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ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 8 USDMF, 2 CEP/COS, 1 JDMF, 2 KDMF, 13 NDC API, 12 Listed Suppliers, $ API Reference Price

18 API Suppliers
8 USDMF
2 CEP/COS
1 JDMF
2 KDMF
13 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

77 FDF Dossiers, 23 FDA Orange Book, 41 Europe, 3 Canada, 2 Australia, 2 South Africa, 6 Listed Dossiers

77 FDF Dossiers
23 FDA Orange Book
41 Europe
3 Canada
2 Australia
2 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.005MG/VIAL, INJECTABLE;INJECTION - 0.01MG/VIAL, INJECTABLE;INJECTION - 0.02MG/VIAL, INJECTABLE;INJECTION - 0.04MG/VIAL

drugProductComposition
INJECTABLE;INJECTION - 0.005MG/VIAL
INJECTABLE;INJECTION - 0.01MG/VIAL
INJECTABLE;INJECTION - 0.02MG/VIAL
INJECTABLE;INJECTION - 0.04MG/VIAL

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 4 Actylis, 2 BASF, 1 Finar, 3 Kerry, 1 Roquette

relatedExcipients
1 Nanjing Well Pharmaceutical
4 Actylis
2 BASF
1 Finar
3 Kerry
1 Roquette

EXCIPIENTS BY APPLICATIONS

4 Parenteral, 3 Co-Processed Excipients, 2 Direct Compression, 2 Topical, 2 Granulation, 1 Fillers, Diluents & Binders, 1 Coating Systems & Additives, 1 Solubilizers, 1 Controlled & Modified Release

excipientsByApplications
4 Parenteral
3 Co-Processed Excipients
2 Direct Compression
2 Topical
2 Granulation
1 Fillers, Diluents & Binders
1 Coating Systems & Additives
1 Solubilizers
1 Controlled & Modified Release

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 31 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
31 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 30 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
30 Finished Drug Prices

MARKET PLACE

24 APIs, 7 FDF Dossiers

marketPlace
24 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 Health Canada Patents

patents
14 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 4 JP , 1 Others

otherSolutions
2 EDQM
1 USP
4 JP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

23,421

Annual Reports (USD Million)

Finished Drug Prices

12 RELATED EXCIPIENT COMPANIES

17EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Prostaglandin e1, 745-65-3, Pge1, Edex, Caverject, Muse

Molecular Formula

C₂₀H₃₄O₅

Molecular Weight

354.5 g/mol

InChI Key

GMVPRGQOIOIIMI-DWKJAMRDSA-N

FDA UNII

F5TD010360

A potent vasodilator agent that increases peripheral blood flow.

Alprostadil is a Prostaglandin Analog and Prostaglandin E1 Agonist. The mechanism of action of alprostadil is as a Prostaglandin Receptor Agonist. The physiologic effect of alprostadil is by means of Genitourinary Arterial Vasodilation and Venous Vasodilation.

1 2D Structure

Alprostadil

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

7-[(1R,2R,3R)-3-hydroxy-2-[(E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic acid

2.1.2 InChI

InChI=1S/C20H34O5/c1-2-3-6-9-15(21)12-13-17-16(18(22)14-19(17)23)10-7-4-5-8-11-20(24)25/h12-13,15-17,19,21,23H,2-11,14H2,1H3,(H,24,25)/b13-12+/t15-,16+,17+,19+/m0/s1

2.1.3 InChI Key

GMVPRGQOIOIIMI-DWKJAMRDSA-N

2.1.4 Canonical SMILES

CCCCCC(C=CC1C(CC(=O)C1CCCCCCC(=O)O)O)O

2.1.5 Isomeric SMILES

CCCCC[C@@H](/C=C/[C@H]1[C@@H](CC(=O)[C@@H]1CCCCCCC(=O)O)O)O

2.2 Other Identifiers

2.2.1 UNII

F5TD010360

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Caverject

2. Edex

3. Lipo Pge1

4. Lipo-pge1

5. Minprog

6. Muse

7. Pge1

8. Pge1alpha

9. Prostaglandin E1

10. Prostaglandin E1alpha

11. Prostavasin

12. Prostin Vr

13. Prostine Vr

14. Sugiran

15. Vasaprostan

16. Viridal

2.3.2 Depositor-Supplied Synonyms

1. Prostaglandin E1

2. 745-65-3

3. Pge1

4. Edex

5. Caverject

6. Muse

7. Prostin Vr

8. Befar

9. Alprostadilum

10. Topiglan

11. Femprox

12. Alprox-td

13. L-prostaglandin E1

14. Liprostin

15. Prostandin

16. Vitaros

17. Prostin Vr Pediatric

18. Prink

19. Pge-1

20. Prostavasin

21. (11alpha,13e,15s)-11,15-dihydroxy-9-oxoprost-13-en-1-oic Acid

22. 7-((1r,2r,3r)-3-hydroxy-2-((s,e)-3-hydroxyoct-1-en-1-yl)-5-oxocyclopentyl)heptanoic Acid

23. Alprostadil(caverject)

24. (-)-prostaglandin E1

25. (13e)-(15s)-11alpha,15-dihydroxy-9-oxoprost-13-enoate

26. 11alpha,15alpha-dihydroxy-9-oxo-13-trans-prostenoic Acid

27. Chembl495

28. U-10136

29. 7-[(1r,2r,3r)-3-hydroxy-2-[(e,3s)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]heptanoic Acid

30. Vasaprostan

31. Chebi:15544

32. 9-oxo-11r,15s-dihydroxy-13e-prostaenoic Acid

33. Ono-1608

34. U-10,136

35. F5td010360

36. Nsc-165559

37. Minprog

38. Sugiran

39. Viridal

40. (13e,15s)-11alpha,15-dihydroxy-9-oxoprost-13-en-1-oic Acid

41. (1r,2r,3r)-3-hydroxy-2-((e)-(3s)-3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic Acid

42. Lipoprost

43. Promostan

44. Prostivas

45. Alista

46. Femlife

47. Prostaglandine1

48. Rayva

49. Caverject Impulse

50. Pge1alpha

51. 7-((1r,2r,3r)-3-hydroxy-2-((s,e)-3-hydroxyoct-1-enyl)-5-oxocyclopentyl)heptanoic Acid

52. 7-[(1r,3r)-3-hydroxy-2-[(1e,3s)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl]heptanoic Acid

53. Smr000112594

54. Befar (tn)

55. Prink (tn)

56. Edex (tn)

57. Muse (tn)

58. (-)-protaglandin E1

59. U 10136

60. L-pge1

61. Sr-01000597593

62. Mr-256

63. Alprostadilum [inn-latin]

64. Prostin Vr Pediatric (tn)

65. Alprostadil Prostoglandin E1

66. Bml1-f06

67. Unii-f5td010360

68. Alprostadil(usan)

69. Hei-507

70. Ncgc00016535-01

71. Cas-745-65-3

72. Ono 1608

73. Einecs 212-017-2

74. (13e)-(15s)-11-alpha,15-dihydroxy-9-oxoprost-13-enoate

75. Mfcd00077860

76. Nsc 165559

77. Alprostadil [usan:usp:inn:ban:jan]

78. 11,15-dihydroxy-9-oxoprost-13-en-1-oic Acid

79. Pge1;prostaglandin E1

80. Ai3-62116

81. Prestwick2_001018

82. Prestwick3_001018

83. Alprostadil [inn]

84. Alprostadil [jan]

85. Dsstox_cid_2578

86. Alprostadil [usan]

87. Alprostadil [vandf]

88. Pge1 (prostaglandin E1)

89. Alprostadil [mart.]

90. Dsstox_rid_76640

91. Dsstox_gsid_22578

92. Schembl33317

93. Alprostadil [usp-rs]

94. Alprostadil [who-dd]

95. Bspbio_001175

96. Bspbio_001488

97. Mls000758964

98. Mls001424250

99. Bidd:gt0747

100. Prostaglandin E1 [mi]

101. Bpbio1_001293

102. Gtpl1882

103. Alprostadil (jp17/usp/inn)

104. Dtxsid9022578

105. Alprostadil [orange Book]

106. Pge1, Prostaglandin E1, Powder

107. Alprostadil [usp Impurity]

108. Hms1361k10

109. Hms1571k17

110. Hms1791k10

111. Hms1989k10

112. Hms2052l11

113. Hms2090l08

114. Hms2098k17

115. Hms3268i09

116. Hms3402k10

117. Hms3414n09

118. Hms3648o17

119. Hms3678n07

120. Hms3715k17

121. Alprostadil [usp Monograph]

122. Amy30076

123. Bcp01740

124. Ex-a1411

125. Hy-b0131

126. Zinc3813088

127. Tox21_110482

128. 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoic Acid

129. 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic Acid

130. Bdbm50101853

131. L-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxocyclopentaneheptanoic Acid

132. Lmfa03010134

133. S1508

134. Akos015961103

135. Prost-13-en-1-oic Acid, 11,15-dihydroxy-9-oxo-, (11.alpha.,13e,15s)-

136. Prost-13-en-1-oic Acid, 11,15-dihydroxy-9-oxo-, (11alpha,13e,15s)-

137. Ac-6095

138. Bcp9000277

139. Ccg-101188

140. Cs-1905

141. Db00770

142. Nc00438

143. Idi1_033958

144. Prostaglandin E1, >=99.0% (tlc)

145. Smp2_000271

146. Ncgc00025234-02

147. Ncgc00025234-03

148. Ncgc00025234-04

149. Ncgc00025234-05

150. As-16360

151. Prostaglandin E1, Pge1, 745-65-3

152. Alprostadil 100 Microg/ml In Acetonitrile

153. 11,15-dihydroxy-9-oxoprost-13-en-1-oate

154. Ab00514004

155. B2154

156. P1917

157. Alprostadil, Meets Usp Testing Specifications

158. C04741

159. C76381

160. D00180

161. Prostaglandin E1, >=98% (hplc), Synthetic

162. Ab00514004-06

163. Ab00514004-08

164. Ab00514004_09

165. 11,15-dihydroxy-9-oxoprost-13-en-1-oic Acidl

166. 745p653

167. A838163

168. Q579348

169. Sr-01000946253

170. Sr-01000597593-1

171. Sr-01000597593-5

172. Sr-01000597593-6

173. Sr-01000946253-1

174. W-104416

175. Brd-k52459643-001-06-0

176. Brd-k52459643-001-10-2

177. Brd-k52459643-001-17-7

178. (13e)-(15s)-11,15-dihydroxy-9-oxoprost-13-enoate

179. (13e)-(15s)-11,15-dihydroxy-9-oxoprost-13-enoic Acid

180. Alprostadil, European Pharmacopoeia (ep) Reference Standard

181. (13e)-(15s)-11alpha,15-dihydroxy-9-oxoprost-13-enoic Acid

182. (11?,13e,15s)-11,15-dihydroxy-9-oxo-prost-13-en-1-oic Acid

183. (13e)-(15s)-11-alpha,15-dihydroxy-9-oxoprost-13-enoic Acid

184. 11,15-dihydroxy-9-oxoprost-13-en-1-oic Acid (acd/name 4.0)

185. 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoate

186. Alprostadil, United States Pharmacopeia (usp) Reference Standard

187. (+)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoate

188. (+)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoic Acid

189. (-)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoate

190. (-)-3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-cyclopentaneheptanoic Acid

191. (11alpha,12alpha,13e,15s)-11,15-dihydroxy-9-oxoprost-13-en-1-oic Acid

192. Cyclopentaneheptanoic Acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, L-

193. Prost-13-en-1-oic Acid, 11,15-dihydroxy-9-oxo-, (11a,13e,15s)-

194. Prostaglandin E1, Synthetic, Powder, Bioreagent, Suitable For Cell Culture

195. Cyclopentaneheptanoic Acid, 3-hydroxy-2-(3-hydroxy-1-octenyl)-5-oxo-, (-)-

196. Prostaglandin E1, Powder, Gamma-irradiated, Bioxtra, Suitable For Cell Culture

197. Xpg

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₃₄O₅
Molecular Weight	354.5 g/mol
XLogP3	3.2
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	13
Exact Mass	354.24062418 g/mol
Monoisotopic Mass	354.24062418 g/mol
Topological Polar Surface Area	94.8 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	432
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 12
Drug Name	Caverject
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.Alprostadil is a white to off-white c...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.005mg/vial; 0.02mg/vial; 0.04mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

2 of 12
Drug Name	Caverject impulse
Drug Label	CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.Alprostadil is a white to off-white c...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.02mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

3 of 12
Drug Name	Edex
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	edex (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex is supplied in single-dose,...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.02mg/vial; 0.04mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Auxilium Pharms

4 of 12
Drug Name	Muse
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	MUSE (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository mea...
Active Ingredient	Alprostadil
Dosage Form	Suppository
Route	Urethral
Strength	0.5mg; 1mg; 0.25mg; 0.125mg
Market Status	Prescription
Company	Meda Pharms

5 of 12
Drug Name	Prostin vr pediatric
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol.The chemical name for alprostadil is (11,13E,15S)-11,15 dihydroxy-9-oxo-pros...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.5mg/ml
Market Status	Prescription
Company	Pharmacia And Upjohn

6 of 12
Drug Name	Alprostadil
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.5mg/ml
Market Status	Prescription
Company	Teva Pharms Usa; Eurohlth Intl

7 of 12
Drug Name	Caverject
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.Alprostadil is a white to off-white c...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.005mg/vial; 0.02mg/vial; 0.04mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

8 of 12
Drug Name	Caverject impulse
Drug Label	CAVERJECT contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1) and is designated chemically as (11,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.Alprostadil is a white to off-white c...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.02mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Pharmacia And Upjohn

9 of 12
Drug Name	Edex
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	edex (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1). edex is supplied in single-dose,...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.02mg/vial; 0.04mg/vial; 0.01mg/vial
Market Status	Prescription
Company	Auxilium Pharms

10 of 12
Drug Name	Muse
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	MUSE (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository mea...
Active Ingredient	Alprostadil
Dosage Form	Suppository
Route	Urethral
Strength	0.5mg; 1mg; 0.25mg; 0.125mg
Market Status	Prescription
Company	Meda Pharms

11 of 12
Drug Name	Prostin vr pediatric
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol.The chemical name for alprostadil is (11,13E,15S)-11,15 dihydroxy-9-oxo-pros...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.5mg/ml
Market Status	Prescription
Company	Pharmacia And Upjohn

12 of 12
Drug Name	Alprostadil
PubMed Health	Alprostadil
Drug Classes	Endocrine-Metabolic Agent, Erectile Dysfunction Agent, Prostaglandin
Drug Label	Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-...
Active Ingredient	Alprostadil
Dosage Form	Injectable
Route	Injection
Strength	0.5mg/ml
Market Status	Prescription
Company	Teva Pharms Usa; Eurohlth Intl

4.2 Drug Indication

For palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Also for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Alprostadil (prostaglandin E1) is produced endogenously to relax vascular smooth muscle and cause vasodilation. In adult males, the vasodilatory effects of alprostadil on the cavernosal arteries and the trabecular smooth muscle of the corpora cavernosa result in rapid arteriolar inflow and expansion of the lacunar spaces within the corpora. As the expanded corporal sinusoids are compressed against the tunica albuginea, venous outflow through the subtunical vessels is impeded and penile rigidity develops. This is referred to as the corporal veno-occlusive mechanism. In infants, the vasodilatory effects of alprostadil increase pulmonary or systemic blood flow.

5.2 MeSH Pharmacological Classification

Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)

Platelet Aggregation Inhibitors

Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

ALPROSTADIL

5.3.2 FDA UNII

F5TD010360

5.3.3 Pharmacological Classes

Prostaglandin Analog [EPC]; Prostaglandin E1 Agonist [EPC]; Prostaglandin Receptor Agonists [MoA]; Prostaglandins [CS]; Venous Vasodilation [PE]; Genitourinary Arterial Vasodilation [PE]

5.4 ATC Code

C - Cardiovascular system

C01 - Cardiac therapy

C01E - Other cardiac preparations

C01EA - Prostaglandins

C01EA01 - Alprostadil

G - Genito urinary system and sex hormones

G04 - Urologicals

G04B - Urologicals

G04BE - Drugs used in erectile dysfunction

G04BE01 - Alprostadil

5.5 Absorption, Distribution and Excretion

Absorption

The absolute bioavailability of alprostadil has not been determined.

Route of Elimination

Alprostadil must be infused continuously because it is very rapidly metabolized. As much as 80% of the circulating alprostadil may be metabolized in one pass through the lungs, primarily by - and -oxidation. The metabolites are excreted primarily by the kidney, and excretion is essentially complete within 24 hours after administration.

5.6 Metabolism/Metabolites

5.7 Biological Half-Life

5 to 10 minutes (after a single dose), in healthy adults and neonates.

5.8 Mechanism of Action

Alprostadil causes vasodilation by means of a direct effect on vascular and ductus arteriosus (DA) smooth muscle, preventing or reversing the functional closure of the DA that occurs shortly after birth. This is because, as a form of prostaglandinE1 (PGE1) it has multiple effects on blood flow. This results in increased pulmonary or systemic blood flow in infants. In cyanotic congenital heart disease, alprostadil's actions result in an increased oxygen supply to the tissues. In infants with interrupted aortic arch or very severe aortic coarctation, alprostadil maintains distal aortic perfusion by permitting blood flow through the DA from the pulmonary artery to the aorta. In infants with aortic coarctation, alprostadil reduces aortic obstruction either by relaxing ductus tissue in the aortic wall or by increasing effective aortic diameter by dilating the DA. In infants with these aortic arch anomalies, systemic blood flow to the lower body is increased, improving tissue oxygen supply and renal perfusion. When administered by intracavernosal injection or as an intraurethral suppository, alprostadil acts locally to relax the trabecular smooth muscle of the corpora cavernosa and the cavernosal arteries. Swelling, elongation, and rigidity of the penis result when arterial blood rapidly flows into the corpus cavernosum to expand the lacunar spaces. The entrapped blood reduces the venous blood outflow as sinusoids compress against the tunica albuginea.

API SUPPLIERS

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USDMF

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CEP/COS

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JDMF

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KDMF

01

EUROAPI

France

Bio-Europe 2024

Exhibiting

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Contact Supplier

France

Virtual Booth

Digital Content

Alprostadil

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2023-02-02

Registration Number : 20230202-210-J-1440

Manufacturer Name : EUROAPI Hungary Ltd.

Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary

02

Yonsung Fine Chemicals

South Korea

SupplySide West 2024

Not Confirmed

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NDC API

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API Reference Price

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