Sai Life Sciences Pharmaceutical API Manufacturing Site Receives Inspection Certificate from PMDA, Japan

Make the announcement, Krishna Kanumuri, CEO and Managing Director, said: “We are delighted to receive an official inspection certificate from PMDA, Japan. We have been a reliable supplier of Pharmaceutical APIs in the Japanese market for over five years and this certification is a reaffirmation of our commitment to the highest quality standards of the regulatory agency. ”

Sai Life Sciences is increasingly present in the Japanese market. It was the launch site for commercial API provisioning of an NCE for Japan and has supplied over 50 tons of API over the past five years. It is a registered raw material supplier for three commercial APIs. The company has also started working with a large pharmaceutical company on providing APIs for a recently launched animal and human health product. From a drug discovery perspective, the company has helped several biotech and pharmaceutical companies advance HIT programs to the advanced optimization / candidate stage, through its chemistry, biology and DMPK services. . The company opened its representative office in Tokyo, Japan last year, which serves as the basis for the company’s awareness of innovative pharmaceutical and biotechnology companies in Japan and other countries of the Asia Pacific Region.

Some of the notable highlights of Sai Life Sciences’ Bidar Manufacturing Plant:

  • 100% successful inspection history –
    • USFDA (4 times)
    • PMDA (twice)
    • COFEPRIS, Mexico (once)
  • 450KL capacity with 50 production trains
  • Containment level of 1µg / m3
  • Reactor sizes from 0.25 to 10 KL
  • 21CFR Compliant Single Fluid Automation System
  • 7 clean rooms & 4 ISO – 8 suites (Class 100,000)
  • Freeze drying at pilot and commercial scale
  • Commercial scale chromatography
  • Cryo reactions on the 2.5 KL, 4 KL and 5 KL scale
  • Very powerful API installation (Q1-2022)
  • Installation of Amidites (Q1-2022)
  • Upcoming installations
    • Facility dedicated to pet health products
    • Intermediate manufacturing capacity and additional API of 200KL
  • ISO 14001: 2015 and ISO 45001: 2018 certified
  • Installation without liquid discharge
  • Several awards for excellence in energy management and EHS practices.

About Sai Life Sciences

Sai Life Sciences is a full-service CRO-CDMO that works with innovative pharmaceutical and biotechnology companies globally, to accelerate the discovery, development and commercialization of complex small molecules. The company has more than 2,200 employees in its facilities India, United Kingdom and United States. Sai Life Sciences is a private company backed by global investors, TPG Capital and HBM Healthcare Investments.


SOURCE Sai Life Sciences

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