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

Data Compilation
#PharmaFlow

Stock Recap
#PipelineProspector

Tapentadol Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 6 USDMF, 6 CEP/COS, 9 EU WC, 1 KDMF, 5 NDC API, 29 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

266 FDF Dossiers, 30 FDA Orange Book, 169 Europe, 8 Canada, 5 Australia, 5 South Africa, 49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 1 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, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 25 Controlled & Modified Release, 21 Granulation, 17 Direct Compression, 17 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 13 Solubilizers, 12 Topical, 11 Lubricants & Glidants, 9 Film Formers & Plasticizers, 8 Co-Processed Excipients, 7 Taste Masking, 6 Parenteral, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Chewable & Orodispersible Aids, 3 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

38 News #PharmaBuzz

38 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

48 US Patents, 8 US Exclusivities, 67 Health Canada Patents

$ Xls download

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	Noramco	U.S.A	NORAMCO LLC	21084	TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE	2008-01-23	Active	II	Complete	2020-08-05	2020-07-30
29/01/2026	Alkem Laboratories	India	ALKEM LABORATORIES LTD	31435	TAPENTADOL HYDROCHLORIDE	2017-03-27	Active	II	Complete	2017-08-18	2017-03-30

Privacy policy
Terms and conditions
Disclaimers
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.

Tapentadol Hydrochloride

Tapentadol Hydrochloride

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers

6 USDMF

6 CEP/COS

9 EU WC

1 KDMF

5 NDC API

29 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

266 FDF Dossiers

30 FDA Orange Book

169 Europe

8 Canada

5 Australia

5 South Africa

49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

1 SPI Pharma

1 Pharm-RX Chemical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 ACG Worldwide

3 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

19 BASF

1 Bioplus Life Sciences

1 CD Formulation

10 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

5 Ideal Cures

1 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

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

10 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

SOLUTION;ORAL - EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons