Breaking News

Novasep Completes FDA Inspections at France Sites

July 22, 2014

Will produce NME for U.S. market

Novasep has successfully completed FDA pre-approval inspections at two of its sites in Chasse-sur-Rhone and Pompey, France. The company is now authorized to produce a new molecular entity (NME) currently approved in the U.S.
 
The inspection covered a multi-site project Novasep manages for synthesizing and purifying a kinase inhibitor active ingredient. The Chasse-sur-Rhone site is responsible for the synthesis of late stage intermediates and the API, and the Pompey site is responsible for the last purification step.  
 

 
“We are proud of the results achieved during these two FDA inspections,” said Thierry Van Nieuwenhove, president of the Synthesis BU at Novasep. This positive outcome is a real testimony to Novasep’s strength in offering specialized technologies and its ability to combine expertise and skills across all of its sites. For this particular success, the CSR team aligned its skills and long experience in the scale-up, validation and commercial launch of APIs in collaboration with Pompey, our center of excellence for cGMP chromatographic purification. Novasep has a genuine know-how in bringing together top European quality level services and technologies.”
blog comments powered by Disqus
  • API Sourcing Trends

    Kristin Brooks, Contract Pharma||April 11, 2016
    Drug product complexities, quality and regulatory hurdles drive market shift

  • U.S. Pharma Market Trends

    Kristin Brooks, Contract Pharma||April 8, 2016
    CPhI Report sees return of generic and API manufacturing to U.S. market

  • Flexible Manufacturing Strategies

    Kristin Brooks, Contract Pharma||April 4, 2016
    Michael Lehmann of Patheon discusses solutions for pharmaceutical forecasting errors

  • CMO Systems

    CMO Systems

    Philip K. Burns, CRO Consulting||April 5, 2016
    A CMO system includes four aspects of the product lifecycle: regulatory, technical, compliance, and operations.

  • Injectables: The New Oral?

    Injectables: The New Oral?

    Tugrul Kararli, Kurt Sedo, Josef Bossart, PharmaCircle LLC||April 5, 2016
    The growth trend of injectables continues across the pharma landscape.

  • Continuous Pharmaceutical Processes and Their Demands

    Continuous Pharmaceutical Processes and Their Demands

    Girish Malhotra, EPCOT International||April 5, 2016
    A look at the unique characteristics of continuous processes in pharmaceutical manufacturing.