Suven Pharmaceuticals Limited announced that the US Food and Medication Administration (USFDA) has given an EIR for its Subsidiary Casper Pharma’s plant in Hyderabad.
The pre-approval inspection was conducted between July 25 to July 29 this year and covered three applications: 2 ANDAs and 1 New Drug Application (NDA)
The company stated that the inspection concluded with no observation (FDA-483) issued. According to the EIR obtained from the US FDA states site is recommended for approval.
Venkat Jasti, Managing Director of Suven Pharmaceuticals stated, "We are pleased to have completed the first-ever USFDA audit of this plant successfully with Zero observations and now with the receipt of EIR recommending the site."
Suven Pharmaceuticals was trading more than three lower at Rs 428.40.
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