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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Fentaz

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 13 USDMF, 11 CEP/COS, 4 JDMF, 2 EU WC, 4 KDMF, 15 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

552 FDF Dossiers, 77 FDA Orange Book, 431 Europe, 13 Canada, 3 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE, TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE, TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE, TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 18 SPI Pharma, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 5 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 5 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 11 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 8 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

55 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 30 Disintegrants & Superdisintegrants, 27 Direct Compression, 19 Taste Masking, 19 Thickeners and Stabilizers, 18 Chewable & Orodispersible Aids, 17 Controlled & Modified Release, 16 Granulation, 13 Parenteral, 12 Co-Processed Excipients, 10 Lubricants & Glidants, 9 Film Formers & Plasticizers, 6 Solubilizers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Topical, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 12 Regulatory FDF Prices, 8 Annual Reports

MARKET PLACE

14 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
04/06/2025	Rusan Pharma	India	M/s Rusan Pharma Ltd	WC-0278	Fentanyl Citrate EP/BP/USP	2025-02-11	2027-06-09	Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
30/01/2026	Pioneer Agro Extracts	India	M/s M/s. Pioneer Agro Industries Sanvin Laboratories Private Limited	WC-0174	Fentanyl Citrate USP/EP	2026-01-19	2028-12-09	Plot No.8,7,6,20 & 24, MIDC Industrial Area, Post Kulgaon, Badlapur, Dist. Thane-Zone4 21503, Maharashtra, India

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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.

Fentaz

Fentaz

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

38 API Suppliers

13 USDMF

11 CEP/COS

4 JDMF

2 EU WC

4 KDMF

15 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

552 FDF Dossiers

77 FDA Orange Book

431 Europe

13 Canada

3 South Africa

28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE

TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE

TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE

TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

18 SPI Pharma

2 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

2 Pfanstiehl

5 Kirsch Pharma

1 ACG Worldwide

6 Actylis

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 BASF

1 CD Formulation

10 Corel Pharma Chem

4 DFE Pharma

1 Finar

5 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

5 Ingredion Pharma Solutions

11 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons