By AqVida GmbH
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AqVida brings highly automated Dassow plant on line for cGMP production
Hamburg, Germany: – AqVida, the innovative oncology generics specialist, has obtained full Good Manufacturing Practice (GMP) certification for its leading edge production plant in Northern Germany.
Less than a year after it formally opened, ultramodern Dassow plant near Hamburg is now in full scale operation, with a fully functional and cGMP robotic filling line and just in time lean production concepts inspired by the microprocessor and automotive industries that set new standards for the pharma industry.
Robotic aseptic filling
In particular, the isolator technology used at Dassow eliminates risk of contamination, while all aseptic filling itakes place in cleanroom-standard environments. The plant also features highly advanced automated process control and robotic handling technologies that ensure absolute batch control, safety and process quality.
AqVida’s latest corporate brochure, downloadable from the company’s website, features a full presentatons of the Dassow plant’s features.
Made in Germany
AqVida Managing Director and founder, Wolfgang Heinze, commented: “Reaching full-scale cGMP production at Dassow represents a major milestone and foundation for our future. More than ever, we are able to offer ‘Made in Germany’ quality products that are cGMP licenced to the highest safety and quality regulatory standards to support a series of fast to market products.”
The plant is reaching full-scale cGMP production just as the first of a new generation of AqVida oncology generic, Sunitinib, is about to reach markets, with EMA approval now at an advanced stage.
The hi-tech AqVida stand at Booth 91A63 in the new FDF (Finished Dosage Formulations) zone at Messe Frankfurt will partly be constructed from the same advanced MRC Cleanroom Systems panels used at Dassow.
AqVida will feature latest development Sunitinib and its stable mate, Imatinib, prominently alongside new production capabilities at the upcoming CPhI Worldwide show in Frankfurt,
AqVida is a German oncology FDF manufacturer that is fully dedicated and specialized in the development, registration, manufacturing and distribution of finished dosage forms mainly for the oncology sector. It has developed a portfolio of medicines for treating the most common types of cancer.
AqVida’s expertise in generic oncology products has made the company a leading partner in the pharmaceutical industry.
AqVida works alongside some of the leading names in the oncology sector. In co-operation with its partners, AqVida has achieved substantial development and growth with its oncology portfolio.
AqVida is a pharmaceutical company with an impressive track record in fulfilling all client requirements from API sourcing through to EU market release for finished products. Teams of experts in development, regulatory affairs, patent issues and laboratory work bring skills and knowledge together to achieve optimum results for customers.
AqVida complies with all German and EU legal requirements for the pharmaceutical industry and is GMP certified by the German Health Authorities. As a European organization, AqVida has the knowledge and resources to provide regulatory support to meet the requirements of the complex and highly regulated EU market.