Sai Life Sciences has received Establishment Inspection Reports (EIR) from the US Food and Drug Administration (USFDA) for its R&D (Unit II, Hyderabad), and Manufacturing (Unit IV, Bidar) sites.
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.
“These audit outcomes reflect Sai Life Sciences’ commitment to maintaining the highest standards of quality and compliance across its R&D and manufacturing facilities,’‘ Krishna Kanumuri, CEO & Managing Director of Sai Life Sciences, said in a release.