Suven Life Sciences, an ISO 9001, ISO 14001 and OHSAS 18001 company has undergone US FDA renewal inspection at their facility in Pashamylaram near Hyderabad for the manufacture and supply of active pharmaceutical ingredients (bulk drugs), intermediates and formulations under cGMP during April 4 to April 14, 2016.
Based on the inspection and the review thereafter US-FDA has concluded that the inspection is ‘closed’ under 21CFR20.64 (d) (3) and the agency has issued an Establishment Inspection Report (EIR) for Suven facility at Pashamylaram dtd July 15, 2016. So far Suven Life Sciences has filed 19 DMF’s and 4 ANDA’s from this facility which is FDA complaint under cGMP and continued after renewal inspection.
