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Voltaren, Solaraze, Ecofenac, Benfofen, Diclofenac sodium

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 21 USDMF, 16 CEP/COS, 13 JDMF, 9 EU WC, 22 KDMF, 30 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

494 FDF Dossiers, 100 FDA Orange Book, 100 Europe, 39 Canada, 62 South Africa, 193 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TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG, TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG, SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 1%, SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 6 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Capital Farma, 1 ACG Worldwide, 15 Actylis, 3 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 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, 4 Silverline Chemicals, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 74 Coating Systems & Additives, 49 Solubilizers, 48 Controlled & Modified Release, 40 Topical, 40 Thickeners and Stabilizers, 39 Disintegrants & Superdisintegrants, 38 Direct Compression, 35 Granulation, 25 Parenteral, 24 Film Formers & Plasticizers, 23 Lubricants & Glidants, 19 Taste Masking, 18 Co-Processed Excipients, 18 Emulsifying Agents, 10 API Stability Enhancers, 10 Chewable & Orodispersible Aids, 8 Surfactant & Foaming Agents, 8 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

63 News #PharmaBuzz

63 News #PharmaBuzz

GLOBAL SALES INFORMATION

96 Regulatory FDF Prices, 5 Annual Reports

MARKET PLACE

65 APIs, 23 FDF Dossiers

PATENTS & EXCLUSIVITIES

26 US Patents, 3 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
25/04/2025	Amoli Organics	India	AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)	20849	DICLOFENAC SODIUM USP	2007-09-13	Active	II	Complete	2013-07-23	2013-07-10
25/04/2025	Amoli Organics	India	AMOLI ORGANICS LTD	11676	DICLOFENAC SODIUM	1995-09-26	Inactive	II	N/A

Voltaren, Solaraze, Ecofenac, Benfofen, Diclofenac Sodium

Voltaren, Solaraze, Ecofenac, Benfofen, Diclofenac sodium

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

107 API Suppliers

21 USDMF

16 CEP/COS

13 JDMF

9 EU WC

22 KDMF

30 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

494 FDF Dossiers

100 FDA Orange Book

100 Europe

39 Canada

62 South Africa

193 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

6 Faran Shimi Pharmaceutical

12 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Capital Farma

1 ACG Worldwide

15 Actylis

3 Aeon Procare

3 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

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

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

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

SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons