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ACTIVE PHARMA INGREDIENTS

62 API Suppliers, 24 USDMF, 16 CEP/COS, 13 JDMF, 16 EU WC, 34 KDMF, 25 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 144 FDA Orange Book, 24 Europe, 13 Canada, 2 Australia, 35 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 6 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 10 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 30 BASF, 1 Bioplus Life Sciences, 2 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 10 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 28 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 69 Coating Systems & Additives, 43 Direct Compression, 40 Controlled & Modified Release, 36 Thickeners and Stabilizers, 34 Solubilizers, 32 Disintegrants & Superdisintegrants, 28 Granulation, 28 Taste Masking, 25 Parenteral, 22 Topical, 20 Co-Processed Excipients, 18 Lubricants & Glidants, 17 Chewable & Orodispersible Aids, 15 Film Formers & Plasticizers, 10 Emulsifying Agents, 10 Rheology Modifiers, 9 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 31 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

41 APIs, 42 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 6 USP, 16 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/11/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	14309	FAMOTIDINE USP	1999-07-22	Active	II	Complete	2014-01-03	2013-11-25
28/11/2024	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	25581	FAMOTIDINE USP	2011-12-12	Active	II	N/A

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

62 API Suppliers

24 USDMF

16 CEP/COS

13 JDMF

16 EU WC

34 KDMF

25 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers

144 FDA Orange Book

24 Europe

13 Canada

2 Australia

35 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

7 Rochem International Inc

17 SPI Pharma

2 Seqens

6 DKSH

2 Pharm-RX Chemical

9 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

10 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

30 BASF

1 Bioplus Life Sciences

2 Clariant

13 Corel Pharma Chem

7 DFE Pharma

2 Finar

12 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

18 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

10 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

28 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

3 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders

TABLET;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FOR SUSPENSION;ORAL - 40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons