HYDERABAD, India, Dec. 1, 2021 /PRNewswire/ — Sai Life Sciences, a leading global organization in research, progression and contract production (CRO/CDMO), announced that Japan’s regulatory firm, the Pharmaceuticals and Medical Devices Agency (PMDA) conducted a paper compliance inspection of its intermediate production plant and API in Bidar, in India, and issued a certificate of inspection. Previously, the company conducted a three-day physical audit in 2016 and issued an inspection certificate.
In the announcement, Krishna Kanumuri, CEO and Managing Director, said: “We are very pleased to obtain an official inspection certificate from PMDA, Japan. We have been a reliable supplier of pharmaceutical APIs to the Japanese market for over five years and this certification is a reaffirmation of our commitment to the regulatory agency’s quality standards. “
Sai Life Sciences is offered in the Japanese market. It was the launch site of NCE’s advertising API materials in Japan and has provided over 50 tons of APIs over the more than five years. It is a supplier of uncooked fabrics registered for 3 advertising APIs. The company has also begun working with a giant pharmaceutical company to offer APIs for a newly introduced animal and human fitness product. From a drug discovery perspective, the company has helped several biotechnology and pharmaceutical companies advance HIT systems to the level of advance/candidate optimization through its chemistry, biology, and DMPK services. The company opened its supply workplace in Tokyo, Japan last year, which serves as the foundation for the company’s outreach to cutting-edge pharmaceutical and biotechnology corporations in Japan and other countries in the Asia-Pacific region.
Some of the highlights of Sai Life Sciences’ Bidar production plant:
100% history of successful inspections –
Capacity 450KL with 50 trains
Containment of 1μg / m3
Reactor sizes from 0. 25 to 10 KL
Unmarried fluid automation system that complies with 21CFR
7 blank rooms
Pilot scale freeze-drying and
Commercial-scale chromatography
Cryogenic reactions on the scale of 2, 5 KL, 4 KL and 5 KL
Very rugged API installation (Q1-2022)
Installation of Amidites (Q1-2022)
Upcoming facilities
ISO 14001: 2015 and ISO 45001: 2018 certification
Installation liquid discharge
Several awards for excellence in energy control and EHS practices.
About Sai Life Sciences
Sai Life Sciences is a full-service CRO-CDMO that works with cutting-edge pharmaceutical and biotechnology corporations globally to drive the discovery, progression and commercialization of complex small molecules. Sai Life Sciences is a private company subsidized through global investors, TPG Capital and HBM Healthcare Investments.
SOURCE Sai Life Sciences