13-06-2025
NATCO Pharma receives one observation after US FDA inspection at Mekaguda API facility
NATCO Pharma Limited has announced the successful conclusion of a routine inspection by the U.S. Food and Drug Administration (US FDA) at its Active Pharmaceutical Ingredients (API) manufacturing facility in Mekaguda, Hyderabad.
The inspection was conducted over a five-day period from June 9 to June 13, 2025. Upon conclusion, NATCO received only one observation in the Form 483 issued by the US FDA. According to the company, the observation is procedural in nature, and it is confident in addressing it comprehensively and in a timely manner.
In the excahgne filings, the company shared, 'The U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from June 9th – June 13th, 2025. On conclusion of the inspection, the Company received 1 (One) observation in the Form-483. The Company believes that the observation is procedural in nature. The Company is confident to address this observation comprehensively.'
NATCO emphasized its ongoing commitment to current Good Manufacturing Practices (cGMP) and assured stakeholders of its continued focus on producing high-quality pharmaceutical products for global markets.
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