Strides Pharma Science’s step-down wholly owned subsidiary, Strides Pharma Global has received approval for Prednisone Tablets USP, 10 mg and 20 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).
The US market for Prednisone Tablets USP, 10 mg and 20 mg is approximately $60 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. The company has 127 cumulative ANDA filings with USFDA of which 98 ANDAs have been approved and 29 are pending approval.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
