Sai Life Sciences receives EIRs from USFDA for India RnD, Manufacturing facilities
Hyderabad: Sai Life Sciences, a Indian Contract Research, Development and Manufacturing Organization (CRDMO), has 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."
Read also: Alembic Pharma successfully completes USFDA inspection at Panelav Oncology formulation facility
Sai Life Sciences is a contract research, development, and manufacturing organisation (CRDMO) among listed Indian peers (in terms of revenue CAGR as well as EBITDA CAGR from FY22 to FY24).
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