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Tuesday, May 03, 2005

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USFDA nod for Aurobindo unit

Our Bureau

HYDERABAD: The Unit VIII facility of Aurobindo Pharma Ltd (APL) has received approvals from the United States Federal Drug Authority (USFDA) as a site to manufacture Active Pharmaceutical Intermediates (APIs) for the US market.

The Unit VIII of the Hyderabad-based APL consists of four production blocks, of which three are geared for APIs for regulated markets in the anti-retro virals CNS /anti-allergics / CVS segments.

This is the third approval for the company given by USFDA. The others being unit I for APIs and unit III for formulations. Unit VIII facility is situated at Gaddapotharam Village, Kazipally - IDA, Jinnaram (Mandal), Medak District, Andhra Pradesh.

APL has around 65 APIs in the non-antibiotics and over 55 APIs in the antibiotic segment. It markets these products globally in over 100 countries, according to a company press release today.

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