Sai Life Sciences’ pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan

Sai Life Sciences, a leading global Contract Research, Development & Manufacturing Organization (CRO/ CDMO), today announced that the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based compliance inspection of its intermediate & API manufacturing facility in Bidar, India and issued a Certificate of Inspection. Previously, 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, CEO & Managing 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 fulfill 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 for commercial API supplies of an NCE to Japan and has supplied over 50 tonnes of API over the past five years. It is a supplier of registered starting materials for three commercial APIs. The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product. From a drug discovery perspective, the company has helped several biotech and pharma companies advance programs from HIT to lead optimization / candidate stage, through its chemistry, biology and DMPK services. The company opened its representative office in Tokyo, Japan last year, which serves as base for the company’s outreach to innovator pharmaceutical and biotech companies in Japan and other countries in the Asia Pacific region.

Some 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 1µg/m3
. 0.25 – 10 KL reactor sizes
. 21CFR compliant single fluid automation system
. 11 clean rooms of ISO – 8 (Class 100,000)
. Lyophilization at pilot & commercial scale
. Chromatography at commercial scale
. Cryo reactions at 2.5 KL, 4 KL & 5 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.