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

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Afluon

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 14 USDMF, 7 CEP/COS, 2 JDMF, 4 EU WC, 12 KDMF, 14 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers, 40 FDA Orange Book, 154 Europe, 3 Canada, 3 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 3 SPI Pharma, 1 Pharm-RX Chemical, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 10 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 12 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Silverline Chemicals, 3 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 23 Fillers, Diluents & Binders, 21 Parenteral, 19 Thickeners and Stabilizers, 17 Film Formers & Plasticizers, 16 Controlled & Modified Release, 16 Solubilizers, 11 Direct Compression, 11 Taste Masking, 9 Co-Processed Excipients, 7 Granulation, 6 Chewable & Orodispersible Aids, 6 Disintegrants & Superdisintegrants, 5 Topical, 5 Rheology Modifiers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Lubricants & Glidants, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 36 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 9 Regulatory FDF Prices, 14 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 16 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
29/01/2026	Coral Drugs Private Limited	India	CORAL DRUGS PRIVATE LIMITED New Delhi IN	R0-CEP 2021-124 - Rev 00	Azelastine hydrochloride	2022-08-10	Valid	Chemical		1633
29/01/2026	Evonik	Germany	EVONIK OPERATIONS GMBH Essen DE	CEP 2009-333 - Rev 05	Azelastine hydrochloride	2024-04-24	Valid	Chemical		1633

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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.

Afluon

Afluon

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers

14 USDMF

7 CEP/COS

2 JDMF

4 EU WC

12 KDMF

14 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers

40 FDA Orange Book

154 Europe

3 Canada

3 South Africa

15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY

SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

3 Rochem International Inc

3 SPI Pharma

1 Pharm-RX Chemical

4 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

6 Kirsch Pharma

1 ACG Worldwide

11 Actylis

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 BASF

1 Bioplus Life Sciences

1 CD Formulation

10 Corel Pharma Chem

2 DFE Pharma

1 Finar

8 Gangwal Chemicals

4 Ideal Cures

10 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

6 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

1 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

1 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

12 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

8 Sigachi Industries

1 Silverline Chemicals

3 The Dow Chemical Company

1 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives

23 Fillers, Diluents & Binders

21 Parenteral

19 Thickeners and Stabilizers

17 Film Formers & Plasticizers

16 Controlled & Modified Release

SPRAY, METERED;NASAL - 0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION/DROPS;OPHTHALMIC - 0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - 0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons