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Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has obtained approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate pills, used to treat HIV.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets of Gilead Sciences.
Strides Pharma Global, Singapore, has obtained approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the strengths of 200 mg/300 mg in the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Quoting IQVIA moving annual total (MAT) November 2020 data, Strides Pharma Science reported the US market for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is approximately USD 2.4 billion.
The product will be manufactured at the company”s centre at Bengaluru and will be marketed by Strides Pharma in the US marketplace,” the company added.
The business has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 95 ANDAs are approved and 32 are pending approval.
Shares of Strides Pharma Science were trading 0.83 percent higher at Rs 929 apiece on BSE.
