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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
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
| Molecular Weight | 392.6 g/mol |
|---|---|
| Molecular Formula | C24H40O4 |
| XLogP3 | 4.9 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 392.29265975 g/mol |
| Monoisotopic Mass | 392.29265975 g/mol |
| Topological Polar Surface Area | 77.8 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 605 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 10 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Actigall |
| Drug Label | Actigall 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 Ingredient | Ursodiol |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 300mg |
| Market Status | Prescription |
| Company | Watson Pharms |
| 2 of 8 | |
|---|---|
| Drug Name | Urso 250 |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | URSO 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 Ingredient | Ursodiol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 250mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 3 of 8 | |
|---|---|
| Drug Name | Urso forte |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | URSO 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 Ingredient | Ursodiol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 500mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 4 of 8 | |
|---|---|
| Drug Name | Ursodiol |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | Ursodiol 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 Ingredient | Ursodiol |
| Dosage Form | Tablet; Capsule |
| Route | Oral |
| Strength | 250mg; 500mg; 300mg |
| Market Status | Prescription |
| Company | Corepharma; Epic Pharma; Par Pharm; Glenmark Generics; Teva Pharms; Lannett; Mylan; Impax Labs |
| 5 of 8 | |
|---|---|
| Drug Name | Actigall |
| Drug Label | Actigall 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 Ingredient | Ursodiol |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | 300mg |
| Market Status | Prescription |
| Company | Watson Pharms |
| 6 of 8 | |
|---|---|
| Drug Name | Urso 250 |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | URSO 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 Ingredient | Ursodiol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 250mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 7 of 8 | |
|---|---|
| Drug Name | Urso forte |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | URSO 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 Ingredient | Ursodiol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 500mg |
| Market Status | Prescription |
| Company | Forest Labs |
| 8 of 8 | |
|---|---|
| Drug Name | Ursodiol |
| PubMed Health | Ursodiol (By mouth) |
| Drug Classes | Gastrointestinal Agent |
| Drug Label | Ursodiol 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 Ingredient | Ursodiol |
| Dosage Form | Tablet; Capsule |
| Route | Oral |
| Strength | 250mg; 500mg; 300mg |
| Market Status | Prescription |
| Company | Corepharma; Epic Pharma; Par Pharm; Glenmark Generics; Teva Pharms; Lannett; Mylan; Impax Labs |
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
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.
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.)
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
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.
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.
API SUPPLIERS
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 2012-277 - Rev 00
Issue Date : 2018-08-10
Type : Chemical and TSE
Substance Number : 1275
Status : Valid
Registration Number : 303MF10073
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2021-04-27
Latest Date of Registration : --
Registrant Name : Eltech Pharmachem Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-211-J-501
Manufacturer Name : Farmabios SPA
Manufacturer Address : Via Pavia 1-27027, GROPELLO CAIROLI (PV), Italy
| Available Reg Filing : EU, BR |
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-25
Pay. Date : 2019-02-14
DMF Number : 16803
Submission : 2003-09-03
Status : Active
Type : II
Certificate Number : R1-CEP 2014-231 - Rev 00
Issue Date : 2020-04-21
Type : Chemical
Substance Number : 1275
Status : Valid
Registration Number : 218MF10319
Registrant's Address : Via Sicilia, 8/10 42122 Reggio Emilia, ITALY
Initial Date of Registration : 2006-03-09
Latest Date of Registration : --
Date of Issue : 2021-11-01
Valid Till : 2024-10-31
Written Confirmation Number : WC-0512
Address of the Firm :
NDC Package Code : 49345-2612
Start Marketing Date : 2002-05-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kookjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-211-J-434
Manufacturer Name : ICE SPA@Raichem Medicare Pvt. Ltd
Manufacturer Address : Via Sicilia, 8-10-42122 Reggio Nell' Emilia (RE) Italy@Plot No. 24, 25, 26 & 26P, Raichur Growth Center Chicksugur Village Chicksugur - 584 134, Dist: Raichur, Karnataka, India
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39647
Submission : 2024-03-27
Status : Active
Type : II
SuanFarma is present in all origins: Natural, Chemical & Biotechnological.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Sigmak Lifesciences: Empowering Business with High-quality Ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 2009-212 - Rev 00
Issue Date : 2015-10-26
Type : Chemical and TSE
Substance Number : 1275
Status : Valid
Registrant Name : Eltech Pharmachem Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-211-J-501
Manufacturer Name : Farmabios SPA
Manufacturer Address : Via Pavia 1-27027, GROPELLO CAIROLI (PV), Italy
| Available Reg Filing : EU, BR |
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USDMF
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2019-02-14
DMF Number : 16803
Submission : 2003-09-03
Status : Active
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39647
Submission : 2024-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-09
DMF Number : 11379
Submission : 1995-03-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3463
Submission : 1979-02-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3063
Submission : 1977-11-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4217
Submission : 1981-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3608
Submission : 1979-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3312
Submission : 1978-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5830
Submission : 1985-05-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6158
Submission : 1985-12-19
Status : Inactive
Type : II
Portfolio PDF
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CEP/COS
Axplora- The partner of choice for complex APIs.
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 2009-212 - Rev 00
Status : Valid
Issue Date : 2015-10-26
Type : Chemical and TSE
Substance Number : 1275
Axplora- The partner of choice for complex APIs.
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 2012-277 - Rev 00
Status : Valid
Issue Date : 2018-08-10
Type : Chemical and TSE
Substance Number : 1275
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Certificate Number : CEP 2024-006 - Rev 00
Status : Valid
Issue Date : 2024-08-21
Type : Chemical
Substance Number : 1275
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Certificate Number : CEP 2005-198 - Rev 07
Status : Valid
Issue Date : 2024-07-24
Type : Chemical and TSE
Substance Number : 1275
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Ursodeoxycholic acid, Code 2618
Certificate Number : R1-CEP 2010-376 - Rev 02
Status : Valid
Issue Date : 2022-04-26
Type : Chemical and TSE
Substance Number : 1275
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Certificate Number : R1-CEP 1999-047 - Rev 09
Status : Valid
Issue Date : 2021-11-30
Type : Chemical and TSE
Substance Number : 1275
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Ursodeoxycholic acid, Code 2615
Certificate Number : R1-CEP 2014-231 - Rev 00
Status : Valid
Issue Date : 2020-04-21
Type : Chemical
Substance Number : 1275
Certificate Number : R0-CEP 2010-221 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-10-25
Type : Chemical
Substance Number : 1275
Ursodeoxycholic acid, Micronised, non-micronised
Certificate Number : R0-CEP 2015-310 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-06-11
Type : Chemical
Substance Number : 1275
Certificate Number : R0-CEP 2010-233 - Rev 00
Status : Expired
Issue Date : 2011-10-28
Type : Chemical
Substance Number : 1275
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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Ursodeoxycholic Acid BP/EP/Ursodiol USP
Date of Issue : 2021-11-01
Valid Till : 2024-10-31
Written Confirmation Number : WC-0512
Address of the Firm : 100% EOU, Plot No 24, 25,26 and 26P, Raichur Growth Center, Chicksugur, Raichur,...
Ursodeoxycholic Acid IP/USP/EP/BP/JP/KP
Date of Issue : 2020-12-03
Valid Till : 2023-12-02
Written Confirmation Number : WC-0058
Address of the Firm : Village- Pathreri, Bilaspur Tauru Road, Distt. Gurgaon (Haryana)-122 412
Date of Issue : 2022-05-27
Valid Till : 2023-11-23
Written Confirmation Number : WC-0310A3-4
Address of the Firm : Plot No.Z-103/I Dahej Sez, Phase-II Dahej, Dist Bharuch, Gujarat
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Axplora- The partner of choice for complex APIs.
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2020-08-13
Registration Number : 20200813-211-J-501
Manufacturer Name : Farmabios SPA
Manufacturer Address : Via Pavia 1-27027, GROPELLO CAIROLI (PV), Italy
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-211-J-434
Manufacturer Name : ICE SPA@Raichem Medicare Pvt...
Manufacturer Address : Via Sicilia, 8-10-42122 Reggio Nell' Emilia (RE) Italy@Plot No. 24, 25, 26 & 26P, Rai...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-08-08
Registration Number : 20230808-211-J-1475
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : Plot No. 33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, C...
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2023-01-10
Registration Number : 20210723-211-J-885(6)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Hwain Farm Co., Ltd.
Registration Date : 2022-08-05
Registration Number : 20210723-211-J-885(5)
Manufacturer Name : Suzhou Tianlu Bio-Pharmaceut...
Manufacturer Address : 1128 Yinzhong South Road Wuzhong Economic Development Zone,Suzhou Jiangsu 215214 Chin...
Registrant Name : Sanil Pharmaceutical Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(2)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : JSP Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(3)
Manufacturer Name : Suzhou Tianlu Bio-Pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-08-04
Registration Number : 20210723-211-J-885(4)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2021-11-19
Registration Number : 20210723-211-J-885(1)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2023-12-07
Registration Number : 20210723-211-J-885(7)
Manufacturer Name : Suzhou Tianlu Bio-pharmaceut...
Manufacturer Address : 1128 Yin Zhong South Road, Wuzhong Economy Development Zone, Suzhou Jiangsu China-215...
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Drugs in Development
Details:
Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Ursodiol Capsules
Details : Strides Pharma, has received approval for Ursodiol Capsules USP, 300 mg from the USFDA. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 25, 2021
Details:
USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary cholesterol saturation.
Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Urso Forte-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2020
Lead Product(s) : Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides Receives USFDA Approval for Ursodiol Tablets
Details : USFDA approved generic version of Ursodiol Tablet, which is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary ...
Brand Name : Urso Forte-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 21, 2020
Details:
Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Gilead
Deal Size: $320.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 08, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Gilead
Deal Size : $320.0 million
Deal Type : Licensing Agreement
Gilead shells out $320M to J&J to buy out rare liver disease drug royalties
Details : Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.
Brand Name : Livdelzi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 08, 2024
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Ocaliva
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition September 26, 2023
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Alfasigma
Deal Size : $794.0 million
Deal Type : Acquisition
Details : Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate respon...
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : $794.0 million
September 26, 2023
Details:
Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Ocaliva
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Advanz Pharma
Deal Size: $450.0 million Upfront Cash: $405.0 million
Deal Type: Acquisition May 05, 2022
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Advanz Pharma
Deal Size : $450.0 million
Deal Type : Acquisition
Details : Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : $405.0 million
May 05, 2022
Details:
A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Ocaliva
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Duquesne University School of Pharmacy
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Lead Product(s) : Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Duquesne University School of Pharmacy
Deal Size : Not Applicable
Deal Type : Not Applicable
AllianceRx Walgreens Prime Studies Use of Ocaliva® in the Treatment of Primary Biliary Cholangiti...
Details : A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.
Brand Name : Ocaliva
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2022
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Regulatory Info :
Registration Country : Italy
Brand Name : URSODEOXYCHOLIC ACID DOC GENERIC
Dosage Form : Modified Release Hard Capsules
Dosage Strength : 450 mg
Packaging : 20 UNITS 450 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Ursosan
Dosage Form : HARD CAPSULES
Dosage Strength : 250 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : URSILON
Dosage Form : Capsules
Dosage Strength : 300 mg
Packaging : 20 UNITS 300 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Ursochol
Dosage Form : HARD CAPSULES
Dosage Strength : 250 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Ursochol
Dosage Form : Capsule, hard
Dosage Strength : 250 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : URSODEOXYCHOLIC ACID
Dosage Form : Tablets
Dosage Strength : 300 mg
Packaging : 20 UNITS 300 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : URSODEOXYCHOLIC ACID
Dosage Form : Extended Release Tablets
Dosage Strength : 450 mg
Packaging : 20 UNITS 450 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ursodessicolico Acid
Dosage Form : Ursodeoxycholic Acid 150Mg 20 Joined' Oral Use
Dosage Strength : 20 CPR 150 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ursochol 150
Dosage Form : Tabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : Ursoflor
Dosage Form : Ursodeoxycholic Acid 300Mg 20 Joined' Oral Use
Dosage Strength : 20 cps 300 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - CAPSULE;ORAL - 300MG
USFDA APPLICATION NUMBER - 19594
DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 20675
DOSAGE - TABLET;ORAL - 500MG
USFDA APPLICATION NUMBER - 20675
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Dosage Form : Solution
Grade : Oral, Topical
Application : Solubilizers
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Pharmacopoeia Ref : USP/NF
Technical Specs : N/A
Ingredient(s) : Polyoxyl 40 Hydrogenated Castor Oil
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
Analyte : Ursodeoxycholic acid
Method : HPLC/MS/MS
LLOQ : 10
Units : ng/ml
Details : endogenous compound
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