Strides Pharma Science rose 1.69% to Rs 936.95 after the company's Singapore-based subsidiary received US drug regulator's nod for Emtricitabine and Tenofovir Disoproxil Fumarate tablets.
In a BSE filing made before market hours today, the company said that its wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg from the United States Food & Drug Administration (US FDA).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets, 200 mg/300 mg, of Gilead Sciences. 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 November 2020 data, the US market for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg is approximately $2.4 billion.
Emtricitabine and tenofovir belongs to class of medications called nucleoside and nucleotide reverse transcriptase inhibitors. The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications to treat HIV in adults and children.
Strides Pharma Science is a global pharmaceutical company. It focuses on "difficult to manufacture" products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved and 33 are pending approval.
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