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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Elvitegravir, Cobicistat, Emtricitabine, Tenofovir alafenamide-3

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 17 USDMF, 2 JDMF, 12 EU WC, 6 KDMF, 16 NDC API, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

71 Drugs in Development

71 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

295 FDF Dossiers, 60 FDA Orange Book, 130 Europe, 22 Canada, 17 Australia, 53 South Africa, 13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG, TABLET;ORAL - 150MG;150MG;200MG;300MG, TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE, TABLET;ORAL - 120MG;EQ 15MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE, TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE, TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE, CAPSULE;ORAL - 200MG, TABLET;ORAL - 100MG;150MG, TABLET;ORAL - 133MG;200MG, TABLET;ORAL - 167MG;250MG, TABLET;ORAL - 200MG;300MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 10 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 3 Ingredion Pharma Solutions, 21 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 16 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

54 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 27 Controlled & Modified Release, 25 Granulation, 25 Thickeners and Stabilizers, 22 Direct Compression, 19 Disintegrants & Superdisintegrants, 17 Solubilizers, 17 Topical, 15 Lubricants & Glidants, 11 Parenteral, 11 Film Formers & Plasticizers, 11 Taste Masking, 10 Co-Processed Excipients, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

DIGITAL CONTENT

4 Data Compilation #PharmaFlow, 2 Stock Recap #PipelineProspector, 197 News #PharmaBuzz

GLOBAL SALES INFORMATION

24 US Medicaid Prescriptions, 6 Regulatory FDF Prices, 120 Annual Reports

MARKET PLACE

8 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 11 US Exclusivities, 54 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 6 Others

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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	Aurobindo Pharma Limited	India	Aurobindo Pharma Limited	65862-305	Emtricitabine	2024-01-11	2026-12-31	BULK INGREDIENT	POWDER (50kg/50kg)
29/01/2026	Aurore Life Sciences	India	AURORE PHARMACEUTICALS PRIVATE LIMITED	72761-007	Emtricitabine (Process -II)	2019-03-16	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)

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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.

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide-3

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir alafenamide-3

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers

17 USDMF

2 JDMF

12 EU WC

6 KDMF

16 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

71 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

295 FDF Dossiers

60 FDA Orange Book

130 Europe

22 Canada

17 Australia

53 South Africa

13 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG

TABLET;ORAL - 150MG;150MG;200MG;300MG

TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE

TABLET;ORAL - 120MG;EQ 15MG BASE

TABLET;ORAL - 200MG;EQ 25MG BASE

TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE

TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE

TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE

CAPSULE;ORAL - 200MG

TABLET;ORAL - 100MG;150MG

TABLET;ORAL - 133MG;200MG

TABLET;ORAL - 167MG;250MG

TABLET;ORAL - 200MG;300MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

4 SPI Pharma

10 DKSH

1 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Kirsch Pharma

4 ACG Worldwide

5 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

26 BASF

10 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

2 Finar

8 Gangwal Chemicals

5 Ideal Cures

3 Ingredion Pharma Solutions

21 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

16 Roquette

9 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company