Strides Pharma gets USFDA nod for colchicine tablets

Written by MD Bureau Published On 2022-03-12T10:17:54+05:30 | Updated On 12 March 2022 10:17 AM IST

Strides Pharma gets USFDA nod for colchicine tablets

Strides said the product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.

New Delhi: Drug firm Strides Pharma Science on Friday said its subsidiary has received approval from the US health regulator to sell colchicine tablets, used for the treatment and prevention of gout, in the American market. Singapore-based Strides Pharma Global Pte, a step down wholly-owned subsidiary of the company, has received approval from the United States Food & Drug Administration (USFDA) to market the product, Strides Pharma Science said in a statement.

The company's product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda Pharmaceuticals' Colcrys tablets.

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According to IQVIA MAT January 2022 data, the US market for colchicine tablets USP, 0.6 mg is stood at around USD 85 million.

Strides said 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 271 cumulative ANDA filings with USFDA, of which 245 ANDAs have been approved and 26 are pending approval, it added.

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Incorporated in 1990, Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bangalore, India. The Company has two business verticals, viz., Regulated Markets and Emerging Markets.

Strides has a global manufacturing footprint with eight manufacturing facilities spread across four continents, including five US FDA approved facilities and two facilities for the rest of world markets .

The Company has a dedicated R&D facility in India with global filing capabilities and a strong footprint across 100 countries.

Strides PharmaUSFDAgeneric productIQVIA MATRegulated Markets and Emerging Markets.

Source : PTI

MD Bureau

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