Nemera receives drug manufacturing authorisation for Neuenburg plant

Published: 28-Sep-2017

Nemera received pharmaceutical drug manufacturing authorisation from the German Government Drug Administration in accordance with German Drug and Medicinal Product law, at its Neuenburg manufacturing facility in Germany

The certification gives the manufacturing plant the approval to handle, assemble, sterilise and store pharmaceutical drugs and medicinal products for autoinjectors.

This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.

Marc Haeml, CEO at Nemera, said: “There is no limit to Nemera’s ambition to serve patients. We already market devices in more than 40 countries for millions of users. We will keep investing in new products and in state-of-the-art manufacturing equipment, to help even more patients with high quality devices all over the world.”

The pharmaceutical drug manufacturing certification is a required regulatory step to allow Nemera to provide a complete set of services and additional support for the development and manufacturing of pharmaceutical combination products and drug delivery devices to its customers.

Neunburg plant produces billions of Injection molded parts and assembled devices every year.

Nemera's Neuenburg plant quality management key achievements are:

  • short reaction times
  • detailed and comprehensive root cause analysis
  • elimination of quality problems
  • reduction of scrap rates
  • elimination of inefficiencies.

Christian Meusinger, Quality VP of Nemera, said: “Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations."

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