Strides gets US FDA nod to market `Vancomycin' from new facility

Strides Arcolab Limited has received approval from the US Food and Drug Administration (FDA) to commercialise Vancomycin injection. Strides will commence the first shipment in March, the company said in a filing with the Bombay Stock Exchanage (BSE).

The product, being produced at the company's new sterile injectable complex in Bangalore, is currently facing an upswing in demand in the US and the FDA approval allows Strides to use its unconstrained capacity at the new facility to meet the increasing demand, the company said in its filing

"The US FDA approval for the new site is an important milestone in scaling up our business in the USA. With our unconstrained capacity, we are now well positioned to take advantage of the significant opportunity for injectable products in the US market. We will follow this with a series of initiatives to include the new facility in all the approved ANDAs thereby facilitating the launch of more products in the US in the coming quarters," Venkat Iyer, CEO, Agila Specialties, said.

Strides Arcolab expects an aggressive year-on-year growth of 25 per cent in 2011 compared with the previous year, with the specialties business expected to grow at 45 per cent.

As of 31 December 2010, Strides Arcolab had 113 injectable ANDA filings and 33 approvals from the US FDA. Of these, Strides has commercialised only 9 products from its
approved site, which absorbs the total capacity available.

Vancomycin injection utilises 70 per cent of the current capacities, thereby constraining launch of other approved ANDAs, Strides said in its filing.