Glenmark Pharma's North Carolina facility gets 5 USFDA observations; no data integrity issues

Glenmark Pharmaceuticals Ltd on Wednesday informed bourses that the United States Food and Drug Administration (USFDA) conducted a Good Manufacturing Practice (GMP) inspection at its manufacturing facility located in Monroe, North Carolina, USA. The inspection was carried out from June 9 to June 17, 2025.

Following the inspection, the USFDA issued a Form 483 containing five observations. The company clarified that all the observations were procedural in nature and that there were no findings related to data integrity.

In an official exchange filing, Glenmark said, "The Company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline."

A Form 483 is issued by the USFDA when an investigator observes conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. However, the absence of data integrity issues is usually seen as a positive sign.

On the stock-specific front, Glenmark Pharma was trading 0.34 per cent lower at Rs 1,648.10.

Technically, the scrip traded lower than the 5-day simple moving average (SMA) but higher than the 10-day, 20-, 30-, 50-, 100-, 150-day and 200-day simple moving averages (SMAs). Its 14-day relative strength index (RSI) came at 71.06. A level below 30 is defined as oversold while a value above 70 is considered overbought.

The company's stock has a price-to-earnings (P/E) ratio of 28.88 against a price-to-book (P/B) value of 1.94. Earnings per share (EPS) stood at 57.07 with a return on equity (RoE) of 6.72. According to Trendlyne data, Glenmark Pharma has a one-year beta of 0.85, indicating low volatility.

As of March 2025, promoters held a 46.65 per cent stake in the pharma company.