Zydus Lifesciences Achieves USFDA Compliance Milestone

Zydus Lifesciences has been able to accomplish a pre-Approval Inspection PAI successfully without any observation by the US Food and Drug Administration (USFDA) at its SEZ II manufacturing facility in Ahmedabad.

The inspection was carried out as part of the regulatory process to ensure that the requirements of quality and good manufacturing practices (GMP) were met.

The facility was inspected with no deficiencies found and the Establishment Inspection Report (EIR) has been classified as No Action Indicated (NAI) for the entity. The result is a testimony to the company’s excellent compliance model, stringent quality control measures, and overall service to international manufacturing norms.

The SEZ II plant is producing essential pharmaceutical formulations for regulated markets, and the USFDA’s clean report is a confirmation of Zydus Lifesciences’ pledge to conform to global regulatory standards. Besides validating the Ahmedabad facility’s operational integrity and quality assurance systems, the PAI clearance also acts as a catalyst for the company’s capability to fulfill strict international regulatory requirements.

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With the clean EIR in hand, Zydus Lifesciences is in a stronger position to be a dependable pharmaceutical manufacturer worldwide and therefore may continue its expansion in regulated markets.

This achievement is one among many, wherein the company shows its unwavering commitment to patient welfare by producing high-quality meds that are safe and effective, and at the same time, complying with standard regulations and manufacturing practices.

The successful USFDA inspection at SEZ II is the next achievement in Zydus Lifesciences’ journey to grow its presence worldwide and maintain its position as a leader in the pharmaceutical industry.