Chinese pharma development firm WuXi STA has announced that its newly-built facility in Changzhou has received perfect feedback from the US Food and Drug Administration (FDA) in its inaugural inspection.
The company claims to have passed with a faultless record, receiving no observations in its bid for approval. Its success means that WuXi can begin to work on developing two active pharmaceutical ingredients (APIs) for the US market.
WuXi chief executive Minzhang Chen said: "The Changzhou facility passing its first FDA inspection, with no observations – or even written or verbal recommendations – is yet further proof of our commitment to the highest possible quality standards. It’s a point of great pride that we have an exemplary regulatory record, and evidence of the company’s ability to supply the US market with innovative commercial APIs from the Changzhou site.”
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze