phone: 847-330-3953 Email: [email protected] Phone: 801-522-5000 Website: www.atd.com Fax: 801-522-49485 Architectures Email: [email protected] 26 Rue Poncelet Audina Hearing Instruments, Inc. Website: www.bardaccess.com Paris, 75017, France 165 E . Wildmere Ave . Phone: 1-563-33-34 Longwood, FL 32750, United States Bard Peripheral Vascular, Inc. Phone: 800-223-7700 1625 West Third Street Ardus Medical, Inc. Website: www.audina.net Tempe, AZ 85281, United States 11297 Grooms Rd . Year established: 1990 Phone: 480-894-9515 Cincinnati, OH 45242, United States Fax: 480-303-2767 Phone: 513-469-7867 Avail Medical Products Email: [email protected] Fax: 513-469-2329 5950 Nancy Ridge Dr, Ste 500 Website: www.bardpv.com Email: [email protected] San Diego, CA 92121, United States Website: www.ardusmedical.com Phone: 858-635-2206 Bard Reynosa S.A. De C.V. Year established: 1994 Blvd . Montebello #1, Parque Industrial Colonial Avedro, Inc. Reynosa, Tamaulipas, Mexico Argon Medical Devices Inc. 230 Third Avenue Phone: 908-277-8000 1445 Flat Creek Rd . Waltham, MA 02451, United States Athens, TX 75751, United States Phone: 781-768-3400 Bard Shannon Limited Phone: 903-675-9321 Fax: 781-768-3401 San Geronimo Industrial Park, Lot # 1, Road # 3, Km 79 .7 Fax: 903-677-9396 Website: www.avedro.com Humacao, PR 00791, United States Website: www.argonmedical.com Phone: 908-277-8000 Axiom Medical, Inc. Arkray Factory Usa, Inc. 19320 Van Ness Ave . Basi (Bioanalytical Systems, Inc.) 5182 West 76th St . Torrance, CA 90501, United States 2701 Kent Avenue Minneapolis, MN 55439, United States Phone: 310-533-9020 West Lafayette, IN 47906-1382, United States Phone: 952-646-3168 Fax: 310-533-8127 Phone: 765-463-4527 Email: [email protected] Fax: 765-497-1102 Armstrong Medical Industries, Inc. Website: www.AxiomMed.com Email: [email protected] 575 Knightsbridge Pkwy . Year established: 1976 Website: www.bioanalytical.com Lincolnshire, IL 60069-3616, United States Year established: 1974 Phone: 847-913-0101 B. Braun Celsa Fax: 847-913-0138 Avenue Des Temps Modernes Baur Und Haselbarth-Chirurg Gmbh Email: [email protected] Chassenevil, Cedex, France Sauerbruchstr . 7 Website: www.armstrongmedical.com Phone: 610-266-0500 Ellerau, 25479, Germany Year established: 1957 Phone: 041-067-2091

Source: MDRWeb.com 81 Bausch & Lomb Surgical Becton Dickinson And Co. Biomedix, Inc. 3365 Tree Ct . Indust . Blvd . 1 Becton Drive 3895 W . Vernal Pike St . Louis, MO 63122-6615, United States Franklin Lakes, NJ 07417, United States Bloomington, IN 47404, United States Phone: 636-255-5051 Phone: 201-847-6800 Phone: 812-355-7000 Fax: 909-399-1422 Fax: 812-355-7001 Website: www.bausch.com Becton Dickinson And Company Email: [email protected] 1 Becton Dr . Website: www.biomedix-inc.com Baxa Corporation Franklin Lakes, NJ 07417, United States Year established: 1992 9540 S Maroon Circle, Suite 400 Phone: 201-847-6800 Englewood, CO 80112, United States Fax: 201-847-6475 Biomet, Inc. Phone: 303-690-4204 Email: [email protected] 56 E . Bell Dr ., PO Box 587 Fax: 303-690-4804 Website: www.bd.com Warsaw, IN 46581, United States Email: [email protected] Year established: 1897 Phone: 574-267-6639 Website: www.baxa.com Fax: 574-267-8137 Year established: 1975 Becton Dickinson And Company Email: [email protected] 2153 12th Ave . Website: www.biomet.com Baxter Healthcare Corp., Renal Division Columbus, NE 68601, United States Year established: 1977 7511 114th Avenue North Phone: 201-847-4570 Largo, FL 33777, United States Bionica, Inc. Phone: 847-948-2000 Becton Dickinson Infusion Therapy Systems, Inc. 5112 Bailey Loop Fax: 800-756-4952 9450 S . State St . Mcclellan, CA 95652, United States Email: [email protected] Sandy, UT 84070, United States Phone: 916-643-2222 Phone: 888-237-2762 Baxter Healthcare Corporation Fax: 800-847-2220 Blickman 900 Corporate Grove Drive Email: [email protected] 39 Robinson Road Buffalo Grove, IL 60089, United States Website: www.bd.com/infusion Lodi, NJ 07644, United States Phone: 847-473-6141 Phone: 201-909-0807 Becton Dickinson Medical Systems Fax: 201-909-0832 Baxter Healthcare Corporation Nutrition 9630 South 54th St . Email: [email protected] One Baxter Pkwy . Franklin, WI 53132, United States Website: www.blickman.com Deerfield, IL 60015, United States Phone: 201-847-6800 Year established: 1975 Phone: 847-948-2000 Fax: 888-229-0020 Becton, Dickinson & Co., (Bd) Preanalytical System Block Medical De Mexico S.A. De C.V. Email: [email protected] 1575 Airport Rd . La Mesa Parque Industrial, Paseo Reforma S/n, Fracc . Website: www.baxter.com Sumter, SC 29153, United States Tijuana, Bc, Mexico Year established: 1931 Phone: 201-847-6280 Phone: 949-206-2700

Baxter Healthcare Corporation, Global Drug Beech Medical Products, Inc. Boin Medica Co. Ltd. Delivery 2 South Winchester St . 106-9 Cho-Dong 5f Dong, Chon Bldg . One Baxter Parkway West Swanzey, NH 03469, United States Seoul, Chung-Ku, Republic of Korea Deerfield, IL 60015-4625, United States Phone: 11-54-646155 Phone: 800-422-9837 Belmont Instrument Corp. Fax: 800-568-5020 780 Boston Road Brady Precision Converting, Llc Email: [email protected] Billerica, MA 01821-5925, United States 1801 Big Town Blvd ,. Suite 100 Website: www.baxter.com Phone: 978-663-0212 Mesquite, TX 75149, United States Year established: 1931 Fax: 978-663-0214 Phone: 214-275-9595 Email: [email protected] Fax: 214-275-6748 Baxter Healthcare Corporation, Medication Website: www.belmontinstrument.com Email: [email protected] Delivery Year established: 1980 Website: www.pcitechnology.com 17511 Armstrong Ave Year established: 1995 Irvine, CA 92614, United States Bentec Medical, Inc. Phone: 949-851-9066 1380 East Beamer St . Braemar, Inc. Fax: 800-756-4952 Woodland, CA 95776, United States 1285 Corporate Center Dr ., Suite 150 Email: [email protected] Phone: 757-224-0177 Eagan, MN 55121, United States Website: www.baxter.com Phone: 651-286-8620 Year established: 1931 Berghof/America Fax: 651-286-8630 3773 NW 126th Avenue, Building 1 Email: [email protected] Baxter Healthcare Corporation, Medication Coral Springs, FL 33065, United States Website: www.braemarinc.com Delivery Phone: 954-344-2554 Year established: 1998 25212 W . Illinois Route 120 Fax: 954-344-2008 Round Lake, IL 60073, United States Email: [email protected] Brandel Phone: 847-948-4770 Website: www.berghofusa.com 8561 Atlas Dr . Fax: 888-229-0020 Year established: 1992 Gaithersburg, MD 20877-4135, United States Email: [email protected] Phone: 301-948-6506 Website: www.baxter.com Best Vascular, Inc. Fax: 301-869-5570 Year established: 1931 4350 International Blvd . Email: [email protected] Norcross, GA 30093, United States Website: www.brandel.com Baxter Healthcare Corporporation, Alternate Care Phone: 770-717-0904 And Channel Team Brandt Industries, Inc. One Baxter Parkway Bio Plas, Inc. 4461 Bronx Blvd . Deerfield, IL 60015-4625, United States 4340 Redwood Highway, Suite A15 Bronx, NY 10470-1496, United States Phone: 847-948-2000 San Rafael, CA 94903, United States Phone: 718-994-0800 Fax: 800-568-5020 Phone: 415-472-3777 Fax: 718-325-7995 Email: [email protected] Fax: 415-472-3758 Email: [email protected] Website: www.baxter.com Email: [email protected] Website: www.brandtind.com Year established: 1931 Website: www.bioplas.com Year established: 1930 Year established: 1976 Baxter Healthcare S.A. Breg, Inc., An OrthofixC ompany Rd . 721, Km . 0 .3 Bioform Medical, Inc. 2611 Commerce Way, Vista, CA 92081, United States Aibonito, PR 00609, United States 4133 Courtney Road, #10 Phone: 760-599-3000 Phone: 847-948-2000 Franksville, WI 53126, United States Fax: 800-329-2734 Fax: 800-756-4952 Phone: 262-835-3323 Email: [email protected] Email: [email protected] Website: www.breg.com Bio-Logics Products, Inc. Year established: 1989 Baxter Productos Medicos, Ltda. PO Box 505, West Jordan, UT 84084, United States Parque Industrial De Cartago Phone: 801-561-9208 Brenner Metal Products Cartago, 7050, Costa Rica Fax: 801-561-9208 16 Main Ave . Phone: 847-948-2000 Email: [email protected] Wallington, NJ 07057, United States Website: www.biologicsinc.com Phone: (973) 778-0084 Year established: 1972 Fax: 973-778-2466

