WuXi Facility Passes FDA Inspection for Manufacture of API - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

WuXi Facility Passes FDA Inspection for Manufacture of API


WuXiPharmaTech, a pharmaceutical, biotechnology, and medical device R&D outsourcing company with operations in China and the United States, announced that a manufacturing facility of WuXi’s wholly owned subsidiary, Shanghai SynTheAll Pharmaceutical (STA), passed an FDA inspection in July for the manufacture of API for a branded commercial drug.

This inspection is the first FDA inspection of STA’s facilities for the manufacture of an API. In 2013, STA’s manufacturing operations passed an inspection by FDA for the manufacture of an advanced intermediate.

Source: WuXiPharmaTech

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here