Saroglitazar Mg, approved by the DCGI, is an innovative drug from Zydus to treat chronic liver diseases, such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steato Hepatitis (NASH).
Lupin and Zydus Lifesciences entered into a licensing and supply agreement to co-market Saroglitazar Mg, an innovative drug approved by India s DCGI for treating non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS.
New Delhi: Drug firm Cadila Healthcare on Wednesday reported a 29.33 per cent rise in its consolidated net profit to Rs 587.2 crore for the quarter ended on June 30, 2021, mainly on account of robust.
Synopsis
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.
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New Delhi: Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease. The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg,
Cadila Healthcare said in a regulatory filing. Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.