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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL -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 - 201281 / DOSAGE - TABLET;ORAL - 2.5MG;500MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LINAGLIPTIN(UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2)	LINAGLIPTIN	2.5mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)	METFORMIN HYDROCHLORIDE	1000mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Lake Erie Medical DBA Quality Care Products LLC	Medsource Pharmaceuticals	PD-Rx Pharmaceuticals, Inc.	Unit Dose Services	Actavis Pharma Inc.	Impax Generics	Bryant Ranch Prepack	Zydus Pharmaceuticals (USA) Inc.	A-S Medication Solutions	American Health Packaging	Clinical Solutions Wholesale	KAISER FOUNDATION HOSPITALS	NuCare Pharmaceuticals,Inc.	REMEDYREPACK INC.	St Marys Medical Park Pharmacy	Teva Pharmaceuticals USA, Inc.	Mylan Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals, Inc.	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	REMEDYREPACK INC.
ALUMINUM OXIDE(LMI26O6933)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
CALCIUM CARBONATE(H0G9379FGK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (50 MPA.S)(1IVH67816N)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(5KY68S2577)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLENE GLYCOL, (R)-(602HN5L69H)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SORBIC ACID(X045WJ989B)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Metformin Hydrochloride