Strict quality standards and certification or auditing guidelines exist in the pharmaceutical and healthcare industry.

At Aenova we are committed to high quality standards and have a track record of successful inspections by health authorities. We take special care to maintain and ensure all required standards at all of our sites to guarantee the highest product quality and product safety.

We build and live a culture of the highest quality requirements and continuous improvement, thus also ensuring the rapid implementation of new regulatory requirements, such as Annex 1, serialization, the Nitrosamine Regulation.


Our sites have the following regulatory approvals

  • EU-GMP: 14 out of 15 sites
  • US FDA: 12 out of 15 sites
  • ANVISA: 9 out of 15 sites

As well as many other certifications and approvals such as: Swissmedic, GCC, NMPA, PMDA, APAC, MOH Russia and others.

Aenova Quality Management

To ensure rigorous production quality we have implemented a broad set of standards, processes and performance measures.

Aenova's own quality and regulatory management promotes internal standards for product quality and product safety at the highest level through

  • Constant monitoring
  • Proactive compliance
  • Harmonization and standardization
  • Digitization
  • Highly qualified employees
  • Qualified Persons
  • Constant facility and equipment maintenance
  • Validated processes and methods
  • Holistic and systematic quality management systems

Learn more in the Aenova Quality Commitment