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news.Minrad International has successfully passed an audit of its France subsidiary, Wasquehal. It now has French pharmaceutical regulatory agency AFSSAPS approval to open as a French Pharmaceutical Establishment.
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Among other functions, the laboratory in Wasquehal will complete batch release testing for its pharmaceutical partners within the European community. The laboratory was developed in co-operation with the company’s North European partner, Mylan.
The company has also announced that its image guidance manufacturing facility located in Orchard Park, New York, has successfully completed a BSI quality systems audit and has received renewal of its CE certification. This certification is required to distribute and sell its medical devices within the EU member countries.
Minrad also completed a three-year stability testing of its Sojourn Sevoflurane anesthetic agent. Sojourn, manufactured at its pharmaceutical plant in Bethlehem, Pennsylvania, can now be labeled with three-year expiration dating, as approved by the FDA.