Shares of Glenmark Pharmaceuticals Ltd were trading in the red and almost 1% lower on Wednesday, 18 June, after the US Food and Drug Administration (USFDA) issued Form 483 with five observations for the company’s plant in Monroe, North Carolina.

The US drug agency conducted a general manufacturing practice (GMP) inspection of Glenmark Pharma’s plant from 9 June to 17 June 2025. The corporation stated that the five observations are procedural in nature. There was no observation related to data integrity reported, it added.

Glenmark Pharma stated that it would work closely with the agency to resolve the findings and would respond to the USFDA within the timeframe specified.

Glenmark Pharma announced last week the global launch of Brukinsa, a blood cancer treatment medicine approved by the Drugs Controller General of India (DCGI).

The company’s consolidated revenue for the fourth quarter climbed by 6.3% to Rs 3,256 crore from Rs 3,063 crore the prior year. In the March quarter, the company’s earnings before interest, tax, depreciation, and amortization (EBITDA) increased by 11.2% to Rs 561 crore, with an improved EBITDA margin of 17.2% compared to the previous year.

In fiscal year 2025, the company’s consolidated revenue climbed by 12.8% to Rs 13,322 crore from Rs 11,813 crore the previous year. The company’s EBITDA has more than doubled to Rs 2,531 crore, with a 17.6% margin.  Glenmark Pharma’s adjusted PAT rose to Rs 1,389 crore.

However, at 12:17 pm, the shares of Glenmark Pharma were trading 0.34% higher at Rs 1,658.80 on NSE.

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