Strides Arcolab Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for one new drug application (NDA) for fixed dose combination of Lamivudine and Stavudine Tablets 150 mg / 30 mg under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).
According to V S Iyer, chief executive officer - India Operations of Strides Arcolab, this approval is yet another significant milestone in the front line of approvals for key HIV / AIDS medicines. "This takes the total NDAs / ANDAs approvals received to 11 under the PEPFAR programme. This, combined with our pipeline of second line drugs will make us a significant player in the quality, affordable multi-source ARVs business segment."
The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available.
Strides manufactures pharmaceutical formulations in various dosage forms including sterile injectables with dedicated facilities for Penicillin and Penems, Cepahlosporins, Oncolytics and lyophilized injectable products. It is also engaged in the production of formulations in oral dosage forms, including capsules & tablets and Softgel capsules. It has significant presence in Australasia, Africa and India. Through a series of strategies, it is expanding its North American and European growth. In addition, the company has a series of joint ventures and front-ended operations in major markets and is a majority stakeholder of Ascent Pharmahealth Limited (APH), an ASX listed company. The company also collaborates closely with Global Drug Agencies and US PEPFAR and the UNICEF to supply a range of affordable generic pharmaceutical.