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

Stock Recap
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SERTRALINE HCL FORM II

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

85 API Suppliers, 28 USDMF, 27 CEP/COS, 7 JDMF, 17 EU WC, 18 KDMF, 17 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

INTERMEDIATES

21 Intermediate Suppliers

21 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

712 FDF Dossiers, 104 FDA Orange Book, 397 Europe, 57 Canada, 68 Australia, 25 South Africa, 61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 SPI Pharma, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 23 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 5 DKSH, 1 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 21 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 28 Disintegrants & Superdisintegrants, 27 Direct Compression, 26 Solubilizers, 26 Controlled & Modified Release, 25 Granulation, 23 Thickeners and Stabilizers, 21 Topical, 19 Film Formers & Plasticizers, 17 Parenteral, 16 Lubricants & Glidants, 13 Co-Processed Excipients, 8 Taste Masking, 8 Emulsifying Agents, 7 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 5 Empty Capsules, 4 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 37 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 107 Regulatory FDF Prices, 10 Annual Reports

MARKET PLACE

21 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 14 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Labeler	NDC Package Code	Non Proprietary Name	Start Marketing Date	End Marketing Date	Category Code	Dosage Form (Strength)
29/01/2026	Amoli Organics	India	Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)	62512-0080	Sertraline Hydrochloride	2023-05-12	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)
29/01/2026	Aurobindo Pharma Limited	India	Aurobindo Pharma Limited	65862-222	Sertraline Hydrochloride	2024-01-17	2026-12-31	BULK INGREDIENT	POWDER (50kg/50kg)

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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.

SERTRALINE HCL FORM II

SERTRALINE HCL FORM II

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

85 API Suppliers

28 USDMF

27 CEP/COS

7 JDMF

17 EU WC

18 KDMF

17 NDC API

37 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

INTERMEDIATES

21 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

712 FDF Dossiers

104 FDA Orange Book

397 Europe

57 Canada

68 Australia

25 South Africa

61 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 50MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 SPI Pharma

6 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 ACG Worldwide

7 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

23 BASF

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

5 DKSH

1 Esteem Industries

2 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

4 Ingredion Pharma Solutions

21 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

4 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

1 Symrise

2 The Dow Chemical Company

1 Ulanqab Kema New Material

TABLET;ORAL - EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons