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Drug Product Composition: Saxagliptin Hydrochloride

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$ API Ref.Price (USD/KG) : 13,827Xls

USFDA APPLICATION NUMBER - 200678 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metformin hydrochloride(UNII: 786Z46389E)
(metformin - UNII:9100L32L2N)
metformin hydrochloride1000mg | 1000mg | 500mg
saxagliptin hydrochloride(UNII: Z8J84YIX6L)
(saxagliptin anhydrous - UNII:8I7IO46IVQ)
saxagliptin anhydrous2.5mg | 5mg | 5mg

Inactive Ingredients

Ingredient Name
E.R. Squibb & Sons, L.L.C.
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
cellulose, microcrystalline(OP1R32D61U)
hypromellose 2208 (15000 mpa.s)(Z78RG6M2N2)
hypromellose 2910 (15 mpa.s)(36SFW2JZ0W)
magnesium stearate(70097M6I30)