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73 FDA Orange Book
4 Europe
4 Australia
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20 Listed Dossiers

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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 2.5MG, TABLET, EXTENDED RELEASE;ORAL - 5MG

drugProductComposition
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 10MG
TABLET, EXTENDED RELEASE;ORAL - 2.5MG
TABLET, EXTENDED RELEASE;ORAL - 5MG

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3 Evonik
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2 Seqens
14 DKSH
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6 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
14 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
1 ACG Worldwide
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9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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32 BASF
2 Clariant
14 Corel Pharma Chem
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2 Finar
12 Gangwal Chemicals
15 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
39 Kerry
3 Kima Chemical
6 Lonza Capsugel
14 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
6 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
21 Roquette
14 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
2 Valens Pharmachem
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Synopsis

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Chemistry

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Also known as: 29094-61-9, Glucotrol, Glydiazinamide, Melizide, Glibenese, Glucozide

Molecular Formula

C₂₁H₂₇N₅O₄S

Molecular Weight

445.5 g/mol

InChI Key

ZJJXGWJIGJFDTL-UHFFFAOYSA-N

FDA UNII

X7WDT95N5C

An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.

Glipizide is a Sulfonylurea.

1 2D Structure

Glipizide

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methylpyrazine-2-carboxamide

2.1.2 InChI

InChI=1S/C21H27N5O4S/c1-15-13-24-19(14-23-15)20(27)22-12-11-16-7-9-18(10-8-16)31(29,30)26-21(28)25-17-5-3-2-4-6-17/h7-10,13-14,17H,2-6,11-12H2,1H3,(H,22,27)(H2,25,26,28)

2.1.3 InChI Key

ZJJXGWJIGJFDTL-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=CN=C(C=N1)C(=O)NCCC2=CC=C(C=C2)S(=O)(=O)NC(=O)NC3CCCCC3

2.2 Other Identifiers

2.2.1 UNII

X7WDT95N5C

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Glidiazinamide

2. Glucotrol

3. Glupitel

4. Glydiazinamide

5. Glypidizine

6. K 4024

7. K-4024

8. K4024

9. Melizide

10. Mindiab

11. Minidiab

12. Minodiab

13. Ozidia

2.3.2 Depositor-Supplied Synonyms

1. 29094-61-9

2. Glucotrol

3. Glydiazinamide

4. Melizide

5. Glibenese

6. Glucozide

7. Glupizide

8. Sucrazide

9. Dipazide

10. Glupitel

11. Mindiab

12. Minidiab

13. Minodiab

14. Napizide

15. Ozidia

16. Glucotrol Xl

17. Glibetin

18. Glucolip

19. Aldiab

20. Digrin

21. Glican

22. Glidiab

23. Glipid

24. Minidab

25. Glyde

26. Gluco-rite

27. Glipizida

28. Glipizidum

29. Glipizidum [inn-latin]

30. K 4024

31. Glipizida [inn-spanish]

32. Metaglip

33. N-(4-(n-(cyclohexylcarbamoyl)sulfamoyl)phenethyl)-5-methylpyrazine-2-carboxamide

34. Cp 28720

35. K-4024

36. Cp-28720

37. Tk 1320

38. Cp 28,720

39. N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methylpyrazine-2-carboxamide

40. Glipizide Slow Release

41. Glipizide (glucotrol)

42. Cp-28,720

43. 1-cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl)urea

44. Glide

45. Nsc-759120

46. Chembl1073

47. X7wdt95n5c

48. Mls000069386

49. N-[2-(4-{[(cyclohexylcarbamoyl)amino]sulfonyl}phenyl)ethyl]-5-methylpyrazine-2-carboxamide

50. Pyrazinecarboxamide, N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-5-methyl-

51. Chebi:5384

52. Cp 28720;k 4024

53. N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-5-methylpyrazine-2-carboxamide

54. N-(4-(beta-(5-methylpyrazine-2-carboxamido)ethyl)benzenesulphonyl)-n'-cyclohexylurea

55. Ncgc00015462-07

56. Smr000058455

57. Cas-29094-61-9

58. 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea

59. Dsstox_cid_20676

60. Dsstox_rid_79535

61. Urea, 1-cyclohexyl-3-((p-(2-(5-methylpyrazinecarboxamido)ethyl)phenyl)sulfonyl)-

62. Dsstox_gsid_40676

63. 29094-66-4

64. 1-cyclohexyl-3-({p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl}sulfonyl)urea

