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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
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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 : 7055
Submission : 1987-07-07
Status : Inactive
Type : II
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Axplora- The partner of choice for complex APIs.
Axplora- The partner of choice for complex APIs.
Ursodeoxycholic Acid, UDCAe "c"
Certificate Number : CEP 2018-115 - Rev 01
Status : Valid
Issue Date : 2024-06-17
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
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
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 1999-047 - Rev 10
Status : Valid
Issue Date : 2024-10-28
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.
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
Certificate Number : R0-CEP 2010-233 - Rev 00
Status : Expired
Issue Date : 2011-10-28
Type : Chemical
Substance Number : 1275
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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:
Ursodiol is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol and the secretion of cholesterol.
Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Urso DS-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2024
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
Sunshine Biopharma Launches a New Generic Prescription Drug
Details : Ursodiol is indicated for the treatment of patients with Primary Biliary Cirrhosis. It inhibits the absorption of cholesterol and the secretion of cholesterol.
Brand Name : Urso DS-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 22, 2024
Details:
Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2024
Lead Product(s) : Seladelpar Lysine,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
With FDA Approval of Livdelzi, Gilead Launches an Inflammatory Drug for The First Time
Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Brand Name : Livdelzi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 15, 2024
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ursotan
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 180X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : RX
Registration Country : USA
Brand Name : URSO 250
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Packaging :
Approval Date : 1997-12-10
Application Number : 20675
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : URSO FORTE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2004-07-21
Application Number : 20675
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2020-05-08
Application Number : 205789
Regulatory Info : RX
Registration Country : USA
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Regulatory Info : RX
Registration Country : USA
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 400MG
Packaging :
Approval Date : 2020-05-08
Application Number : 205789
Regulatory Info : RX
Registration Country : USA
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code : AB
Brand Name : URSO 250
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date : 1997-12-10
Application Number : 20675
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : URSO FORTE
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Approval Date : 2004-07-21
Application Number : 20675
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
RLD : No
TE Code :
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Approval Date : 2020-05-08
Application Number : 205789
RX/OTC/DISCN : RX
RLD : No
TE Code :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
RLD : No
TE Code :
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 400MG
Approval Date : 2020-05-08
Application Number : 205789
RX/OTC/DISCN : RX
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 2021-01-22
Application Number : 210344
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date : 2020-08-20
Application Number : 213504
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG
Approval Date : 2020-08-20
Application Number : 213504
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : ACTIGALL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 150MG
Approval Date : 1987-12-31
Application Number : 19594
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AB
Brand Name : ACTIGALL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 300MG
Approval Date : 1987-12-31
Application Number : 19594
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : URSODIOL
Dosage Form : TABLET;ORAL
Dosage Strength : 250MG
Approval Date : 2018-10-30
Application Number : 211145
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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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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USP
ANALYTICAL
ABOUT THIS PAGE
A Ursodiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ursodiol, including repackagers and relabelers. The FDA regulates Ursodiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ursodiol 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 Ursodiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ursodiol supplier is an individual or a company that provides Ursodiol active pharmaceutical ingredient (API) or Ursodiol finished formulations upon request. The Ursodiol suppliers may include Ursodiol API manufacturers, exporters, distributors and traders.
click here to find a list of Ursodiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ursodiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ursodiol active pharmaceutical ingredient (API) in detail. Different forms of Ursodiol DMFs exist exist since differing nations have different regulations, such as Ursodiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ursodiol DMF submitted to regulatory agencies in the US is known as a USDMF. Ursodiol USDMF includes data on Ursodiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ursodiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ursodiol suppliers with USDMF on PharmaCompass.
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 Ursodiol Drug Master File in Japan (Ursodiol JDMF) empowers Ursodiol 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 Ursodiol JDMF during the approval evaluation for pharmaceutical products. At the time of Ursodiol 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 Ursodiol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ursodiol Drug Master File in Korea (Ursodiol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ursodiol. The MFDS reviews the Ursodiol KDMF as part of the drug registration process and uses the information provided in the Ursodiol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ursodiol 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 Ursodiol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ursodiol suppliers with KDMF on PharmaCompass.
A Ursodiol CEP of the European Pharmacopoeia monograph is often referred to as a Ursodiol Certificate of Suitability (COS). The purpose of a Ursodiol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ursodiol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ursodiol to their clients by showing that a Ursodiol CEP has been issued for it. The manufacturer submits a Ursodiol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ursodiol CEP holder for the record. Additionally, the data presented in the Ursodiol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ursodiol DMF.
A Ursodiol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ursodiol 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 Ursodiol suppliers with CEP (COS) on PharmaCompass.
A Ursodiol written confirmation (Ursodiol WC) is an official document issued by a regulatory agency to a Ursodiol manufacturer, verifying that the manufacturing facility of a Ursodiol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ursodiol APIs or Ursodiol finished pharmaceutical products to another nation, regulatory agencies frequently require a Ursodiol WC (written confirmation) as part of the regulatory process.
click here to find a list of Ursodiol suppliers with Written Confirmation (WC) on PharmaCompass.
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 Ursodiol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ursodiol API and other APIs are published in this directory by the FDA.
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 Ursodiol 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.
The NDC directory also contains data on finished compounded human drug products that contain Ursodiol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ursodiol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ursodiol suppliers with NDC on PharmaCompass.
Ursodiol 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 Ursodiol 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 Ursodiol GMP manufacturer or Ursodiol GMP API supplier for your needs.
A Ursodiol CoA (Certificate of Analysis) is a formal document that attests to Ursodiol's compliance with Ursodiol specifications and serves as a tool for batch-level quality control.
Ursodiol CoA mostly includes findings from lab analyses of a specific batch. For each Ursodiol 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.
Ursodiol may be tested according to a variety of international standards, such as European Pharmacopoeia (Ursodiol EP), Ursodiol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ursodiol USP).
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