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Drug Product Composition: Sevelamer Hydrochloride

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$ API Ref.Price (USD/KG) : 116Xls

USFDA APPLICATION NUMBER - 21179 / DOSAGE - TABLET;ORAL - 800MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER HYDROCHLORIDE(UNII: GLS2PGI8QG)
(SEVELAMER - UNII:941N5DUU5C)
SEVELAMER HYDROCHLORIDE800mg | 400mg

Inactive Ingredients

Ingredient Name
Glenmark Pharmaceuticals Inc., USA
NorthStar RxLLC
Cardinal Health
Lupin Pharmaceuticals, Inc.
AMMONIA(5138Q19F1X)  
BUTYL ALCOHOL(8PJ61P6TS3)  
DIACETYLATED MONOGLYCERIDES(5Z17386USF)  
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)   
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)   
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)  
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)  
ISOPROPYL ALCOHOL(ND2M416302) 
LACTOSE MONOHYDRATE(EWQ57Q8I5X)  
MANNITOL(3OWL53L36A)  
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)   
POLYETHYLENE GLYCOL 6000(30IQX730WE)   
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)   
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O) 
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)  
STEARIC ACID(4ELV7Z65AP)  
TALC(7SEV7J4R1U) 
WATER(059QF0KO0R)   
ZINC STEARATE(H92E6QA4FV)