Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall® Capsules, 300 mg, of Allergan Sales, LLC.
According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg is approximately US$ 45 Mn. 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 has 127 cumulative ANDA filings with USFDA of which 96 ANDAs have been approved and 31 are pending approval.
Shares of Strides Pharma Science Ltd was last trading in BSE at Rs.850.55 as compared to the previous close of Rs. 878.9. The total number of shares traded during the day was 28079 in over 1106 trades.
The stock hit an intraday high of Rs. 886 and intraday low of 843. The net turnover during the day was Rs. 24378104.