Source: MDRWeb.com 82 Brewer Company, The Cardinal Healthcare 209, Inc. Circulatory Technology, Inc. N88 W13901 Main St . 5225 Verona Rd . 21 Singworth St . Menomonee Falls, WI 53051, United States Madison, WI 53711-4495, United States Oyster Bay, NY 11771, United States Phone: 262-251-9530 Phone: 610-862-0800 Phone: 516-624-2424 Fax: 262-251-2332 Email: [email protected] Carmel Pharma Ab. Clark Company Inc., David Website: www.brewercompany.com 16-B Flojelbergsgatan 360 Franklin St . Year established: 1947 Molndal, Sweden Worcester, MA 01615-0054, United States Phone: 46-31-703040 Phone: 508-756-6216 Bridger Biomed, Inc. Fax: 508-753-5827 2430 North 7th Ave . Carolina Medical, Inc. Email: [email protected] Bozeman, MT 59715, United States 157 Industrial Dr ., King, NC 27021-0307, United States Website: www.davidclark.com Phone: 908-277-8000 Phone: 336-983-5132 Fax: 336-983-8992 Clinical Pharmacies, Inc. Bryton Corp. Email: [email protected] 21622 Surveyor Circle, #8-C 4310 Guion Rd . Website: www.caromed.com Huntington Beach, CA 92646, United States Indianapolis, IN 46254-3111, United States Phone: 714-969-6818 Phone: 317-334-8700 Carticept Medical, Inc Fax: 714-969-2320 Fax: 317-334-8787 6120 Windward Parkway, Suite 220 Email: [email protected] Email: [email protected] Alpharetta, GA 30005, United States Website: www.cpmednet.com Website: www.brytoncorp.com Phone: (770) 754-3800 Year established: 1981 Year established: 1981 Fax: (770) 754-3808 Clinimed, Incorporated Byron Medical Cas Medical Systems, Inc. 303 Markus Court, Sandy Brae Industrial Park 602 W . Rillito 44 E . Industrial Rd ., Branford, CT 06405, United States Newark, DE 19713-1187, United States Tucson, AZ 85705, United States Phone: 203-488-6056 Phone: 302-454-8400 Phone: 520-573-0857 Fax: 203-488-9438 Fax: 302-737-8900 Fax: 520-746-1757 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.casmed.com Website: www.clinimed.us Website: www.byronmedical.com Year established: 1984 Year established: 1978 Year established: 2002 Catalent Pharma Solutions Cmt, Inc. Cadence Science Inc. 2200 Lake Shore Dr . Post Office Box 297 1979 Marcus Ave, Suite 215 Woodstock, IL 60098, United States Hamilton, MA 01936-0297, United States Lake Success, NY 11042, United States Phone: 815-338-9500 Phone: 978-768-2555 Phone: 516-248-0300 Fax: 815-206-1335 Fax: 978-768-2555 Fax: 516-747-1188 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.catalent.com. Website: www.habitatmonitor.com Website: www.cadencescience.com Year established: 1984 Year established: 1922 Catheter Innovations, Inc. 3598 West 1820 South Codan Us Corporation Calibra Medical Inc. Salt Lake City, UT 84104-4859, United States 3511 W . Sunflower Avenue 220 saginaw drive Phone: 801-954-8444 Santa Ana, CA 92704-6944, United States Redwood City, CA 94063, United States Fax: 801-954-8484 Phone: 714-545-2111 Phone: 650-298-4710 Website: www.bostonscientific.com Fax: 714-545-9111 Email: [email protected] Email: [email protected] Website: www.myfinesse.com Catheter Research, Inc. (Cri) Website: www.codanus.com 5610 W . 82nd St . Cameron-Miller, Inc. Indianapolis, IN 46278, United States Coeur Inc., Sheboygan 5410 West Roosevelt, Road #241 Phone: 317-872-0074 3411 Behrens Pkwy . Chicago, IL 60644, United States Fax: 317-872-0169 Sheboygan, WI 53081, United States Phone: 773-379-2624 Email: [email protected] Phone: 920-458-4664 Fax: 773-379-2686 Website: www.catheterresearch.com Fax: 920-458-1368 Email: [email protected] Year established: 1987 Website: www.vpicorp.com Website: cameron-miller.com Year established: 1951 Year established: 1915 Centurion Medical Products Corp. 3310 South Main St . Conmed Corporation Camtec Salisbury, NC 28147, United States 310 Broad Street 1959 Church Creek Rd . Phone: 517-545-1135 Utica, NY 13501, United States Cambridge, MD 21613, United States Website: www.tristate.com Phone: 800-448-6506 Phone: 410-228-1156 Fax: 800-438-3051 Centurion Medical Products Corporation Email: [email protected] Carbon Medical Technologies, Inc. 3173 East 43rd St ., Yuma, AZ 85365, United States Website: www.conmed.com 1290 Hammond Road Phone: 517-546-5400 Year established: 1970 Saint Paul, MN 55110, United States Fax: 517-546-1195 Phone: 651-653-8512 Email: [email protected] Conmed Integrated Systems (Cmis) Fax: 651-407-1975 1815 NW 169th Place, Suite 4020 Email: [email protected] Changchun Kangda Medical Supply Co., Ltd. Beaverton, OR 97006, United States Website: www.carbonmed.com 4 Huo Ju Rd . Phone: 800-448-6506 Year established: 1994 Changchun, China Fax: 800-438-3051 Phone: 86-431-51797 Email: [email protected] Cardinal Health 200, Inc Website: www.conmed.com 200 Mcknight St Chase Medical, Lp Jacksonville, TX 75766, United States 1876 Firman Dr . Conmed Linvatec Phone: 847-785-3323 Richardson, TX 75081, United States 11311 Concept Blvd Website: www.cardinal.com Phone: 972-783-0644 Largo, FL 33773-4908, United States Phone: 800-448-6506 Cardinal Health 200, Inc Chf Solutions, Inc. Fax: 800-438-3051 One Butterfield Trail 7601 Northland Dr . Ste . 170 Email: [email protected] El Paso, TX 79906, United States Brooklyn Center, MN 55428, United States Website: www.conmed.com Phone: 847-785-3323 Phone: 763-463-4600 Year established: 1963 Website: www.cardinal.com Churchill Medical Systems, Inc. Cook Inc. Cardinal Health 303,Inc. 103a Park Drive PO Box 489 1515 Ivac Way Montgomeryville, PA 19044, United States Bloomington, IN 47402-0489, United States Creedmoor, NC 27522, United States Phone: 215-956-0585 Phone: 812-339-2235 Phone: 858-458-7830 Fax: 215-672-6740 Fax: 812-339-5369 Website: www.cardinal.com Email: [email protected] Email: [email protected] Website: www.ChurchillMedicalSystems.com Website: www.cookgroup.com Year established: 1987 Year established: 1963

