Metformin Hydrochloride

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ACTIVE PHARMA INGREDIENTS

106 API Suppliers, 55 USDMF, 40 CEP/COS, 13 JDMF, 29 EU WC, 100 KDMF, 38 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1847 FDF Dossiers, 416 FDA Orange Book, 545 Europe, 120 Canada, 102 Australia, 137 South Africa, 527 Listed Dossiers

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 - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM, TABLET;ORAL - EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL - 500MG, TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE, TABLET;ORAL - 1GM;EQ 50MG BASE, TABLET;ORAL - 500MG;EQ 50MG BASE, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

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EXCIPIENTS BY APPLICATIONS

126 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 62 Direct Compression, 58 Controlled & Modified Release, 50 Thickeners and Stabilizers, 50 Disintegrants & Superdisintegrants, 47 Solubilizers, 41 Granulation, 39 Film Formers & Plasticizers, 38 Taste Masking, 36 Topical, 32 Lubricants & Glidants, 31 Parenteral, 24 Chewable & Orodispersible Aids, 23 Co-Processed Excipients, 15 Emulsifying Agents, 12 API Stability Enhancers, 10 Rheology Modifiers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

21 DATA COMPILATION #PharmaFlow, 362 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 505 Finished Drug Prices, 25 Annual Reports

MARKET PLACE

80 APIs, 51 FDF Dossiers

PATENTS & EXCLUSIVITIES

538 US Patents, 50 US Exclusivities, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 11 Others

ANALYTICAL

2 BioAnalytical Methods, 1 Analytical Methods

$ Xls

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)	metformin hydrochloride	1000mg \| 1000mg \| 500mg
saxagliptin hydrochloride(UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ)	saxagliptin anhydrous	2.5mg \| 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)

Drug Product Composition: Metformin Hydrochloride