Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 2.5 mg and 5 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co. According to IQVIA MAT September 2020 data, the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately US$ 30 Mn. 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 127 cumulative ANDA filings with USFDA of which 93 ANDAs have been approved and 34 are pending approval.

Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bengaluru, 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 (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida). The Company focusses on “difficult to manufacture” products that are sold in over 100 countries