Date:07/07/2007 URL: http://www.thehindubusinessline.com/2007/07/07/stories/2007070750010200.htm

Back Shasun facility gets US FDA nod

Chennai, July 4

Shasun Chemicals & Drugs Ltd, manufacturer of finished dosage forms, API (active pharmaceutical ingredients) and intermediates for global pharma companies, has announced that the US Food and Drug Administration (FDA) has approved the company’s formulation facility in Puducherry. Quoting Mr Govindarajan, CEO and Managing Director of the company, a press release from Shasun Chemicals says, “With the formulation facility having already undergone successful MHR A (Medicines and Healthcare Products Regulatory Agency) of UK and now FDA audits, we are in the process of diversifying our business by making a foray into formulation exports, predominantly into the regulated markets such as the US, Canada and Europe.” According to the release, the company has forged marketing alliances with two multinational companies and expects to launch its products in the US by the second half of 2008. Besides, the company has filed three ANDAs (Abbreviated New Drug Application) so far and is expected to file another eight to nine in the current fiscal.

— Our Bureau