65. N-{4-[beta-(5-methylpyrazine-2-carboxamido)ethyl]benzenesulphonyl}-n'-cyclohexylurea

66. Glucotrol (tn)

67. Pyrazinecarboxamide, N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-5-methyl-

68. Glipizide (usp/inn)

69. Sr-01000000010

70. Einecs 249-427-6

71. Mfcd00072159

72. Unii-x7wdt95n5c

73. Brn 0903495

74. Glipizide, Solid

75. N-(4-[n-(cyclohexylcarbamoyl)sulfamoyl]phenethyl)-5-methylpyrazine-2-carboxamide

76. Glipizide [usan:usp:inn:ban]

77. Glipizide/glucotrol

78. Glipizide,(s)

79. Prestwick_242

80. Ks-1068

81. Metaglip (salt/mix)

82. Glipizide [inn]

83. Glipizide [jan]

84. Glipizide [mi]

85. Lopac-g-117

86. Glipizide [usan]

87. Opera_id_1908

88. Prestwick0_000131

89. Prestwick1_000131

90. Prestwick2_000131

91. Prestwick3_000131

92. Glipizide [vandf]

93. G-117

94. Glipizide [mart.]

95. 1-cyclohexyl-3-{4-[2-(5-methylpyrazine-2-carboxamido)ethyl]phenylsulfonyl}urea

