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 Tablets USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Urso 250® Tablets, 250 mg and Urso Forte Tablets®, 500 mg, of Allergan Sales, LLC.
Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).
According to IQVIA MAT June 2020 data, the US market for Ursodiol Tablets USP, 250 mg and 500 mg is approximately US$ 35 Mn. The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 126 cumulative ANDA filings with USFDA of which 88 ANDAs have been approved and 38 are pending approval.
Shares of Strides Pharma Science Ltd was last trading in BSE at Rs.567 as compared to the previous close of Rs. 576.9. The total number of shares traded during the day was 117229 in over 2323 trades.
The stock hit an intraday high of Rs. 576.8 and intraday low of 567. The net turnover during the day was Rs. 66898667.