Our Manufacturing Facility
Contura’s state-of-the-art manufacturing facility in Denmark has over 20 years of experience
producing 2.5% iPAAG* injectables. It is certified according to EU, US and other international
standards, using proprietary technology and stringent quality control measures to deliver
the highest quality products.
Solely dedicated to the production of 2.5% iPAAG, the facility uses proprietary automated processes to control manufacturing,
including the ALPH (Automated Line for Production of Hydrogel), a one-of-a-kind machine designed specifically for Contura.
ALPH’s advanced capabilities and design reflect our commitment to innovation and excellence in hydrogel production.
We have a team of highly qualified scientists and engineers who oversee the production process and ensure our syringes
are tightly monitored to meet release specifications.
Medical Device Certification
Certified quality management system
As manufacturer of medical devices and medicinal products, customer satisfaction and compliance with all applicable regulatory requirements are the focus of our quality management system.
To meet these requirements, Contura International A/S has established a comprehensive quality management system.
We hold the following certificates:
QM system according EN ISO 13485:2016
QM system according to MDSAP (including the country-specific requirements of Canada and Australia)
MDR Certificates: Regulation (EU) 2017/745 according to Annex IX Chapters I and III
MDD Certificates: Directive 93/42/EEC, Annex II and V
GMP Authorisation DKMA
GMP Certificate Korea
Should certificates be required you can request these by mail: [email protected]
