Zydus Lifesciences has recently undergone a USFDA surveillance inspection at its Active Pharmaceutical Ingredient (API) manufacturing unit located in Dabhasa, Gujarat. The inspection, conducted from April 21st to 25th, 2025, resulted in a total of six observations. Importantly, none of these observations were related to Data Integrity, which is a critical focus for regulatory bodies.
In a statement, Zydus Lifesciences assured stakeholders that the company is fully committed to addressing the observations in a timely and efficient manner. While the specific details of the observations were not disclosed, the company emphasized that it would take all necessary actions to comply with regulatory standards and ensure the highest level of quality in its operations.
In the exchange filing, the company shared, “We wish to inform that the USFDA conducted a surveillance inspection at the group’s API Unit, located at Dabhasa in Gujarat. The inspection was conducted from April 21st to 25th, 2025. The inspection concluded with 6 observations and none of them were related to Data Integrity. The company is confident to address the observations expeditiously.”
