Gland Pharma Ltd, a prominent Hyderabad-based pharmaceutical company, revealed on August 2 that the U.S. Food and Drug Administration (USFDA) conducted a surprise inspection of its Pashamylaram facility.

The inspection, which spanned from July 25 to August 2, was aimed at evaluating the company's adherence to Good Manufacturing Practices (GMP).

As a result of this inspection, the USFDA issued three Form 483 observations. These observations, as the company clarified in a regulatory filing, are procedural in nature.

Gland Pharma emphasized that the identified issues are neither recurring nor related to data integrity.

"We will submit corrective and preventive actions to the US FDA within the required timeframe," the company stated, indicating its commitment to addressing the observations promptly and ensuring compliance.

A Form FDA 483 is issued to a company's management when, during an inspection, an investigator identifies conditions that may potentially violate the Food, Drug, and Cosmetic (FD&C) Act or other relevant laws and regulations.

The observations documented on a Form 483 are considered critical as they highlight areas where the company needs to improve its compliance with regulatory standards.

This inspection at the Pashamylaram facility is notable as it marks the second surprise inspection conducted by the USFDA within a week.

Earlier, on July 25, the USFDA had inspected Gland Pharma's Dundigal facility in Hyderabad, also focusing on Good Manufacturing Practices.

This earlier inspection took place from July 22 to July 25, 2024.

In the midst of these regulatory inspections, Gland Pharma is preparing to announce its financial results for the first quarter of the fiscal year 2025 (Q1FY25) on August 6.

The company has shown robust financial performance in recent quarters.

For instance, in the fourth quarter of the fiscal year 2024 (Q4FY24), Gland Pharma reported a significant 145 percent increase in consolidated net profit, amounting to Rs 192.4 crore, compared to Rs 78.7 crore in the corresponding period of the previous year.

Additionally, the company's revenue surged by 96 percent, reaching Rs 1,537.5 crore, up from Rs 785 crore in the year-ago quarter.

Despite the scrutiny from the USFDA, Gland Pharma's stock performance has been resilient. Shares of the company closed at Rs 2,126, reflecting a marginal increase of 0.2 percent.

Over the past month, Gland Pharma shares have experienced a rally, gaining 17 percent in value.

Gland Pharma's response to the USFDA's observations and its continued focus on maintaining high standards of manufacturing practices will be crucial for sustaining investor confidence and ensuring compliance with international regulatory requirements.

As the company navigates these regulatory challenges, its financial health and operational resilience will be closely monitored by stakeholders and market observers.