Source: MDRWeb.com 83 Cordis Neurovascular, Inc. Crest Healthcare Supply Debiotech Sa 14201 NW 60 Avenue 195 Third Street South, Dassel, MN 55325, United States Le Portique, Avenue de Sévelin 28 Miami Lakes, FL 33014, United States Phone: 320-275-3382 Lausanne, CH 1004, Switzerland Phone: 786-313-6550 Fax: 320-275-2306 Phone: +41 21 623-6000 Website: www.cordis.com Email: [email protected] Fax: +41 21 623-6001 Year established: 1959 Website: www.cresthealthcare.com Email: [email protected] Year established: 1968 Website: www.debiotech.com CorMatrix Cardiovascular Inc. Year established: 1990 155-a moffett park drive, Suite 240 Cryolife, Inc. Sunnyvale, CA 94089, United States 1655 Roberts Blvd . NW . Deka Research & Development Corp. Phone: 408-734-2628 Kennesaw, GA 30144, United States 340 Commercial St . Fax: 408-734-2629 Phone: 770-419-3355 Manchester, NH 03101-1121, United States Email: [email protected] Fax: 770-426-0031 Phone: 603-669-5139 Website: www.cormatrix.com Email: [email protected] Fax: 603-624-0573 Year established: 2001 Website: www.cryolife.com Email: [email protected] Year established: 1984 Website: www.dekaresearch.com Corpak Medsystems, Inc. 100 Chaddick Dr . Csl Behring Depuy Mitek, Inc. Wheeling, IL 60090, United States 1020 First Ave ,. P .O . Box 61501 325 Paramount Dr . Phone: 847-403-3400 King of Prussia, PA 19406-0901, United States Raynham, MA 02767, United States Fax: 847-541-9526 Phone: 610-878-4000 Phone: 508-880-8100 Email: [email protected] Fax: 610-878-4009 Fax: 508-880-8122 Website: www.corpakmedsystems.com Website: www.cslbehring.com Email: [email protected] Year established: 1979 Website: www.depuyspine.com Ctp Coil Inc. Year established: 1895 Cotran Corp. 1801-D Howard Street 574 Park Avenue, PO Box 130 Elk Grove Village, IL 60007, United States Deroyal Surgical - Rose Hill Portsmouth, RI 02871, United States Phone: 847-228-8818 100 Rose Hill Industrial Park Phone: 401-682-1555 Fax: 847-593-3930 Rose Hill, VA 24281, United States Fax: 401-682-1775 Email: [email protected] Phone: 865-362-6022 Email: [email protected] Website: www.ctpcoil.co.uk Email: [email protected] Website: www.cotrancorp.com Year established: 1994 Website: www.deroyal.com Year established: 1986 Year established: 1973 Custom Healthcare Systems, Inc. Covidien 4205 Eubank Rd . Deroyal Wound Care 5870 Stoneridge Drive, Suite 6 Richmond, VA 23231, United States 164 giles hollow road, P .O . Box 309 Pleasanton, CA 94588, United States Phone: 804-421-5959 Rose Hill, VA 24281, United States Phone: 303-305-2382 Phone: 865-362-6022 Website: www.covidien.com Custom Tape Company Email: [email protected] 6270 Claude Way East Website: www.deroyal.com Covidien Lp Inver Grove Heights, MN 55076, United States Year established: 1973 15 Hampshire St . Phone: 651-228-7044 Mansfield, MA 02048, United States Deuteronomy Management Services,Inc. Phone: 508-261-8000 Customed, Inc. 1439 Live Oak St ., Suite A Email: [email protected] Calle Igualdad #7 Niceville, FL 32578-8829, United States Website: www.covidien.com Fajardo, PR 00738, United States Phone: 850-897-3321 Phone: 787-801-0101 Covidien Lp, Formerly Registered As Kendall Diablo Sales & Marketing, Inc. 986 Faichney Dr Cw Medical, Inc. PO Box 408 Watertown, NY 13601, United States 5595 Daniels St, Suite E, Chino, CA 91710, United States Diablo, CA 94526, United States Phone: 315-788-0301 Phone: 909-591-5220 Phone: 925-648-1611 Email: [email protected] Fax: 909-591-5769 Fax: 925-648-1711 Website: www.covidien.com Email: [email protected] Email: [email protected] Website: www.cwmedical.us Website: www.diablosales.com Covidien Lp, Formerly Registered As Kendall Year established: 1994 Year established: 1987 444 Mcdonnell Blvd . Hazelwood, MO 63042, United States Cypress Medical Products Directmed, Inc. Phone: 800-962-9888 1202 S . Rte . 31 150 Pratt Oval, Glen Cove, NY 11542, United States Email: [email protected] McHenry, IL 60050, United States Phone: 516-656-3377 Website: www.covidien.com Fax: 815-385-0114 Fax: 516-656-5574 Email: [email protected] Email: [email protected] Covidien Lp, Formerly Registered As Kendall Website: www.cypressmed.com Website: www.directmed.com 815 Tek Dr . Year established: 1988 Year established: 1997 Crystal Lake, IL 60039, United States Phone: 815-444-2500 Dale Medical Products, Inc. Dma Med-Chem Corporation Email: [email protected] 7 Cross St . 49 Water Mill Lane Website: www.covidien.com Plainville, MA 02762-0556, United States Great Neck, NY 11021-4234, United States Phone: 508-695-9316 Phone: 516-829-1200 Covidien Lp, Formerly Registered As Ludlow Fax: 508-695-6587 Fax: 516-487-1239 Two Ludlow Park Dr . Email: [email protected] Email: [email protected] Chicopee, MA 01022, United States Website: www.dalemed.com Website: www.dmamed.com Phone: 413-593-6400 Year established: 1961 Year established: 1982 Email: [email protected] Website: www.covidien.com David Clark Company, Inc. Durden Enterprises 360 Franklin St . 1317 4th Ave ., P .O . Box 909 Covidien Lp, Formerly Registered As Tyco Worcester, MA 01604, United States Auburn, GA 30011, United States Healthcare Phone: 508-751-5800 Phone: 770-963-0637 15 Hampshire Street Fax: 508-753-5827 Fax: 770-995-7067 Mansfield, MA 02048, United States Email: [email protected] Email: [email protected] Phone: 508-261-8000 Website: www.davidclark.com Website: www.sterisystems.com Email: [email protected] Year established: 1935 Year established: 1971 Website: www.covidien.com David Scott Company Eagle Laboratories Covidien Lp, Formerly Registered As United States 59 Fountain St . 10201-A Trademark Street Surgical Framingham, MA 01702, United States Rancho Cucamonga, CA 91730-5850, United States 195 Mcdermott Road Phone: 508-875-3333 Phone: 909-481-0011 North Haven, CT 06473, United States Fax: 508-875-3375 Fax: 909-481-4481 Phone: 203-492-5000 Email: [email protected] Email: [email protected] Website: www.covidien.com Website: www.davidscottco.com Website: www.eaglelabs.com Year established: 1972 Year established: 1988

Source: MDRWeb.com 84 Edge I-Wear Corp. Ethox International Fresenius Medical Care North America 1775 Curtiss Ct . 251 Seneca St . 920 Winter Street La Verne, CA 91750, United States Buffalo, NY 14204, United States Waltham, MA 02451, United States Phone: 909-598-7679 Phone: 716-842-4000 Phone: 781-699-9000 Fax: 716-842-4040 Website: www.fmcna.com Edwards Lifesciences Research Medical Email: [email protected] 6864 South 300 West Website: www.ethoxint.com Fresenius Medical Care North America Midvale, UT 84047, United States Year established: 1966 420 Industrial Dr Phone: 949-250-2500 Livingston, CA 95334, United States Eurospital S.P.A. Phone: 781-699-9068 Edwards Lifesciences Technology Sarl Via Flavia 122 Website: www.fmcna.com State Rd . 402 N .km 1 .4 Trieste, 34147, Italy Anasco, PR 00610-1577, United States Phone: 003-904-0899 Fresenius Medical Care North America Phone: 949-250-2500 750 North Lallendorf Rd Ev3 Neurovascular Oregon, OH 43616, United States Edwards Lifesciences, Llc. 9775 Toledo Way Phone: 781-699-9068 One Edwards Way Irvine, CA 92618, United States Website: www.fmcna.com Irvine, CA 92614, United States Phone: 949-837-3700 Phone: 949-250-2500 Fax: 949-837-2044 Fresenius Medical Care North America Fax: 949-250-2525 Email: [email protected] 5201 Regent Blvd Website: www.edwards.com Website: www.ev3.net Irving, TX 75063, United States Year established: 1958 Year established: 2000 Phone: 781-699-9068 Website: www.fmcna.com Ekos Corp. Evans Medical Inc. 11911 N Creek Parkway South 1529 Terracina Drive Fresenius Medical Care North America Bothell, WA 98011, United States El Dorado Hills, CA 95762, United States 475 West 13th St Phone: 425-415-3100 Phone: 916-939-2451 Ogden, UT 84404, United States Fax: 425-415-3102 Phone: 781-699-9068 Email: [email protected] Excelsior Medical Corp. Website: www.fmcna.com Website: www.ekoscorp.com 1933 Heck Ave . Year established: 1995 Neptune, NJ 07753, United States Fresenius Usa, Inc. Phone: 732-776-7525 920 Winter Street Elcam Medical, Inc. Fax: 732-776-7600 Waltham, MA 02451-1457, United States 2 University Plaza, suite 620 Website: www.excelsiormedical.com Phone: 781-699-900 Hackensack, NJ 07601, United States Website: www.fmc-ag.com Phone: 201-457-1120 Exelint International Co. Fax: 201-457-1125 5840 W . Centinela Ave . Fresnel Prism & Lens Co. Email: [email protected] Los Angeles, CA 90045, United States 6824 Washington Avenue Website: www.elcam-medical.com Phone: 727-827-1922 Eden Prairie, MN 55344, United States Year established: 1970 Fax: 727-827-1635 Phone: 952-496-0432 Email: [email protected] Entracare, Llc Website: www.exelint.com Fuji Medical Instr Mfg., Co. Ltd. 11315 Strang Line Rd . 5-5-21 Nipponbashi, Naniwa-Ku Lenexa, KS 66215, United States Farley Inc., W.T. Osaka, 556-0005, Japan Phone: 913-451-2234 931 Via Alondra Phone: 310-978-3897 Camarillo, CA 93012, United States Erika De Reynosa, S.A. De C.V. Phone: 805-437-7090 Fujinomiya Factory Of Terumo Corporation Brecha E99 Sur; Parque, Industrial Reynos, Bldg . Ii Fax: 805-437-7098 818 Misono-Daira Cd, Reynosa, Tamps, Mexico Email: [email protected] Fujinomiya, 418-0004, Japan Phone: 781-402-9068 Website: www.wtfarley.com Phone: 011-81-33374 Year established: 1968 Ernst Flow Industries Fukui Koki Co. Ltd. 116 Main St . Farmatap S.A. De C.V. 1-1-40 Sanroku-Cho Farmingdale, NJ 07727-1495, United States 117 Alfonso Esparza Oteo Sabae, 916-0021, Japan Phone: 732-938-5641 Mexico Df 01020, Mexico Phone: 077-851-2833 Fax: 888-992-2843 Email: [email protected] Fenwal Inc. G.E.M. Water Systems, Int’L., Llc Website: www.ernstflow.com Three Corporate Drive 6351 Orangethorpe Avenue Year established: 1962 Lake Zurich, IL 60073, United States Buena Park, CA 90620, United States Phone: 847-550-2300 Phone: 714-736-9990 Escalon Trek Medical Fax: 847-550-5788 Fax: 714-736-9402 2440 S . 179th St . Email: [email protected] Email: [email protected] New Berlin, WI 53146, United States Website: www.fenwalinc.com Website: www.gemwater.com Phone: 262-821-9182 Year established: 1949 Year established: 1981 Fax: 262-821-9927 Email: [email protected] Ferguson Production, Inc. Galaxy Medical Manufacturing Co. Website: www.escalonmed.com 2130 Industrial Drive 5411 Sheila Street Conway, KS 67460, United States Commerce, CA 90040-2103, United States Ethicon, Inc Phone: (620) 241-2400 Phone: 323-728-3980 3348 Pulliam St . Fax: (620) 241-2084 Fax: 323-728-5971 San Angelo, TX 76905, United States Email: [email protected] Email: [email protected] Phone: 908-218-2996 Website: www.fergusonproduction.com Website: www.galaxymfg.com Website: www.ethicon.com Year established: 1949 Filtrona Extrusion, Inc./Pexco® Medical Products Div. Ethicon, Inc. 764 south athol road Gargoyles Eyewear Route 22 West, p .o . box 151 Athol, MA 01331, United States 500 George Washington Hwy Somerville, NJ 08876, United States Phone: 404-564-8560 Smithfield, RI 02917, United States Phone: 908-218-0707 Fax: 404-584-8579 Phone: 800-426-6396 Fax: 908-218-2471 Website: www.filtronaextrusion.com Website: gargoyleseyewear.com Website: www.ethicon.com Year established: 1949 General ScientificS afety Equipment Co. Ethicon, Llc. Fpp, Inc. 2553 E Somerset St . 1st Floor Rd . 183, Km . 8 .3,, Industrial Area Hato 6800 S .W . 66th St . Philadelphia, PA 19134-4742, United States San Lorenzo, PR 00754, United States Ocala, FL 34476-5526, United States Phone: 215-739-7559 Phone: 908-218-2887 Phone: 352-622-4595 Fax: 215-739-7441 Website: www.ethicon.com Fax: 352-237-4855 Year established: 1988 Email: [email protected]

