FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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Chlophazolin

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 19 USDMF, 6 CEP/COS, 6 EU WC, 20 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

210 FDF Dossiers, 121 FDA Orange Book, 48 Europe, 14 Canada, 8 Australia, 4 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 5 SPI Pharma, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 21 BASF, 1 CD Formulation, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 12 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 13 Seppic, 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, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 41 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 32 Direct Compression, 31 Granulation, 22 Solubilizers, 22 Thickeners and Stabilizers, 20 Controlled & Modified Release, 18 Parenteral, 17 Lubricants & Glidants, 15 Taste Masking, 13 Co-Processed Excipients, 12 Film Formers & Plasticizers, 11 Chewable & Orodispersible Aids, 8 Topical, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents

DIGITAL CONTENT

1 Stock Recap #PipelineProspector, 34 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 US Patents

8 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

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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
29/01/2026	Enaltec Labs	India	ENALTEC LABS PRIVATE LTD	31386	CLONIDINE HYDROCHLORIDE USP	2017-08-28	Active	II	Complete	2018-03-01	2017-10-27
29/01/2026	Seqens	France	PCAS	4778	CLONIDINE HYDROCHLORIDE	1983-01-21	Active	II	Complete	2015-01-29	2015-01-16

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Chlophazolin

Chlophazolin

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers

19 USDMF

6 CEP/COS

6 EU WC

20 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

FINISHED DOSAGE FORMULATIONS

210 FDF Dossiers

121 FDA Orange Book

48 Europe

14 Canada

8 Australia

4 South Africa

15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

5 SPI Pharma

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

21 BASF

1 CD Formulation

1 Clariant

11 Corel Pharma Chem

6 DFE Pharma

12 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

25 Roquette

13 Seppic

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

2 Ulanqab Kema New Material

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders

41 Coating Systems & Additives

40 Disintegrants & Superdisintegrants

TABLET;ORAL - 0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons