Metformin Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL -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

RELATED EXCIPIENT COMPANIES

2 Minakem, 4 Evonik, 8 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 15 DKSH, 3 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 13 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 12 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 38 BASF, 1 Bioplus Life Sciences, 2 Clariant, 27 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 22 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 12 Pluviaendo, 6 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 35 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

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

Filters

Xls

USFDA APPLICATION NUMBER - 21842 / DOSAGE - TABLET;ORAL - 850MG;EQ 15MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)	metformin hydrochloride	850mg
pioglitazone hydrochloride(UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S)	pioglitazone	15mg

Inactive Ingredients

Ingredient Name	AvKARE, Inc.	Teva Pharmaceuticals USA	Teva Pharmaceuticals USA, Inc.	Torrent Pharmaceuticals Limited	Cardinal Health	Mylan Pharmaceuticals Inc.	Takeda Pharmaceuticals America, Inc.
cellulose, microcrystalline(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
hypromellose 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
magnesium stearate(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
polyethylene glycol 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL (100000 MW)(949E52Z6MY)
POLYVINYL ALCOHOL(532B59J990)
POVIDONE K25(K0KQV10C35)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Metformin Hydrochloride