Source: MDRWeb.com 85 Genesis Biosystems, Inc. Haemotronic, S.P.A. Advanced Medical Hill-Rom, Inc. 1500 Eagle Court, Lewisville, TX 75057, United States Technologies 4115 Dorchester Rd ,. Unit 600 Phone: 972-315-7888 Via Morandi 12 North Charleston, SC 29405, United States Fax: 972-315-7818 Mirandola, 41037, Italy Phone: 812-934-7777 Email: [email protected] Phone: 011-39-535-6 Website: www.hill-rom.com Website: www.genesisbiosystems.com Year established: 2001 Halex Istar Industria Farmaceutica Ltda. Hollister-Stier Laboratories, Llc Br 153 Conjunto Caicara 3525 North Regal St . George Tiemann & Co. Goiania, Go, Brazil Spokane, WA 99207-5788, United States 25 Plant Ave . Phone: 305-477-4069 Phone: 509-489-5656 Hauppauge, NY 11788-3804, United States Fax: 509-484-4320 Phone: 631-273-6199 Halkey-Roberts Corp. Email: [email protected] Fax: 631-273-6199 2700 Halkey-Roberts Place North Website: www.Hollister-Stier.com Email: [email protected] St . Petersburg, FL 33716, United States Year established: 1921 Website: www.georgetiemann.com Phone: 727-471-4200 Fax: 727-578-0450 Homak Manufacturing Company Inc. Glo Touch Corporation Email: [email protected] 1605 Old Route 18, Suite 4-36 3075 Judd Rd . Website: www.halkeyroberts.com Wampum, PA 16157, United States Milan, MI 48160, United States Year established: 1941 Phone: 724-535-1080 Phone: 734-439-8248 Fax: 724-535-1081 Email: [email protected] Harmac Medical Products, Inc. Email: [email protected] Year established: 2000 2201 Bailey Avenue Website: www.homakmfg.com Buffalo, NY 14211-1797, United States Global Healthcare Phone: 716-897-4500 Hospira Inc. 1495 Hembree Rd ., Ste . 700 Fax: 716-897-0016 275 N . Field Drive Roswell, GA 30076, United States Email: [email protected] Lake forest, IL 60045, United States Phone: 770-522-7520 Website: www.harmac.com Phone: 224-212-2000 Fax: 770-522-7518 Website: www.hospira.com Email: [email protected] Harvard Apparatus, Inc. Website: www.globalhealthcare.net 84 October Hill Road, Holliston, MA 01746, United States Hospira, Inc. Year established: 1993 Phone: 508-893-8999 Hwy . 301 North Fax: 508-429-5732 Rocky Mount, NC 27801, United States Globe Medical Tech, Inc. Email: [email protected] Phone: 224-212-2000 1766 W . Sam Houston Pkwy N . Website: www.harvardapparatus.com Website: www.hospira.com Houston, TX 77043, United States Year established: 1901 Phone: 713-365-9595 Hospira, Inc. Fax: 713-365-9935 Hatu’- Ico S.P.A. 755 Jarvis Drive Email: [email protected] Via Andrea Costa 160 Morgan Hill, CA 95037, United States Website: www.globemedtech.com Bologna, 40134, Italy Phone: 877-946-7747 Website: www.hospira.com Graymills Corp. Hausmann Industries, Inc. 3705 N . Lincoln Avenue 130 Union St . Hurricane Medical Chicago, IL 60613-3517, United States Northvale, NJ 07647-2207, United States 5315 Lena Road Phone: 773-477-4100 Phone: 201-767-0255 Bradenton, FL 34211, United States Fax: 773-477-4133 Fax: 201-767-1369 Phone: 941-751-0588 Email: [email protected] Email: [email protected] Website: www.graymills.com Website: www.hausmann.com I.V. League Medical Year established: 1939 460 S . Lombard St . Health Care Logistics, Inc. Oxnard, CA 93030, United States Greattec Vision S.A. De C.V. 450 East Town St ., PO Box 25 Phone: 805-988-1010 Circuito De La Amistad #2700 Circleville, OH 43113, United States Mexicali B .c ., Mexico Phone: 740-477-1686 Icu Medical (Ut), Inc Fax: 800-447-2923 4455 Atherton Dr . Greiner Bio-One Gmbh Email: [email protected] Salt Lake City, UT 84123, United States Bad Haller Straße 32 Website: www.healthcarelogistics.com Phone: 949-366-2183 Kremsmünster, 4550, Austria Year established: 1978 Phone: 43-0-7583679 Icu Medical, Inc. Health Supply Company Inc., The 951 Calle Amanecer Greylor Co. 2902 Marlin Cir . San Clemente, CA 92673-6212, United States 2340 Andalusia Blvd . Atlanta, GA 30341-5118, United States Phone: 949-366-2183 Cape Coral, FL 33909, United States Phone: 770-452-0090 Fax: 949-366-8368 Phone: (239) 574-2011 Email: [email protected] Website: www.icumed.com Fax: (239) 574-2036 Website: www.hsc-usa.com Year established: 1984 Email: [email protected] Website: www.greylor.com Hemedex Incorporated I-Flow Corporation 222 Third Street, Suite 0123 20202 Windrow Dr . Guidant Corporation Cambridge, MA 02142, United States Lake Forest, CA 92630, United States 8934 Kirby Drive, Houston, TX 77054, United States Phone: 617-577-1759 Phone: 949-206-2700 Phone: 408-845-3995 Fax: 617-577-9328 Fax: 949-206-2600 Website: www.bostonscientific.com Email: [email protected] Email: [email protected] Website: www.hemedex.com Website: www.I-flowcorp.com Gulden Ophthalmics Year established: 2000 Year established: 1985 225 Cadwalader Avenue Elkins Park, PA 19027-0154, United States Hemerus Medical, Llc. Imp Group Ltd. Phone: 215-884-8105 5000 Township Parkway 400-2651 Dutch Village Rd Fax: 215-884-0418 St . Paul, MN 55110, United States Halifax, B3L 4T1, Canada Email: [email protected] Phone: 651-635-0070 Phone: 902-453-2400 Website: www.guldenindustries.com Year established: 1938 Hill Top Research Corp Indo German Surgical Corp. P .o . Box 138, 6088 Main & Mill Streets 151 Kaliandas Udyog Bhavan, Near Century Bazar, Gustav Ehinger Gmbh & Co. Miamiville, OH 45147, United States Prabhadevi Erlaheimer Str . 3 Phone: 513-831-3114 Bombay, India Balingen, 72336, Germany Phone: 800-354-7848 Phone: 004-974-3321 Hill-Rom Holdings, Inc. 1069 State Route 46 East Infusion Medix, Ltd. Haemonetics Corp. Batesville, IN 47006, United States 5 Rakefet St . 400 Wood Road, P .O . Box 9114 Phone: 812-934-7777 Ceasaria, Israel Braintree, MA 02184, United States Fax: 812-934-8189 Phone: 001-972-6326 Phone: 800-225-5242 Website: www.hill-rom.com Website: www.haemonetics.com Year established: 1929

Source: MDRWeb.com 86 Innovative Medical Designs Izumi Optical Co. Kentron Health Care, Inc. 130 West Rampart Rd . 2-21 Shinmachi, Sakai 3604 Kelton Jackson Road, P .o . Box 120 Shelbyville, IN 46176, United States Osaka, 590, Japan Springfield, TN 37172, United States Phone: 317-421-0308 Phone: 072--2324267 Phone: 615-384-0573

