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

Data Compilation
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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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Amaryl, Glista OD, Glimepiride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

89 API Suppliers, 19 USDMF, 24 CEP/COS, 8 JDMF, 13 EU WC, 35 KDMF, 10 NDC API, 39 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

535 FDF Dossiers, 72 FDA Orange Book, 207 Europe, 5 Canada, 24 Australia, 41 South Africa, 186 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 2 Actylis, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 21 BASF, 6 DFE Pharma, 8 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 12 Kerry, 3 Keval Exports, 11 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 11 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 10 Sigachi Industries, 4 Silverline Chemicals, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

41 Fillers, Diluents & Binders, 35 Disintegrants & Superdisintegrants, 27 Granulation, 25 Direct Compression, 20 Solubilizers, 15 Thickeners and Stabilizers, 13 Lubricants & Glidants, 12 Co-Processed Excipients, 10 Parenteral, 8 Controlled & Modified Release, 7 Chewable & Orodispersible Aids, 6 Coating Systems & Additives, 5 Surfactant & Foaming Agents, 5 Topical, 5 Emulsifying Agents, 5 Film Formers & Plasticizers, 4 Taste Masking, 3 Rheology Modifiers, 2 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 23 News #PharmaBuzz

GLOBAL SALES INFORMATION

15 US Medicaid Prescriptions, 51 Regulatory FDF Prices, 6 Annual Reports

MARKET PLACE

22 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 JP, 15 Others

ANALYTICAL

2 BioAnalytical Methods, 5 Analytical Methods

$ 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
29/01/2026	Daito Pharmaceutical	Japan	Daito Co., Ltd.	221MF10121	Glimepiride	2009-06-16	2009-06-16	326 Yokamachi, Toyama City, Toyama Prefecture
29/01/2026	DongWoo Syntech	South Korea	INIST ST CO. , LTD.	221MF10122	Glimepiride	2009-06-16	2009-06-16	500, Sinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do, Korea

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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.

Amaryl, Glista OD, Glimepiride

Amaryl, Glista OD, Glimepiride

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

89 API Suppliers

19 USDMF

24 CEP/COS

8 JDMF

13 EU WC

35 KDMF

10 NDC API

39 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

INTERMEDIATES

20 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

535 FDF Dossiers

72 FDA Orange Book

207 Europe

5 Canada

24 Australia

41 South Africa

186 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

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

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Kirsch Pharma

2 Actylis

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

21 BASF

6 DFE Pharma

8 Gangwal Chemicals

1 Ideal Cures

2 Ingredion Pharma Solutions

12 Kerry

3 Keval Exports

11 Microlex e.U

2 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

11 Roquette

6 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

10 Sigachi Industries

4 Silverline Chemicals

2 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

41 Fillers, Diluents & Binders

35 Disintegrants & Superdisintegrants

27 Granulation

25 Direct Compression

20 Solubilizers

15 Thickeners and Stabilizers

13 Lubricants & Glidants

12 Co-Processed Excipients

10 Parenteral

8 Controlled & Modified Release

7 Chewable & Orodispersible Aids

6 Coating Systems & Additives

5 Surfactant & Foaming Agents

5 Topical

5 Emulsifying Agents

5 Film Formers & Plasticizers

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

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

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