Tapentadol

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 6 USDMF, 6 CEP/COS, 9 EU WC, 2 KDMF, 6 NDC API, 29 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

242 FDF Dossiers, 30 FDA Orange Book, 145 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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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, 5 DKSH, 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

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USFDA APPLICATION NUMBER - 203794 / DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
tapentadol hydrochloride(UNII: 71204KII53) (tapentadol - UNII:H8A007M585)	tapentadol	20mg in 1

Inactive Ingredients

Ingredient Name	Janssen Pharmaceuticals, Inc.
citric acid monohydrate(2968PHW8QP)
sodium hydroxide(55X04QC32I)
sucralose(96K6UQ3ZD4)
water(059QF0KO0R)

Setid E921054f B3f1 4624 8edd F6628c6f0fd9 Applno 203794 Form Solution Oral Dosage Eq 20mg Base Ml - Drug Product Composition: Tapentadol

Tapentadol

Tapentadol

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers

6 USDMF

6 CEP/COS

9 EU WC

2 KDMF

6 NDC API

29 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

242 FDF Dossiers

30 FDA Orange Book

145 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

5 DKSH

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

SOLUTION;ORAL - EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons