DCS Pharma Portfolio

Total Page:16

File Type:pdf, Size:1020Kb

DCS Pharma Portfolio PORTFOLIO PHARMA API+ Controlled substances Hormones & steroids Muscle relaxants Oncology products Comprehensive services THE DCS PLUS+ FOR API PRODUCERS FOR GENERICS PRODUCERS Take advantage of We distinguish ourselves through ■ our in-depth market know-how ■ top products ■ a worldwide network that we have ■ world-class manufacturers developed over decades ■ the right documentation ■ a transparent exchange of information ■ a customer support that will exceed your expectations PORTFOLIO YOUR PHARMA API EXPERTS The highest quality, specialized knowledge, and transparency: this is what we bring to active pharmaceutical ingre- dients. We are your specialists with clearly-defined schedules, extensive high-quality Swiss services, and a global network built up over decades. We focus on a few select therapeutic groups and set the right priorities. Because we’re quality-conscious. US- US- PRODUCT GROUP CEP EDMF PRODUCT GROUP CEP EDMF DMF DMF Abiraterone Acetate Oncology Hydrocortisone Acetate Corticosteroid Amorolfine HCl Antiinfective Hydrocortisone Base Corticosteroid Atropine Sulfate Nervous system Hyoscine Butylbromide Alimentary tract Azacitidine Oncology PREP Imatinib Mesylate Oncology Bendamustine HCl Oncology Levonorgestrel Micro Hormone Betamethasone Dipropionate Corticosteroid Methadone HCl Nervous system Betamethasone Valerate Corticosteroid Methylprednisolone Corticosteroid Bortezomib Oncology Mometasone Furoate Corticosteroid Calcium Polystyrene Sulfonate Cation exchanger Mupirocin Antiinfective Carfilzomib Oncology PREP Neostigmine Bromide Nervous system Caspofungin Acetate Antiinfective Neostigmine Methylsulfate Nervous system Cinchocaine HCl Anesthetic Noradrenaline Bitartrate Cardiovascular Cisatracurium Besylate Muscle relaxant Oxaliplatin Oncology Clindamycin HCl/Phosphate Antiinfective Oxeladine Citrate Respiratory tract Clobetasol Propionate Corticosteroid Pentosan Polysulfate Sodium Urology Clostebol Acetate Corticosteroid Phenobarbital Nervous system Codeine Phosph. Hemihydrate Respiratory tract Phentermine HCl Antiobesity Cyproterone Acetate Hormone Prednisolone (various salts) Corticosteroid Dapagliflozin Antidiabetic Prednisone Base Corticosteroid Deflazacort Corticosteroid Progesterone Hormone Dexamethasone Base Corticosteroid Pseudoephedrine HCl Respiratory tract Dexamethasone Sod. Phosphate Corticosteroid Pyridostigmine Bromide Nervous system Dexmedetomidine HCl Nervous system Ropivacaine HCl Anesthetic Digoxin Cardiovascular Spectinomycin Sulphate Antiinfective Diosmin Flavonoid Spironolactone Cardiovascular Docetaxel Oncology Suxamethonium Chloride Muscle relaxant Ergotamine Tartrate Nervous system Testosterone (various salts) Hormone Etoposide Oncology Tibolone Hormone Fluorouracil (5-FU) Oncology Ticagrelor Antithrombotic Fulvestrant Oncology Troxerutin Flavonoid Gemcitabine HCl Oncology Valproic Acid Nervous system Hesperidin Flavonoid PREP Vinorelbine Tartrate Oncology Information Legend Well documented API. All transactions are carried out in conformity with patent Available laws applicable in the user country. Responsibility with respect to third parties PREP In preparation patent rights in a specific country lies exclusively with the user. EDMF Active Substance Master File suitable for submission in the EU US-DMF Drug Master File in CTD format for US-FDA approval DCS Pharma AG • Immengasse 9 • CH-4001 Basel / Switzerland Tel: +41 41 766 04 90 • Fax: +41 41 766 04 99 • [email protected] • www.dcspharma.com 2019-10/CB&KV.
