Suven Life Sciences gets establishment inspection report from USFDA
NEW DELHI: Suven Life Sciences 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 USFDA 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 DMFs (Drug Master File) and 4 ANDAs (Abbreviated New Drug Application) from this facility which is FDA complaint under cGMP and continued after renewal inspection.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd