Diclofenac Sodium

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ACTIVE PHARMA INGREDIENTS

111 API Suppliers, 21 USDMF, 17 CEP/COS, 13 JDMF, 9 EU WC, 22 KDMF, 31 NDC API, 45 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

601 FDF Dossiers, 100 FDA Orange Book, 207 Europe, 34 Canada, 62 South Africa, 198 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 7 Evonik, 1 Rochem International Inc, 11 SPI Pharma, 9 DKSH, 12 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 6 Kirsch Pharma, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 48 BASF, 1 BioSpectra, 1 CD Formulation, 18 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 13 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 15 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

69 Coating Systems & Additives, 66 Fillers, Diluents & Binders, 50 Solubilizers, 43 Direct Compression, 43 Thickeners and Stabilizers, 43 Controlled & Modified Release, 42 Topical, 40 Granulation, 39 Disintegrants & Superdisintegrants, 27 Parenteral, 23 Lubricants & Glidants, 23 Film Formers & Plasticizers, 19 Taste Masking, 19 Emulsifying Agents, 16 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 10 API Stability Enhancers, 9 Surfactant & Foaming Agents, 8 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules

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63 News #PharmaBuzz

GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 22 Regulatory FDF Prices

MARKET PLACE

68 APIs, 23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21005 / DOSAGE - GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
diclofenac sodium(UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)	diclofenac sodium	30mg in 1

Inactive Ingredients

Ingredient Name	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	PharmaDerm a division of Fougera Pharmaceuticals Inc.
benzyl alcohol(LKG8494WBH)
hyaluronate sodium(YSE9PPT4TH)
water(059QF0KO0R)

Setid 1088cda3 A4d7 447b 9199 Fb3aebc34f8f Applno 21005 Form Gel Topical Dosage 3 - Drug Product Composition: Diclofenac Sodium