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

2 Drugs in Development

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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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

EXCIPIENTS BY APPLICATIONS

46 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 25 Controlled & Modified Release, 21 Granulation, 19 Thickeners and Stabilizers, 17 Direct Compression, 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, 5 Coloring Agents, 5 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents

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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)

Setid 07c33315 90c9 4a73 Bf1d Bca70c7e0ff5 Applno 22304 Form Tablet Oral Dosage Eq 50mg Base - Drug Product Composition: Tapentadol

Tapentadol

Tapentadol

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CHEMISTRY

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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

2 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