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Cohance Lifesciences proudly announced the successful completion of a USFDA cGMP (Current Good Manufacturing Practice) audit at its API Unit-1 in Jaggayapet, Andhra Pradesh, held from September 8–11, 2025. The inspection concluded with zero Form 483 observations, marking a significant quality milestone for the company.
This accomplishment reflects Cohance’s unwavering commitment to global regulatory standards, operational excellence, and its mission to support innovators in advancing science for patients worldwide.
“Achieving a zero 483 outcome is a testament to the dedication of our teams and the strength of our quality systems. It reinforces our position as a trusted partner for global pharmaceutical companies,” said a Cohance Lifesciences spokesperson.
The USFDA audit plays a crucial role in evaluating manufacturing facilities’ compliance with stringent cGMP regulations. A “zero 483” outcome signifies that the facility meets or exceeds the regulator’s expectations without any major observations, further enhancing Cohance’s reputation in regulated markets.
