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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

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3 Drugs in Development

3 Drugs in Development

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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

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

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

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1 Roquette

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

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14 Health Canada Patents

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Synopsis

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Europe

Canada

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South Africa

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REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

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US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

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US Medicaid (USD)

23,421

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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

01

Chirogate International

Taiwan

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

Medlab Asia & Asia Health

Not Confirmed

Chirogate is a professional Prostaglandin manufacturer.

Contact Supplier

Taiwan

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

02

EUROAPI

France

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

DDL Conference

Attending

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

Contact Supplier

France

Virtual Booth

Digital Content

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF CN, RU, ...

AUDIT

03

LGM Pharma

U.S.A

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

Medlab Asia & Asia Health

Not Confirmed

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

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

07

Ono Pharmaceutical

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

Medlab Asia & Asia Health

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Euroapi Hungary Ltd

France

Antibody Engineering

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

Alprostadil

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10948

Submission : 1994-06-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

China

Antibody Engineering

Not Confirmed

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CEP/COS

01

EUROAPI HUNGARY Ltd. Budapest HU

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

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Alprostadil

Certificate Number : R1-CEP 2015-302 - Rev 00

Status : Valid

Issue Date : 2022-01-31

Type : Chemical

Substance Number : 1488

02

EVERLIGHT CHEMICAL INDUSTRIAL CORPO...

Taiwan

Antibody Engineering

Not Confirmed

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JDMF

01

EUROAPI Hungary Ltd.

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

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Alprostadil

Registration Number : 220MF10064

Registrant's Address : To(´) utca 1-5. , 1045 Budapest, Hungary

Initial Date of Registration : 2008-02-25

Latest Date of Registration : 2016-12-20

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KDMF

01

EUROAPI

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

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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

Antibody Engineering

Not Confirmed

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NDC API

01

Chirogate International Inc

Taiwan

Antibody Engineering

Not Confirmed

Chirogate is a professional Prostaglandin manufacturer.

Contact Supplier

Taiwan

Virtual Booth

Digital Content

ALPROSTADIL

NDC Package Code : 68245-0007

Start Marketing Date : 2005-01-01

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

02

EUROAPI Hungary Ltd.

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

Digital Content

ALPROSTADIL

NDC Package Code : 82231-101

Start Marketing Date : 2014-10-28

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

03

Chinoin Pharmaceutical and Chemical...

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

Digital Content

ALPROSTADIL

NDC Package Code : 45542-1152

Start Marketing Date : 2014-10-28

End Marketing Date : 2025-09-20

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

Marketing Category : BULK INGREDIENT

04

Qingdao Biopeptek Co., Ltd.

U.S.A

Antibody Engineering

Not Confirmed

05

DARMERICA, LLC

U.S.A

Antibody Engineering

Not Confirmed

06

Everlight Chemical Industrial Corpo...

Taiwan

Antibody Engineering

Not Confirmed

07

LETCO MEDICAL, LLC

U.S.A

Antibody Engineering

Not Confirmed

08

Ono Pharmaceutical Co., Ltd.

Japan

Antibody Engineering

Not Confirmed

09

Pharmacia and Upjohn Company LLC

U.S.A

Antibody Engineering

Not Confirmed

10

Spectrum Laboratory Products, Inc.

U.S.A

Antibody Engineering

Not Confirmed

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Listed Suppliers

01

Chirogate International

Taiwan

Antibody Engineering

Not Confirmed

Chirogate is a professional Prostaglandin manufacturer.

Contact Supplier

Taiwan

Virtual Booth

Digital Content

Alprostadil

About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reput...

Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. With a focus on quality and compliance, Chirogate has built a reputation as a professional API supplier. Through innovative proprietary processes and advanced technology platforms, Chirogate offers competitively priced prostaglandin products to customers in both regulated and unregulated markets worldwide. Its activities adhere to stringent cGMP regulations and international drug manufacturing codes, guaranteeing the safety and quality of its products. Chirogate has been successfully inspected by regulatory agencies like the USFDA.

02

EUROAPI

France

Antibody Engineering

Not Confirmed

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

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France

Virtual Booth

Digital Content

Alprostadil

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.

03

LGM Pharma

U.S.A

Antibody Engineering

Not Confirmed

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

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U.S.A

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Digital Content

Alprostadil

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

Portfolio PDF

Product Web Link

South Korea

Antibody Engineering

Not Confirmed

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API Reference Price

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