Tapentadol Hydrochloride

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- EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE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

DIGITAL CONTENT

33 News #PharmaBuzz

33 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 50 Regulatory FDF Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

48 US Patents, 8 US Exclusivities, 67 Health Canada Patents

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USFDA APPLICATION NUMBER - 200533 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
tapentadol hydrochloride(UNII: 71204KII53) (tapentadol - UNII:H8A007M585)	tapentadol	100mg

Inactive Ingredients

Ingredient Name	Janssen Pharmaceuticals, Inc.	LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC	Lake Erie Medical DBA Quality Care Products LLC
.ALPHA.-TOCOPHEROL(H4N855PNZ1)
ALUMINUM OXIDE(LMI26O6933)
FD&C BLUE NO. 2(L06K8R7DQK)
ferric oxide yellow(EX438O2MRT)
ferrosoferric oxide(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED (3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
hypromelloses(3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
polyvinyl alcohol(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
PROPYLENE GLYCOL (6DC9Q167V3)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC (46N107B71O)
SHELLAC(46N107B71O)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE (15FIX9V2JP)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 8aac7e48 F10c 4623 8fb5 1d74d5e22520 Applno 200533 Form Tablet Extended Release Oral Dosage Eq 200mg Base - Drug Product Composition: Tapentadol Hydrochloride