Recommended publications
  • Zhejiang Xianju Pharmaceutical Co. Ltd
    No.1, Xianyao Road, Xianju, Zhejiang, China, 317300 Xianju Pharma Outline Outline I. Brief Introduction II. Quality Unit III. Production System IV. EHS System I. Brief Introduction Xianju Pharma Zhejiang Xianju Pharmaceutical Co., Ltd. A professional manufacturer of steroids and hormone products with largest scale and maximum varieties in China. A state-designated manufacturer of contraceptive drugs in China. Company Milestones Jan 1972 Foundation of company May 1997 Incorporated into Zhejiang Medicine Co., Ltd Oct. 1999 Listed in Shanghai Stock Market Jun. 2000 Reorganized into Xianju Pharmaceutical Co., Ltd Dec. 2001 Reformed to Zhejiang Xianju Pharmaceutical Co., Ltd Jan. 2010 listed in Shenzhen Stock Market Location of Xianju There are six airports around Shanghai Xianju, which makes us easily accessible for our partners. Headquarter Hangzhou Located in Xianju, Taizhou City Ningbo Yangfu Site (FPPs) Located in Yangfu, Xianju, Taizhou Yiwu City 6.8km from headquarter Duqiao Site (APIs) Located in LinHai, TaiZhou City, 82.9km from headquarter Taizhou Wenzhou Yangfu Site (APIs) Under construction, finish at 2017 Company Organization General Manager Vice G.M for Vice G.M Vice G.M for Vice G.M for Vice G.M for Quality Director Sales for Market Administration Finance Technology Finance Dept Finance Dept Application Tech Dept Endineering Construction Domestic DrugRegistrationDept. Research& Development Dept. Marketing Dept. Marketing Quality Control Quality Domestic Trading Dept International TradeDep Quality Assurance For FPP Quality Assurance For API Regulatory AffairsDept Human Resource Dept Information Technology Dept Dept Enterprise Management Dept Affairs Administrative Taizhou Xianju Quality System Quality Xianju Taizhou . t G.M. Assistant EHS Dept Production Management Dept G.M.
    [Show full text]
  • This Fact Sheet Provides Information to Patients with Eczema and Their Carers. About Topical Corticosteroids How to Apply Topic
    This fact sheet provides information to patients with eczema and their carers. About topical corticosteroids You or your child’s doctor has prescribed a topical corticosteroid for the treatment of eczema. For treating eczema, corticosteroids are usually prepared in a cream or ointment and are applied topically (directly onto the skin). Topical corticosteroids work by reducing inflammation and helping to control an over-reactive response of the immune system at the site of eczema. They also tighten blood vessels, making less blood flow to the surface of the skin. Together, these effects help to manage the symptoms of eczema. There is a range of steroids that can be used to treat eczema, each with different strengths (potencies). On the next page, the potencies of some common steroids are shown, as well as the concentration that they are usually used in cream or ointment preparations. Using a moisturiser along with a steroid cream does not reduce the effect of the steroid. There are many misconceptions about the side effects of topical corticosteroids. However these treatments are very safe and patients are encouraged to follow the treatment regimen as advised by their doctor. How to apply topical corticosteroids How often should I apply? How much should I apply? Apply 1–2 times each day to the affected area Enough cream should be used so that the of skin according to your doctor’s instructions. entire affected area is covered. The cream can then be rubbed or massaged into the Once the steroid cream has been applied, inflamed skin. moisturisers can be used straight away if needed.
    [Show full text]
  • Betamethasone Valerate Foam: a Look at the Clinical Data
    Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs.
    [Show full text]
  • Information for the User ZYTIGA 500 Mg Film-Coated Tablets Abiraterone
    Package leaflet: Information for the user ZYTIGA 500 mg film-coated tablets abiraterone acetate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What ZYTIGA is and what it is used for 2. What you need to know before you take ZYTIGA 3. How to take ZYTIGA 4. Possible side effects 5. How to store ZYTIGA 6. Contents of the pack and other information 1. What ZYTIGA is and what it is used for ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy ). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.
    [Show full text]
  • 4. Antibacterial/Steroid Combination Therapy in Infected Eczema
    Acta Derm Venereol 2008; Suppl 216: 28–34 4. Antibacterial/steroid combination therapy in infected eczema Anthony C. CHU Infection with Staphylococcus aureus is common in all present, the use of anti-staphylococcal agents with top- forms of eczema. Production of superantigens by S. aureus ical corticosteroids has been shown to produce greater increases skin inflammation in eczema; antibacterial clinical improvement than topical corticosteroids alone treatment is thus pivotal. Poor patient compliance is a (6, 7). These findings are in keeping with the demon- major cause of treatment failure; combination prepara- stration that S. aureus can be isolated from more than tions that contain an antibacterial and a topical steroid 90% of atopic eczema skin lesions (8); in one study, it and that work quickly can improve compliance and thus was isolated from 100% of lesional skin and 79% of treatment outcome. Fusidic acid has advantages over normal skin in patients with atopic eczema (9). other available topical antibacterial agents – neomycin, We observed similar rates of infection in a prospective gentamicin, clioquinol, chlortetracycline, and the anti- audit at the Hammersmith Hospital, in which all new fungal agent miconazole. The clinical efficacy, antibac- patients referred with atopic eczema were evaluated. In terial activity and cosmetic acceptability of fusidic acid/ a 2-month period, 30 patients were referred (22 children corticosteroid combinations are similar to or better than and 8 adults). The reason given by the primary health those of comparator combinations. Fusidic acid/steroid physician for referral in 29 was failure to respond to combinations work quickly with observable improvement prescribed treatment, and one patient was referred be- within the first week.
