Strides gets USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte Singapore, has received approval for Efavirenz (600mg), Emtricitabine (200mg), Tenofovir Disproxil Fumurate (300mg), (EET) tablets from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Atripla Tablets of Gilead Sciences LLC. The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products.

The EET tablet has a market opportunity in the US of $7.5 million per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.

The PEPFAR approval for Strides qualifies the Company to participate in global donor funded programs that procure this lifesaving medicine and it is supplied in 10 countries. As of full year 2022, donor procurement for EET Tablets is estimated at a value of $15million. This product further strengthens the available offerings in HIV treatment from Strides.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.