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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Pristiq

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 29 USDMF, 15 EU WC, 13 KDMF, 14 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

132 FDF Dossiers, 36 FDA Orange Book, 14 Europe, 20 Canada, 34 Australia, 12 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 25MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 SPI Pharma, 6 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Kirsch Pharma, 1 Panvo Organics, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 10 BASF, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 12 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 29 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 22 Lubricants & Glidants, 21 Thickeners and Stabilizers, 16 Topical, 12 Film Formers & Plasticizers, 10 Co-Processed Excipients, 9 Direct Compression, 8 Granulation, 8 Solubilizers, 7 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Empty Capsules, 5 Taste Masking, 5 Coloring Agents, 5 Emulsifying Agents, 5 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Rheology Modifiers, 4 Parenteral

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 16 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 5 Regulatory FDF Prices, 6 Annual Reports

MARKET PLACE

12 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

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
04/01/2026	SNJ Labs	India	SNJ LABS PVT LTD	42639	DESVENLAFAXINE SUCCINATE USP	2025-09-23	Active	II	N/A
30/12/2025	Ami Lifesciences Private Limited	India	AMI LIFESCIENCES PRIVATE LTD	38066	DESVENLAFAXINE SUCCINATE	2023-03-03	Active	II	N/A

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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.

Pristiq

Pristiq

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

55 API Suppliers

29 USDMF

15 EU WC

13 KDMF

14 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

132 FDF Dossiers

36 FDA Orange Book

14 Europe

20 Canada

34 Australia

12 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 25MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem

2 SPI Pharma

6 DKSH

5 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Kirsch Pharma

1 Panvo Organics

1 ACG Worldwide

3 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

10 BASF

1 CD Formulation

1 Clariant

10 Corel Pharma Chem

2 DFE Pharma

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

5 Ideal Cures

12 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

1 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

9 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives

29 Fillers, Diluents & Binders

22 Controlled & Modified Release

22 Lubricants & Glidants