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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 1GM, TABLET, EXTENDED RELEASE;ORAL -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

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USFDA APPLICATION NUMBER - 21748 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG

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.	NuCare Pharmaceuticals,Inc.	Citron Pharma LLC	Eon Labs, Inc.	Aphena Pharma Solutions - Tennessee, LLC	Ascend Laboratories, LLC	Avera McKennan Hospital	Denton Pharma, Inc. dba Northwind Pharmaceuticals	Lake Erie Medical DBA Quality Care Products LLC	Laurus Labs Limited	NCS HealthCare of KY, LLC dba Vangard Labs	Nivagen Pharmaceuticals Inc	Northwind Pharmaceuticals, LLC	RedPharm Drug, Inc.	REMEDYREPACK INC.	SANDOZ INC.	A-S Medication Solutions	Preferred Pharmaceuticals Inc.	Proficient Rx LP	TWi Pharmaceuticals, Inc.	Depomed, Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	Nostrum Laboratories Inc.	Actavis Pharma, Inc.	Torrent Pharmaceuticals Limited	QPharma Inc	Teva Pharmaceuticals USA, Inc.	IntelliPharmaCeutics Corp.	Apotex Corp.	St. Marys Medical Park Pharmacy	AlignScience Pharma Inc.	Golden State Medical Supply, Inc.	Hudson Scientific LLC	Major Pharmaceuticals	Unit Dose Services	NuCare Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.	St Marys Medical Park Pharmacy	AvKARE
ACETONE(1364PS73AF)
AMMONIA(5138Q19F1X)
AMMONIO METHACRYLATE COPOLYMER TYPE A(8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
ANHYDROUS CITRIC ACID(XF417D3PSL)
BUTYL ALCOHOL(8PJ61P6TS3)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CARBOMER HOMOPOLYMER TYPE A(F68VH75CJC)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%)(4J4P6L645M)
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED(K679OBS311)
CELLULOSE ACETATE(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
CROSPOVIDONE (120 .MU.M)(68401960MK)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)
ETHYLCELLULOSE (7 MPA.S)(H3UP11403C)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL BEHENATE(R8WTH25YS2)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROGENATED CASTOR OIL(ZF94AP8MEY)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(5Y0974F5PW)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)
HYPROMELLOSE 2208 (15000 MPA.S)(Z78RG6M2N2)
HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MAGNESIUM TRISILICATE(C2E1CI501T)
MALTODEXTRIN(7CVR7L4A2D)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
METHYLCELLULOSE (100 MPA.S)(4GFU244C4J)
METHYLCELLULOSE (25 CPS)(BI55GG2WLI)
METHYLCELLULOSE (25 MPA.S) (BI55GG2WLI)
METHYLCELLULOSE (25 MPA.S)(BI55GG2WLI)
MICROCRYSTALLINE CELLULOSE 101(7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(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 CARBONATE(45P3261C7T)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)
VINYL ACETATE(L9MK238N77)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Metformin Hydrochloride