Suven Life Science has undergone US Food and Drug Administration (USFDA) 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 February 5 - 15, 2018.
Based on this USFDA 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).
Also, USFDA has concluded that the inspection is closed and the agency has issued an Establishment Inspection Report (EIR) for its facility at Pashamylaram. So far, the company has filed 19 DMF’s and 5 ANDA’s from this facility which is USFDA complaint under cGMP and continued after renewal inspection.
Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets.