96. Glipizide [usp-rs]

97. Glipizide [who-dd]

98. Cbiol_001788

99. Lopac0_000621

100. Schembl17094

101. Bspbio_000202

102. Bspbio_001349

103. Kbiogr_000069

104. Kbioss_000069

105. Mls001148176

106. Bidd:gt0476

107. Spbio_002141

108. Bpbio1_000224

109. Gtpl6821

110. Glipizide [orange Book]

111. Dtxsid0040676

112. Glipizide [ep Monograph]

113. Kbio2_000069

114. Kbio2_002637

115. Kbio2_005205

116. Kbio3_000137

117. Kbio3_000138

118. Glipizide [usp Monograph]

119. Bio1_000074

120. Bio1_000563

121. Bio1_001052

122. Bio2_000069

123. Bio2_000549

124. Hms1361d11

125. Hms1568k04

126. Hms1791d11

127. Hms1989d11

128. Hms2089c21

129. Hms2093j09

130. Hms2095k04

131. Hms2233n11

132. Hms3259k12

133. Hms3261n04

134. Hms3369l12

135. Hms3402d11

136. Hms3655g04

137. Hms3712k04

138. Pharmakon1600-01505433

139. Zinc537795

140. Metaglip Component Glipizide

141. Bcp09195

142. Hy-b0254

143. Tox21_110156

144. Tox21_301834

145. Tox21_500621

146. Bbl028143

147. Bdbm50012956

148. Nsc759120

149. Nsc813218

150. S1715

151. Stk631952

152. Akos005564405

153. Glipizide Component Of Metaglip

154. N-[4-(3-cyclohexylureidosulfonyl)phenethyl]-5-methyl-2-pyrazinecarboxamide

155. Tox21_110156_1

156. Ccg-204710

157. Db01067

158. Lp00621

159. Nc00564

160. Nsc 759120

161. Nsc-813218

162. Sdccgsbi-0050603.p003

163. Idi1_033819

164. N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-5-methyl-pyrazine-2-carboxamide

165. Glipizide 100 Microg/ml In Acetonitrile

166. Ncgc00015462-01

167. Ncgc00015462-02

168. Ncgc00015462-03

169. Ncgc00015462-04

170. Ncgc00015462-05

171. Ncgc00015462-06

172. Ncgc00015462-08

173. Ncgc00015462-09

174. Ncgc00015462-10

175. Ncgc00015462-11

176. Ncgc00015462-12

177. Ncgc00015462-14

178. Ncgc00015462-23

179. Ncgc00016802-01

180. Ncgc00023748-03

181. Ncgc00023748-04

182. Ncgc00023748-05

183. Ncgc00023748-06

184. Ncgc00023748-07

185. Ncgc00255522-01

186. Ncgc00261306-01

187. Ac-15789

188. Sbi-0050603.p002

189. Eu-0100621

190. Ft-0626714

191. Ft-0659737

192. G0369

193. Sw196549-3

194. D00335

195. 094g619

196. Q3108899

197. Sr-01000000010-2

198. Sr-01000000010-5

199. W-107005

200. Brd-k12219985-001-04-8

201. Brd-k12219985-001-15-4

202. Z1880962274

203. Glipizide, European Pharmacopoeia (ep) Reference Standard

204. Glipizide, United States Pharmacopeia (usp) Reference Standard

205. Glipizide, Pharmaceutical Secondary Standard; Certified Reference Material

206. 1-cyclohexyl-3-(4-(2-(2-methylpyrazine-5-carboxamido)ethyl)phenylsulfonyl)urea

207. 1-cyclohexyl-3-{{p=[2-[5-methylpyrazine-carboxamido)-ethyl]phenyl}sulphonyl}urea

208. N-(4-(.beta.-(5-methylpyrazine-2-carboxamido)ethyl)benzenesulphonyl)-n'-cyclohexylurea

209. 172964-66-8

210. 2-pyrazinecarboxamide, N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-5-methyl-

211. N-(2-[4-(([(cyclohexylamino)carbonyl]amino)sulfonyl)phenyl]ethyl)-5-methyl-2-pyrazinecarboxamide

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₇N₅O₄S
Molecular Weight	445.5 g/mol
XLogP3	1.9
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	7
Exact Mass	445.17837553 g/mol
Monoisotopic Mass	445.17837553 g/mol
Topological Polar Surface Area	139 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	697
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Glipizide
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Tentative Approval; Prescription
Company	Apotex; Accord Hlthcare; Sun Pharm Inds; Sandoz; Par Pharm; Watson Labs; Ivax Sub Teva Pharms; Zydus Pharms Usa; Mylan

2 of 6
Drug Name	Glucotrol
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg
Market Status	Prescription
Company	Pfizer

3 of 6
Drug Name	Glucotrol xl
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Pfizer

4 of 6
Drug Name	Glipizide
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet, extended release; Tablet
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Tentative Approval; Prescription
Company	Apotex; Accord Hlthcare; Sun Pharm Inds; Sandoz; Par Pharm; Watson Labs; Ivax Sub Teva Pharms; Zydus Pharms Usa; Mylan

5 of 6
Drug Name	Glucotrol
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg
Market Status	Prescription
Company	Pfizer

6 of 6
Drug Name	Glucotrol xl
PubMed Health	Glipizide (By mouth)
Drug Classes	Hypoglycemic
Drug Label	Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular...
Active Ingredient	Glipizide
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Pfizer

