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USFDA issues warning letter to Natco Pharma for Telangana plant



Natco Pharma gets warning letter from USFDA for Telangana plant, ET HealthWorld

Natco Pharma, a leading pharmaceutical company, has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) issued the letter after inspecting the company’s Kothur-based formulation facility and identifying eight observations under Form 483. The inspection took place from October 9 to October 18, 2023.

In a regulatory filing, Natco Pharma stated that the warning letter dated April 8, 2024, was received from the USFDA. The company remains confident that the warning letter will not impact supplies or current revenues from the facility. However, it may result in delays or withholding of pending product approvals from the site.

The drug firm has committed to responding to the letter within the specified timelines and collaborating closely with the USFDA to address the concerns and ensure sustained compliance. A warning letter is issued by the US health regulator when a manufacturer is found to have significantly violated its regulations.

Following this development, the shares of Natco Pharma were trading 0.5% higher at Rs 1,004 per share on the BSE. The company will now focus on resolving the issues highlighted in the warning letter to meet the compliance standards set by the USFDA.

Published on April 9, 2024, at 12:32 PM IST, this news highlights the importance of regulatory compliance in the pharmaceutical industry and the measures companies must take to address issues raised by regulatory authorities.

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