Glibenclamide

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 9 CEP/COS, 4 JDMF, 6 EU WC, 1 KDMF, 6 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers, 83 FDA Orange Book, 26 Europe, 7 Canada, 2 Australia, 19 South Africa, 44 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 SPI Pharma, 2 Seqens, 5 DKSH, 6 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 27 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 6 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

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USFDA APPLICATION NUMBER - 21178 / DOSAGE - TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
glyburide(UNII: SX6K58TVWC) (glyburide - UNII:SX6K58TVWC)	glyburide	5mg \| 2.5mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)	metformin hydrochloride	500mg \| 500mg

Inactive Ingredients

Ingredient Name	Bristol-Myers Squibb Company
cellulose, microcrystalline(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
magnesium stearate(70097M6I30)
POVIDONES(FZ989GH94E)

Drug Product Composition: Glibenclamide

Glibenclamide

Glibenclamide

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers

15 USDMF

9 CEP/COS

4 JDMF

6 EU WC

1 KDMF

6 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers

83 FDA Orange Book

26 Europe

7 Canada

2 Australia

19 South Africa

44 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG

TABLET;ORAL - 2.5MG

TABLET;ORAL - 5MG

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**

RELATED EXCIPIENT COMPANIES

2 Evonik

7 SPI Pharma

2 Seqens

5 DKSH

6 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 ACG Worldwide

5 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

27 BASF

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

2 Finar

11 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

6 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

12 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

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