THE NEWS: The United States Food and Drug Administration (FDA) inspectors gave STA, WuXi’s small molecule process R&D and manufacturing business unit, a clean bill without 483 after a general GMP and Pre-Approval Inspection. We sat down with Minzhang Chen, Vice President and General Manager of STA, to discuss this important STA milestone.
QUESTION: What was the outcome of the inspection?
Chen: The take home message is that no FDA Form 483 was issued. We place a big emphasis on quality at our manufacturing plants – it’s vital to both clients and patients – so we’re very pleased FDA recognized our efforts.
QUESTION: What is the significance of the visit?
Chen: STA aims to become one of the only facilities in China after FDA approval to manufacture commercial New Molecular Entity (NME) intermediates and APIs. Our clients can source intermediates and active pharmaceutical ingredients from STA for the US market, and know they will receive a high-quality, reliable supply.
QUESTION: What sort of projects can you now support?
Chen: STA’s mission has been to build a fully integrated small molecule API development and manufacturing platform on which we can support all client needs for APIs from tox studies all the way through clinical studies to commercial launch. The outcome of FDA inspection completes the last piece of this platform and takes STA to the next level of bettering serving our customers.