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

HYDERABAD, India, Oct. 28, 2024 (GLOBE NEWSWIRE) -- 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.

About Sai Life Sciences:

Sai Life Sciences is the fastest-growing 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). As a pure-play, full-service CRDMO, we work with over 280 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialisation of their NCE small molecule programmes. Over the past 25 years, Sai Life Sciences has served a diverse set of programmes, consistently delivering value based on its quality and responsiveness. As of March 2024, we had 2845 employees across our facilities in India, UK, USA and Japan. https://www.sailife.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a591e96-ed90-416a-b690-4cf120b64d12