Gland Pharma Gets Three FDA Observations For Visakhapatnam Facility

Gland Pharma Ltd. said on Tuesday that the US Food and Drug Administration has issued a Form 483 with three observations to its facility in Visakhapatnam.

According to the company’s exchange filing, the FDA had conducted a pre-approval inspection for sterile active pharmaceutical ingredients at the company's facility at Jawaharlal Nehru Pharma City in Visakhapatnam between Feb. 19 and Feb. 25.

"The said inspection was concluded with three Form 483 Observations. These observations are procedural in nature," the company added in the disclosure.

The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period, the company said, adding that the observations issued are neither repeated observations nor related to data integrity.

According to the US FDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic Act and related Acts.

At the conclusion of an inspection, the Form 483 is presented and discussed with the company’s senior management.

The US FDA website states that companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

For the quarter ended December 2024, Gland Pharma had reported a 7% rise in net profit to Rs 205 crore. In comparison, its net profit for the similar quarter in the year-ago period stood at Rs 191.8 crore.

The pharma manufacturer's earnings before interest, tax, depreciation and amortisation has risen 1% to Rs 359.9 crore for the quarter under review from Rs 356.2 crore in the similar period of the previous fiscal.

Shares of Gland Pharma closed 4.62% higher at Rs 1,595.50 apiece on the BSE, compared to a 0.20% advance in the benchmark Sensex.

(With PTI inputs)