USFDA issues EIR for Suven Pharmaceuticals' subsidiary; stock skids ~2%

4 Oct 2022 , 02:08 PM

Suven Pharmaceuticals Limited announced that the US Food and Medication Administration (USFDA) has given 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 between July 25 to July 29, 2022.

Pre-approval Inspections covered three applications: NDA 016084, ANDA 217020, and ANDA 217030.

The inspection concluded with no observation (FDA-483) issued, stated the company.

According to the EIR obtained from the US FDA, the site is recommended for approval of the three NDAs and ANDAs indicated above.

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.”

At around 2.13 PM, Suven Pharmaceuticals was trading 1.74% lower at Rs435, against previous close of Rs442.70 on NSE. The scrip hit an intraday high and low of Rs449.45 and Rs425 respectively.

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