Suven receives EIR for Pashamylaram facility

Suven receives EIR for Pashamylaram facility

Geyatee Deshpande
/ Categories: Trending, DSIJ News

Suven Life Sciences reported that the company underwent USFDA renewal inspection at its facility in Pashamylaram near Hyderabad.

The facility is responsible for manufacturing and supply of Active Pharmaceutical Ingredients (API), that is, bulk drugs, intermediates, and formulations. The inspection under cGMP took place from October 21 to November 1, 2019. As a result of the inspection, the USFDA determined that the inspection of the facility is Voluntary Action Indicated (VAI), concluding with establishment inspection report (EIR) for Suven’s facility at Pashamylaram. The company has filed 22 DMFs, 6 ANDAs, and 2 ANADAs from this facility, which are FDA complaint under cGMP and continued after renewal inspection.

Suven Life Sciences Limited is a Hyderabad-based biopharmaceutical company, a pioneer in contract research and manufacturing services (CRAMS) and drug discovery and development. Its drug discovery program is focused on discovering, developing, and commercializing novel pharmaceutical products, which are qualitative CNS therapies through the use of GPCR targets.

On Friday the stock of the company closed at Rs 298.10, up by 0.17 per cent or Rs 0.50 on the BSE. The 52-week high is Rs 334.90 and 52-week low is Rs 183.25 on the BSE.

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