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Lead Product(s): L-Ornithine L-aspartate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Hepa-Merz
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Winhealth Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 08, 2021
Details:
The strategic cooperation between the two parties marks the obtainment of Winhealth Pharma for the exclusive commercial rights of Hepa-Merz® (L-ornithine L-aspartate, an important product under Merz' product portfolio) in China.
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Lead Product(s): Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
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.
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Lead Product(s): Saroglitazar magnesium
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Lipaglyn
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
The Drug Controller General of India (DCGI) has approved the new drug application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India, Zydus NSE 0.27 % Cadila said in a regulatory filing.
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Lead Product(s): Autologous pancreatic islets cells
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Kyslecel
Highest Development Status: Approved Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Orgenesis
Deal Size: $16.3 million Upfront Cash: Undisclosed
Deal Type: Acquisition September 29, 2020
Details:
Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well.
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Lead Product(s): Defibrotide Sodium
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2020
Details:
Enrollment in the study was stopped early based on the recommendation from an IDMC, which concluded it would be highly unlikely to reach statistical significance for the primary endpoint.
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