Strides Pharma gets USFDA nod for Ursodiol capsules

The drug will be marketed by Strides Pharma Inc. in the US market.

Strides Pharma Science on Monday announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore has received approval for Ursodiol capsules from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall capsules of Allergan Sales. Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).

According to IQVIA MAT November 2020 data, the US market for Ursodiol capsules is approximately $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.

Strides Pharma Science is a global pharmaceutical company. It focuses on "difficult to manufacture" products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.

Shares of Strides Pharma were trading 1.06% lower at Rs 838.75 on BSE. Meanwhile, the S&P BSE Sensex was down 30.71 points or 0.06% at 48,847.83.

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