Inrad J. T. Posey Co. Kmi Kolster Methods, Inc. 4375 Donker Court S .E . 5635 Peck Rd . 3185 Palisades Dr . Kentwood, MI 49512, United States Arcadia, CA 91006-5851, United States Corona, CA 92880, United States Phone: 616-301-7800 Phone: 626-443-3143 Phone: 909-737-5476 Fax: 616-301-7799 Fax: 626-443-5014 Email: [email protected] Website: www.posey.com Kofu Factory Of Terumo Corp. Website: inrad-inc.com Year established: 1937 1727-1 Tsuijiarai, Showa-Cho Year established: 1981 Nakakoma-Gun, Japan J.E.M. Sales Ltd. Phone: 011-81-33374 Insource, Inc. 6-110 Norfinch Dr PO Box 9 Toronto, M3N 1X1, Canada Kollsut Scientific Corporation Bastian, VA 24314, United States Phone: 416-663-7313 3286 North 29th Court Phone: 540-688-4121 Hollywood, FL 33020, United States Fax: 800-869-8895 Jardon Eye Prosthetics, Inc. Phone: 630-290-5746 Email: [email protected] 15920 W 12 Mile Road Website: www.insourceonline.com Southfield, MI 48076-2115, United States Kontes Glass Co. Year established: 1991 Phone: 248-424-8560 1022 Spruce St . Fax: 248-424-8561 Vineland, NJ 08360-2841, United States Instrument Specialists, Inc. Email: [email protected] Phone: 856-692-8500 32390 IH-10 West Website: jardoneye.com Fax: 856-794-9762 Boerne, TX 78006, United States Email: [email protected] Phone: 800-537-1945 Jedmed Instruments Co. Website: www.kontes.com Fax: 830-249- 9433 5416 Jedmed Ct . Year established: 1993 Email: [email protected] St . Louis, MO 63129-2221, United States Website: www.isisurgery.com Phone: 314-845-3770 Koven Technology, Inc. Year established: 1978 Fax: 314-845-3771 12125 Woodcrest Executive Dr ., Suite 320 Email: [email protected] St . Louis, MO 63141, United States Integra Biotechnical Llc Website: www.jedmed.com Phone: 314-542-2101 2755 Dos Aarons Way, Suite B Fax: 314-542-6020 Vista, CA 92081, United States Johnson & Johnson De Monterrey, Sa De Cv Email: [email protected] Phone: 760-597-9878 Carretera Miguel Aleman,km21 .7 Website: www.koven.com Fax: 760-597-9879 Apodaca, Monterrey, Mexico Website: www.integrabio.com Phone: 817-262-5211 Labomed Sre 3, Via Partigiani Integra Lifesciences Corp. Jorgensen Laboratories Ripalta Cremasca Cr, Italy 311 Enterprise Drive 1450 N . Van Buren Avenue Plainsboro, NJ 08536, United States Loveland, CO 80538-3683, United States Leonids Traders Pvt. Ltd. Phone: 609-275-0500 Phone: 970-669-2500 36 Lenin Sarani Fax: 609-275-5363 Fax: 970-663-5042 Calcutta, 700001, India Email: [email protected] Email: [email protected] Phone: 800-354-7848 Website: www.integra-ls.com Website: www.jorvet.com Year established: 1965 Lexamed Integra Lifesciences Of Ohio 705 Front St . 4900 Charlemar Drive, Building A Jostra Bentley, Inc. Northwood, OH 43605, United States Cincinnati, OH 45227, United States Rd . 402 N . Km 1 .4, Industrial Park Phone: 419-693-5307 Phone: 800-654-2873 Anasco, PR 00610-1577, United States Email: [email protected] Phone: 302-454-9959 Lifemed Of California 1216 So . Allec St . Integrated Biomedical Technology, Inc. K Medical Anaheim, CA 92805-6301, United States 2931 Moose Trail PO Box 5224 Phone: 714-517-6900 Elkhart, IN 46514, United States Fort Lauderdale, FL 33310, United States Fax: 714-517-6911 Phone: 574-264-0025 Phone: 954-974-3078 Email: [email protected] Fax: 954-974-7437 Website: www.lifemedofcalifornia.com Intercos Gmbh Email: [email protected] Klosterweg 25 Website: www.Face-Shields.com Lifescan, Inc. Fernwald, 35463, Germany 1000 Gibraltar Dr Phone: 011-49-64042 Kawasumi Laboratories America, Inc. Milpitas, CA 95035-6314, United States 4723 Oakfair Blvd Phone: 408-263-9789 International Medical Industries Tampa, FL 33610, United States Fax: 408-942-6070 2881 West McNab Road Phone: 813-630-5554 Email: [email protected] Pompano Beach, FL 33069, United States Fax: 813-630-5033 Website: www.lifescan.com Phone: 954-917-9570 Email: [email protected] Fax: 954-917-9244 Website: www.kawasumiamerica.com Lisca Ab Email: [email protected] Year established: 1991 Berzelius Science Park Website: www.imiweb.com LinkÃping, 582 25, Sweden Kbd, Inc. Phone: +46 13 473 International Medication Systems, Ltd. 2550 American Ct 1886 Santa Anita Ave . Crescent Springs, KY 41017, United States Livengood Engineering Inc. South El Monte, CA 91733, United States Phone: 859-331-0800 1112 Oakridge Dr ., #104 Pmb 51 Phone: 800-423-4136 Fax: 859-331-0802 Fort Collins, CO 80525, United States Fax: 909-909-5726 Email: [email protected] Phone: 970-493-2569 Email: [email protected] Website: www.sperti.com Website: www.ims-limited.com Lsl Industries, Inc. Kelsar, S.A. 5535 N . Wolcott Avenue Interpore Cross International Blvd . Insurgentes, Libriamento a La Chicago, IL 60640, United States 181 Technology Dr ., Irvine, CA 92618, United States Tijuana, 22450, Mexico Phone: 773-878-1100 Phone: 949-453-3200 Phone: 508-261-8000 Fax: 773-878-9100 Fax: 949-453-3225 Email: [email protected] Website: www.interpore.com Kentec Medical Inc. Website: www.LSLIND.com Year established: 1975 17871 Fitch, Irvine, CA 92614, United States Year established: 1981 Phone: 949-863-0810 Iradimed Corporation Fax: 949-833-9730 Lt Acquisition, Inc. 7457 Aloma Ave ., Suite 201 Email: [email protected] 4489 East Paris Ave . Winter Park, FL 32792, United States Website: www.kentecmedical.com Grand Rapids, MI 49512, United States Phone: 407-677-8022 Year established: 1975 Phone: 616-698-1830

Source: MDRWeb.com 87 Lucomed Inc. Medex Medical Ltd. Medone Surgical, Inc. 45 Kulick Rd . St . Crispin Way, Haslingden 670 Tallevast Road Fairfield, NJ 07004, United States Rossendale, Lancashier, United Kingdom Sarasota, FL 34243, United States Phone: 973-575-0614 Phone: 614-889-2220 Phone: 941-359-3129 Fax: 973-227-0151 Email: [email protected] Medical Action Industries, Inc. Medrecon, Inc. Website: www.lucomedinc.com 25 Heywood Rd 257 South Avenue Year established: 1991 Arden, NC 28704, United States Garwood, NJ 07027-1341, United States Phone: 800-645-7042 Phone: 908-789-2050 Lundy Medical Product, Llc Fax: 631-231-3075 Fax: 908-789-3275 9376 East Bahia, Suite D-101 Website: www.medical-action.com Email: [email protected] Scottsdale, AZ 85260, United States Year established: 1977 Website: www.medrecon.com Phone: 480-473-7330 Year established: 1972 Fax: 480-315-1790 Medical Depot Email: [email protected] 99 Seaview Blvd . Medron, Inc. Website: www.lundymedical.com Port Washington, NY 11050, United States 1518 S . Gladiola St . Year established: 1978 Phone: 516-998-4600 Salt Lake City, UT 84104, United States Phone: 801-974-3010 Macosta S.N.C. Medical Technologies Of Georgia, Inc. Fax: 801-974-3063 Via Volta 36 15151 Prater Drive Email: [email protected] Mirandola, 41037, Italy Covington, GA 30014, United States Website: www.medroninc.com Phone: 201-760-9550 Phone: 404-394-2478 Year established: 1994

Maquet Cardiovascular LLC Medical Technology Products, Inc. Medtronic Cardiovascular Surgery, 45 Barbour Pond Dr . 2221-16 5th Avenue The Heart Valve Div. Wayne, NJ 07470, United States Ronkonkoma, NY 11779, United States 1851 East Deere Ave . Phone: 888-880-2874 Phone: 631-285-6640 Santa Ana, CA 92705, United States Fax: 973-709-7699 Fax: 631-285-6641 Phone: 800-328-2518 Email: [email protected] Email: [email protected] Website: www.medtronic.com Website: www.maquet.com Website: www.medtechproducts.com Year established: 2003 Year established: 1982 Medtronic Heart Valves 8299 Central Ave ., N .e . Maquet, Inc. Medi-Crush Company Spring Lake Park, MN 55432-3576, United States 45 Barbour Pond Drive P .O . BOX 321381 Phone: 800-227-3191 Wayne, NJ 07470, United States Flowood, MS 39232, United States Website: www.medtronic.com Phone: 1-888-MAQUET3 Phone: 800-262-6334 Email: [email protected] Fax: 601-898-3249 Medtronic Minimed Website: www.maquet.com Email: [email protected] 18000 Devonshire Northridge, CA 91325, United States Maquet, Inc. Medi-Dose, Inc. Phone: 818-362-5958 7371 Spartan Blvd . East 70 Industrial Drive Fax: 818-576-6534 N Charleston, SC 29418, United States Ivyland, PA 18974, United States Website: www.minimed.com Phone: 843-552-8652 Phone: 215-396-8600 Year established: 1983 Website: www.maquet.com Fax: 800-323-8966 Email: [email protected] Medtronic Navigation, Inc. Mar Cor Purification Website: www.medi-dose.com 826 Coal Creek Cir . 4450 Township Line Road Year established: 1971 Louisville, CO 80027, United States Skippack, PA 19474-1429, United States Phone: 720-890-3200 Phone: 484-991-0220 Medikmark Inc. Fax: 720-890-3500 Fax: 484-991-0230 3600 Bur Wood Email: [email protected] Email: [email protected] Waukegan, IL 60085-8399, United States Website: www.medtronicnavigation.com Website: www.mcpur.com Phone: 847-887-8400 Year established: 1970 Fax: 847-887-0766 Medved Products, Inc. Email: [email protected] P .O . Box 120883 Marquette Medical, Inc. Website: www.medikmark.com St . Paul, MN 55112-0883, United States 2600 Cabover Drive, Suite J Year established: 1987 Phone: 651-482-8413 Hanover, MD 21076, United States Fax: 651-482-8413 Phone: 800-296-2134 Mediq/Prn Email: [email protected] Fax: 410-987-2998 1 Mediq Plaza Website: www.medvedproducts.com Email: [email protected] Pennsauken, NJ 08110, United States Year established: 1989 Website: www.pilotmedicalproducts.com Phone: 609-662-3200 Year established: 1985 Fax: 856-661-0223 Megadyne Medical Products, Inc. Email: [email protected] 11506 S . State St . Mast Biosurgery Usa Inc. Website: www.mediq.net Draper, UT 84020, United States 6749 Top Gun St ., Suite 108 Phone: 801-576-9669 San Diego, CA 92121, United States Medis S.R.L. Fax: 801-576-9698 Phone: 858-550-8050 Viale Dei Mille 5 Email: [email protected] Milano, 20129, Italy Website: www.megadyne.com Maverick Technologies, Inc. Phone: 02-718-672 Year established: 1985 1754 Grove Drive Clearwater, FL 33759, United States Medistad Medical Bv MEI Corporation Phone: 727-791-6151 Nijverheidsweg 1, PO Box 99 4907 South 90th St ,. Omaha, NE 68127, United States Medemblik, NOORD HOLLAND 1670 AB, Netherlands Phone: 402-339-3300 Medefil, Inc. Phone: +31 227 546600 Fax: 402-339-1333 250 Windy Point Drive Fax: +31 227 542230 Email: [email protected] Glendale Heights, IL 60139, United States Email: [email protected] Website: www.meicorp.net Phone: 630-682-4600 Website: www.medistad.com Fax: 630-681-9100 Year established: 1979 Mentor Texas, Inc. Email: [email protected] 3041 Skyway Circle North, Irving, TX 75038, United States Website: www.medefil.com Medi-Stim A/S Phone: 972-252-6060 Year established: 1998 Sandakerveien 110 Website: www.mentorcorp.com Oslo, 483, Norway Year established: 1969 Medegen Medical Products, Llc Phone: 47-23-05 96 209 Medegen Drive Merit Medical Systems Inc. Gallaway, TN 38036-0228, United States Medivice Systems, Ltd. 12701 Kingston Ave Phone: 901-867-2951 Harton 9 , Har Hahozvim Chesterfield, VA 23837, United States Fax: 901-867-8954 Jerusalem, 91999, Israel Phone: 804-416-1030 Email: [email protected] Phone: 972 2 540 Fax: 804-416-1031 Website: www.medegen.com Website: www.merit.com Year established: 1874 Year established: 1997

