Saxagliptin Hydrochloride

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ACTIVE PHARMA INGREDIENTS

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

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 30 FDA Orange Book, 8 Europe, 9 Canada

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 5 DKSH, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 BASF, 1 Clariant, 5 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Keval Exports, 1 Kima Chemical, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 1 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

31 Fillers, Diluents & Binders, 22 Coating Systems & Additives, 19 Direct Compression, 18 Thickeners and Stabilizers, 16 Granulation, 15 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 8 Controlled & Modified Release, 8 Co-Processed Excipients, 7 Rheology Modifiers, 6 Film Formers & Plasticizers, 3 Chewable & Orodispersible Aids, 3 Parenteral, 3 Taste Masking, 3 Solubilizers, 3 Topical, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 1 Surfactant & Foaming Agents

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PATENTS & EXCLUSIVITIES

82 US Patents, 15 Health Canada Patents

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USFDA APPLICATION NUMBER - 22350 / DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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	E.R. Squibb & Sons, L.L.C.	Cardinal Health
cellulose, microcrystalline(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
lactose monohydrate(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)

Setid 97b7f4d7 43a0 4e31 B8bc Cb52f2bb31f4 Applno 22350 Form Tablet Oral Dosage Eq 5mg Base - Drug Product Composition: Saxagliptin Hydrochloride