PRODUCT PORTFOLIO GLASS TUBING, PHARMACEUTICAL PACKAGING, LABORATORY SERVICES, ACCESSORIES FOR KIT-PACKAGING PHARMAPACKAGING FUELED BY INNOVATION, QUALITY, AND PARTNERSHIP

Nipro PharmaPackaging is a leading global manufacturer of glass primary packaging in the pharmaceutical industry. For more than 60 years, we have developed and manufactured an innovative portfolio of Japanese quality products, including pre-fillable syringes, vials, cartridges, and ampoules. Our state of the art manufacturing plants and premium quality products comply to the highest quality standards (ISO 15378, ISO 9001, ISO 14001) of the industry. Through our personnel, products, and services, we provide packaging solutions that contribute to optimizing drug safety and efficacy, ultimately ensuring safer and healthier administrations.

Vertically integrated You will benefit from the know-how and synergies of a vertically integrated company. As a glass tubing manufacturer, continued supply of consistent high quality glass tubing is a given. Upon defining your primary packaging, state of the art converting lines, equipped with the latest inspection technologies, yield precise dimensional and cosmetic results – Be it pre-fillable syringes, cartridges, vials, or ampoules. For exceptional packaging challenges, our highly trained laboratory service team will collaborate with you to analyze the situation and find convincing solutions. You can choose from a wide range of accessories, which can be by-packed with your primary container to improve the end-user experience.

2 Benefits of cooperating with a vertically integrated partner

Glass Tubing Primary Packaging Advising you on glass tubing Offering you primary packaging that suits you best that matches your drug product requirements

Laboratory Services Accessories for Kit-packaging Optimizing your packaging Enabling you to differentiate your characteristics drug product

The optimal packaging solution for your drug product 3 Glass Tubing EXPERTISE REFLECTED IN GLASS

To satisfy all the specifications of your final packaging, we begin with glass tubing. Nipro offers you professional advice on which glass tubing will serve as the optimal raw material for your primary packaging by meeting your dimensional and cosmetic requirements. Ensuring continuous supply of glass tubing, while keeping a consistent high quality, is essential for the production of premium containers. Our global network, with a capacity of more than 90,000 metric tons, is one of the largest in the glass tubing industry. Our sites are ISO 9001, ISO 15378, and OHSAS 18001 certified. Our premium glass tubing complies to the European Pharmacopoeia, Japanese Pharmacopeia, and United States Pharmacopoeia. Our commitment to Japanese quality is reflected by using the latest manufacturing equipment, combined with an extensive array of dimensional and cosmetic inspection systems. To provide the same high quality and professional service at every manufacturing site, all facilities are aligned in terms of production, quality assurance, and supply chain. With decades of experience in supplying a broad range of high quality clear and amber glass tubing to leading players of the pharmaceutical industry, Nipro has acquired the expertise to advise you on the glass tubing that is best suited for your primary container and ultimately for your drug product.

NSV51* W33 WG06* G38 Clear Clear Clear Amber Boroslicate Borosilicate Soda Lime Borosilicate Type I Type I Type III Type III Exp.: 51 Exp.: 33 Exp.: 93 Exp.: 76

* Optional with cerium

Advising you on glass tubing that suits you best 4 Quality Levels FOR PHARMACEUTICAL PACKAGING

In an increasingly competitive market environment, pharmaceutical companies are facing substantial challenges when confronted with the choice of the right drug delivery system.

On one side, a growing number of complex biotech drugs require highly sophisticated systems, while generic drugs primarily focus on cost effectiveness and fast time to market. Safeguarding patients, as the principle objective, results in even stricter standards amid rising end-user expectation in terms of safe and easy to use systems.

As a result, primary packaging, an inherent part of drug delivery systems, must meet the challenging requirements of pharmaceutical companies, regulatory standards, and end-users alike.

The process of defining the right quality for your primary packaging, in order to meet your drug product requirements, is a complex process. To facilitate the process, you can choose from three distinct quality levels that address varying drug product requirements. They form the perfect base to capture and fine- tune your quality and service requirements.

Quality fine-tuned to your drug product requirements!

Level of Customization & Product Complexity

5 Pre-fillable Syringes PRIMARY PACKAGING

Nipro offers pre-fillable syringes in eNable, eNhance, and eNgage quality.

