Shares of Suven Pharma hit a 52-week high on September 9 after the company cited US drug regulator's report saying remedial action has been initiated by subsidiary Casper Pharma, and the inspection has been closed, as shown in the Establishment Inspection Report (EIR) from the regulator.
Share prices cooled off later in early trade to hover near Rs 1,188 level at 11am, in line with the weakness in broader market and benchmark indices.
EIR or Establishment Inspection Report is a document issued by the US Food and Drug Administration (USFDA) after inspection of a pharmaceutical facility in Hyderabad, conveying the inspection has been closed. In July, Suven Pharma had received a Form 483 from USFDA, with two observations regarding Casper Pharma, which the company said were procedural in nature, assuring these would be addressed in stimulated time.
The formulations plant, a unit of Casper Pharma, is a wholly-owned subsidiary of Suven, and was audited by the USFDA with two procedural observations.
During the June quarter, Suven's revenue fell by 34% YoY while gross margins improved by 157 bps YoY driven by the improved business mix. The company has said that the CDMO segment is expected to deliver growth in the second half of FY25 shipments.
The pharma company was in the news earlier this year for its proposed merger with Cohance Lifesciences. The company has received approvals from the stock exchange and SEBI, and has submitted petition to the NCLT Mumbai bench. The company expects the merger to be completed in the next 10 months, it said in August.
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