Indian pharmaceutical company Strides Pharma on Friday in an exchange filing said that its wholly owned subsidiary, Strides Pharma Global received tentative approval for its New Drug Application (NDA) of Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate tablets from the United States Food and Drug Administration (USFDA).
Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate tablets are a complete regimen for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.
The product will be manufactured at the company’s facility in Bengaluru. Approval of this product under the president's emergency plan for AIDS Relief (PEPFAR) program completes Strides’ qualification to all major markets and donor programs including global fund and South Africa, the company said in a statement.
The PEPFAR tentative approval for Strides qualifies the company to participate in the PEPFAR programs that procure this lifesaving medicine.
Through country tenders and donor-funded programs, it is estimated that the value of procurement for Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate tablets is USD 650 million. The company has set a target to launch 60 new products over the next three years in the US.
The company's stock soared by 5.48 per cent and closed at Rs 494.10 on BSE.