Your fast, efficient solution for The optimal choice for highly Customize your syringe prevailing drug products sensitive drugs (Large molecules, specifications to meet particular (Small molecules, anticoagulants, vaccines, biotechs, cosmetics, drug product requirements that WFI, diluents) ophthalmics) surpass the eNhance quality level. • Optimized processability for • Excellent drug-container reduced TCO compatibility • Full data package for fast • Smooth integration into auto- acceptance of goods injection devices • Designed for reliable and safer • Optimized processability for manual administration minimal drug loss

Syringe Size & Type Volume (ml) Outer Ø (mm) Inner Ø (mm) Staked needle Luer Luer lock 0.5 6.85 4.65 • • • 1.0 std. 8.15 6.35 • • • 1.0 long 10.85 8.65 • • • 2.25 10.85 8.65 • • • 3.0 10.85 8.65 • • Staked Needle Outer Ø (G | mm) Inner Ø (mm) Free length (inch | mm) Bevel Wall type 25 | 0.50 0.30 ⅝ | 16.0 V-bevel Regular 27 | 0.40 0.20 ½ | 12.7 V-bevel Regular 27 | 0.40 0.26 ½ | 12.7 V-bevel Thin 29 | 0.33 0.13 ½ | 12.7 V-bevel Regular 29 | 0.33 0.19 ½ | 12.7 V-bevel Thin 30 | 0.30 0.12 ½ | 12.7 V-bevel Ultra-thin

6 Syringe Components CLOSURE

Staked needle Luer lock Luer

SNS RNS LInC™ V-OVS® Easy-turn Ribbed Tip cap Tip cap

Plunger stopper Plunger rod Safety devices Standard Transparent Safe’N’Sound Coated Color Novaguard - - Ypsomed

Rubber components are supplied by the prevailing manufacturers of the pharmaceutical industry

Specialty syringes

Dual Chamber Syringe Dual chamber syringes combine the storage of a powdered/liquid drug and a diluent into one primary packaging. By simply exerting pressure on the plunger, the liquid of the lower chamber is forced into the chamber that houses the drug product. Afterwards, the content of both chambers can be mixed and easily administered.

Syringe with Integrated Nasal Spray We offer compact-sized, multidose intranasal sprays for more convenient and accurate administrations.

7 Direct-To-Fill STERILE PACKAGING SOLUTIONS

Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow.

Nest & tub are cleaned with ionized air Washed syringes are loaded into nest & tub

Covered with insert(s) and sealed with lid (Tyvek®)

Sealed tub is entered into breather bag(s) and welded closed

100% camera inspection confirms each tub is correctly filled & sealed

Tubs are transferred into outer boxes

Outer boxes are placed on pallets and secured for safe transportation

External sterilization is performed & EtO exposure is confirmed by the indicator on the label

Key Technologies

ETO

No glass-to-glass EtO sensitive 100% in-line Cleaned with contact indicator on label camera inspection ionized air

8 Glass Vials PRIMARY PACKAGING

Nipro, with more than 60 years of experience, offers a wide range of vials in three distinct quality levels (eNable, eNhance, and eNgage) that answer to your specific drug requirements.

.vials that answer to the prevailing ..vials that are the optimal choice …vials that are customized to requirements of drug products, for highly sensitive drugs, such as meet extraordinary drug product such as small molecules. biotechs and large molecules. requirements. These vials feature optimized They offer excellent drug-container processability for reduced TCO compatibility, exceptional surface and are provided with a full data durability (Vialex™), and optimized package for fast acceptance of processability for minimized drug goods delivered. waste.

Vial Range d2 Crimp neck

Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 2R 16 13 35 1 4R 16 13 45 1 6R 22 20 40 1 8R 22 20 45 1 10R 24 20 40 1 h 15R 24 20 60 1 s 20R 30 20 55 1.2 25R 30 20 64 1.2 30R 40 20 75 1.2 50R 40 20 73 1.5 75 47 28 75 1.7 75 47 20 75 1.5 d1 75 47 32 75 1.95 75 40 20 100 1.5 Blowback: EU / US / None 100R 47 20 95 1.5 Surface: Ammonium sulfate 100 47 28 95 1.5 treatment / VIALEX™ 100 47 23 95 1.95 Printing: Ceramic 9 d2 Screw neck

Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 5 18 14 45 1.2 7.5 22 18 40 1.2 10 24 18 45 1.2 15 24 18 60 1.2 20 30 22 55 1.2 25 30 22 65 1.2 h 30 30 22 75 1.2 s 50 40 22 / 28 / 32 73 1.5 60 40 22 / 28 / 32 80 1.5 70 40 22 / 28 / 32 90 1.5 75 40 22 / 28 / 32 95 1.5 75 47 22 / 28 / 32 80 1.7 80 47 22 / 28 / 32 85 1.7 90 47 22 / 28 / 32 90 1.7 Blowback: EU / US / None | Surface: Ammonium sulfate treatment / VIALEX™ d1 Printing: Ceramic

d2 Unit / Bi-dose

Volume (ml) d1 (mm) d2 (mm) h (mm) s (mm) 0.35 6.6 8.75 19.5 0.8 0.5 6.6 8.75 28 0.8 h s

d1

Specialty vials We offer a broad range of special and customized vials:

High recovery High pressure V-bottom

10 Direct-To-Fill STERILE PACKAGING SOLUTIONS

Our fully automated packaging process takes place in an ISO 7 / ISO 8 cleanroom with 100% monitoring under laminar air flow.

