Strides Pharma receives USFDA nod for anti-HIV drugs by admin- Friday, January 15th, 2021 03:22:44 PM
Strides Pharma Science has introduced that its step-down totally owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has obtained acclaim for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically
equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 2 hundred mg/three hundred mg, of Gilead Sciences.
According to IQVIA MAT November 2020 records, the United States marketplace for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, two hundred mg/300 mg is approximately US$ 2.4 Bn. The product will be synthetic on the company’s facility at Bengaluru and can be advertised with the aid of Strides Pharma Inc. Inside the US marketplace.
The organisation has 127 cumulative ANDA filings with USFDA of which 95 ANDAs had been authorised and 32 are pending approval.