By: IPP Bureau
Last updated : October 05, 2022 8:22 am
The inspection concluded with no observation (FDA-483) issued.
Suven Pharmaceuticals Ltd announces that the US Food and Drug Administration (USFDA) has issued an EIR for its wholly owned Subsidiary Casper Pharma Private Limited, a finished dosage drug Manufacturer for human use.
The pre-approval inspection was conducted during 25th July 22 through 29th July 22 Pre-Approval Inspections covering of three applications: NDA 016084, ANDA 217020, & ANDA 217030.
The inspection concluded with no observation (FDA-483) issued.
EIR received from US FDA states that the site is recommended for approval of the three NDA & ANDA listed above.
We are glad to have completed the first ever US FDA audit of this facility successfully with Zero observations and now with the receipt of EIR recommending the site, says Venkat Jasti, Managing Director of Suven Pharmaceuticals Limited.