ANVISA AUDIT OF CARBOGEN AMCIS' SHANGHAI FACILITY COMPLETES

KUALA LUMPUR, March 20 (Bernama) -- Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has completed its first Brazilian Regulatory Authority Agency (ANVISA) routine inspection of its facility in Shanghai.

A five-day inspection was undertaken between Nov 6 to 10, 2023, which concluded successfully with no critical and no major observations raised, in addition to the site being granted a Good Manufacturing Practice (GMP) certificate by the authority.

“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.

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“The GMP certification is a reflection of our high-quality standards and the commitment of our teams at this important site,” said CARBOGEN AMCIS Chief Executive Officer, Pascal Villemagne in a statement.

Meanwhile, its Shanghai site General Manager, Harry Wong 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.”

CARBOGEN AMCIS’ Shanghai site employs 140 people and specialises in large-scale manufacturing of raw materials, intermediates and API; manufacturing of highly potent chemicals up to category III; as well as 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.

-- BERNAMA