PBC is a progressive disease of the liver caused by a buildup of bile within the liver that results in damage to the small bile ducts that drain bile from the liver.
Strides Pharma Global, Singapore, has received approval for Ursodiol tablets USP in the strengths of 250 mg and 500 mg from the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.
The product is a generic version of Urso 250 tablets, 250 mg, and Urso Forte Tablets, 500 mg, of Allergan Sales, LLC.
Quoting IQVIA moving annual total (MAT) June 2020 data, Strides Pharma Science said the US market for Ursodiol tablets USP, 250 mg and 500 mg, is approximately USD 35 million.
Strides Pharma Science said the product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma 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 were trading 6.60 per cent higher at Rs 605.75 apiece on BSE.