Strides Pharma gallops after USFDA nod for Ursodiol tablets

Strides Pharma Science jumped 6.43% to Rs 604.80 after the company said it received US drug regulator's approval Ursodiol tablets.

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, 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 $35 million.

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.

The company's consolidated net profit stood at Rs 101.84 crore in Q1 June 2020 as compared to Rs 2.91 crore in Q1 June 2020. The pharma major witnessed a 14% Y-o-Y (year-on-year) increase in net sales to Rs 781.80 crore in Q1 FY21 over Q1 FY20.

Strides is a global pharmaceutical company. It focuses on "difficult to manufacture" products that are sold in over 100 countries.

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