Metformin Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

104 API Suppliers, 55 USDMF, 41 CEP/COS, 13 JDMF, 29 EU WC, 100 KDMF, 38 NDC API, 40 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1806 FDF Dossiers, 413 FDA Orange Book, 545 Europe, 120 Canada, 102 Australia, 137 South Africa, 489 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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL -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 Jai Radhe Sales, 3 Pharm-RX Chemical, 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, 11 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, 4 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

128 Fillers, Diluents & Binders, 65 Coating Systems & Additives, 63 Direct Compression, 58 Controlled & Modified Release, 51 Disintegrants & Superdisintegrants, 50 Thickeners and Stabilizers, 48 Solubilizers, 41 Granulation, 39 Film Formers & Plasticizers, 38 Taste Masking, 36 Topical, 32 Lubricants & Glidants, 31 Parenteral, 24 Chewable & Orodispersible Aids, 22 Co-Processed Excipients, 15 Emulsifying Agents, 12 API Stability Enhancers, 10 Rheology Modifiers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

20 DATA COMPILATION #PharmaFlow, 355 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

76 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 - 21748 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	500mg \| 1000mg

Inactive Ingredients

Ingredient Name	EPIC PHARMA, LLC	GLENMARK PHARMACEUTICALS INC., USA	NorthStar RxLLC	Solco Healthcare US, LLC.	American Health Packaging	AvKARE, Inc.	Bryant Ranch Prepack	Granules India Ltd	Lupin Pharmaceuticals, Inc.	Micro Labs Limited	Preferred Pharmaceuticals, Inc.	Lake Erie Medical DBA Quality Care Products LLC	Proficient Rx LP	REMEDYREPACK INC.	TWi Pharmaceuticals, Inc.	Depomed, Inc.
ACETONE(1364PS73AF)
AMMONIA(5138Q19F1X)
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
ANHYDROUS CITRIC ACID(XF417D3PSL)
BUTYL ALCOHOL(8PJ61P6TS3)
CANDELILLA WAX(WL0328HX19)
CELLULOSE ACETATE(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
DIBUTYL SEBACATE(4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)
FD&C BLUE NO. 2(L06K8R7DQK)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL BEHENATE(R8WTH25YS2)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
Propylene Glycol (6DC9Q167V3)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)
VINYL ACETATE(L9MK238N77)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Metformin Hydrochloride