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Drug Product Composition: Bosentan

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$ API Ref.Price (USD/KG) : 2,826Xls

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

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bosentan(UNII: Q326023R30)
(bosentan anhydrous - UNII:XUL93R30K2)
bosentan anhydrous62.5mg | 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)