Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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Diazepam

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers, 127 FDA Orange Book, 129 Europe, 15 Canada, 31 Australia, 18 South Africa, 37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG, GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 2.5MG/0.5ML (5MG/ML), GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 1 DKSH, 1 Jai Radhe Sales, 5 Faran Shimi Pharmaceutical, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 30 Direct Compression, 28 Disintegrants & Superdisintegrants, 26 Controlled & Modified Release, 20 Thickeners and Stabilizers, 19 Granulation, 19 Lubricants & Glidants, 18 Film Formers & Plasticizers, 16 Topical, 15 Co-Processed Excipients, 13 Taste Masking, 9 Solubilizers, 9 Parenteral, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Rheology Modifiers, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 136 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

29 APIs, 24 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 8 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 10 Others

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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
28/10/2024	Cambrex Corporation	U.S.A	CAMBREX PROFARMACO MILANO SRL	1478	DIAZEPAM	1970-02-03	Active	II	Complete	2018-07-13	2018-06-20
28/10/2024	Centaur Pharmaceuticals	India	CENTAUR PHARMACEUTICALS PRIVATE LTD	21860	DIAZEPAM USP	2008-07-24	Active	II	Complete	2021-07-08	2021-07-06

Diazepam

Diazepam

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers

7 USDMF

4 CEP/COS

2 JDMF

3 EU WC

9 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers

127 FDA Orange Book

129 Europe

15 Canada

31 Australia

18 South Africa

37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 2MG

TABLET;ORAL - 5MG

GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 2.5MG/0.5ML (5MG/ML)

GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

1 DKSH

1 Jai Radhe Sales

5 Faran Shimi Pharmaceutical

13 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 ACG Worldwide

4 Actylis

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

2 Clariant

10 Corel Pharma Chem

7 DFE Pharma

3 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

27 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

5 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

66 Fillers, Diluents & Binders

47 Coating Systems & Additives

30 Direct Compression

GEL;RECTAL - 10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons