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New Delhi, Jan 25 (PTI) Strides Pharma Science on Monday said it has received approval from the US health regulator to market generic Ursodiol capsules, used in the treatment of Primary Biliary Cirrhosis (PBC), in the American market. The company”s product is bioequivalent and therapeutically equivalent to Allergan Sales” Actigall capsules, it added.
Based on IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP 300 mg is approximately USD 45 million.
“The product will be manufactured at the company”s facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,” the company said.
Bengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with USFDA of which 96 have been approved and 31 are pending approval.
