Metformin

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ACTIVE PHARMA INGREDIENTS

179 API Suppliers, 57 USDMF, 42 CEP/COS, 13 JDMF, 31 EU WC, 99 KDMF, 39 NDC API, 46 Listed Suppliers, $ API Reference Price

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651 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1937 FDF Dossiers, 431 FDA Orange Book, 534 Europe, 134 Canada, 136 Australia, 140 South Africa, 562 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;1GM, TABLET;ORAL - 2.5MG;500MG, TABLET;ORAL - 2.5MG;850MG, TABLET;ORAL - EQ 12.5MG BASE;1GM,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- EQ 12.5MG BASE;500MG, TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM, TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG, TABLET, EXTENDED RELEASE;ORAL -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- 50MG;500MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn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 **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**, SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 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 EUROAPI, 2 Minakem, 8 Evonik, 7 Rochem International Inc, 23 SPI Pharma, 19 DKSH, 2 Pharm-RX Chemical, 13 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 1 ACG Worldwide, 12 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 38 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 2 Clariant, 27 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 5 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 22 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 11 Pluviaendo, 5 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, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 21574 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

Inactive Ingredients

Ingredient Name	Lake Erie Medical DBA Quality Care Products LLC
CANDELILLA WAX(WL0328HX19)
CELLULOSE ACETATE(3J2P07GVB6)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE(FZ989GH94E)
SODIUM LAURYL SULFATE(368GB5141J)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Drug Product Composition: Metformin

Metformin

Metformin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

179 API Suppliers

57 USDMF

42 CEP/COS

13 JDMF

31 EU WC

99 KDMF

39 NDC API

46 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

651 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1937 FDF Dossiers

431 FDA Orange Book

534 Europe

134 Canada

136 Australia

140 South Africa

562 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 **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**

SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 EUROAPI

2 Minakem

8 Evonik

7 Rochem International Inc

23 SPI Pharma

19 DKSH

2 Pharm-RX Chemical

13 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

12 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

6 Kirsch Pharma

1 ACG Worldwide

12 Actylis

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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;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

TABLET, EXTENDED RELEASE;ORAL - 1GM 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

SOLUTION;ORAL - 500MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons