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Developments Hepatology (Liver, Pancreatic, Gall Bladder) Approved
India 
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) 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:
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.
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
