Suven Pharma facility gets EIR from USFDA

Suven Pharmaceuticals announced that Casper Parma, its wholly owned subsidiary has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) after the pre-approval inspection at a facility.

Casper Parma is a finished dosage drug manufacturer for human use. The pre-approval inspection was conducted at its facility from 25 July 2022 to 29 July 2022. The inspection was concluded with no observation (FDA-483) issued, said the company.

EIR received from US FDA states that the site is recommended for approval of the three NDA & ANDA applied by the pharma company.

Venkat Jasti, managing director of Suven Pharmaceuticals said, 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.

Suven Pharmaceuticals is in the business of Contract Development & Manufacturing Organisation (CDMO), catering to the needs of global pharma industry.

The pharma major reported 2.3% rise in consolidated net profit to Rs 107.54 crore on a 28.4% increase in net sales to Rs 338.80 crore in Q1 FY23 over Q1 FY22.

The scrip shed 1.78% to currently trade at Rs 435 on the BSE.

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