sitagliptin phosphate anhydrous

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ACTIVE PHARMA INGREDIENTS

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9 Drugs in Development

INTERMEDIATES

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55 Intermediates Suppliers

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551 FDF Dossiers, 65 FDA Orange Book, 231 Europe, 80 Australia, 11 South Africa, 164 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - 1GM;EQ 50MG BASE, TABLET;ORAL - 500MG;EQ 50MG BASE

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GLOBAL SALES INFORMATION

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PATENTS & EXCLUSIVITIES

45 US Patents, 16 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21995 / DOSAGE - TABLET;ORAL - EQ 25MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SITAGLIPTIN PHOSPHATE(UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)	SITAGLIPTIN	100mg

Inactive Ingredients

Ingredient Name	Avera McKennan Hospital	Cardinal Health	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	A-S Medication Solutions	REMEDYREPACK INC.
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: sitagliptin phosphate anhydrous