Gland Pharma on Friday announced that the United States Food and Drug Administration (USFDA) completed the inspection of its Dundigal facility in Hyderabad with one observation.

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The US drug regulator conducted a Good Manufacturing Practice (GMP) inspection at Dundigal facility between July 3-14, 2023, the company stated in a filing to the stock exchanges.

A form 483 was issued along with the one observation.

The USFDA issues 483 observations after inspection of a plant or drug manufacturing site highlighting any potential regulatory violations found during a routine inspection. The observations could be related to a pharma company's facility, equipment, processes, products or employee practices.

The corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period, Gland Pharma said, adding that the observation issued is neither a repeated observation nor related to data integrity.

Hyderabad-based Gland Pharma last month had announced that its Pashamylaram facility at Hyderabad had also received one observation following the pre-approval inspection (PAI) for seven products by the USFDA.

The observation issued was neither a repeated observation nor related to data integrity, the company stated.

Gland Pharma this week also received approval from the US FDA for its new drug application for Fomepizole, a competitive ADH inhibitor used for treatment of ethylene glycol and methanol poisoning.

Shares of Gland Pharma are trading 2.3 percent higher at Rs 1,131.50.

First Published:Jul 14, 2023 2:30 PM IST