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Reflects Sai Life Sciences’ commitment to maintaining the highest standards of quality and compliance across its R&D and manufacturing facilities.
October 28, 2024
By: Charlie Sternberg
Sai Life Sciences, an Indian Contract Research, Development and Manufacturing Organization (CRDMO), has received Establishment Inspection Reports (EIR) from the US Food and Drug Administration (FDA) for its R&D (Unit II, Hyderabad), and Manufacturing (Unit IV, Bidar) sites in India. The General Good Manufacturing Practices (GMP) audit was conducted at the integrated R&D campus (Unit II) in April 2024, while the pre-approval inspection (PAI) & General GMP audit was conducted at the Manufacturing facility (Unit IV) in Bidar in June 2024. Krishna Kanumuri, CEO & Managing Director of Sai Life Sciences, said, “These audit outcomes reflect Sai Life Sciences’ commitment to maintaining the highest standards of quality and compliance across its R&D and manufacturing facilities. It demonstrates the company’s robust quality systems and its readiness to support the supply of high-quality pharmaceutical products to global markets.”
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