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

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Polaramine

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 5 USDMF, 1 CEP/COS, 4 EU WC, 3 KDMF, 3 NDC API, 9 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers, 14 FDA Orange Book, 7 Europe, 3 South Africa, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML, SYRUP;ORAL - 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 3 SPI Pharma, 2 Pharm-RX Chemical, 7 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 6 Actylis, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 7 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 4 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 11 Kerry, 1 Keval Exports, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 18 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 Silverline Chemicals, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

38 Fillers, Diluents & Binders, 20 Direct Compression, 19 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 16 Granulation, 14 Film Formers & Plasticizers, 13 Taste Masking, 11 Lubricants & Glidants, 11 Parenteral, 11 Co-Processed Excipients, 9 Coating Systems & Additives, 9 Chewable & Orodispersible Aids, 6 Solubilizers, 6 Controlled & Modified Release, 5 Topical, 3 API Stability Enhancers, 3 Emulsifying Agents, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

4 News #PharmaBuzz

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

2 US Medicaid Prescriptions

MARKET PLACE

7 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
29/01/2026	Supriya Lifescience	India	SUPRIYA LIFESCIENCE LTD	35855	DEXCHLORPHENIRAMINE MALEATE USP	2021-04-17	Active	II	N/A
29/01/2026	Industriale Chimica	Italy	INDUSTRIA CHIMICA MILANESE SPA	5328	DEXCHLORPHENIRAMINE MALEATE	1984-03-30	Inactive	II	N/A

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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.

Polaramine

Polaramine

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers

5 USDMF

1 CEP/COS

4 EU WC

3 KDMF

3 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

27 FDF Dossiers

14 FDA Orange Book

7 Europe

3 South Africa

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML

SYRUP;ORAL - 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

3 SPI Pharma

2 Pharm-RX Chemical

7 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

6 Actylis

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

7 BASF

1 Bioplus Life Sciences

2 CD Formulation

4 DFE Pharma

1 Finar

7 Gangwal Chemicals

1 Ideal Cures

11 Kerry

1 Keval Exports

10 Microlex e.U

2 Nitika Pharmaceutical Specialities

1 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

18 Roquette

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

8 Sigachi Industries

2 Silverline Chemicals

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

38 Fillers, Diluents & Binders

20 Direct Compression

19 Thickeners and Stabilizers

16 Disintegrants & Superdisintegrants

16 Granulation

14 Film Formers & Plasticizers

13 Taste Masking

11 Lubricants & Glidants

11 Parenteral

11 Co-Processed Excipients

9 Coating Systems & Additives

9 Chewable & Orodispersible Aids

6 Solubilizers

6 Controlled & Modified Release

SUSPENSION, EXTENDED RELEASE;ORAL - EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SYRUP;ORAL - 2MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons