Hyderabad: Drugmaker, Natco Pharma, Mekaguda-based Active Pharmaceutical Ingredients (API) plant has received one observation under the form 483 from the US Food and Drug Administration (FDA).
In a stock exchange filing the company informed that the US Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, from June 9th – June 13th and on conclusion of the inspection, the Company has received one observation in the Form-483.”
The Company believes that the observation is procedural in nature and is confident to address this observation comprehensively.
An observation under the Form 483 is issued if the FDA observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. However the observations are early warning of potential compliance issues and allows the company to address them before further regulatory action is considered.
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