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Tapentadol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

34 API Suppliers, 5 USDMF, 5 CEP/COS, 6 EU WC, 2 KDMF, 5 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers, 30 FDA Orange Book, 115 Europe, 8 Canada, 5 Australia, 5 South Africa, 56 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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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, 5 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 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, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 30 Controlled & Modified Release, 18 Granulation, 18 Thickeners and Stabilizers, 16 Direct Compression, 16 Disintegrants & Superdisintegrants, 13 Solubilizers, 11 Topical, 11 Lubricants & Glidants, 10 Film Formers & Plasticizers, 7 Co-Processed Excipients, 6 Taste Masking, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 5 Parenteral, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

30 News #PharmaBuzz

30 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 93 Regulatory FDF Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

48 US Patents, 8 US Exclusivities, 56 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
28/03/2025	Noramco	U.S.A	NORAMCO LLC	21084	TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE	2008-01-23	Active	II	Complete	2020-08-05	2020-07-30
28/03/2025	Alkem Laboratories	India	ALKEM LABORATORIES LTD	26519	TAPENTADOL HYDROCHLORIDE	2012-10-23	Active	II	Complete	2013-03-01	2012-11-08

Tapentadol

Tapentadol

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

34 API Suppliers

5 USDMF

5 CEP/COS

6 EU WC

2 KDMF

5 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

219 FDF Dossiers

30 FDA Orange Book

115 Europe

8 Canada

5 Australia

5 South Africa

56 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

5 DKSH

1 Pharm-RX Chemical

5 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

19 BASF

1 Bioplus Life Sciences

10 Corel Pharma Chem

5 DFE Pharma

2 Finar

7 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

31 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

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

11 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

51 Coating Systems & Additives

47 Fillers, Diluents & Binders

30 Controlled & Modified Release

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