Novo Nordisk Pharmatech lives up to the company’s high-quality standards, providing pure, efficacious and safe products. Its entire supply chain, manufacturing and quality control takes place in Denmark.
The company’s recombinant Insulin Human AF is manufactured in accordance with Novo Nordisk Pharma’s quality systems, which are based on ISO: 9001 standards and meet the requirements of all relevent European and US regulatory guidelines. They are produced under current good manufacturing practice (cGMP) compliance and analysed according to the current European Pharmacopoeia (Ph Eur) and US Pharmacopoeia (USP).
Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and health authorities.
Novo Nordisk’s recombinant insulin supports major growth media suppliers’ definition for an animal-free product. No animal origin components are used in the cell bank or manufacturing processes.
The yeast organism used for production does not contain genes nor express antigens of livestock or disease agents. In addition, the trypsin is replaced by a proprietary process of non-animal origin and the insulin is antibiotic-free, both in terms of production facilities and on a cell bank level.