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

25 API Suppliers, 11 USDMF, 5 CEP/COS, 4 JDMF, 6 EU WC, 5 KDMF, 7 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

298 FDF Dossiers, 143 FDA Orange Book, 131 Europe, 12 Canada, 5 South Africa, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 23 BASF, 1 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 39 Direct Compression, 32 Granulation, 31 Solubilizers, 30 Thickeners and Stabilizers, 29 Controlled & Modified Release, 24 Disintegrants & Superdisintegrants, 22 Taste Masking, 20 Film Formers & Plasticizers, 19 Parenteral, 18 Chewable & Orodispersible Aids, 17 Topical, 16 Lubricants & Glidants, 15 Co-Processed Excipients, 9 Emulsifying Agents, 7 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

2 News #PharmaBuzz

2 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 53 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

3 APIs

3 APIs

REF. STANDARDS & IMPURITIES

1 Others

1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
29/01/2026	Neuland Laboratories	India	Aging Life Science Co., Ltd.	20200707-209-J-678	Ropinirole hydrochloride	2020-07-07	Neuland laboratories Ltd. (Unit-I)	India	Sy. No. 347, 473, 474, 490/2 Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District-502313 Telangana State, India
29/01/2026	Alembic Pharmaceuticals Limited	India	Pharmapia Co., Ltd.	20190104-209-J-175	Ropinirole hydrochloride	2019-01-04	Alembic Pharmaceuticals Limited (API Unit-I).	India	AT-Panelav, Tal-Halol, City : Panelav, Dist : Panchmahal, Gujarat State, India

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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.

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers

11 USDMF

5 CEP/COS

4 JDMF

6 EU WC

5 KDMF

7 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

298 FDF Dossiers

143 FDA Orange Book

131 Europe

12 Canada

5 South Africa

7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

18 SPI Pharma

4 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

8 Nanjing Well Pharmaceutical

1 Pfanstiehl

2 Kirsch Pharma

1 ACG Worldwide

6 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

23 BASF

1 CD Formulation

1 Clariant

12 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

5 Ideal Cures

4 Ingredion Pharma Solutions

26 Kerry

3 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

23 Roquette

13 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

TABLET;ORAL - EQ 0.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET;ORAL - EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons