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Chemistry

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Also known as: Ursodiol, 128-13-2, Actigall, Ursodeoxycholate, Udca, Ursofalk
Molecular Formula
C24H40O4
Molecular Weight
392.6  g/mol
InChI Key
RUDATBOHQWOJDD-UZVSRGJWSA-N
FDA UNII
724L30Y2QR

Ursodeoxycholic Acid
An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.
Ursodiol is a Bile Acid.
1 2D Structure

Ursodeoxycholic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
2.1.2 InChI
InChI=1S/C24H40O4/c1-14(4-7-21(27)28)17-5-6-18-22-19(9-11-24(17,18)3)23(2)10-8-16(25)12-15(23)13-20(22)26/h14-20,22,25-26H,4-13H2,1-3H3,(H,27,28)/t14-,15+,16-,17-,18+,19+,20+,22+,23+,24-/m1/s1
2.1.3 InChI Key
RUDATBOHQWOJDD-UZVSRGJWSA-N
2.1.4 Canonical SMILES
CC(CCC(=O)O)C1CCC2C1(CCC3C2C(CC4C3(CCC(C4)O)C)O)C
2.1.5 Isomeric SMILES
C[C@H](CCC(=O)O)[C@H]1CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2[C@H](C[C@H]4[C@@]3(CC[C@H](C4)O)C)O)C
2.2 Other Identifiers
2.2.1 UNII
724L30Y2QR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3 Alpha,7 Beta Dihydroxy 5 Beta Cholan 24 Oic Acid

2. 3 Alpha,7 Beta-dihydroxy-5 Beta-cholan-24-oic Acid

3. Acid, Deoxyursocholic

4. Acid, Ursacholic

5. Acid, Ursodeoxycholic

6. Cholit-ursan

7. Cholofalk

8. Delursan

9. Deoxyursocholic Acid

10. Destolit

11. Sodium Ursodeoxycholate

12. Urdox

13. Ursacholic Acid

14. Urso

15. Urso Heumann

16. Ursobilane

17. Ursochol

18. Ursodeoxycholate, Sodium

19. Ursodiol

20. Ursofalk

21. Ursogal

22. Ursolite

23. Ursolvan

2.3.2 Depositor-Supplied Synonyms

1. Ursodiol

2. 128-13-2

3. Actigall

4. Ursodeoxycholate

5. Udca

6. Ursofalk

7. Ursolvan

8. Urso

9. Delursan

10. Ursodesoxycholic Acid

11. Urso Forte

12. Destolit

13. Ursochol

14. Cholit-ursan

15. Litursol

16. Solutrat

17. Ursobilin

18. Ursodamor

19. Arsacol

20. Deursil

21. Lyeton

22. Ursacol

23. Urso Ds

24. Udcs

25. 3alpha,7beta-dihydroxy-5beta-cholan-24-oic Acid

26. Ursosan

27. Urso 250

28. 3-alpha,7-beta-dioxycholanic Acid

29. Ursocholic Acid, Deoxy-

30. 3-alpha,7-beta-dihydroxycholanic Acid

31. Ursonorm

32. Nsc 683769

33. (3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic Acid

34. 3-alpha,7-beta-dihydroxy-5-beta-cholanoic Acid

35. Ursodeoxycholicacid

36. (4r)-4-[(3r,5s,7s,8r,9s,10s,13r,14s,17r)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]pentanoic Acid

37. Nsc 657950

38. Brn 3219888

39. 3,7-dihydroxycholan-24-oic Acid

40. Peptarom

41. Ursodeoxycholic Acid [inn]

42. Chembl1551

43. Mls000028461

44. Chebi:9907

45. 724l30y2qr

46. Nsc-683769

47. Ursodiol [usan]

48. Antigall

49. Smr000058403

50. Urosiol

51. Cholan-24-oic Acid, 3,7-dihydroxy-, (3.alpha.,5.beta.,7.beta.)-

52. 7-beta-hydroxylithocholic Acid

53. Ursodexycholic Acid

54. Acido Ursodeossicolico [italian]

55. (r)-4-((3r,5s,7s,8r,9s,10s,13r,14s,17r)-3,7-dihydroxy-10,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanoic Acid

56. Acido Ursodeoxicolico

57. Acido Ursodeossicolico

58. Acido Ursodeoxicolico [inn-spanish]

59. Acidum Ursodeoxycholicum [inn-latin]

60. Acide Ursodesoxycholique

61. Acide Ursodesoxycholique [inn-french]

62. Acidum Ursodeoxycholicum

63. Actigall (tn)

64. Ursodiol (usp)

65. (4r)-4-[(1s,2s,5r,7s,9s,10r,11s,14r,15r)-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic Acid

66. Ccris 5502

67. Urso (tn)

68. Sr-01000737091

69. Ursodiol [usan:usp]

70. Einecs 204-879-3

71. Mfcd00003680

72. Ursodexycholate

73. Paptarom

74. Udiliv

75. Desol

76. Urdes

77. Unii-724l30y2qr

78. Urosdesoxycholate

79. 17-beta-(1-methyl-3-carboxypropyl)etiocholane-3-alpha,7-beta-diol

80. Ursodeoxycholoc Acid

81. Urosdesoxycholic Acid

82. 5beta-cholanic Acid-3alpha,7beta-diol

83. Ursodiol [inci]

84. Cholan-24-oic Acid, 3,7-dihydroxy-, (3alpha,5beta,7beta)-

85. 3alpha,7beta-dihydroxy-5beta-cholanic Acid

86. Ursodiol [mi]

87. Ursodiol (actigal Urso)

88. Ursodiol [vandf]

89. Prestwick0_000958

90. Prestwick1_000958

91. Prestwick2_000958

92. Prestwick3_000958

93. U0030

94. 7a-hydroxylithocholic Acid

95. Ursodiol [usp-rs]

96. Ec 204-879-3

97. U-9000

98. Schembl27200

99. Bspbio_000956

100. 4-10-00-01604 (beilstein Handbook Reference)

101. 7bet.-hydroxylithocholic Acid

102. Cid_31401

103. Mls001066373

104. Mls002548885

105. Spbio_003105

106. Ursodeoxycholic Acid, >=99%

107. Ursodiol [orange Book]

108. Bpbio1_001052

109. Gtpl7104

110. 7.beta.-hydroxylithocholic Acid

111. Ursodiol (ursodeoxycholic Acid)

112. 5-beta-cholan-24-oic Acid, 3-alpha,7-beta-dihydroxy-

113. Dtxsid6023731

114. Ursodiol [usp Monograph]

115. Bdbm53721

116. (3alpha,5beta,7beta,8xi)-3,7-dihydroxycholan-24-oic Acid

117. Hms1570p18

118. Hms2097p18

119. Hms2233l14

120. Hms3259a13

121. Hms3714p18

122. Ursodeoxycholic Acid (jp17/inn)

123. Ursodeoxycholic Acid [jan]

124. 3alpha,7beta-dihydroxycholanic Acid

125. Act02676

126. Cholan-24-oic Acid, 3,7-dihydroxy-, (3-alpha,5-beta,7-beta)-

127. Zinc3914809

128. 3a,7b-dihydroxy-5b-cholan-24-oate

129. Lmst04010033

130. S1643

131. Ursodeoxycholic Acid [mart.]

132. Ursodeoxycholic Acid [who-dd]

133. 5a-cholan-24-oic Acid-3a,7a-diol

134. Akos015955898

135. Ccg-220958

136. Cs-1932

137. Db01586

138. Ks-5243

139. Nc00487

140. Smp2_000012

141. 3.alpha.,7.beta.-dihydroxycholanic Acid

142. 3a,7a-dihydroxy-5a-holan-24-oic Acid

143. 3a,7b-dihydroxy-5b-cholan-24-oic Acid

144. Ncgc00179363-01

145. Ncgc00179363-12

146. Ac-18919

147. Cas#128-13-2

148. Cpd000058403

149. Hy-13771

150. Nci60_028904

151. Ursodeoxycholic Acid [ep Impurity]

152. Ursodeoxycholic Acid [ep Monograph]

153. Ab00513977

154. (3a,5b,7b)-3,7-dihydroxy-cholan-24-oate

155. 3alpha, 7beta-dihydroxy-5beta-cholanoic Acid

156. 5bet.-cholan-24-oic Acid-3alp.,7bet.-diol

157. (3a,5b,7b)-3,7-dihydroxycholan-24-oic Acid

158. C07880

159. D00734

160. ((3a,5b,7b)-3,7-dihydroxycholan-24-oic Acid

161. (3a,5b,7b)-3,7-dihydroxy-cholan-24-oic Acid

162. Ab00513977-09

163. Ab00513977_10

164. 3alp.,7bet.-dihydroxy-5bet.-cholan-24-oic Acid

165. A905413

166. Q241374

167. 3.alpha.,7.beta.-dihydroxy-5.beta.-cholanic Acid

168. J-005566

169. J-650210

170. Sr-01000737091-3

171. Sr-01000737091-4

172. Brd-k15697815-001-16-2

173. 3.alpha.,7.beta.-dihydroxy-5.beta.-cholan-24-oic Acid

174. Z2786051717

175. 3.alpha.,7.beta.-dihydroxy-5b-cholan-24-oic Acid

176. 5.beta.-cholan-24-oic Acid, 3.alpha.,7.beta.-dihydroxy-

177. Ursodiol, United States Pharmacopeia (usp) Reference Standard

178. Ursodeoxycholic Acid, British Pharmacopoeia (bp) Reference Standard

179. Ursodeoxycholic Acid, European Pharmacopoeia (ep) Reference Standard

180. 17.beta.-(1-methyl-3-carboxypropyl)etiocholane-3.alpha.,7.beta.-diol

181. 3,7-dihydroxycholan-24-oic Acid-, (3.alpha.,5.beta.,7.beta.)- #

182. Ursodeoxycholic Acid, 500 Mug/ml In Methanol, Certified Reference Material

183. Ursodiol, Pharmaceutical Secondary Standard; Certified Reference Material

184. Ursodeoxycholic Acid For System Suitability, European Pharmacopoeia (ep) Reference Standard

185. (4r)-4-[(1s,2s,5r,7s,9s,10r,11s,14r,15r)-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.02,1.011,1]heptadecan-14-yl]pentanoic Acid

186. (4r)-4-[(3r,5s,7s,8r,9s,10s,13r,14s,17r)-10,13-dimethyl-3,7-bis(oxidanyl)-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]pentanoic Acid

187. (4r)-4-[(3r,5s,7s,8r,9s,10s,13r,14s,17r)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]valeric Acid

188. 108609-27-4

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 392.6 g/mol
Molecular Formula C24H40O4
XLogP34.9
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count4
Exact Mass392.29265975 g/mol
Monoisotopic Mass392.29265975 g/mol
Topological Polar Surface Area77.8 Ų
Heavy Atom Count28
Formal Charge0
Complexity605
Isotope Atom Count0
Defined Atom Stereocenter Count10
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameActigall
Drug LabelActigall is a bile acid available as 300 mg capsules suitable for oral administration.Actigall is ursodiol, USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other m...
Active IngredientUrsodiol
Dosage FormCapsule
RouteOral
Strength300mg
Market StatusPrescription
CompanyWatson Pharms

2 of 8  
Drug NameUrso 250
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelURSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurrin...
Active IngredientUrsodiol
Dosage FormTablet
RouteOral
Strength250mg
Market StatusPrescription
CompanyForest Labs

3 of 8  
Drug NameUrso forte
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelURSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurrin...
Active IngredientUrsodiol
Dosage FormTablet
RouteOral
Strength500mg
Market StatusPrescription
CompanyForest Labs

4 of 8  
Drug NameUrsodiol
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelUrsodiol Capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration.Ursodiol, USP (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain ot...
Active IngredientUrsodiol
Dosage FormTablet; Capsule
RouteOral
Strength250mg; 500mg; 300mg
Market StatusPrescription
CompanyCorepharma; Epic Pharma; Par Pharm; Glenmark Generics; Teva Pharms; Lannett; Mylan; Impax Labs

5 of 8  
Drug NameActigall
Drug LabelActigall is a bile acid available as 300 mg capsules suitable for oral administration.Actigall is ursodiol, USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other m...
Active IngredientUrsodiol
Dosage FormCapsule
RouteOral
Strength300mg
Market StatusPrescription
CompanyWatson Pharms

6 of 8  
Drug NameUrso 250
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelURSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurrin...
Active IngredientUrsodiol
Dosage FormTablet
RouteOral
Strength250mg
Market StatusPrescription
CompanyForest Labs

7 of 8  
Drug NameUrso forte
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelURSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurrin...
Active IngredientUrsodiol
Dosage FormTablet
RouteOral
Strength500mg
Market StatusPrescription
CompanyForest Labs

8 of 8  
Drug NameUrsodiol
PubMed HealthUrsodiol (By mouth)
Drug ClassesGastrointestinal Agent
Drug LabelUrsodiol Capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration.Ursodiol, USP (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain ot...
Active IngredientUrsodiol
Dosage FormTablet; Capsule
RouteOral
Strength250mg; 500mg; 300mg
Market StatusPrescription
CompanyCorepharma; Epic Pharma; Par Pharm; Glenmark Generics; Teva Pharms; Lannett; Mylan; Impax Labs

4.2 Drug Indication

The drug decreases the absorption of cholesterol and is used to dissolve (cholesterol) gallstones in patients as an alternative to a surgical procedure to remove the gallstones.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ursodiol (commonly known as ursodeoxycholic acid) is a product of metabolism of bacteria in the intestine. It is considered a secondary bile acid. The other type of bile acid, primary bile acids, are produced hepatically and subsequently stored in the gallbladder. When primary bile acids are secreted into the large intestine, they can be broken down into secondary bile acids by bacteria present in the intestine. Both types of bile acids assist in the metabolism of dietary fat. Ursodeoxycholic acid regulates cholesterol levels by slowing the rate at which the intestine is able to absorb cholesterol and also acts to break down micelles, which contain cholesterol. Because of this property, ursodeoxycholic acid is used to treat gall stones non-surgically.


5.2 MeSH Pharmacological Classification

Cholagogues and Choleretics

Gastrointestinal agents that stimulate the flow of bile into the duodenum (cholagogues) or stimulate the production of bile by the liver (choleretic). (See all compounds classified as Cholagogues and Choleretics.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
URSODIOL
5.3.2 FDA UNII
724L30Y2QR
5.3.3 Pharmacological Classes
Bile Acids and Salts [CS]; Bile Acid [EPC]
5.4 ATC Code

A05AA02

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

A05 - Bile and liver therapy

A05A - Bile therapy

A05AA - Bile acids and derivatives

A05AA02 - Ursodeoxycholic acid


5.5 Absorption, Distribution and Excretion

Route of Elimination

Only small quantities of ursodiol appear in the systemic circulation and very small amounts are excreted into urine. Eighty percent of lithocholic acid formed in the small bowel is excreted in the feces, but the 20% that is absorbed is sulfated at the 3-hydroxyl group in the liver to relatively insoluble lithocholyl conjugates which are excreted into bile and lost in feces.


5.6 Mechanism of Action

Ursodeoxycholic acid reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells. The main mechanism if anticholelithic. Although the exact process of ursodiol's anticholelithic action is not completely understood, it is thought that the drug is concentrated in bile and decreases biliary cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting its intestinal absorption. The reduced cholesterol saturation permits the gradual solubilization of cholesterol from gallstones, resulting in their eventual dissolution.


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02-Jan-2021
17-Feb-2025
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Regulatory Info : Originator

Registration Country : South Africa

Ursodeoxycholic Acid

Brand Name : Ursotan

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 180X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ursodeoxycholic acid

Brand Name : Ursofalk

Dosage Form : CAP

Dosage Strength : 250mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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DOSAGE - CAPSULE;ORAL - 300MG

USFDA APPLICATION NUMBER - 19594

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DOSAGE - TABLET;ORAL - 250MG

USFDA APPLICATION NUMBER - 20675

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DOSAGE - TABLET;ORAL - 500MG

USFDA APPLICATION NUMBER - 20675

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ABOUT THIS PAGE

Looking for 128-13-2 / Ursodeoxycholic Acid API manufacturers, exporters & distributors?

Ursodeoxycholic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ursodeoxycholic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ursodeoxycholic Acid manufacturer or Ursodeoxycholic Acid supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ursodeoxycholic Acid manufacturer or Ursodeoxycholic Acid supplier.

PharmaCompass also assists you with knowing the Ursodeoxycholic Acid API Price utilized in the formulation of products. Ursodeoxycholic Acid API Price is not always fixed or binding as the Ursodeoxycholic Acid Price is obtained through a variety of data sources. The Ursodeoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ursodeoxycholic Acid

Synonyms

Ursodiol, 128-13-2, Actigall, Ursodeoxycholate, Udca, Ursofalk

Cas Number

128-13-2

Unique Ingredient Identifier (UNII)

724L30Y2QR

About Ursodeoxycholic Acid

An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.

Ursobilane Manufacturers

A Ursobilane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ursobilane, including repackagers and relabelers. The FDA regulates Ursobilane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ursobilane API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Ursobilane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ursobilane Suppliers

A Ursobilane supplier is an individual or a company that provides Ursobilane active pharmaceutical ingredient (API) or Ursobilane finished formulations upon request. The Ursobilane suppliers may include Ursobilane API manufacturers, exporters, distributors and traders.

click here to find a list of Ursobilane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ursobilane USDMF

A Ursobilane DMF (Drug Master File) is a document detailing the whole manufacturing process of Ursobilane active pharmaceutical ingredient (API) in detail. Different forms of Ursobilane DMFs exist exist since differing nations have different regulations, such as Ursobilane USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ursobilane DMF submitted to regulatory agencies in the US is known as a USDMF. Ursobilane USDMF includes data on Ursobilane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ursobilane USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ursobilane suppliers with USDMF on PharmaCompass.

Ursobilane JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Ursobilane Drug Master File in Japan (Ursobilane JDMF) empowers Ursobilane API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Ursobilane JDMF during the approval evaluation for pharmaceutical products. At the time of Ursobilane JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Ursobilane suppliers with JDMF on PharmaCompass.

Ursobilane KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Ursobilane Drug Master File in Korea (Ursobilane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ursobilane. The MFDS reviews the Ursobilane KDMF as part of the drug registration process and uses the information provided in the Ursobilane KDMF to evaluate the safety and efficacy of the drug.

After submitting a Ursobilane KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ursobilane API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ursobilane suppliers with KDMF on PharmaCompass.

Ursobilane CEP

A Ursobilane CEP of the European Pharmacopoeia monograph is often referred to as a Ursobilane Certificate of Suitability (COS). The purpose of a Ursobilane CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ursobilane EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ursobilane to their clients by showing that a Ursobilane CEP has been issued for it. The manufacturer submits a Ursobilane CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ursobilane CEP holder for the record. Additionally, the data presented in the Ursobilane CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ursobilane DMF.

A Ursobilane CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ursobilane CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Ursobilane suppliers with CEP (COS) on PharmaCompass.

Ursobilane WC

A Ursobilane written confirmation (Ursobilane WC) is an official document issued by a regulatory agency to a Ursobilane manufacturer, verifying that the manufacturing facility of a Ursobilane active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ursobilane APIs or Ursobilane finished pharmaceutical products to another nation, regulatory agencies frequently require a Ursobilane WC (written confirmation) as part of the regulatory process.

click here to find a list of Ursobilane suppliers with Written Confirmation (WC) on PharmaCompass.

Ursobilane NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ursobilane as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ursobilane API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Ursobilane as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ursobilane and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ursobilane NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ursobilane suppliers with NDC on PharmaCompass.

Ursobilane GMP

Ursobilane Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ursobilane GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ursobilane GMP manufacturer or Ursobilane GMP API supplier for your needs.

Ursobilane CoA

A Ursobilane CoA (Certificate of Analysis) is a formal document that attests to Ursobilane's compliance with Ursobilane specifications and serves as a tool for batch-level quality control.

Ursobilane CoA mostly includes findings from lab analyses of a specific batch. For each Ursobilane CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ursobilane may be tested according to a variety of international standards, such as European Pharmacopoeia (Ursobilane EP), Ursobilane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ursobilane USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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