Strides Pharma Inc. Receives Approval for Prednisone Tablets by USFDA


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Comserve Inc.

Sep 09, 2020, 07:31 EST


Bronx, United States, Sep 09, 2020, 07:31 /Comserve / -- Strides Pharma Science Limited (Strides) on Thursday, i.e., September 3, 2020, stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited

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Bengaluru, September 4, 2020: Strides Pharma Science Limited (Strides) on Thursday, i.e., September 3, 2020, stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.  

As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc.  

Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years. 

As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year. 

Till now, the company has filed 126 cumulative ANDAs with USFDA, out of which 89 ANDAs have been accepted, and 37 are still waiting to be approved. 

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