Our commitment to quality – signed, sealed and delivered

For the safe manufacture of pharmaceutical products there are national and international guidelines that apply to drug products and pharmaceutical production practices. Compliance with these guidelines is regularly verified and certified by the pertinent health agencies. Constant controls assure the quality of our products. We procure the starting materials for our organ extracts from selected audited companies. Moreover, we have also established high standards for environmental protection and occupational health and safety, which are consistently implemented.

Manufacturing authorisations and GMP certificates

Nordmark holds manufacturing authorisation from the relevant agency, the Landesamt für soziale Dienste Schleswig-Holstein [Schleswig-Holstein Social Services Agency] for the production of active pharmaceutical ingredients and pharmaceutical drug products in human and veterinary medicine. The GMP inspections carried out by this authority with the collaboration of the Federal German umbrella agency, the BfArM or Bundesinstitut für Arzneimittel und Medizinprodukte [Federal Institute for Drugs and Medicinal Products] comply with EC Directive 2003/94 as well as with the GMP recommendations of the World Health Organisation (WHO).

For active pharmaceutical ingredients

  • Pancreatin
  • Collagenase
  • Heparin / low molecular weight heparin
  • Pepsin
  • Liver extract
  • Tannin albuminate

For active pharmaceutical ingredients

  • Human and veterinary pharmaceutical products as well as clinical trial preparations

FDA approval of pancreatin/pancrelipase for the US market

In 2009, the FDA granted US marketing approval for the Nordmark pancreatin products to our US customers. This approval substantiated the FDA’s acknowledgment of Nordmark’s special competencies, as it was only with the special in-house know-how and state-of-the-art laboratories (specialising in protein analysis, enzyme analysis, molecular biology techniques for virus analysis and cell culture techniques) that Nordmark was able to meet the strict FDA requirements.

ISO-14001 certified since 2008

With the ISO-14001 certification, an independent certification body attests the implementation of an environmental management system that complies with the requirements of the ISO 14001 Standard. It also confirms that the system is suitable to ensure achievement of the company’s own environmental protection goals and a sustainable improvement of its environmental protection performance.

Authorized economic Operator since June 2014

With the AEOF Authorized Economic Operator certification by the Itzehoe Main Customs Office, Nordmark passes on the benefits of being a fixed member of the supply chain and a reliable business partner to its customers worldwide. This status is currently mutually recognized by: China, Japan, Norway, Switzerland and the United States of America.

Known Consignor since February 2012 - DE/KC/00116-01/0217

With the Known Consignor certification, Nordmark responds to the continually increasing security requirements of the international community and prevents temperature-sensitive deliveries to its customers worldwide from further testing outside of controlled areas. 

Audited by

FDA - U.S. Food and Drug Administration

Certified by

National Institutes of Health Schleswig Holstein

Certified by

TÜV South Germany

Certified by

Customs

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