    [Show full text]
  • Abiraterone Acetate for Chemotherapy-Naive
    Fan et al. BMC Urology (2018) 18:110 https://doi.org/10.1186/s12894-018-0416-6 RESEARCHARTICLE Open Access Abiraterone acetate for chemotherapy- naive metastatic castration-resistant prostate cancer: a single-centre prospective study of efficacy, safety, and prognostic factors Liancheng Fan†, Baijun Dong†, Chenfei Chi†, Yanqing Wang†, Yiming Gong†, Jianjun Sha, Jiahua Pan, Xun Shangguan, Yiran Huang, Lixin Zhou* and Wei Xue* Abstract Background: To evaluate the efficacy and safety of abiraterone acetate (AA) plus prednisone compared with prednisone alone in Asian patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), and to identify predictive factors. Methods: We reviewed the medical records of 60 patients with chemotherapy-naive mCRPC at Renji Hospital who were treated with AA plus prednisone (n = 43) or prednisone alone (n = 17). All patients were assessed for prostate- specific antigen (PSA) response, PSA progression-free survival (PSA PFS), radiographic progression-free survival (rPFS), and overall survival (OS). The ability of several parameters to predict PSA PFS, rPFS, and OS was studied. Results: The median follow-up time was 14.0 months (range 7.0–18.5 months), at which time 19 death events had been reported: 11 in the AA + prednisone group and 8 in the prednisone group. The AA + prednisone group had significantly longer median PSA PFS (10.3 vs 3.0 months, P < 0.001), rPFS (13.9 vs 3.9 months, P < 0.001), and OS (23. 3 vs 17.5 months, P = 0.016) than the prednisone-alone group. The most frequently reported grade 3 or 4 adverse event in both the AA + prednisone and prednisone-alone groups was elevated alanine aminotransferase level in 5 of 43 patients (11.6%) and 2 of 17 patients (11.8%), respectively.
    [Show full text]
  • Bluecross Blueshield of Western New York Formulary 1 Please Bring This Guide with You the Next Time You Visit Your Doctor
    BlueCross BlueShield of Western New York Formulary 1 Please bring this guide with you the next time you visit your doctor. If you have questions about your prescription drug benefit, visit the Pharmacy Services section of the BlueCross BlueShield web site at www.bcbswny.com. CRP2107_009678.1 MG009678A (Revise Date 07/01/2021) A Division of HealthNow New York Inc. An independent licensee of the BlueCross BlueShield Association. The Cross and Shield are registered trademarks of the BlueCross BlueShield Association. Inside front cover TABLE OF CONTENTS INTRODUCTION . iii UNDERSTANDING THE SYMBOLS USED THROUGHOUT THIS BOOK . iii USING THIS FORMULARY BOOK TO HELP CONTAIN COSTS . iv Save Money on Your Prescription Drugs . iv Finding Medications in the Guide . v SECTION 1 — THERAPEUTIC DRUG CATEGORIES . 1 SECTION II — INDEX . 8 ii The BlueCross BlueShield of Western New York Formulary 1 is a list of drugs to help guide physicians and pharmacists to select the medication that provides the appropriate treatment for the best price. INTRODUCTION BlueCross Blue Shield of Western New York has established an independent committee of practicing physicians and a pharmacist to help ensure that our formularies are medically sound and that they support your patients’ health. This committee—called the Pharmacy and Therapeutics Committee—reviews and evaluates medications on the formulary based on safety and efficacy to help maintain clinical integrity in all therapeutic categories. UNDERSTANDING THE SYMBOLS USED THROUGHOUT THIS BOOK Throughout this book, you will see certain symbols that indicate a management program is in place for selected medications. The symbols are as follows: Key P = A step edit applies to this drug.
