SUVEN’S Pashamylaram’s Unit Successfully completes US FDA Inspection

Suven Life Sciences Limited 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 Feb 5th through 15th 2018.

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”). Also 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. So far Suven Life Sciences has filed 19 DMF’s and 5 ANDA’s from this facility which is FDA
complaint under cGMP and continued after renewal inspection. Suven Life Sciences is a Hyderabad based biopharmaceutical company, a pioneer in Contract Research and Manufacturing Services (CRAMS) since 1995 and Drug Discovery and Development since 2005 . Suvens’s Drug Discovery program is focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR targets. Suven has 4 clinical stage compounds, a Phase 2 undergoing SUVN-502, Phase 2 ready SUVN-G3031, Phase 1 completed SUVN-D4010 and Phase 1 undergoing SUVN-911. In addition to these clinical compounds the Company has nine (9) internally-discovered therapeutic drug candidates currently in various stages of pre-clinical development targeting conditions such as Alzheimer’s disease, ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease, pain and sleep disorders.

For more information please visit our Web site at http://www.suven.com



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