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CARBOGEN AMCIS announces successful ANVISA audit of its facility in China

Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announces the successful completion of its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.

Between 6-10th November 2023, a five-day inspection was undertaken, which concluded successfully with no critical and no major observations raised. A Good Manufacturing Practice (GMP) certificate has been granted to the site by the authority.

Pascal Villemagne, CEO of CARBOGEN AMCIS, said: “I want to congratulate the Shanghai team on their first successful independent regulatory inspection, and for being commended by the inspectors for their transparent and open approach. The GMP certification is a reflection of our high-quality standards and the commitment of our teams at this important site.”

CARBOGEN AMCIS’ Shanghai site employs 140 people and specializes in large-scale manufacturing of raw materials, intermediates and API; manufacturing of highly potent chemicals up to category III; GMP product release and analytical support for development activities.

The ANVISA audit was focused on areas including utilities, maintenance and calibration, production, quality control and assurance.

Harry Wong, General Manager of CARBOGEN AMCIS’ Shanghai site, said: “We are delighted to establish ourselves as a crucial part of the CARBOGEN AMICS CDMO network, meeting the same high standards our clients expect globally. We are an integral part of the company supply chain, offering the group great possibilities in terms of capacity and geographical flexibility.”

Martin Schneider, Vice President Quality & ESH of CARBOGEN AMCIS, said: “I was pleased to support the Shanghai site through their first international authority inspection and impressed by how professional the inspection was prepared and hosted. This success adds to our history of positive global inspections at our facilities around the world, which we are, and the local team can be very proud of.”

 

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