Diclofenac Sodium

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 21 USDMF, 16 CEP/COS, 13 JDMF, 7 EU WC, 20 KDMF, 28 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

FINISHED DOSAGE FORMULATIONS

460 FDF Dossiers, 99 FDA Orange Book, 100 Europe, 37 Canada, 62 South Africa, 162 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TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Evonik, 1 Rochem International Inc, 11 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 12 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 48 BASF, 1 BioSpectra, 18 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 14 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 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, 12 Sigachi Industries, 2 The Dow Chemical Company, 4 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

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86 Fillers, Diluents & Binders, 72 Coating Systems & Additives, 50 Direct Compression, 50 Controlled & Modified Release, 47 Solubilizers, 41 Disintegrants & Superdisintegrants, 39 Topical, 38 Thickeners and Stabilizers, 35 Granulation, 29 Parenteral, 25 Lubricants & Glidants, 24 Film Formers & Plasticizers, 23 Co-Processed Excipients, 20 Taste Masking, 19 Emulsifying Agents, 10 Chewable & Orodispersible Aids, 9 API Stability Enhancers, 8 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Rheology Modifiers, 4 Vegetarian Capsules

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GLOBAL SALES INFORMATION

96 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

60 APIs, 23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 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)

Drug Product Composition: Diclofenac Sodium