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Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S (formerly FeF Chemicals) is one of Europe’s leading manufacturers of pharmaceutical ingredients for the pharmaceutical and biopharmaceutical industries. It specializes in producing quaternary ammonium compounds (Quats) used as active pharmaceutical ingredient (APIs) and excipients, as well as recombinant insulin as a cell culture medium used to enhance cell growth.
Established in 1949 and acquired by Denmark’s Novo Nordisk in 1986, Novo Nordisk Pharmatech now forms a key part of the global healthcare company’s pharmaceutical group.
The company has attracted an extensive roster of leading pharmaceutical clients by delivering excellence at every step – through manufacturing and quality control, precision delivery and a comprehensive risk mitigation strategy, all helping keep developments on track and ensuring reliable supply to laboratories, hospitals and patients.
Novo Nordisk Pharmatech aims to be the best supplier of insulin for cell culture processes by excelling throughout the supply chain – beginning with highest quality insulin, sourced directly from parent company Novo Nordisk, the world’s largest producer.
Insulin Human AF
This product consists of insulin human crystals, a biosynthetic product produced by recombinant microbial expression in yeast, and is optimized for as a cell culture medium for further manufacturing, rather than therapeutic use.
Human insulin AF is manufactured in accordance with internal quality systems, based on ISO 9001 and cGMP and is analyzed according to the current European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP).
The product is manufactured in Novo Nordisk’s parent cGMP facilities, packaged in HDPE bottles and supplied by Novo Nordisk Pharmatech A/S.
Pharmaceutical Quaternary ammonium compounds
The quality of Novo Nordisk Pharmatech’s crystalline quaternary ammonium compounds (quats) is enhanced by an innovative synthesis process that ensures excellent antimicrobial and surface-active properties, together with exceptionally high purity that makes them suited for a wide range pharmaceutical applications, such as vaccine production as well as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams.
Novo Nordisk quats are active against the most common micro-organisms, such as bacteria, fungi and algae. They are widely used as APIs or excipients, because of their preserving properties. They are differentiated by form (powder, viscous liquid, solution), by alkyl (carbon) chain length of the tertiary amines used, and by anion (chloride or bromide).
Quats are produced according to the highest cGMP standards, backed by complete regulatory documentation. They are manufactured using only high-purity tertiary amines with various alkyl chain lengths, normally ranging from C12 to C18. Quat properties vary with alkyl chain length but all offer:
- Proven efficacy against a broad spectrum of microorganisms
- Effectiveness across a wide pH range
- Odorless and colorless product formulation
- Surface active / adhesive cationic agent
- High stability, proven under ICH Q1 conditions
- Five-year shelf life
- Global compliance
Novo Nordisk Pharmatech’s range of quaternary ammonium ‘quat’ compounds includes:
- Benzalkonium chloride – a range of ten crystalline or solution formulations to Ph.Eur, USP/NF or JP standards
- Cetrimide – Trimethyl tetradecyl ammonium bromide containing approximately 99% active ingredients, manufactured to cGMP Guideline ICH Q7 and analyzed according to European Pharmacopoeia (Ph.Eur.)
- CTAB – Hexadecyl trimethyl ammonium bromide, containing 99% active ingredients and analyzed according to USP/NF
- Strong cetrimide solution – Formulations of dodecyl trimethyl ammonium bromide (20%), Trimethyl tetradecyl ammonium bromide (70%) and Hexadecyl Trimethyl ammonium bromide, in solution of ethanol or isopropyl alcohol. Both solutions are analyzed at 40% active ingredient, according to British Pharmacopoeia (BP)
Structure and History
Novo Nordisk Pharmatech A/S was established in 1949 as Ferrosan Fine Chemicals, part of the Ferrosan Group that was acquired by Novo Industries in 1986, becoming part of Novo Nordisk A/S with the 1989 merger of Novo with Nordisk Gentofte.
The following year, Novo Nordisk initiated the sale of Ferrosan Group but retained Ferrosan Fine Chemicals as a wholly owned subsidiary, subsequently changing its name to FeF Chemicals A/S.
In 1992, FeF received initial GMP approval by the Danish Medicines Agency for the manufacture of quats, becoming part of Novo Nordisk’s Product Supply division in 2004.
Between 2010 and 2012, FeF became a fully integrated business unit of Novo Nordisk A/S, by now a USD 12 bn. global diabetes care and biopharma company, and began producing insulin human for cell growth media, with new clean room packaging facility.
On September 1, 2015, the company changed its name to Novo Nordisk Pharmatech A/S, operating as a division of Novo Nordisk A/S from Koege, south of Copenhagen.
Standards and Compliance
Novo Nordisk Pharmatech’s quality management system complies with DS/EN ISO 9001 in all aspects of production, QA/QC, sales and marketing, R&D, information and customer services. High product quality is ensured through efficient quality control, rigorous training systems, well-established SOPs and quality analysis carried out by highly experienced professionals.
All manufacture is carried out in accordance with cGMP (ICH Q7), ISO9001 Standard Operating Procedures (SOP) Qualification & Validation. Filling of Quats is performed under full clean room conditions while Insulin Human AF is packed in a classified (Class C) facility.
Novo Nordisk Pharmatech also observes ICH Q9 Quality Risk Management standards and is certified as a Known Consignor supplier.