Novo Nordisk Pharmatech A/S is a global manufacturer of pharmaceutical ingredients for the biopharmaceutical and pharmaceutical industries. The company specializes in Recombinant Insulin for use in cell culture media to enhance cell growth, viability, and productivity. The company also has more than 70 years of experience in manufacturing quaternary ammonium compounds (Quats) used as active pharmaceutical ingredients (APIs) and excipients.
Novo Nordisk Pharmatech helps the world´s largest pharmaceutical and biopharmaceutical industries reduce their risk for raw materials by using pharma-grade products with a high level of consistency, purity, quality, and reliability. The mission is to enable better medicines by providing sustainable pharmaceutical materials.
Product: Insulin Human AF
The high-purity, non-therapeutic Recombinant 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.
Recombinant Insulin stimulates the proliferation of cells, enhances the yield, and is a key component in serum-free growth media for mammalian cells. Insulin Human AF is used to manufacture monoclonal antibodies, virus vaccines, gene therapy products and other biological drug products approved by regulatory bodies worldwide, including the FDA and EMA.
With Recombinant Insulin from Novo Nordisk Pharmatech, you avoid the risk of impurities such as mycoplasmas, which can pass line to line from the upstream bioreactor and contaminate your whole line. The Insulin Human AF is manufactured under internal quality systems, based on ISO 9001 and cGMP, and analyzed 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. The product has a shelf life of 60 months.
Product: Pharmaceutical grade Quats
As a leading supplier of pharmaceutical-grade quaternary ammonium compounds (Quats), Novo Nordisk Pharmatech provides only the best and safest ingredients for the pharmaceutical and personal care industries.
Novo Nordisk Pharmatech is a specialist and dedicated manufacturer of Quats in an unequalled, full cGMP grade, ensuring exceptionally high purity and batch-to-batch consistency. The product range (including Benzalkonium Chloride, Cetrimide, and Cetrimonium Bromide/CTAB) is suited for a wide range of pharmaceutical applications requiring high purity and quality, such as vaccine production and preservatives (excipients) or active ingredients (APIs) in many ophthalmic, nasal, oral, and topical drugs and in various solutions ointments, gels, and creams.
Novo Nordisk Pharmatech’s s Quats products have excellent antimicrobial and surface-active properties and are active against a broad spectrum of microorganisms, such as gram + and – & acid-fast bacteria, yeasts, molds, and enveloped vira such as HIV, herpes, and corona. They are effective through a wide pH range, are surface-active/adhesive cationic agents, and do not add unpleasant odour/colour to finished formulations.
The multi-compendial range of Quats complies with the highest regulatory guidelines, including ICH Q7, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). In addition, some Quats products also follow the Japanese Pharmacopoeia (JP), the British Pharmacopoeia (BP) or the Chinese Pharmacopoeia (ChP).
Combining high-purity products and regulatory services has made the company an approved supplier to many of the world’s leading pharmaceutical companies. With over 70 years of experience producing Quats and more than 30 years of cGMP manufacturing, Novo Nordisk Pharmatech delivers the same high-quality products batch after batch.
Quality and control
All manufacturing is carried out following cGMP (ICH Q7), ISO9001 Standard Operating Procedures (SOP) Qualification & Validation. Filling of Quats is performed under full cleanroom conditions while Insulin Human AF is packed in a classified (Class C) facility. High product quality is ensured through efficient quality control, rigorous training systems, well-established SOPs, and quality analysis carried out by highly experienced professionals.
The cornerstone of their quality organization is a stringent Quality Management System (QMS) which ensures high-quality products with a high degree of consistency. Novo Nordisk Pharmatech’s QMS complies with DS/EN ISO 9001 in all aspects of the value chain and receives excellent ratings in audits from customers and authorities, including the FDA and EMA.
A comprehensive documentation package and tailored support, which continues through the entire product life cycle, gives you total peace of mind. The company provides one-stop compliance and regulatory package, providing you with up-front access to certificates from authorities (including cGMP, ISO 9001, 14001, and 45001), qualification dossiers, statements, declarations, stability and analysis documents, and much more. They also support their customers after supplier qualification and delivery and through their product life cycle.
Novo Nordisk Pharmatech has proudly been CO2-neutral since 2018. Supplied with renewable energy produced by windmills and gas consumption comes from biogas certificates, they have zero CO2 emissions from energy consumption. The company follows Novo Nordisk´s environmental strategy, Circular for Zero. The ambition is Zero environmental impact by 2030. Working with our suppliers is paramount to achieving zero impact, both up and down our supply chain.