Suven Life Sciences Limited recently received the EIR following the renewal inspection by US health regulator at their facility in Pashamylaram near Hyderabad for the supply and manufacture of active pharmaceutical ingredients (bulk drugs), intermediates and formulations under cGMP during Oct 21st till Nov 1st, 2019.
As per USFDA inspection and the review after their observation, the US Food and Drug Administration (USFDA) have made a decision that the inspection categorization of this facility is “voluntary action indicated” (“VAI”).
Also, USFDA has come to a conclusion that this inspection is “closed” under 21CFR20.64 (d) (3) and an issuance have been done by the agency for an Establishment Inspection Report (EIR) for the Suven facility at Pashamylaram.
Till date Suven Life Sciences has submitted 22 DMF’s, 6 ANDA’s and 2 ANADA’s from this facility which is in compliance with USFDA under cGMP and continued after renewal inspection.
Drug Discovery program by Suven is committed on founding, creating and commercializing new pharmaceutical products, which are 1st in class or best in class CNS therapies through the utilization of GPCR targets. The company has four clinical-stage compounds, a Phase II
undergoing SUVN-G3031, Phase II completed SUVN-502, Phase I completed SUVN-D4010 and SUVN-911.
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