Suven Life Sciences Pashamylaram facility gets EIR from USFDA

Hyderabad: Suven Life Sciences Limited recently announced that the company has undergone the US health regulator's 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 Oct 21st through Nov 1st, 2019.

Based on this USFDA inspection and the review thereafter, the US Food ad Drug Administration (USFDA) has determined that the inspection classification of this facility is “voluntary action indicated” (“VAI”).

Also, USFDA has concluded that this inspection is “closed” under 21CFR20.64 (d) (3) and the agency has issued an Establishment Inspection Report (EIR) for the Suven facility at Pashamylaram.

So far Suven Life Sciences has filed 22 DMF’s, 6 ANDA’s and 2 ANADA’s from this facility which is USFDA compliant under cGMP and continued after renewal inspection.

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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.

Suven’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. The company has 4 clinical-stage compounds, a Phase 2 completed SUVN-502, Phase 2 undergoing SUVN-G3031, Phase 1 completed SUVN-D4010 and 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.

Also Read: Suven Life Sciences Q2 revenue up 39pc to Rs 280 crore