Glass vials are loaded into the tray Front wall and lid are assembled onto the tray

Packaging is entered into inner & outer Tyvek® breather bags and welded closed

100% camera inspection confirms each tub is correctly filled & sealed

Trays are transferred into outer boxes

Outer boxes are placed on pallets and secured for safe transportation

External sterilization is performed & EtO exposure is confirmed by the indicator on the label

Key Technologies

ETO

No glass-to-glass EtO sensitive 100% in-line contact indicator on the label camera inspection

11 Glass Cartridges PRIMARY PACKAGING

Glass cartridges are frequently incorporated into diabetes pens and dental injection systems. Nipro PharmaPackaging cartridges meet the high quality requirements of the pharmaceutical industry. Depending on your drug product requirements, eNable, eNhance, or eNgage cartridges will be the optimal choice.

.cartridges that answer to the ..cartridges that are the optimal …cartridges that are customized to prevailing requirements for dental choice for highly sensitive drug meet extraordinary drug product applications. products, such as insulin. requirements. These cartridges feature optimized They offer a reliable integration processability for reduced TCO, into pens, excellent drug-container tight dimensional tolerance, and compatibility, and pristine cosmetic high durability for safe integration appearance. with dental devices.

Cartridges

Volume (ml) Outer Ø (mm) Printing Special 1.8 to 3.0 8.15 to 11.60 Ceramic Double chamber

12 Ampoules PRIMARY PACKAGING

Ampoules are an economical and well-proven primary packaging for drug products. In large parts of the pharmaceutical market, ampoules are chosen as the preferred primary container. As a long standing player with an annual sales quantity of several billion high- quality ampoules, Nipro has acquired the experience to offer unparalleled service in ampoule development and conversion. Benefits • Broad product portfolio • Premium quality and compliance • Tight dimensional tolerances Ampoules

Form Volume (ml) Outer Ø (mm) Breaking systems Printing Code rings B 1.0 to 25.0 10.75 to 22.5 C 1.0 to 25.0 10.75 to 22.5 Color Break Ring Text 1 to 3 rings D 1.0 to 20.0 10.75 to 22.5 Open Point Cut (max. 2 colors) (max. 3 colors) Fine tip 1.0 to 20.0 10.75 to 22.5 Scoring Ring Double tip 1.0 to 20.0 10.75 to 22.5 Quality & Compliance Converting sites: ISO 9001, ISO 15378, ISO 14001, OHSAS 8001

13 Dual Chamber Infusion Bags PRIMARY PACKAGING

Dual chamber bags combine the storage of a powdered/liquid drug and a diluent into one primary packaging. By simply exerting higher pressure on the diluent chamber, the seal between the two chambers is forced open, and the content of both chambers can be mixed with each other.

Dual Chamber Infusion Bags

Description Powder chamber Diluent chamber Port

Infusion bag with two chambers, one for powder & Spike port or Rubber 1 g to 5 g 50 ml to 100 ml one for diluent, seperated by a seal stopper

Benefits • Simplified preparation procedure of a powdered drug and diluent • Closed system mixing procedure reduces the risk of contamination • Prevents errors in dosage and volume • Easy bedside preparation and administration • Neither oxygen nor humidity are permeable through the packaging • Needle-free reconstitution increases user safety

14 Laboratory Services OPTIMIZING YOUR GLASS PERFORMANCE

Glass is the prevailing primary packaging material of the pharmaceutical industry. The inherent robustness and chemical inertness of glass, combined with the available scientific data to back it up – It is clear why glass remains the predominant material for storing drug products. Even though glass is close to optimal, there are still imperfections. This has lead to various challenges for glass packaging within the drug arena: Drug–Packaging compatibility, difficulties during Fill-Finish, transportation, integration with devices, during inspection, etc.

Exceptional Expertise Advanced Equipment

Over 100 years of technical and scientific expertise We operate a distinct assortment of advanced in pharmaceutical packaging equips us with an analytical equipment dedicated to the testing and exceptional know-how in chemical, mechanical, characterization of pharma packaging. physical, and thermal properties of packaging material, as well as their corresponding analytics.

