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Drug Product Composition: Topiramate

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$ API Ref.Price (USD/KG) : 172Xls

USFDA APPLICATION NUMBER - 205122 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOPIRAMATE(UNII: 0H73WJJ391)
(TOPIRAMATE - UNII:0H73WJJ391)
TOPIRAMATE100mg

Inactive Ingredients

Ingredient Name
Glenmark Pharmaceuticals Inc., USA
NorthStar RxLLC
REMEDYREPACK INC.
AMMONIA(5138Q19F1X) 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)  
D&C RED NO. 30(2S42T2808B) 
DIETHYL PHTHALATE(UF064M00AF)  
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)
FD&C RED NO. 40(WZB9127XOA) 
FD&C YELLOW NO. 5(I753WB2F1M) 
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) 
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U) 
POLYETHYLENE GLYCOL 6000(30IQX730WE) 
POTASSIUM HYDROXIDE(WZH3C48M4T) 
PROPYLENE GLYCOL(6DC9Q167V3) 
SHELLAC(46N107B71O) 
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)