Date:16/08/2006 URL: http://www.thehindu.com/2006/08/16/stories/2006081605730400.htm

Karnataka - Bangalore

Strides Arcolab gets tentative nod for drug

Special Correspondent

Nevirapine is a key anti-retroviral drug used in the treatment of AIDS

Tentative approval from the U.S. Food and Drug Administration
This is the company's first product approval

Four applications are under review with the FDA

Bangalore: Strides Arcolab has received tentative approval from the U.S. Food and Drug Administration (FDA) for Nevirapine Tablets 200 mg. This is the company's first product approval. The application was reviewed under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme.

Arun Kumar, vice-chairman and chief executive officer, Strides Arcolab, said, "We are pleased to receive this first ANDA (Abbreviated New Drug Application) tentative approval from the FDA. This approval represents a significant opportunity for Strides to commercialise Nevirapine, a key anti-retroviral (ARV) in the treatment of AIDS."

Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This ARV drug is used in combination with other ARV agents for the treatment of HIV-1 infection.

The company has four applications under review with the FDA under the same programme and another four in the pipeline for submission. The company already has five WHO pre-qualified ARVs, which are supplied to more than 37 countries in Africa and Asia.

The company is also partnering the Clinton Foundation to ensure the availability of affordable, good quality generic ARVs in the least developed countries.

Competency centre

EDS Technologies (EDST), product lifecycle management (PLM) solutions and service provider will be setting up a technology competency centre for PLM solutions and applications in Bangalore. The centre will help Indian customers — original equipment manufacturers, small and medium enterprises and engineering and design service providers — derive benefits from the use of PLM solutions for their businesses.

Venkata Siva Prasad will be the head of the centre. According to S. Senthil, vice-president (Operations), EDST, the centre will have a dedicated team of specialists in IBM and Dassault Systems PLM products.

Customer support

Lyric Labs, a linguistic support services organisation, has expanded its operations by launching a customer support centre in Bangalore. With this, the company has extended its presence to five cities in India. Catering to corporates, the company operates through it customer support centres located in Mumbai, Pune, Chennai and Coimbatore.

The service addresses the industry, software, manufacturing, engineering, pharmaceutical and biotechnology sectors.

Selected

Bangalore-based MetricStream, which is into enterprise-wide compliance and the quality management market, has announced that Pegasus Wireless, a provider of advanced wireless solutions, has selected its solution for sustainable and cost-effective compliance with the Sarbanes-Oxley Act and ISO quality standards. With this selection, Pegasus Wireless has taken a significant step towards consolidating all compliance programmes and managing regulatory requirements in an integrated and consistent manner.