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Marksans Pharma Shares Rally 7% Over US FDA Inspection Report with Zero Observations

The Levetiracetam will be manufactured at the company’s UK manufacturing facility.

Shares of Marksans Pharma gained more than 7% in trade on Friday after the company announced that its subsidiary received the Establishment Inspection Report from the United States Food and Drug Administration (USFDA) with zero observations.

Time-Cap Laboratories Inc, a wholly-owned subsidiary of Marksans Pharma, received an Establishment Inspection Report (EIR) from the US drug regulator after the audit conducted in October 2023, per the company’s filing to the stock exchanges. The USFDA did not issue any Form 483 observations in its inspection report. 

Earlier on November 1, the company announced the successful inspection of its manufacturing facility in Verna, Goa, by the German health authorities, with no critical or major observations during the inspection.

Marksans Pharma is involved in the research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company has manufacturing units in India, the United Kingdom, and the US.

Last month, the Mumbai-based company announced that it had received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Esomeprazole, used to treat certain stomach and oesophagus problems such as acid reflux and ulcers.

Following the announcement, shares of Marksans Pharma surged more than 7% to an intraday high of Rs 117.15. The stock closed at Rs 113.30, up 3.75% from the previous closing price on the National Stock Exchange (NSE).

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