4.2 Drug Indication

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Glipizide is a blood glucose-lowering agent. The initial onset of blood glucose-lowering effect occurs around 30 minutes post-administration with the duration of action lasting for about 12 to 24 hours. While the chronic use of glipizide does not result in elevations in the fasting insulin levels over time, the postprandial insulin response, or insulin response to a meal, is observed to be enhanced, even after 6 months of treatment. The main therapeutic actions of glipizide primarily occur at the pancreas where the insulin release is stimulated, but glipizide also mediates some extrapancreatic effects, such as the promotion of insulin signaling effects on the muscles, fat, or liver cells. Due to its action on the endogenous cells, sulfonylureas including glipizide is associated with a risk for developing hypoglycemia and weight gain in patients receiving the drug. Chronic administration of glipizide may result in down-regulation of the sulfonylurea receptors on pancreatic beta cells, which are molecular targets of the drug, leading to a reduced effect on insulin secretion. Like other sulfonylureas, glipizide may work on pancreatic delta () cells and alpha () cells to stimulate the secretion of somatostatin and suppress the secretion of glucagon, which are peptide hormones that regulate neuroendocrine and metabolic pathways. Other than its primary action on the pancreas, glipizide also exerts other biological actions outside of the pancreas, or "extrapancreatic effects", which is similar to other members of the sulfonylurea drug class. Glipizide may enhance the glucose uptake into the skeletal muscles and potentiate the action of insulin in the liver. Other effects include inhibited lipolysis in the liver and adipose tissue, inhibited hepatic glucose output, and increased uptake and oxidation of glucose. It has also been demonstrated by several studies that the chronic therapeutic use of sulfonylureas may result in an increase in insulin receptors expressed on monocytes, adipocytes, and erythrocytes.

5.2 MeSH Pharmacological Classification

Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

GLIPIZIDE

5.3.2 FDA UNII

X7WDT95N5C

5.3.3 Pharmacological Classes

Sulfonylurea [EPC]; Sulfonylurea Compounds [CS]

5.4 ATC Code

A10BB07

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BB - Sulfonylureas

A10BB07 - Glipizide

5.5 Absorption, Distribution and Excretion

Absorption

Gastrointestinal absorption of glipizide is uniform, rapid, and essentially complete. The absolute bioavailability of glipizide in patients with type 2 diabetes receiving a single oral dose was 100%. The maximum plasma concentrations are expected to be reached within 6 to 12 hours following initial dosing. The steady-state plasma concentrations of glipizide from extended-release oral formulations are maintained over the 24-hour dosing interval. In healthy volunteers, the absorption of glipizide was delayed by the presence of food but the total absorption was unaffected.

Route of Elimination

Glipizide is mainly eliminated by hepatic biotransformation, where less than 10% of the initial dose of the drug can be detected in the urine and feces as unchanged glipizide. About 80% of the metabolites of glipizide is excreted in the urine while 10% is excreted in the feces.

Volume of Distribution

The mean volume of distribution was approximately 10 L following administration of single intravenous doses in patients with type 2 diabetes mellitus. In mice and rat studies, the presence of the drug and its metabolites was none to minimal in the fetus of pregnant female animals. Other sulfonylurea drugs were shown to cross the placenta and enter breast milk thus the potential risk of glipizide in fetus or infants cannot be excluded.

Clearance

The mean total body clearance of glipizide was approximately 3 L/hr following administration of single intravenous doses in patients with type 2 diabetes mellitus.

5.6 Metabolism/Metabolites

Glipizide is subject to hepatic metabolism, in which its major metabolites are formed from aromatic hydroxylation. These major metabolites are glipizide are reported to be pharmacologically inactive. In contrast, an acetylaminoethyl benzine derivative is formed as a minor metabolite which accounts for less than 2% of the initial dose and is reported to have one-tenth to one-third as much hypoglycemic activity as the parent compound.

Glipizide has known human metabolites that include 4-trans-hydroxy-glipizide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

5.7 Biological Half-Life

The mean terminal elimination half-life of glipizide ranged from 2 to 5 hours after single or multiple doses in patients with type 2 diabetes mellitus.

