Bosentan Hydrate

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 21 USDMF, 9 JDMF, 20 EU WC, 6 KDMF, 12 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

160 FDF Dossiers, 27 FDA Orange Book, 44 Europe, 10 Canada, 64 Australia, 15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 125MG, TABLET;ORAL - 62.5MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 2 Rochem International Inc, 5 SPI Pharma, 3 DKSH, 3 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Capital Farma, 1 ACG Worldwide, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 11 Corel Pharma Chem, 4 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 15 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 28 Disintegrants & Superdisintegrants, 23 Direct Compression, 23 Controlled & Modified Release, 16 Thickeners and Stabilizers, 14 Lubricants & Glidants, 13 Granulation, 12 Taste Masking, 12 Co-Processed Excipients, 11 Film Formers & Plasticizers, 7 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Solubilizers, 3 Rheology Modifiers, 1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 27 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 29 Finished Drug Prices, 4 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

2 US Patents, 3 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

6 USP, 6 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21290 / DOSAGE - TABLET;ORAL - 125MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
bosentan(UNII: Q326023R30) (bosentan anhydrous - UNII:XUL93R30K2)	bosentan anhydrous	62.5mg \| 125mg

Inactive Ingredients

Ingredient Name	Lupin Pharmaceuticals, Inc.	Alembic Pharmaceuticals Inc.	Alembic Pharmaceuticals Limited	Amneal Pharmaceuticals LLC	Cipla USA Inc.	CoTherix, Inc.	Sun Pharmaceutical Industries, Inc.	Zydus Pharmaceuticals USA Inc.	Alvogen Inc.
CETYL ALCOHOL(936JST6JCN)
CROSCARMELLOSE SODIUM(M28OL1HH48)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR)
GLYCERYL DIBEHENATE(R8WTH25YS2)
hypromellose, unspecified(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SODIUM STARCH GLYCOLATE TYPE B POTATO(27NA468985)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Bosentan Hydrate