Source: MDRWeb.com 88 Merit Medical Systems, Inc. Mmj S.A. De C.V. Neo-Care Arrow International 1600 W . Merit Pkwy . 716 Ponciano Arriaga 5714 Epsilon Rd . South Jordan, UT 84095, United States Cd . Juarez, Chih ., Mexico San Antonio, TX 78249-3407, United States Phone: 801-253-1600 Phone: 314-654-2000 Phone: 210-696-4061 Fax: 801-253-1652 Fax: 210-696-1305 Email: [email protected] Mobile I.V. Systems, Llc Email: [email protected] Website: www.merit.com 23630 N . 35th Dr Website: www.neocare.com Year established: 1987 Glendale, AZ 85310, United States Year established: 1994 Phone: 623-434-3136 Merit Medical Systems, Inc. Neotech Products, Inc. 1111 South Velasco Model Eye Industry 27822 Fremont Ct Angleton, TX 77515, United States 2nd Fl . 807-52 Sankyuk, 1-Dong Buk-Gu Valencia, CA 91355, United States Phone: 801-253-1600 Daegu, Republic of Korea Phone: 661-775-7466 Fax: 1-801-253-1652 Phone: 82-53-941050 Fax: 800-966-0585 Email: [email protected] Merlyn Pharmaceuticals, Inc. Modular Services Company Website: www.neotechproducts.com 8175 Kroger Farm Rd . 109 N .e . 38th St . Year established: 1986 Cincinnati, OH 45243-1639, United States Oklahoma City, OK 73105, United States Phone: 513-831-3005 Phone: 405-521-9923 Nexus Medical, Llc Fax: 513-831-5237 11315 Strang Line Road Email: [email protected] Monogen, Inc. Lenexa, KS 66215, United States Website: merlynp.homestead.com 3630 Bur Wood Dr . Phone: 913-451-2234 Waukegan, IL 60085, United States Mettler Electronics Corp. Phone: 847-573-6700 Nikkiso Co. Ltd. 1333 S . Claudina Street Fax: 847-758-4273 498/1 Shizutani, Haibara-Gun Anaheim, CA 92805-6235, United States Email: [email protected] Haibara, 421-0404, Japan Phone: 714-533-2221 Website: www.monogen.com Phone: 3-3443-3711 Fax: 714-635-7539 Year established: 1996 Email: [email protected] Nipro Diabetes Systems, Inc. Website: www.mettlerelectronics.com Moog Inc. 3361 Enterprise Way Year established: 1957 Jamison Rd . Miramar, FL 33025, United States East Aurora, NY 14052, United States Phone: 816-637-2233 Mfg One, Llc Phone: 716-652-2000 Fax: 954-435-9295 3900 Skyhawk Dr . Fax: 716-687-4457 Website: www.nipro.com Chantilly, VA 20151, United States Email: [email protected] Phone: 703-437-9838 Website: www.moog.com Norfolk Medical Products, Inc. Year established: 1951 7350 North Ridgeway Microgroup Skokie, IL 60076, United States 7 Industrial Park Road Morrison Medical Phone: 847-674-7075 Medway, MA 02053, United States 3735 Paragon Drive Phone: 508-533-4925 Columbus, OH 43228, United States Novo Nordisk Pharmaceuticals, Inc. Fax: 508-533-5691 Phone: 614-461-4400 100 College Road West Email: [email protected] Fax: 614-469-9696 Princeton, NJ 08540-7810, United States Website: www.microgroup.com Email: [email protected] Phone: 609-987-5800 Year established: 1971 Website: www.morrisonmed.com Fax: 609-921-8082 Year established: 1970 Email: [email protected] Milestone Scientific Inc. Website: www.novonordisk-us.com 220 South Orange Ave . Mps Acacia Year established: 1950 Livingston, NJ 07039, United States 785 Challenger St . Phone: 800-862-1125 Brea, CA 92821, United States Novosci Corp. Website: www.milestonescientific.com Phone: 714-257-0470 2828 N . Crescent Ridge Drive Fax: 714-257-0513 The Woodlands, TX 77381, United States Millar Instruments, Inc. Email: [email protected] Phone: 281-363-4949 6001-A Gulf Freeway Website: www.mpsacacia.com Fax: 888-570-4009 Houston, TX 77023-5417, United States Year established: 1990 Email: [email protected] Phone: 832-667-7000 Website: www.novosci.us Fax: 832-667-7001 Myco Medical Year established: 2003 Email: [email protected] 158 Towerview Court Website: www.millarinstruments.com Cary, NC 27513, United States Np Medical, Inc. Year established: 1971 Phone: 919-460-2535 101 Union St . Fax: 919-460-2536 Clinton, MA 01510, United States Millipore Corporation Email: [email protected] Phone: 978-368-4514 290 Concord Road Website: www.mycomedical.com Fax: 978-365-4025 Billerica, MA 01821, United States Year established: 1993 Email: [email protected] Phone: 978-715-4321 Website: www.npmedical.com Fax: 800-645-5439 Nalge Nunc International Year established: 1955 Email: [email protected] 75 Panorama Creek Drive Website: www.millipore.com Rochester, NY 14625-2303, United States Nxstage Medical, Inc. Year established: 1954 Phone: 585-586-8800 439 South Union St ., 5th Floor Fax: 585-586-3294 Lawrence, MA 01843, United States Minntech Corporation Email: [email protected] Phone: 978-687-4700 14605 28th Avenue N . Website: www.NALGENE.com Fax: 978-687-4809 Minneapolis, MN 55447, United States Year established: 1949 Website: www.nxstage.com Phone: 763-553-3300 Fax: 763-553-3387 Navilyst Medical Nypro Singapore Pte. Ltd. Email: [email protected] 26 Forest Street 29 Joo Koon Circle Website: www.minntech.com Marlborough, MA 01752, United States Singapore, 629058, Singapore Year established: 1974 Phone: 508.658.7990 Phone: 978-365-9721 Website: www.navilystmedical.com Mizuho Osi Year established: 2008 Ohmeda Medical 30031 Ahern Avenue 8880 Gorman Road Union City, CA 94587-1234, United States Neo Medical Inc. Laurel, MD 20723, United States Phone: 510-429-1500 42514 Albrea Street Phone: 410-888-5200 Fax: 510-429-8500 Fremont, CA 94538, United States Fax: 301-483-8340 Email: [email protected] Phone: 888-450-3334 Email: [email protected] Website: www.osiosi.com Website: www.gehealthcare.com Year established: 1978

