Sat, 22 Jan 2022

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.

This story is provided by PRNewswire. ANI will not be responsible in any way for the content of this article. (ANI/PRNewswire)

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