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List of Drug Master Files (JDMF) for AM20070538 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

AM20070538

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

76 API Suppliers, 35 USDMF, 27 CEP/COS, 1 JDMF, 15 EU WC, 59 KDMF, 33 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

7 API Suppliers

7 API Suppliers

FINISHED DOSAGE FORMULATIONS

757 FDF Dossiers, 171 FDA Orange Book, 349 Europe, 66 Canada, 49 Australia, 26 South Africa, 96 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 300MG, CAPSULE;ORAL - 400MG, TABLET;ORAL - 300MG, TABLET;ORAL - 450MG, TABLET;ORAL - 600MG, TABLET;ORAL - 750MG, TABLET;ORAL - 900MG

RELATED EXCIPIENT COMPANIES

5 Rochem International Inc, 24 SPI Pharma, 2 Seqens, 18 DKSH, 2 Jai Radhe Sales, 7 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 34 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 21 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 25 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

114 Fillers, Diluents & Binders, 61 Coating Systems & Additives, 56 Direct Compression, 42 Thickeners and Stabilizers, 36 Solubilizers, 35 Disintegrants & Superdisintegrants, 34 Controlled & Modified Release, 33 Granulation, 27 Taste Masking, 24 Parenteral, 23 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 21 Topical, 21 Lubricants & Glidants, 21 Co-Processed Excipients, 9 Emulsifying Agents, 9 Empty Capsules, 8 Rheology Modifiers, 7 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 58 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 282 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

36 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 20 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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01 1HIKAL LIMITED.

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HIKAL LIMITED.

AAPS 2024

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