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Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S 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 ingredients (APIs) and excipients, and Recombinant Insulin for use in cell culture media to enhance cell growth, viability and productivity.
Novo Nordisk Pharmatech is fully owned by Novo Nordisk.
Insulin Human AF
Our high purity, non-therapeutic Insulin is sourced directly from parent company Novo Nordisk, the world’s largest insulin producer.
It consists of insulin human crystals, biosynthetically produced by recombinant microbial expression in yeast, and optimized for use in cell culture medium for further biopharmaceutical manufacturing.
Insulin Human AF is manufactured in accordance with internal quality systems, based on ISO 9001 and cGMP and is analysed according to the current European (Ph. Eur.) and US (USP) Pharmacopoeias. 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 (Quats)
Novo Nordisk Pharmatech’s quaternary ammonium compounds (Quats) are manufactured using a full cGMP synthesis process, that ensures exceptionally high purity and batch consistency. They are suited for a wide range of pharmaceutical applications, such as vaccine production and as preservatives (excipients) or active ingredients (APIs) in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments, gels and creams.
Novo Nordisk Quats have excellent antimicrobial and surface-active properties, and are active against the most common micro-organisms, such as bacteria, fungi, algae and enveloped viruses. They are differentiated by form (powder, viscous liquid, solution), by alkyl (carbon) chain length of the tertiary amines used (C12 to C18), and by anion (chloride or bromide).
- Proven efficacy against a broad spectrum of microorganisms
- Effectiveness across a wide pH range
- Odourless and colourless product formulation
- Surface active / adhesive cationic agent
- High stability, proven under ICH Q1 conditions
- Five-year shelf life
- Global compliance
- Full regulatory package
All below Quats are manufactured in accordance with ICHQ7.
- Benzalkonium chloride – a range of formulations from 17% to 100%, according to Ph.Eur, USP/NF or JP standards.
- Cetrimide – Trimethyl tetradecyl ammonium bromide powder, containing approximately 99% active ingredients, according to Ph.Eur.
- CTAB – Hexadecyl trimethyl ammonium bromide, or Cetrimonium bromide, a powder containing 99% active ingredients, according to USP/NF.
- Strong cetrimide solution – 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 at 40% active ingredient, according to British Pharmacopoeia (BP).
Standards and Compliance
- Novo Nordisk Pharmatech’s QMS 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.
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.
In 1990 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.
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.