In a significant achievement for Switzerland-based CARBOGEN AMCIS, a leading name in pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing, the company announced its successful clearance of the Brazilian Regulatory Authority Agency (ANVISA) routine inspection at its Shanghai facility. Conducted from November 6 to 10, 2023, the five-day inspection concluded with the granting of a Good Manufacturing Practice (GMP) certificate to the site, affirming the high-quality standards maintained by CARBOGEN AMCIS.

Pascal Villemagne, CEO of CARBOGEN AMCIS, praised the Shanghai team for their exemplary performance during their first independent regulatory inspection. Highlighting the team’s transparent and open approach, Villemagne noted, “The GMP certification is a reflection of our high-quality standards and the commitment of our teams at this important site.”

The Shanghai site of CARBOGEN AMCIS, employing 140 people, is specialized in the large-scale manufacturing of raw materials, intermediates, and APIs, including the manufacturing of highly potent chemicals up to category III, GMP product release, and analytical support for development activities. This certification by ANVISA recognizes the site’s adherence to stringent quality control and assurance measures, crucial utilities, maintenance, calibration, and production standards.

Harry Wong, General Manager of the Shanghai site, emphasized the site’s integral role within the CARBOGEN AMCIS CDMO (Contract Development and Manufacturing Organization) network, showcasing its capacity and geographical flexibility to meet global standards expected by clients. Martin Schneider, Vice President Quality & ESH of CARBOGEN AMCIS, also commended the professional preparation and hosting of the inspection, marking it as another positive milestone in the company’s history of global inspections.

This certification not only demonstrates CARBOGEN AMCIS’ commitment to maintaining high standards of quality and safety in pharmaceutical manufacturing but also strengthens its position in the global pharmaceutical supply chain. The successful inspection and subsequent GMP certification underscore the company’s ability to meet rigorous international standards, offering a promising outlook for its operations in Shanghai and beyond.

The achievement of GMP certification from ANVISA for CARBOGEN AMCIS’ Shanghai facility is a testament to the company’s unwavering dedication to quality and regulatory compliance. This milestone is not only significant for CARBOGEN AMCIS but also for the pharmaceutical manufacturing industry at large, highlighting the importance of global compliance and the role of rigorous inspections in ensuring the safety and efficacy of pharmaceutical products. As the industry continues to evolve, such certifications will become increasingly crucial in maintaining trust and reliability among stakeholders in the pharmaceutical supply chain.

  ANVISA, CARBOGEN AMCIS, GMP certification, Pharmaceutical Manufacturing, regulatory inspection, Shanghai facility