By: IPP Bureau
Last updated : July 31, 2022 10:15 pm
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
Suven Pharmaceuticals Ltd announces that the US Food and Drug Administration (USFDA) completed a pre-approval inspection at Casper Pharma formulations manufacturing facility situated at GMR Hyderabad SEZ, a wholly owned subsidiary of Suven Pharmaceuticals Limited Hyderabad, India.
The inspection was conducted from July 25th through Jul 29th, 2022. The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
We are glad to have completed the audit successfully with Zero observations and at the end of the inspection no form 483 was issued by USFDA which signifies compliance and conformance to applicable cGMP regulations, says Venkat Jasti, Managing Director, Suven Pharmaceuticals Limited.