Bengaluru: Drug major, Strides Pharma Science Limited, today announced that the company's 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.
Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg is approximately US$ 45 Mn.
The company has 127 cumulative ANDA filings with USFDA of which 96 ANDAs have been approved and 31 are pending approval.
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Strides is a global pharmaceutical company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor‐funded markets.
The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.
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