Natco Pharma Ltd, a leading Indian pharmaceutical company, announced today that it has received a Warning Letter from the United States Food and Drug Administration (USFDA) regarding its manufacturing facility located in Kothur, Telangana.
The letter, dated April 8, 2024, follows a routine current Good Manufacturing Practices (cGMP) inspection conducted by the USFDA at the facility in October 2023.
The Kothur facility produces various pharmaceutical products for the company. While the company did not disclose specific details about the products manufactured at this site, it stated that the warning letter is not expected to disrupt supplies or impact existing revenues from the facility.
However, the letter may result in delays or withholding of pending product approvals from the Kothur site, it added.Hit Follow
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