Source: MDRWeb.com 89 Omni Medical Supply Inc. Prizm Medical, Inc. Renal Solutions Inc. 4153 Pioneer Drive P .O .Box 40 770 Commonwealth Drive, Suite 101 Walled Lake, MI 48390, United States Oakwood, GA 30566, United States Warrendale, PA 15086, United States Phone: 248-360-8000 Phone: 770-622-0933 Phone: 724-772-6900 Fax: 248-360-9375 Fax: 678-714-7243 Fax: (724) 772-6925 Email: [email protected] Website: www.renalsolutionsinc.com Website: www.omnimedicalsupply.com Pro-Optics, Inc. Year established: 1992 317 Woodwork Lane ReNu Medical Inc. Palatine, IL 60067-4993, United States 9800 Evergreen Way One Optical Co., Ltd. Fax: 847-991-9696 Everett, WA 98204, United States 644-2, Chimsan-3dong, Buk-Ku Email: [email protected] Phone: 877-252-1110 Taegu, Republic of Korea Website: www.proopticsinc.com Fax: 425-353-9116 Phone: 053-357-2470 Email: [email protected] Protech Leaded Eyewear Website: www.renumedical.com Panatrex, Inc. 10415 riverside drive Year established: 2000 1648 Sierra Madre Cir . Palm Beach Gardens, FL 33410, United States Placentia, CA 92870-6626, United States Phone: 561-627-9769 Retractable Technologies, Inc. Phone: 714-630-5582 Fax: 561-627-0923 511 Lobo Lane Email: [email protected] Little Elm, TX 75068, United States Patton Medical Devices Website: www.protecheyewear.com Phone: 972-294-1010 31058 N . Lamar Blvd ., Austin, TX 78705, United States Fax: 972-292-3600 Phone: 512-279-4545 Provita Gmbh Medizintechnik Email: [email protected] Year established: 2004 Wermelskirchener Str . 20 Website: www.vanishpoint.com Wermelskirchen, 42929, Germany Year established: 1994 Paul Instruments (India) Phone: 49-219-35105 11/2 Tamer Ln . Richmond Products, Inc. Calcutta, 700001, India Pryor Products 4400 Silver Se Phone: 606-259-4924 1819 Peacock Blvd . Albuquerque, NM 87108, United States Oceanside, CA 92056-3578, United States Phone: 505-275-2406 Peaktop Ltd. Phone: 619-724-8244 Changzhen Village, Gongming, Town, Baoan, Qu District Fax: 619-724-0944 Rismed Oncology Systems Shenzhen City, Guangdong Prov ., China Email: [email protected] 2494 Washington Street Phone: 714-639-6590 Website: www.pryorproducts.com Huntsville, AL 35811-1663, United States Year established: 1972 Phone: 256-534-6993 Pedicraft, Inc. Fax: 256-534-6996 4134 St . Augustine Road Q.I. Medical, Inc. Email: [email protected] Jacksonville, FL 32247, United States 440-C Lower Grass Valley Road Website: www.rismed.com Phone: 904-396-9627 Nevada City, CA 95959, United States Year established: 1977 Fax: 904-346-3947 Phone: 530-265-4820 Email: [email protected] Fax: 530-265-9416 Rockford Medical & Safety Co. Website: www.pedicraft.com Email: [email protected] 2420 Harrison Avenue, PO Box 5646 Year established: 1966 Website: www.qimedical.com Rockford, IL 61125-0646, United States Year established: 1992 Phone: 815-394-4809 Pedigo Products Fax: 800-368-7891 4000 S .E . Columbia Way Q.T.I. Corp. Email: [email protected] Vancouver, WA 98661, United States 879 Del Valle Drive Website: www.r-m-s-c.com Phone: 360-695-3500 Fallbrook, CA 92028, United States Year established: 1976 Fax: 360-696-1700 Phone: 760-723-9825 Email: [email protected] Rymed Technologies, Inc. Website: www.pedigo-usa.com Quality Control Corp. 137 Third Avenue North Year established: 1947 7315 W . Wilson Ave . Franklin, TN 37064, United States Harwood Heights, IL 60706, United States Phone: 615-790-8093 Perioptix, Inc. Phone: 708-887-5400 Fax: 615-790-8984 1001 Avenida Pico, #C62 Email: [email protected] San Clemente, CA 92763, United States Quest Medical, Inc. Website: www.rymedtech.com Phone: 949-366-3333 1 Allentown Pkwy . Email: [email protected] Allen, TX 75002-4211, United States Rz Medizintechnik Gmbh Website: www.perioptix.com Phone: 972-390-9800 Zollernstr . 4 Fax: 972-390-7173 Tuttlingen, 78532, Germany Phelan Manufacturing Corp. Email: [email protected] Phone: 497-461-9331 2523 Minnehaha Ave . Website: www.questmedical.com Minneapolis, MN 55404-4119, United States Year established: 1994 S4j Manufacturing Services, Inc. Phone: 612-724-3677 2685 N .E . 9th Avenue Radiation Products Design, Inc. Cape Coral, FL 33909, United States Philips Medical Systems North America 5218 Barthel Industrial Dr . Phone: 239-574-9400 2301 Fifth Ave .,, Ste . 200 Albertville, MN 55301, United States Fax: 239-574-9567 Seattle, WA 98121, United States Phone: 763-497-2071 Email: [email protected] Phone: 800-934-7372 Fax: 763-497-2295 Website: www.s4jluer.com Website: www.medical.philips.com Email: [email protected] Year established: 1964 Website: www.rpdinc.com Plasco, Inc. Saint-Gobain Performance Plastics--Akron Carretera Presta La Amistad, Km .19 Razel Scientific Instruments, Inc. 2664 Gilchrist Rd . Acuna, Coahila, Mexico PO Box 111 Akron, OH 44305, United States Phone: 847-662-4400 St . Albans, VT 05478, United States Phone: 330-798-9240 Phone: 203-324-9914 Fax: 330-798-6968 Porex Technologies Gmbh Fax: 802-527-5095 Email: [email protected] Industriestrasse Email: [email protected] Website: www.medical.saint-gobain.com Singwitz/Bautzen, SAXONIA 2692, Germany Website: www.razelscientific.com Phone: +49 3591/37220 Year established: 1968 Schad Medical Instruments Gmbh Fax: +49 3591/44531 Hegaustrasse 9 Email: [email protected] Rbm Services, Llc. Neuhausen 1, Germany Website: www.porex.de 101-b Valley Court Phone: 074-67-94610 Year established: 1990 Oak Ridge, TN 37830, United States Phone: 865-483-0067 Servo-Med Industries Pvt. Ltd. Primrose Medical, Inc. Email: [email protected] 8-30 Veera Desai Rd . 478 High Plain St ., Walpole, MA 02081, United States Andheri,mumbai, Bombay, India Phone: 508-660-8688 Rd Medical Mfg. Inc. Phone: 011-912-2 63 Fax: 508-660-8699 Road 183, Km 21 .6, Las Piedras Industrial Park Email: [email protected] Las Piedras, PR 00771, United States Website: www.primrosemedical.com Phone: 787-716-6363

Source: MDRWeb.com 90 Sharn, Inc. Sofard Co., Ltd. Steelcraft, Inc. 4517 George Road Suite 200 82/31 Shino-Cho 115 W . Main St . Tampa, FL 33634-6236, United States Fukui, 910-2148, Japan Millbury, MA 01527, United States Phone: 813-889-9614 Phone: 81-776-41722 Phone: 508-865-4445 Fax: 813-886-2701 Fax: 508-865-4600 Email: [email protected] Somanetics Corp. Email: [email protected] Website: www.sharn.com 2600 Troy Center Drive Year established: 1983 Troy, MI 48084, United States Stryker Instruments, Instruments Div. Phone: 248-244-1400 4100 East Milham Ave . Sharps Compliance Corp. Fax: 248-244-0978 Kalamazoo, MI 49001, United States 9220 Kirby Drive, Suite 500 Email: [email protected] Phone: 800-253-3210 Houston, TX 77054, United States Website: www.somanetics.com Fax: 800-999-3811 Phone: 713-432-0300 Email: [email protected] Fax: 713-838-0508 Sorb Technology, Inc. Website: www.instrumedinc.com Email: [email protected] 3631 S .w . 54th St . Website: www.sharpsinc.com Oklahoma City, OK 73119, United States Stryker Puerto Rico, Ltd. Year established: 1992 Phone: 405-682-1993 Hwy . 3, Km . 131 2,. Las Guasimas Ind . Park Arroyo, PR 00714, United States Shelhigh, Inc. Sorin Group Usa Phone: 939-307-2500 650 Liberty Ave . 14401 W . 65th Way Fax: 939-307-2501 Union, NJ 07083, United States Arvada, CO 80004-3599, United States Phone: 908-206-8706 Phone: 303-425-5508 Sts Division Of Ethox International Fax: 303-467-6584 7500 West Henrietta Rd . Sigma International, Llc. Email: [email protected] Rush, NY 14543, United States 711 Park Avenue Website: www.soringroup-usa.com Phone: 585.533.1672 Medina, NY 14103-0756, United States Year established: 1999 Fax: 585.533.1796 Phone: 585-798-3901 Email: [email protected] Fax: 585-798-3909 Sparton Corporation Website: www.ethoxsts.com Email: [email protected] 22740 Lunn Road Website: www.sigmapumps.com Strongsville, OH 44149, United States Sunlite Plastics, Inc. Year established: 1992 Phone: 440-878-4630 W194 N11340 McCormick Dr . Website: sparton.com Germantown, WI 53022, United States Smisson-Cartledge Biomedical Phone: 262-253-0600 487 Cherry St, Third Street Tower Specialized Health Products International, Inc. Fax: 262-253-0601 Macon, GA 31201, United States 585 W . 500 S . Email: [email protected] Phone: 1-866-944-9992 Bountiful, UT 84010, United States Website: www.sunliteplastics.com Fax: 478-744-9996 Phone: 801-298-3360 Year established: 1946 Email: [email protected] Fax: 801-298-1759 Email: [email protected] Sun-Med Smith & Nephew Inc., Endoscopy Div. Website: www.shpi.com 12393 Belcher Road, Suite #450 76 S . Meridian Ave . Year established: 1993 Largo, FL 33773, United States Oklahoma City, OK 73107-6512, United States Phone: 727-530-7099 Phone: 978-749-1000 Specialty Manufacturing Co., The Fax: 727-531-3991 Website: www.endo.smith-nephew.com 5858 Centerville Rd . Email: [email protected] St . Paul, MN 55127-6804, United States Website: www.sunmedusa.com Smith & Nephew, Inc., Endoscopy Division Phone: 651-653-0599 150 Minuteman Road Fax: 651-653-0989 Symbios Medical Products, Llc Andover, MA 01810-1031, United States Email: [email protected] 7301 Georgetown Rd, Suite 150 Phone: 978-749-1000 Website: www.specialtymfg.com Indianapolis, IN 46268, United States Fax: 978-749-1599 Year established: 1901 Phone: 317-225-4447 Email: [email protected] Website: www.endo.smith-nephew.com Spectra Medical Devices, Inc. Synovis Life Technologies, Inc 4C Henshaw St . 2575 University Ave . W Smith & Nephew, Inc., Endoscopy Division Woburn, MA 01801, United States St . Paul, MN 55114, United States 130 Forbes Blvd . Phone: 781-938-8649 Phone: 651-796-7300 Mansfield, MA 02048, United States Fax: 781-938-0357 Fax: 651-642-9018 Phone: 978-749-1000 Email: [email protected] Website: www.synovislife.com Fax: 978-748-1599 Year established: 1995 Website: www.endo.smith-nephew.com Tandem Medical, Inc. Spectrum Laboratories, Inc. 535 Encinitas Blvd, Suite 109 Smiths Medical Asd, Inc. 18617 Broadwick St . Encinitas, CA 92024, United States 1265 Grey Fox Road Rancho Dominguez, CA 90220, United States Phone: 760-943-0100 St . Paul, MN 55112, United States Phone: 310-885-4600 Fax: 760-943-0143 Phone: 651-633-2556 Fax: 310-885-4666 Email: [email protected] Fax: 651-628-7459 Email: [email protected] Website: www.autodose.com Email: [email protected] Website: www.spectrumlabs.com Year established: 1997 Website: www.smiths-medical.com Year established: 1970 Year established: 1983 Tarry Manufacturing Spencer Italia S.R.L. 22 Shelter Rock Lane Smiths Medical Asd, Inc. Strada Cavi, 7 Danbury, CT 06810-8156, United States 5200 Upper Metro Place, Suite 200 Collecchio, PR 43034, Italy Phone: 203-794-1438 Dublin, OH 43017, United States Phone: 0521/5411 Fax: 203-792-5581 Phone: 214-618-0218 Fax: 0521/541222 Email: [email protected] Fax: 614-734-0254 Email: [email protected] Website: www.tarrymfg.com Email: [email protected] Website: www.spencer.it Year established: 1982 Website: www.smiths-medical.com Sperian Eye & Face Protection Inc. Tecan Systems Smiths Medical Asd, Inc. 10 Thurber Blvd . 2450 Zanker Rd ,. San Jose, CA 95131, United States 201 West Queen St . Smithfield, RI 02917, United States Phone: 408-953-3100 Southington, CT 06489, United States Phone: 401-232-1200 Fax: 408-953-3101 Phone: 614-791-5568 Email: [email protected] State Trading Corporation Of India, Ltd. Website: www.tecan.com Smiths Medical OEM 350 5th Ave ,. Ste . 1124, 11th Fl . 5200 Upper Metro Place, Suite 200 New York, NY 10118, United States Telos Medical Equipment (Austin & Assoc., Inc.) Dublin, OH 43017, United States Phone: 212-244-3317 1109 Sturbridge Road Phone: 614-210-7300 Fax: 212-244-3319 Fallston, MD 21047-1905, United States Fax: 614-889-2651 Email: [email protected] Phone: 410-877-3029 Email: [email protected] Fax: 410-877-0544 Website: www.smiths-medical.com Email: [email protected] Website: www.telosmedical.com

