PR93375

HYDERABAD, India, Dec. 1, 2021 /PRNewswire=KYODO JBN/ --

    Sai Life Sciences, a leading global Contract Research, Development and

Manufacturing Organization [

https://www.sailife.com/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

] (CRO/ CDMO), today announced that the Japanese regulatory agency,

Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based

compliance inspection of its intermediate and API manufacturing facility [

https://www.sailife.com/bidar-india/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

] 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 and 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 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 for commercial API supplies [

https://www.sailife.com/services/manufacturing/late-phase-manufacturing/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

] 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, [

https://www.sailife.com/services/discovery/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

] through its chemistry [

https://www.sailife.com/services/discovery/synthetic-medicinal-chemistry/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

], biology [

https://www.sailife.com/services/discovery/biology/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

] and DMPK services [

https://www.sailife.com/services/discovery/dmpk-in-vitro-adme/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

]. The company opened its representative office in Tokyo [

https://www.sailife.com/sai-life-sciences-opens-representative-office-in-tokyo-japan/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

], 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

   -        7 clean rooms and 4 suits of ISO – 8 (Class 100,000)

   -        Lyophilization at pilot and commercial scale

   -        Chromatography at commercial scale

   -        Cryo reactions at 2.5 KL, 4 KL and 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.

    About Sai Life Sciences

    Sai Life Sciences is a full-service CRO-CDMO [

https://www.sailife.com/?utm_source=pr&utm_medium=web&utm_campaign=pmda-inspection-certificate

]that works with innovator pharma and biotech companies globally, to accelerate

the discovery, development and commercialisation of complex small molecules.

The company has over 2200 employees across its facilities in India, UK and USA.

Sai Life Sciences is privately held and backed by global investors, TPG Capital

and HBM Healthcare Investments. https://www.sailife.com/

    Logo: https://mma.prnewswire.com/media/1044186/Sai_Life_Sciences_Logo.jpg  

    Photo:

https://mma.prnewswire.com/media/1699238/Sai_Life_Sciences_API_Manufacturing_facility.jpg

    Source: Sai Life Sciences