5.8 Mechanism of Action

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder with increasing prevalence worldwide. Characterized by higher-than-normal levels of blood glucose, T2DM is a complex disorder that arises from the interaction between genetic, environmental and behavioral risk factors. Insulin is a peptide hormone that plays a critical role in regulating blood glucose levels. In response to high blood glucose levels, insulin promotes the uptake of glucose into the liver, muscle cells, and fat cells for storage. Although there are multiple events occurring that lead to the pathophysiology of T2DM, the disorder mainly involves insulin insensitivity as a result of insulin resistance, declining insulin production, and eventual failure of beta cells of pancreatic islets that normally produce insulin. Early management with lifestyle intervention, such as controlled diet and exercise, is critical in reducing the risk of long-term secondary complications, such as cardiovascular mortality. Glipizide, like other sulfonylurea drugs, is an insulin secretagogue, which works by stimulating the insulin release from the pancreatic beta cells thereby increasing the plasma concentrations of insulin. Thus, the main therapeutic action of the drug depends on the functional beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea receptor expressed on the pancreatic beta-cell plasma membrane, leading to the closure of the ATP-sensitive potassium channel and reduced potassium conductance. This results in depolarization of the pancreatic beta cell and opening of the voltage-sensitive calcium channels, promoting calcium ion influx. Increased intracellular concentrations of calcium ions in beta cells stimulates the secretion, or exocytosis, of insulin granules from the cells. Apart from this main mechanism of action, the blood-glucose-lowering effect of glipizide involves increased peripheral glucose utilization via stimulating hepatic gluconeogenesis and by increasing the number and sensitivity of insulin receptors.

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Fermion Oy

Finland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Finland

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USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

03

USV Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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India

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USDMF

CEP/COS JDMF EU-WC

NDC

KDMF VMF Others AUDIT

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04

Zeon Pharma Industries India Pvt L...

India

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Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.

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05

Urquima S.A. Grupo Uriach

Spain

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Antibody Engineering

Not Confirmed

06

Taizhou Highsun Pharmaceutical Co....

China

India

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USDMF

01

Fermion Oy

Finland

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Finland

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Glipizide

GDUFA

DMF Review : Complete

Rev. Date : 2020-06-12

Pay. Date : 2020-06-05

DMF Number : 15174

Submission : 2000-12-04

Status : Active

Type : II

02

Usv Private Ltd

India

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USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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India

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Glipizide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12374

Submission : 1997-02-24

Status : Active

Type : II

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10

Prostinex

Country

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CEP/COS

01

SRI KRISHNA PHARMACEUTICALS LIMITED...

India

Gabon

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EU WC

01

USV Private Limited

India

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USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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Glipizide BP/Ph.Eur./USP

Date of Issue : 2022-06-27

Valid Till : 2025-06-02

Written Confirmation Number : WC-0012

Address of the Firm : MIs USV Private Limited ,B-1/8,MIDC, Lote Parshuram, Tal., Dist. Ratnagiri, Khed...

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02

J.B.Chemicals & Pharmaceuticals

India

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03

Kreative Organics

India

Antibody Engineering

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04

Sri Krishna Pharmaceuticals

India

Antibody Engineering

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05

Unichem Laboratories Limited

India

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NDC API

01

Fermion Oy

Finland

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GLIPIZIDE

NDC Package Code : 12780-4680

Start Marketing Date : 2000-12-04

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

02

USV Private Limited

India

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India

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GLIPIZIDE

NDC Package Code : 62147-0400

Start Marketing Date : 2009-08-05

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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03

USV Private Limited

India

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India

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GLIPIZIDE

NDC Package Code : 62147-0001

Start Marketing Date : 2009-09-08

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Olon SpA

Italy

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09

Professional Compounding Centers of...

United Kingdom

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10

Professional Compounding Centers of...

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17783

DOSAGE - TABLET;ORAL - 2.5MG **Federal Regist...DOSAGE - TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17783

DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17783

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 20329

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 20329

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 20329

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TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

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

TABLET, EXTENDED RELEASE;ORAL - 10MG

TABLET, EXTENDED RELEASE;ORAL - 2.5MG

TABLET, EXTENDED RELEASE;ORAL - 5MG

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TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons