FDA issues Establishment Inspection Report to Suven Life

Suven Life Sciences Limited today said the US Food and Drug Administration, which audited its facility near here, has closed the inspection 'no action Indicated (NAI) and issued an Establishment Inspection Report (EIR).

According to a filing by the city-based drug maker, the facility at Pashamylaram here for the manufacture and supply of active pharmaceutical ingredients (bulk drugs), intermediates and formulations has undergone inspection by the regulator under cGMP during from February 5-15.

'Based on this FDA inspection and the review thereafter, the facility is considered to be in an acceptable state of compliance with regards to Current Good Manufacturing Processes (CGMP) and the agency has determined that the inspection classification of this facility is no action indicated (NAI)," Suven said.

Suven Life Sciences, a biopharmaceutical company, is into Contract Research and Manufacturing Services (CRAMS) since 1995 and Drug Discovery and Development since 2005.

Suven shares closed at Rs 189.50 apiece. up 4.55 per cent apiece over the previous close on BSE.