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

Data Compilation
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Stock Recap
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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 16 USDMF, 7 CEP/COS, 3 JDMF, 4 EU WC, 3 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

201 FDF Dossiers, 116 FDA Orange Book, 42 Europe, 13 Canada, 5 Australia, 17 South Africa, 8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 12 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 24 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 40 Coating Systems & Additives, 30 Direct Compression, 27 Granulation, 21 Controlled & Modified Release, 18 Disintegrants & Superdisintegrants, 15 Thickeners and Stabilizers, 14 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 10 Taste Masking, 10 Solubilizers, 8 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Parenteral, 3 Emulsifying Agents, 2 Coloring Agents, 2 Rheology Modifiers

DIGITAL CONTENT

22 News #PharmaBuzz

22 News #PharmaBuzz

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 13 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 5 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	MF Registration No.	Classification	Initial Date of Reg.	Latest Date of Reg.	Registrant's Address
02/02/2026	Aresko Life Sciences	India	Aresko Life Sciences Private Limited	306MF10093	Norethisterone	2024-07-03	2024-07-03	Village - Sakhanpur, P. O. - Pirumadara - 244715, Tehsil - Ramnagar, Distt. - Nainital, Uttarakhand, India
29/01/2026	Bayer AG	Germany	Bayer AG	219MF10281	Norethisterone	2007-09-10	2012-11-28	Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany

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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.

JENCYCLA

JENCYCLA

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers

16 USDMF

7 CEP/COS

3 JDMF

4 EU WC

3 NDC API

19 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

201 FDF Dossiers

116 FDA Orange Book

42 Europe

13 Canada

5 Australia

17 South Africa

8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG

TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL-28 - 0.35MG

TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

12 BASF

11 Corel Pharma Chem

6 DFE Pharma

7 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

3 Ingredion Pharma Solutions

24 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nitika Pharmaceutical Specialities

3 Novo Excipients

3 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

17 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

2 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders

40 Coating Systems & Additives

30 Direct Compression

27 Granulation

21 Controlled & Modified Release

18 Disintegrants & Superdisintegrants

TABLET;ORAL-28 - 0.35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.035MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons