Saxagliptin Hydrochloride

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 12 USDMF, 8 EU WC, 5 NDC API, 6 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 30 FDA Orange Book, 2 Europe, 9 Canada

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE, TABLET;ORAL - EQ 2.5MG BASE, TABLET;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 4 DKSH, 1 Jai Radhe Sales, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Clariant, 5 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 26 Kerry, 1 Kima Chemical, 13 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 1 The Dow Chemical Company, 3 Vasa Pharmachem

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49 Fillers, Diluents & Binders, 23 Coating Systems & Additives, 21 Direct Compression, 17 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 13 Lubricants & Glidants, 12 Co-Processed Excipients, 11 Granulation, 9 Controlled & Modified Release, 6 Film Formers & Plasticizers, 6 Rheology Modifiers, 3 Parenteral, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 2 Chewable & Orodispersible Aids, 1 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

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PATENTS & EXCLUSIVITIES

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USFDA APPLICATION NUMBER - 22350 / DOSAGE - TABLET;ORAL - EQ 2.5MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
saxagliptin hydrochloride(UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ)	saxagliptin anhydrous	5mg

Inactive Ingredients

Ingredient Name	Amneal Pharmaceuticals LLC	Glenmark Pharmaceuticals Inc., USA	E.R. Squibb & Sons, L.L.C.	Cardinal Health
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
cellulose, microcrystalline(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROCHLORIC ACID(QTT17582CB)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POVIDONE(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Saxagliptin Hydrochloride