Glibenclamide

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 15 USDMF, 9 CEP/COS, 4 JDMF, 7 EU WC, 1 KDMF, 6 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers, 83 FDA Orange Book, 24 Europe, 7 Canada, 2 Australia, 19 South Africa, 45 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TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 8 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 27 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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, 11 Sigachi Industries, 4 Silverline Chemicals, 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NUMBER - 21178 / DOSAGE - TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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)

Setid E222620f 0dc7 4d2d 8ea1 246189d8af9b Applno 21178 Form Tablet Oral Dosage 5mg 500mg - Drug Product Composition: Glibenclamide

Glibenclamide

Glibenclamide

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

31 API Suppliers

15 USDMF

9 CEP/COS

4 JDMF

7 EU WC

1 KDMF

6 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

25 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers

83 FDA Orange Book

24 Europe

7 Canada

2 Australia

19 South Africa

45 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

8 DKSH

8 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 ACG Worldwide

5 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

27 BASF

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

4 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

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

11 Sigachi Industries

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