Source: MDRWeb.com 91 Terumo Cardiovascular Systems (Tcvs) Tulox Plastics Corp. Venetec International., Inc. 28 Howe St . 401 S . Miller Ave ., P .O . Box 984 12555 High Bluff Drive,, Suite 100 Ashland, MA 01721, United States Marion, IN 46952-0984, United States San Diego, CA 92130, United States Phone: 508-881-4858 Phone: 765-664-5155 Phone: 858-509-2400 Fax: 508-231-5210 Fax: 765-664-0257 Fax: 858-350-7899 Website: www.terumo-cvs.com Email: [email protected] Email: [email protected] Year established: 1921 Website: www.tulox.com Website: www.venetec.com Year established: 1983 Terumo Cardiovascular Systems, Corp Ventlab Corp. 6200 Jackson Rd . Tuzik Boston 155 Boyce Drive Ann Arbor, MI 48103-9300, United States 104 Longwater Dr ., Assinippi Park Mocksville, NC 27028, United States Phone: 734-663-4145 Norwell, MA 02061, United States Phone: 336-753-5000 Fax: 734-741-6079 Phone: 781-878-6363 Website: www.terumo-cvs.com Fax: 781-878-6938 Vita Medical Ltd. Year established: 1921 Email: [email protected] 75 Business & Technology Park,, Website: www.tuzikboston.com New Illawarra Rd lucas. Heights Terumo Medical Corporation Sydney, Australia 950 Elkton Blvd ., P .O Box. 605 Tyco Healthcare Ireland Limited Phone: 02-525-5700 Elkton, MD 21921, United States Sragh Industrial Estate Phone: 410-392-8500 Tullamore, Ireland Vital Signs Mn, Inc. Fax: 410-392-7218 Phone: 508-261-8000 12250 Nicollet Ave . Website: www.terumomedical.com Burnsville, MN 55337, United States Year established: 1921 Tyco Healthcare Uk Ltd. Phone: 973-790-1330 Fareham Rd . Email: Customer [email protected] Tfx Medical Oem Gosport, Hants, United Kingdom Website: www.vital-signs.com 50 Plantation Drive Phone: 203-845-1000 Jaffrey, NH 03452, United States Vital Signs, Inc. Phone: 603-532-7706 U.V. Vision Corp. 20 Campus Road Fax: 603-532-6108 7702 e . doubletree ranch road, suite 300 Totowa, NJ 07512, United States Email: [email protected] Scottsdale, AZ 85258, United States Phone: 973-790-1330 Website: www.tfx.com Phone: 480-948-5350 Email: Customer [email protected] Year established: 1981 Website: www.vital-signs.com Ultracell Medical Technologies, Inc. Year established: 1972 The After Market Group 183 Providence New London Tpke . 39400 Taylor Parkway North Stonington, CT 06359, United States Vlv Associates, Inc. N . Ridgeville, OH 44039, United States Phone: 860-599-4883 30-C Ridgedale Ave . Phone: 888-824-8200 Fax: 860-599-4193 East Hanover, NJ 07936, United States Fax: 800-468-0033 Email: [email protected] Phone: 973-428-2884 Website: www.aftermarketgroup.com Website: www.ultracell.com Fax: 973-428-2877 Year established: 1991 Email: [email protected] The Metrix Co. Website: www.vlvassociates.com 4400 Chavenelle Road Unimed S.A. Year established: 1982 Dubuque, IA 52002-2655, United States Grand Pre 10 Phone: 563-556-8800 Lausanne, CH 1002, Switzerland Volcano Corporation Fax: 563-556-4704 Phone: 21/624-2151 3661 Valley Centre Drive, Suite 200 Email: [email protected] Fax: 21/624-5332 Rancho Cordova, CA 92130, United States Website: www.metrixco.com Email: [email protected] Phone: 916-638-8008 Year established: 1964 Website: www.unimed.ch Fax: 916-638-8812 Year established: 1958 Email: [email protected] Therapeutic Silicone Technologies, Inc. Website: www.volcanocorp.com 909 Fifth Avenue Universal Medical Technologies Year established: 2001 New York, NY 10021, United States 15720 N . Greenway Hayden Loop, Suite 8 Phone: 212-606-0830 Scottsdale, AZ 85260, United States Vygon Corp. Phone: 415-924-1133 103a Park Drive Thomas Medical Products, Inc. Montgomeryville, PA 18936, United States 65 Great Valley Pkwy . Uroplasty, Inc. Phone: 800-473-5414 Malvern, PA 19355, United States 5420 Feltl Road Fax: 215-672-6740 Phone: 610-296-3000 Minnetonka, MN 55343, United States Email: [email protected] Fax: 610-296-4591 Phone: 952-426-6140 Website: www.vygonusa.com Email: [email protected] Fax: 952-426-6199 Year established: 1962 Year established: 1990 Email: [email protected] Website: uroplasty.com Vygon S A Tianjin Hanaco Medical Co.,Ltd. Year established: 1992 5-11 Rue Adeline 7 Dong Ting Street, Econ . & Tech . Devel . Zone Ecouen, 95440, France Tianjin, 300061, China Ussc Puerto Rico, Inc. Phone: 331-39-92636 Phone: 86-22-988729 Building 911-67, Sabanetas Industrial Park Ponce, PR 00731, United States W.L. Gore & Associates,Inc Total Molding Services, Inc. Phone: 203-845-1000 1505 North Fourth St . 354 East Broad St . Website: www.covidien.com Flagstaff, AZ 86004, United States Trumbauersville, PA 18970, United States Phone: 928-526-3030 Phone: 215-538-9613 Utah Medical Products, Inc. Fax: 215-538-2519 7043 S . 300 W . Walkmed Infusion Llc Email: [email protected] Midvale, UT 84047, United States 4080 Youngfield St . Website: www.totalmoldingservices.com Phone: 801-566-1200 Wheat Ridge, CO 80033-3862, United States Year established: 1985 Fax: 801-566-2062 Phone: 303-420-9569 Email: [email protected] Fax: 303-420-4545 Trident Medical Products Website: www.utahmed.com Email: [email protected] 1201 Summit Avenue Year established: 1978 Website: www.mckinleymed.com Fort Worth, TX 76102, United States Year established: 1995 Phone: 817-335-4031 Valeritas, Llc Fax: 817-820-0241 800 Boston Turnpike Wells Johnson Co. Email: [email protected] Shrewsbury, MA 01545, United States 8000 South Kolb Road Year established: 1986 Phone: 508-845-1177 Tucson, AZ 85706, United States Email: [email protected] Phone: 520-298-6069 Tss Hudson Website: www.valeritas.com Fax: 520-885-1189 19 Brent Dr Email: [email protected] Hudson, MA 01749, United States Website: www.wellsgrp.com Year established: 1980

Source: MDRWeb.com 92 West Pharmaceutical Services, Inc. Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh Zevex Incorporated 101 Gordon Dr . Rudolf-Diesel-Ring 20 4314 ZEVEX Park Lane Lionville, PA 19341, United States Sauerlach, 82054, Germany Salt Lake City, UT 84123-4650, United States Phone: 610-594-2900 Phone: 801-264-1001 Fax: 610-594-3000 Woosung Industry Co. Fax: 801-264-1051 Email: [email protected] 862-3 Yongsan-Dong Dalseo-Gu Email: [email protected] Website: www.westpharma.com Daegu, Republic of Korea Website: www.zevex.com Year established: 1923 Phone: 82-53-555565 Year established: 1986

West Pharmaceutical Services, Inc. World Precision Instruments (W.P.I.), Inc. Zhejiang Kindly Medical Devices And Plastics Co., 6453 US Highway 15 175 Sarasota Center Blvd . 252 Yongqiang Rd . Montgomery, PA 17752, United States Sarasota, FL 34240-9258, United States Yongzhong, Wenzhou, China Phone: 610-594-3105 Phone: 941-371-1003 Phone: 086-577-6372 Website: www.westpharma.com Fax: 941-377-5428 Year established: 1923 Email: [email protected] Zoll Medical Corp. Website: www.wpiinc.com 269 Mill Road West Pharmaceutical Services, Inc. - Lititz, Pa Year established: 1967 Chelmsford, MA 01824, United States 179 W . Airport Road Phone: 978-421-9655 brickerville, PA 17543, United States Yama, Inc. Fax: 978-421-0025 Phone: 717-560-8460 650 Liberty Ave . Email: [email protected] Fax: 717-560-8468 Union, NJ 07083, United States Website: www.zoll.com Website: www.westpharma.com Phone: 908-206-8706 Year established: 1980

Source: MDRWeb.com 93