Tapentadol

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 5 USDMF, 3 CEP/COS, 6 EU WC, 2 KDMF, 5 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 30 FDA Orange Book, 115 Europe, 8 Canada, 5 Australia, 5 South Africa, 53 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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 6 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 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 31 Controlled & Modified Release, 25 Direct Compression, 18 Granulation, 18 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 14 Solubilizers, 12 Lubricants & Glidants, 12 Co-Processed Excipients, 11 Topical, 10 Film Formers & Plasticizers, 7 Parenteral, 6 Taste Masking, 5 Empty Capsules, 5 Coloring Agents, 4 API Stability Enhancers, 4 Vegetarian Capsules, 3 Emulsifying Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids

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USFDA APPLICATION NUMBER - 22304 / DOSAGE - TABLET;ORAL - EQ 50MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TAPENTADOL(UNII: H8A007M585) (TAPENTADOL - UNII:H8A007M585)	TAPENTADOL	50mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Janssen Pharmaceuticals, Inc.	Lake Erie Medical DBA Quality Care Products LLC
aluminum oxide(LMI26O6933)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
polyethylene glycol(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
polyvinyl alcohol(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Drug Product Composition: Tapentadol

Tapentadol

Tapentadol

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

5 USDMF

3 CEP/COS

6 EU WC

2 KDMF

5 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers

30 FDA Orange Book

115 Europe

8 Canada

5 Australia

5 South Africa

53 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

2 Seqens

3 DKSH

1 Jai Radhe Sales

1 Pharm-RX Chemical

5 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

6 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 Ulanqab Kema New Material

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