Gland Pharma's Hyderabad facility gets 3 form 483 observations from USFDA

Gland Pharma shares have rallied 17 percent in the past month.

Hyderabad-based Gland Pharma Ltd announced on August 2 that the US FDA conducted a surprise inspection of its Pashamylaram facility in Hyderabad from July 25 to August 2, to evaluate Good Manufacturing Practices (GMP).

"The inspection resulted in three 483 Observations, which are procedural," the company reported in a regulatory filing. "We will submit corrective and preventive actions to the US FDA within the required timeframe. The observations are neither recurring nor related to data integrity," they added.

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A Form FDA 483 is provided to a company's management at the end of an inspection when an investigator identifies conditions that, in their judgment, may violate the Food, Drug, and Cosmetic (FD&C) Act and other applicable laws or regulations.

This is the second surprise inspection the USFDA has carried out in a week. On July 25, the organisation conducted a surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) between 22 July 2024 and 25 July 2024.

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The company is slated to announce its Q1FY25 earnings on August 6. In Q4FY24, the pharma major reported a 145 percent rise in consolidated net profit at Rs 192.4 crore from Rs 78.7 crore in the year-ago period. The company's revenue came in at Rs 1,537.5 crore, up 96 percent from the year-ago quarter of Rs 785 crore.

Shares of the company closed at Rs 2,126, marginally higher by 0.2 percent. Gland Pharma shares have rallied 17 percent in the past month.

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