Our ISO-9001:2015 certified manufacturing facility in Dayawan, Guangdong, China was opened in May 2015. The site includes a mid-sized production train, a kilo scale facility, separate warehouses and the necessary supporting functions.
Manufacturing is carried out by dedicated production team, and a range of processing capabilities exist within the site.
Construction of a new, GMP facility in Dayawan will commence in 2019. The site will be built in phase and the first phase is expected to be completed in 2021.
More information can be found at the relevant site page.
With our organization consisting of experienced people with backgrounds in global pharma world leading CMOs, we are aligned with the rigorous quality requirements of the pharma industry. Quality lies at the heart of our manufacturing business and we have developed a quality system that meets the high standards set by our clients and regulators.
• ISO-9001:2015 Certified (Most recent cert issued Jan 2019)
• Dedicated QC servers for ensuring data integrity
• Frequent customer audits
• Dedicated QC analytical teams and equipment
• Stability programs
Safety in manufacturing is a critically important topic and maintaining a system which prevents any harm being inflicted on our staff, the facility, or the environment is vital.
Our process safety program ensures that the process delivered from the labs are safe to operate.
To ensure that processes are run in a safe way, our production team will risk assess it together with the developing chemists to create a set of safe operating instructions.
In addition to the extensive preventative measures taken, we also have engineering controls in place such as the use of nitrogen in all processing equipment including filters and driers. Bursting disks and emergency venting space.