Novo Nordisk Pharmatech A/S

~~Delivering excellence at every step

Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. The company has attracted an extensive roster of leading pharmaceutical companies through unsurpassed product quality, manufacturing and quality control, regulatory documentation, precision delivery and a comprehensive risk mitigation strategy.

Novo Nordisk Pharmatech A/S was established in 1949 as FeF Chemicals, acquired by Novo Nordisk in 1986 and has been part of the pharmaceutical group since then. On 1 September 2015 the company’s name was changed to Novo Nordisk Pharmatech A/S. It is the leading worldwide supplier of products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds (Quats) for the pharmaceutical and personal care industries. Both are manufactured to cGMP standards, and in both product areas the company has distinguished itself for:

· Global regulatory compliance

· Consistent high quality

· Extensive regulatory documentation

· Continuous availability

· Secure global supply chain

· High levels of service and support

Novo Nordisk Pharmatech’s quality system meets DS/EN ISO 9001 as well as ICH Guide Q7 for Active Pharmaceutical Ingredients. In-process samples, as well as finished products, are carefully analysed in a modern, well-equipped laboratory. Fast and reliable services in documentation, analysis and manufacturing – as well as the ability to meet or exceed local and international regulatory requirements – have been the keys to securing customer satisfaction.

The company’s delivery and stock policy is designed to meet the most demanding and urgent requirements of its customers, and pharmaceutical products can be shipped within a week. A range of products is also offered in a variety of packing solutions, meeting demands for small and large packaging.

Best quality insulin

Novo Nordisk Pharmatech aims to be the best supplier of insulin for cell culture processes by providing excellence at every step of the supply chain – beginning with the quality of its insulin, which is sourced directly from Novo Nordisk, the world’s largest producer. Its recombinant insulin is a key component in serum free growth media for mammalian cells. It is used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and many other biological drug products approved by regulatory bodies worldwide, including FDA and EMA.

Novo Nordisk Pharmatech is a reliable partner in helping customers find the right quality ingredients for their projects, even tailoring ingredients to match specific application needs. The company lives up to the highest quality standards, providing pure, efficacious and safe products. Its entire supply chain, manufacturing and quality control takes place in Denmark.

High purity quaternary ammonium compounds (Quats)

An innovative synthesis process makes Novo Nordisk Pharmatech a leading supplier of crystalline Quats for a wide range of applications. High levels of purity for products such as benzalkonium chloride, cetrimide, cetrimonium bromide (CTAB) and a range of others make them particularly suited for pharmaceutical applications, such as vaccine production. They act either as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams. For the cosmetic industry, the Quats’ purity and characteristics provide ideal conditioning, emulsifying and preserving effects in hair and cream products. Because Novo Nordisk Pharmatech’s closely controlled production process keeps batch variation to a minimum, its Quats are also in demand by the diagnostic reagent sector. Novo Nordisk Pharmatech experts can advise customers about the right product for their formulation, or develop a custom-designed product to meet specific needs. The company adheres to the latest European guidelines on Good Distribution Practice (GDP), and all Quats are manufactured in accordance with the cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. Quality analyses are done according to multicompendial pharmacopoeias (BP, Ph.Eur., USP/NF and JP) and are part of the regulatory documentation ensuring global compliance.

Sustainability and triple bottom line

Novo Nordisk is a member of the UN Global Compact and World Business Council for Sustainable Development (WBSCD). As a fully owned subsidiary, Novo Nordisk Pharmatech follows the same general policies for sustainability, business ethics and code of conduct. The company manages its business in accordance with the Triple Bottom Line (TBL) business principle, conducting activities in a financially, environmentally and socially responsible way,