Marksans Pharma Secures EIR from USFDA for Subsidiary’s New York Facility

Marksans Pharma shares edged over 4% higher on Monday, June 30, following updates tied to its U.S. and U.K. subsidiaries. The company said its U.S. arm, Time-Cap Laboratories, received a compliance report from the U.S. drug regulator for its New York facility.

The inspection by the USFDA had taken place between April 16 and 24. After the visit, the company disclosed one observation under Form 483. However, no issues were flagged regarding data integrity. With the Establishment Inspection Report now issued, the inspection process has been formally closed.

In another update, Marksans shared that its U.K. unit, Relonchem, got marketing approval for a new oral drug Oxybutynin Hydrochloride solution. The medicine is typically prescribed to patients with symptoms of an overactive bladder, such as frequent urination and incontinence.

These regulatory updates come soon after Marksans reported its earnings for the March quarter. Profit for the period stood at ₹90.5 crore, which is about 15% higher than the ₹78 crore it posted a year earlier. Revenue for the same quarter also improved, reaching ₹708.5 crore compared to ₹560 crore last year. Strong earnings, paired with regulatory approvals in two key markets, appear to have lifted investor confidence in the stock.

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