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Drug Product Composition: Irbesartan

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$ API Ref.Price (USD/KG) : 176Xls

USFDA APPLICATION NUMBER - 20757 / DOSAGE - TABLET;ORAL - 75MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
irbesartan(UNII: J0E2756Z7N)
(irbesartan - UNII:J0E2756Z7N)
irbesartan300mg | 150mg

Inactive Ingredients

Ingredient Name
Apotex Corp.
West-Ward Pharmaceuticals Corp.
American Health Packaging
REMEDYREPACK INC.
Unit Dose Services
Ajanta Pharma Limited
Carilion Materials Management
Lake Erie Medical DBA Quality Care Products LLC
Legacy Pharmaceutical Packaging, LLC
Teva Pharmaceuticals USA, Inc.
A-S Medication Solutions
Alembic Pharmaceuticals Inc.
Bryant Ranch Prepack
Cardinal Health
Golden State Medical Supply
Proficient Rx LP
Unichem Pharmaceuticals (USA), Inc.
Westminster Pharmaceuticals, LLC
Lupin Pharmaceuticals, Inc.
Rising Pharmaceuticals, Inc.
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                   
ANHYDROUS LACTOSE(3SY5LH9PMK)                   
CALCIUM STEARATE(776XM7047L)                  
CARBOXYMETHYLCELLULOSE CALCIUM(UTY7PDF93L)                 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)             
croscarmellose sodium(M28OL1HH48)      
CROSPOVIDONE(2S7830E561)                   
crospovidone(68401960MK)                  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                   
Hydroxypropyl Cellulose (Type H)(RFW2ET671P)                   
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)                 
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                   
HYPROMELLOSES(3NXW29V3WO)                  
LACTOSE MONOHYDRATE(EWQ57Q8I5X)             
lactose(J2B2A4N98G)                   
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                  
MAGNESIUM STEARATE(70097M6I30)  
MANNITOL(3OWL53L36A)                  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)           
POLOXAMER 188(LQA7B6G8JG)           
POLYETHYLENE GLYCOL 3000(SA1B764746)                  
POLYSORBATE 80(6OZP39ZG8H)                   
POVIDONE K29/32(390RMW2PEQ)                  
POVIDONE K30(U725QWY32X)           
POVIDONE(FZ989GH94E)                   
POVIDONE, UNSPECIFIED(FZ989GH94E)                 
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE(368GB5141J)                   
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                 
SODIUM STEARYL FUMARATE(7CV7WJK4UI)                   
STARCH, CORN(O8232NY3SJ)         
TALC(7SEV7J4R1U)                 
TITANIUM DIOXIDE(15FIX9V2JP)