25-03-2010 - Introducing the New Aquamid® Manufactured by Contura International A/S

New State-of-the-Art Facility Certified for the Production of Hydrogel

Contura’s new manufacturing facility has been approved by the European and Canadian authorities, initially for the manufacturing of Aquamid. The first Aquamid products have been released for sale.

The new facility is designed to fulfill all FDA requirements and will deliver Contura’s range of hydrogel products at the highest quality level. The automated manufacturing process ensures consistent quality and takes place in fully controlled clean room environment (Class 8 Clean Room in Operation). An advanced water purification process provides Water for Injection at exceptional quality.

In parallel to the factory validation, changes in packaging and Instructions For Use (IFU) have been implemented and approved by the authorities. Contura replaces Ferrosan as the legal manufacturer of the new Aquamid product. The IFU has been revised to reflect the newest knowledge about Aquamid e.g. the guidelines for treating adverse events have been updated with new recommendations of antibiotics. Also the approved indication and usage of Aquamid and Aquamid Reconstruction are now identical. Finally we have updated the design of the Aquamid packaging material to achieve a more modern look.

Together with the successful US clinical data for Aquamid, the new facility represents a strong platform for the FDA application to market Aquamid in the United States. Moreover, the new Aquamid offers our international customers a hydrogel of second-to-none quality level.