Certification

The active pharmaceutical ingredients and pharmaceutical production segments are governed by national and international regulations on the safe manufacture of medicinal products. Compliance with these regulations is verified and certified on the basis of regular national and international health authority inspections. Health is Nordmark's major concern as a pharmaceutical company, and we place great importance on strict compliance with high environmental and occupational safety standards. Areas relevant to environmental protection are certified in accordance with the EC eco-management and audit scheme (EMAS).

Continuous monitoring inspections uphold the high standard of our products.
The starting materials for our organ extracts (pancreatic glands, for example) are sourced from selected EU-certified abattoirs.

Further particulars are contained in the Certificate of Origin.

 

Certificates and Awards

February ´92 prizewinner „Environmentally friendly facility in Schleswig Holstein“
March '97 EMAS audit pursuant to EEC Directive No. 1836/93
Certificate No.: DE-S-140 000 10
June '00 EMAS audit revalidation pursuant to EEC Directive No. 1836/93 Certificate No.: DE-S-140 000 10
March '01 Inspection of the Schleswig-Holstein State Office for Health and Occupational Safety for issue of the „License to manufacture pharmaceuticals for human/animal use pursuant to section 13 of the German Drug Law“
June '05 Inspection of the Schleswig-Holstein State Office for Health and Occupational Safety for extension of the „License to manufacture pharmaceuticals pursuant to section 13 of the German Drug Law (GMP certificate)“
March '06 Last Update of the „License to manufacture pharmaceuticals for human and animal use pursuant to section 13 of the German Drug Law“ by the Schleswig-Holstein State Office for Health and Occupational Safety
July '06 Last Update of the „License to manufacture drug substances of animal origin pursuant to section 13 of the German Drug Law“ by the Schleswig-Holstein State Office for Health and Occupational Safety
Feb./Mar. '07 GMP-Inspection of the Brazilian State Office for Health ANVISA with reference to manufacture of solid dosage forms (GMP certificate)
July '07 GMP-Inspection of the NIH (National Institut of Health/USA) with reference to manufacture the drug substance Collagenase NB(GMP certificate)