    [Show full text]
  • Superior Nuclear Receptor Selectivity and Therapeutic Index of Methylprednisolone Aceponate Versus Mometasone Furoate
    DOI:10.1111/j.1600-0625.2007.00597.x www.blackwellpublishing.com/EXD Original Article Superior nuclear receptor selectivity and therapeutic index of methylprednisolone aceponate versus mometasone furoate Parham Mirshahpanah1, Wolf-Dietrich Do¨ cke2, Udo Merbold2, Khusru Asadullah2, Lars Ro¨se2, Heike Scha¨ cke2 and Thomas M. Zollner1 1Research Business Area Dermatology, Berlex Biosciences, Richmond, CA, USA; 2Corporate Research Area Inflammation, Bayer Schering Pharma, Berlin, Germany Correspondence: Thomas M. Zollner, TRG Inflammation, Bayer Schering Pharma, Berlin, Germany, Tel.: +1 510 669 4272, e-mail: [email protected] Accepted for publication 18 June 2007 Abstract: Although introduced more than 50 years ago, topical a relevant rodent model in vivo. We demonstrate that glucocorticoids are still the first line therapy for many methylprednisolone aceponate displays higher specificity in inflammatory skin disorders such as atopic eczema, contact nuclear receptor binding compared with mometasone furoate. dermatitis and many others. Recently, significant improvements Methylprednisolone aceponate was also markedly superior in have been made to optimize the ratio of desired to unwanted terms of minimizing induction of skin atrophy or telangiectasias effects. While with early compounds such as triamcinolone, when compared with mometasone furoate. Based on these topical side effects such as skin atrophy and telangiectasias can be observations, methylprednisolone aceponate is expected to have a observed rather frequently, newer drugs such as methyl- greater therapeutic index as compared with mometasone furoate, prednisolone aceponate or mometasone furoate have a at least in the test systems used here. The degree to which this significantly improved therapeutic index. The present study observation may translate into a clinical setting requires compared these two modern topical glucocorticoids, which confirmation.
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
    [Show full text]
  • Intravesical Cocktails PBS/IC
    International Painful Bladder Foundation Interstitial Cystitis/Painful Bladder Syndrome Anaesthetic intravesical cocktails 1. Anaesthetic cocktail – Robert Moldwin, MD 1:1 mixture of 0.5% Marcaine and 2% Lidocaine jelly – about 40 cc total. To this solution are added: Heparin sulphate 10,000 IU Triamcinolone 40 mg Gentamycin 80 mg or a post-procedural prophylactic antibiotic. Administration: Patients are instructed to hold the solution for about 30 minutes, then to void. When given as a diagnostic test, patients will generally sense relief of pain within 5-10 minutes. The only (rare) problems that we’ve encountered are the following: Patients may experience “rebound” pain once the solution has worn off (within 3-5 hours). This generally resolves with continued instillations. When given as therapy, we usually administer the cocktail on a weekly basis for 8-12 weeks. This is the length of time usually needed to get a prolonged response. Then, the duration between instillations is increased to q 2 weeks to q 3 weeks, etc., ultimately with the goal of discontinuance. Patients may experience urinary retention requiring catheterization. This seems to be particularly a problem in patients who appear to have pre-existing voiding dysfunction, those patients who initially present with a poor urinary flow rate, an interrupted urinary stream, etc. The urinary retention can usually be circumvented by delivering a lower total volume. 2. Marcaine with steroid cocktail – Nagendra Mishra, MD Marcaine 40 ml Heparin sulphate 10,000 IU Dexamethasone 2 cc Sodium bicarbonate 20 ml Administration: This cocktail should be held in the bladder for 20 minutes. It should be administered every 15 days for a total of 6 treatments and then as needed.
    [Show full text]
  • Pharmacy and Poisons Act 1979
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS ACT 1979 1979 : 26 TABLE OF CONTENTS PART I PRELIMINARY 1 Short title 2 Interpretation PART II THE PHARMACY COUNCIL 3 The Pharmacy Council 4 Membership of the Council 4A Functions of the Council 4B Protection from personal liability 4C Annual Report 5 Proceedings of the Council, etc PART III REGISTRATION OF PHARMACISTS 6 Offence to practise pharmacy if not registered 7 Registration as a pharmacist 7A Re-registration as non-practising member 7AA Period of validity of registration 8 Code of Conduct 9 Pharmacy Profession Complaints Committee 10 Investigation of complaint by Committee 10A Inquiry into complaint by Council 10B Inquiry by Council of its own initiative 11 Surrender of registration 12 Restoration of name to register 1 PHARMACY AND POISONS ACT 1979 13 Proof of registration 14 Appeals 14A Fees 14B Amendment of Seventh Schedule 15 Regulations for this part PART IV REGISTRATION OF PHARMACIES 16 Register of pharmacies 17 Registration of premises as registered pharmacies 18 Unfit premises: new applications 19 Unfit premises: registered pharmacies 20 Appeals 21 When certificates of unfitness take effect 22 Regulations for this Part PART V CONTROL OF PRESCRIPTIONS AND IMPORTATION 23 Prescriptions to be in a certain form 23A Validity of a prescription 24 Supply by registered pharmacist of equivalent medicines 25 Restrictions on the importation of medicines 26 Declaration relating to imported medicines [repealed] PART VI CONTROL OF DRUGS 27 Certain substances to be sold on prescription
    [Show full text]