Strides Pharma gets USFDA nod for therapeutically equivalent of Deltasone Tablets
Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti- inflammatory or an immunosuppressant medication.
Bengaluru: Strides Pharma Science Limited has recently announced that the company's 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.
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.
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.