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Sai Life Sciences Receives EIRs from FDA for India Facilities

Reflects Sai Life Sciences’ commitment to maintaining the highest standards of quality and compliance across its R&D and manufacturing facilities.

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By: Charlie Sternberg

Associate Editor

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 th...

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