Tapentadol Hydrochloride

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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

4 API Suppliers

4 API 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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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, 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 Disintegrants & Superdisintegrants, 18 Granulation, 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 Vegetarian Capsules, 4 API Stability Enhancers, 3 Emulsifying Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids

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30 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 93 Finished Drug Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

53 US Patents, 8 US Exclusivities, 56 Health Canada Patents

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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)

Drug Product Composition: Tapentadol Hydrochloride