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

Data Compilation
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Stock Recap
#PipelineProspector

Allergodil

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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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Solubilizers, 16 Controlled & Modified Release, 11 Taste Masking, 11 Direct Compression, 9 Co-Processed Excipients, 7 Granulation, 6 Chewable & Orodispersible Aids, 6 Disintegrants & Superdisintegrants, 5 Topical, 5 Rheology Modifiers, 5 Empty Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 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	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
29/01/2026	Evonik	Germany	Bukwang Pharmaceutical Co., Ltd.	20080829-44-C-224-06	Azelastine hydrochloride	2008-08-29	Evonik Operations GmbH	Germany	Rodenbacher Chaussee 4 63457 Hanau, Germany
29/01/2026	Daito Pharmaceutical	Japan	Hanlim Pharmaceutical Co., Ltd.	20050915-44-C-200-03(5)	Azelastine hydrochloride	2011-10-21	Daito Pharmaceutical Co., Ltd.	Japan	326 Yokamachi, Toyama-shi, Toyama 939-8221, Japan

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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.

Allergodil

Allergodil

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 Solubilizers

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