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

Data Compilation
#PharmaFlow

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

Stock Recap
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Mezavant XL

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

114 API Suppliers, 53 USDMF, 35 CEP/COS, 13 JDMF, 15 EU WC, 11 KDMF, 39 NDC API, 48 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

639 FDF Dossiers, 45 FDA Orange Book, 461 Europe, 18 Canada, 48 Australia, 17 South Africa, 50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML, CAPSULE, EXTENDED RELEASE;ORAL - 250MG, CAPSULE, EXTENDED RELEASE;ORAL - 500MG, CAPSULE, DELAYED RELEASE;ORAL - 400MG, SUPPOSITORY;RECTAL - 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

8 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 14 DKSH, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 31 BASF, 1 CD Formulation, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 12 Ideal Cures, 1 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 13 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

65 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 42 Thickeners and Stabilizers, 39 Controlled & Modified Release, 28 Disintegrants & Superdisintegrants, 28 Solubilizers, 25 Granulation, 23 Direct Compression, 17 Lubricants & Glidants, 16 Topical, 14 Film Formers & Plasticizers, 12 Rheology Modifiers, 11 Taste Masking, 9 Empty Capsules, 9 Chewable & Orodispersible Aids, 8 Co-Processed Excipients, 5 API Stability Enhancers, 5 Emulsifying Agents, 5 Parenteral, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 72 News #PharmaBuzz

GLOBAL SALES INFORMATION

41 US Medicaid Prescriptions, 119 Regulatory FDF Prices, 37 Annual Reports

MARKET PLACE

27 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 22 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Axplora	Germany	PharmaZell GmbH Raubling DE	CEP 2003-203 - Rev 03	Mesalazine	2023-11-08	Valid	Chemical		1699
29/01/2026	Zhejiang Hengkang Pharmaceutical	China	ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN	CEP 2021-400 - Rev 01	Mesalazine, Pubagang site	2025-12-10	Valid	Chemical		1699

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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.

Mezavant XL

Mezavant XL

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

114 API Suppliers

53 USDMF

35 CEP/COS

13 JDMF

15 EU WC

11 KDMF

39 NDC API

48 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

639 FDF Dossiers

45 FDA Orange Book

461 Europe

18 Canada

48 Australia

17 South Africa

50 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML

CAPSULE, EXTENDED RELEASE;ORAL - 250MG

CAPSULE, EXTENDED RELEASE;ORAL - 500MG

CAPSULE, DELAYED RELEASE;ORAL - 400MG

SUPPOSITORY;RECTAL - 1GM

TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 1.2GM

CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

8 Evonik

3 Rochem International Inc

1 SPI Pharma

14 DKSH

1 Pharm-RX Chemical

5 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Kirsch Pharma

4 ACG Worldwide

3 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

31 BASF

1 CD Formulation

15 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

1 Finar

9 Gangwal Chemicals

12 Ideal Cures

1 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

17 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

13 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

TABLET, DELAYED RELEASE;ORAL - 800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons