Company Watch

Strides gets FDA nod for AIDS drugs

Our News Bureau - Mumbai

Strides Arcolab has received tentative approval from the USFDA for Lamivudine/Zidovudine 150 mg/300 mg tablets co-packaged with Nevirapine 200 mg tablets. This is the company's first NDA approval. This application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme.

Arun Kumar, Vice-Chairman and Managing Director, Strides Arcolab said, "We are pleased to receive our first tentative approval for a NDA from the USFDA. This approval represents a significant opportunity for Strides to commercialise field adaptable fixed dose combination ARVs co-packaged with other ARVs for ease of patient compliance."

The company has received tentative approval from FDA for Stavudine capsules and Nevirapine tablets. Four applications are under review with the USFDA under the same programme and another 12 are in the pipeline for development and submission. The company has six WHO pre-qualified ARVs, which are supplied to more than 37 countries in Africa and Asia. The company is also partnering with the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.

In yet another development, the company was intimated by the Medicines and Healthcare products Regulatory Agency (MHRA), UK that its manufacturing site for sterile products (non-Penicillin and non-Cephalosporins) in Bangalore has been qualified as compliant with the principles and guidelines of good manufacturing practices as laid down in Commission Directive 2003/94/EC.