Gland Pharma shares tank 6% after USFDA issues 3 observations for Hyderabad facility; check details

In a filing to the stock exchanges, the company said that the US drug regulator completed the manufacturing practices inspection at its facility located at Pashamylaram in Hyderabad, Telangana, and issued Form 483 with three observations.

The pharma company informed the bourses that the USFDA team inspected the unit from July 25 to August 2.

The company said that the observations were procedural and not related to data integrity or repeated issues.

“The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period,” said Gland Pharma in the filing.

On Monday, shares of Gland Pharma initially gained 1.09% on the NSE. The stock opened at ₹2,031, lower than its previous close of ₹2,126.65, but rose to a high of ₹2,150 apiece. However, it later pared gains and dropped as much as 5% to a low of ₹2,020 apiece.

Shares of Gland Pharma closed at ₹2,117 apiece, down 0.43%, on the NSE.

Last month, on July 25, Gland Pharma disclosed in another exchange filing that the USFDA conducted an inspection at its Dundigal facility in Hyderabad from July 22 to July 25. The surprise inspection was related to compliance with good manufacturing practices. The US regulator issued Form 483 with two observations after completing the inspection.

In May, Gland Pharma announced its first-ever stock dividend since its listing in 2020. The company declared a dividend of ₹20 per share for FY24.

Gland Pharma, founded in 1978, has evolved from a contract manufacturer of small-volume liquid parenteral products to a leading producer of injectables. The company has a presence in 60 countries, including the United States, Europe, Canada and Australia. Gland Pharma develops, manufactures and markets sterile injectables.