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US FDA 'stamp of approval' testament to WuXi's growth in APIs

Dan Stanton

By Dan Stanton+

Last updated on 19-Aug-2014 at 17:04 GMT2014-08-19T17:04:16Z

US FDA 'stamp of approval' testament to WuXi's growth in APIs

WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

The Chinese facility is run by WuXi’s subsidiary Shanghai SynTheAll Pharmaceutical (STA) and passed an inspection by the US Food and Drug Administration (FDA) last month.

The site makes a number of ingredients for preclinical and clinical candidates but the approval will now allow the firm to supply the API for a branded commercial drug, though spokesman Ron Aldridge was not at liberty to tell which one.

“This inspection not only gives us the right to manufacture this API, but gives the FDA  confidence that we have a facility that complies with current good manufacturing processes (cGMP),” he told us, adding the successful inspection was an “FDA stamp of approval giving confidence to our clients.”

The site was also successfully inspected last year by the FDA for the manufacture of an advanced intermediate.

Strong chemistry

STA is WuXI’s main manufacturing subsidiary and has gone from strength-to-strength, Aldridge said, due to having “one of the strongest process chemistry capabilities in the world.”

In the past three years, revenues from the site in Shanghai have tripled and the firm has seen a doubling of early stage molecules in production and a twenty-fold increase in late stage molecules.

Furthermore, the site has begun offering high-potency API services over the past few months with two Illumina X Ten sequencing machines having recently arrived and are now operational.

STA is also building a second facility in Changzhou, set to open in the next eighteen months. According to Aldridge the new site will “double API production in the short-term” and will increase further over the next few years as new lines commence operations.

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