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Strides Pharma secures USFDA approval for Prednisone Tablets

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-02-12T13:49:48+05:30  |  Updated On 12 Feb 2021 8:19 AM GMT
Strides Pharma secures USFDA approval for Prednisone Tablets

Bengaluru: Drug major, Strides Pharma Science Limited, announced that the company's 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 (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug...

Bengaluru: Drug major, Strides Pharma Science Limited, announced that the company's 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 (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).

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.

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 December 2020 data, the US market for Prednisone Tablets USP, 10 mg and 20 mg is approximately US$ 60 Mn.

The company has 127 cumulative ANDA filings with USFDA of which 98 ANDAs have been approved and 29 are pending approval.

Read also: Strides Pharma to demerge biotech business under Stelis Biopharma

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.

Read also: Strides Pharma secures USFDA okay for Primary Biliary Cirrhosis drug Ursodiol




strides pharma strides pharma news strides pharma science prednisone tablets usfda deltasone tablets corticosteroids allergic disorders skin conditions ulcerative colitis arthritis lupus psoriasis breathing disorders 
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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