Manufacturing
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Home | Services & Solutions | Drug Substance | Manufacturing
Leveraging our global standard quality system, we stand as your reliable partner in drug substance manufacturing, supporting small molecule intermediates, building blocks, drug substance including high potency drugs from a few grams to metric ton scale. To date, we have supported more than 60 commercial products and our products have been launched to 105 countries.
With several hundreds of modern reactors ranging from 5 L to 20,000 L, our total reactor volume exceeds 3,100 m3. Our state-of-the-art facilities are equipped with cutting-edge technologies and digital operation systems, offering highly efficient and top-quality drug substance manufacturing services.
All our sites have one quality system with proven record of inspections from the US FDA, EMA, China NMPA, and other health authorities.
A Reliable Solution for Commercialization and Beyond
Our Changzhou and Shanghai Jinshan sites have supported 50+ PPQ projects. Our experienced cross-functional teams including analytical and global filing guide you through commercialization complexities. Our US FDA, EMA, China NMPA, Japan PMDA, SwissMedic, and Korea MFDS-approved facilities ensure uncompromising quality. Beyond launch, our dedicated life cycle management team continually assesses and enhances your product’s performance, securing its long-term success. Choose us for dependable commercial manufacturing and sustained market leadership.
Sustainable Manufacturing
Through effective sustainability management of drug substance production across all sites, we achieved 36% off carbon emissions, 37% off energy consumption, and 41% off water consumption in 2022. Learn more.
Related Resources
Webinar: Securing new drug development by establishing and maintaining phase-appropriate RSM designation from development to commercial launch