We support pharma companies in finding suitable packaging solutions for new drugs or improvements in the packaging quality of existing drugs. Optimizing your glass performance

15 Wide-Ranging Set of Analytical Areas

GLASS EXTRACTABLES GLASS DEFECT FRACTURE AND LEACHABLES MICROSCOPY ANALYSIS STUDY

GLASS ANALYSIS AGGRESSIVE/ INFRARED & SEM/EDS FOR CHEMICAL & ACCELERATED CONTAMINATION PHYSICAL PROPERTIES STUDIES ANALYSIS

PARTICLE GLASS PHARMACOPOEIA ANALYSIS AND DURABILITY TESTS CHARACTERIZATION STUDY

Committed to Compliance and Quality

In order to provide reliable and meaningful results, all systems and procedures are based on applicable GMPs.

Service-Minded Partner

With flexible solutions, results-driven analysis, and customer-oriented service, Nipro Laboratory Services continuously strives to gain and maintain the position of your preferred business partner.

16 Accessories for Kit-Packaging ENABLING YOU TO DIFFERENTIATE YOUR DRUG PRODUCT

At present, healthcare professionals and patients alike expect an easy and safe reconstitution and administration. We offer a distinct portfolio of accessories to by-pack your drug product in order to optimize handling and ultimately create a positive user experience. Reconstitution Devices Transfer devices enable a fast, simple transfer and mixing for the reconstitution of drug products. Nipro offers transfer devices suitable for mixing drug products stored in vials and syringes.

Indication of connection Compatible vial sizes Air vent with filter Application order on device Order of connection 20 mm Dissolving powder, No No Powder vial → Syringe (neck outer Ø) Mixing solution 20 mm Dissolving powder in Solution vial → Powder vial → Yes Yes (neck outer Ø) evacuated vial Syringe SAFETECT™

Description Pre-filled solution Filling volume Compatible vials Shelf life Pre-filled plastic syringe with 20 mm Water for injection (WFI) 5 ml 3 years pre-connected transfer needle unit (neck outer Ø) Benefits • Fast and easy preparation thanks to easy to use devices • Reduced risk of contamination due to fewer preparation steps • Less risk of exposure as a result of device design • Increased user-safety due to needle-free devices • Avoids misinjection of unmixed solution (SAFETECT only)

17 Accessories for Kit-Packaging ENABLING YOU TO DIFFERENTIATE YOUR DRUG PRODUCT

Hypodermic Needles – Hard case Established as one of the world’s largest needle manufacturers, Nipro has the resources to manufacture and supply large volumes on demand, ensuring continuous supply. Nipro’s focus on quality is highly acknowledged within the industry.

Needle size Wall type Bevel 25G, 27G, 29G, 30G Regular, Thin, Ultra-thin V-bevel

Benefits

• Easy and fast administration of viscous fluids thanks to ultra-thin needle walls • Smooth puncture and placement by virtue of optimized siliconization • Easy integration into automated packaging processes due to hard case packaging

18 Continuous Partnership THROUGHOUT THE ENTIRE PRODUCT LIFE-CYCLE

From your initial idea to the final product realization, and from early development to the entire lifecycle of your drug – You will be supported by 60+ years of experience and expertise. By putting our accumulated market and product knowledge into your service, supplying you with convincing packaging solutions for your specific drug requirements, Nipro PharmaPackaging continuously strives to gain and maintain the position of your preferred business partner.

During drug product development • Broad selection of ampoules, vials, cartridges, syringes • Dedicated team supporting packaging selection • Simple and fast provision of trial samples • Different packaging qualities to meet specific drug product requirements

During drug product approval • Product registered at FDA, Canada Health, NMPA (Drug Master File) • Simple LoA request procedure for DMF

During commercial production • Large manufacturing network for continuous, ensured supply • Switch from vials to syringes or cartridges while keeping the same supplier • Laboratory services – Analytics for glass primary packaging • Experienced technical service • Specialized customer service • Efficient complaint handling • Dedicated sales

During product line extension • Adapted packaging solutions for Generics/ Biosimilars • Dedicated team to advise on optimal packaging solutions

19 Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs.

With a worldwide manufacturing footprint of 14 plants, multiple sales offices, and internal lab services, Nipro PharmaPackaging offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers.

Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 29.000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharma Packaging industries. MM-1334 - Bro-PP_Portfolio-27.Jan.2020 - MM-1334

NIPRO PHARMAPACKAGING INTERNATIONAL HEADQUARTERS Blokhuisstraat 42, 2800 Mechelen, Belgium | [email protected] | www.nipro-group.com