Sai Life Sciences Receives EIRs from USFDA for R&D and Manufacturing Sites

  • Sai Life Sciences has received Establishment Inspection Reports (EIR) from the USFDA for its R&D and manufacturing sites in India.

Sai Life Sciences, an Indian Contract Research, Development and Manufacturing Organization (CRDMO), announced the receipt of Establishment Inspection Reports (EIR) from the US Food and Drug Administration (USFDA). The reports pertain to its R&D facility (Unit II) in Hyderabad and its manufacturing site (Unit IV) in Bidar.

The USFDA conducted a General Good Manufacturing Practices (GMP) audit at the R&D campus in April 2024. A pre-approval inspection (PAI) and General GMP audit were performed at the Bidar manufacturing facility in June 2024. These inspections are critical as they assess compliance with regulatory standards.

Krishna Kanumuri, CEO and Managing Director of Sai Life Sciences, stated, “These audit outcomes reflect Sai Life Sciences’ commitment to maintaining the highest standards of quality and compliance across its R&D and manufacturing facilities.” He further noted that the results demonstrate the company’s robust quality systems and readiness to supply high-quality pharmaceutical products to global markets.

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