Strides Pharma receives US FDA approval for prednisone tablets

Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for prednisone tablets USP, 10 mg and 20 mg from the United States Food & Drug Administration (FDA). 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).

According to IQVIA MAT December 2020 data, the US market for prednisone tablets USP, 10 mg and 20 mg is approximately US$ 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 US FDA of which 98 ANDAs have been approved and 29 are pending approval.

Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It is used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

Bengaluru-based Strides, 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 in Bengaluru , Singapore, Italy: Milan, Kenya: Nairobi and the United States : Florida. It focusses on “difficult to manufacture” products that are sold in over 100 countries.

About Prednisone Tablets Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It is used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

About Strides 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.