BUBENDORF, Switzerland, March 19, 2024 (GLOBE NEWSWIRE) -- 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.”

For Further information contact:

Lucie Framinet +33 7 84 23 10 69 lucie.framinet@carbogen-amcis.com

CARBOGEN AMCIS (www.carbogen-amcis.com) is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India.

Multimedia available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/9e6a224d-17ab-4164-a66c-5d16ac8fc20e

This item of content is a press release from a third party provider who make no warranties or representations in connection with this content and therefore PA can make no warranties in respect of its use.

Tags

More Like This

WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics

Daewoong Pharmaceutical Received GMP Certification from Brazilian ANVISA

Aurisco sets Goals and Plans for Carbon Neutrality by 2027 and Zero Emissions by 2030

EMA Approves Biocon Biologics' New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Ardena’s New State-of-the-Art Nanomedicine Facility Secures Full GMP Approval for Manufacturing

Ajinomoto Bio-Pharma Services Garners Six 'CDMO Leadership Awards,' Further Establishing Its Industry Excellence

WuXi Vaccines Launches Its First Vaccines CDMO Site in China

PCI Pharma Services’ Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection