NEW DELHI, July 21: Drug firm Suven Life Sciences today said it has received the Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant near Hyderabad.
“Suven Life Sciences Ltd has undergone 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 April 4-14, 2016,” the company said in a BSE filing.
It further said: “Based on the inspection and the review thereafter US-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 dated July 15, 2016”.
Suven Life Sciences said so far it has filed 19 DMF’s (Drug Master File) and 4 ANDA’s (Abbreviated New Drug Application) from this facility which is FDA complaint under cGMP and continued after renewal inspection.
(PTI)
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