Hyderabad (Telangana) [India], December 1 (ANI/PRNewswire): Sai Life Sciences, a leadingPreviously, the agency had conducted a three-day long physical audit in the year 2016 and had issued a Certificate of Inspection.
Making the announcement, Krishna Kanumuri, CEOManaging Director, said, "We are delighted to receive a formal Certificate of Inspection from PMDA, Japan. We have been a reliable supplier of pharmaceutical API to the Japanese market for over five years and this certification is a reaffirmation of our commitment to fulfil the most stringent quality standards of the regulatory agency."Sai Life Sciences has a growing presence in the Japanese market. It was the launch site forSome of the notable highlights of the Bidar manufacturing facility of Sai Life Sciences: 100% track record of successful inspections -- USFDA (4 times)- PMDA (twice)- COFEPRIS, Mexico (once) 450KL capacity with 50 production trains Containment level of 1ug/m3 0.25 - 10 KL reactor sizes 21CFR compliant single fluid automation system 7 clean rooms4 suits of ISO - 8 (Class 100,000) Lyophilization at pilotcommercial scale Chromatography at commercial scale Cryo reactions at 2.5 KL, 4 KL5 KL scale Highly Potent API facility (Q1-2022) Amidites facility (Q1-2022) Upcoming facilities- Dedicated facility for companion animal health products- Additional 200KL intermediate and API manufacturing capacity ISO 14001:2015 and ISO 45001:2018 certified Zero liquid discharge facility Multiple awards for excellence in energy management and EHS practices.
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