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2024.10.28

Advanced manufacturing facility at Sai Life Sciences, showcasing state-of-the-art equipment and quality control, featured in a blog post about receiving Establishment Inspection Reports (EIRs) from the USFDA.

Sai Life Sciences receives EIRs from USFDA for India R&D & Manufacturing facilities

Sai Life Sciences, the fastest-growing Indian Contract Research, Development and Manufacturing Organization (CRDMO)[1], announced that it 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 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.

Making the announcement, 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."

[1] Among listed Indian peers in terms of revenue CAGR as well as EBITDA CAGR over FY22-24.

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