This comes after the US drug regulator conducted a general manufacturing practice (GMP) inspection at Glenmark Pharma’s facility from June 9 to June 17, 2025.
The company said the five observations are procedural in nature. There was no observation related to data integrity reported, it added.
Glenmark Pharma said it would work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline.
Last week, Glenmark Pharma announced the launch of a blood cancer treatment drug, marketed globally as Brukinsa, after receiving approval from the Drugs Controller General of India (DCGI).
The company’s consolidated revenue for the fourth quarter increased 6.3% to ₹3,256 crore from ₹3,063 crore in the previous year. Its earnings before interest, tax, depreciation and amortisation (EBITDA) was up 11.2% at ₹561 crore in the March quarter and its EBITDA margin improved to 17.2% from the year-ago period.
For the entire financial year 2025, the company’s consolidated revenue increased 12.8% to ₹13,322 crore from 11,813 crore in the previous year. Its EBITDA more than doubled to ₹2,531 crore with an EBITDA margin of 17.6%. Glenmark Pharma’s adjusted PAT increased to ₹1,389 crore.
Shares of Glenmark Pharma were trading 0.37% lower at at ₹1,647.1 apiece at 10.05 am on Wednesday, June 17. The stock has gained 14.5% in the past month.
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