Novo Nordisk Pharmatech A/S is a global and leading manufacturer of pharmaceutical ingredients for the pharmaceutical and biopharmaceutical industries. The company is specialised 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 supports the world´s largest pharmaceutical and biopharmaceutical industries reducing their risks related to raw materials, by using pharma-grade products with a high level of consistency, purity, quality, and reliability.
The company’s mission is to enable better medicines by providing sustainable pharmaceutical materials through innovative and customised solutions
Mitigating Raw-Material Risks During a Pandemic
For many pharmaceutical and biopharmaceutical companies, the COVID-19 pandemic has put supply chains to the test, while regulatory requirements are increasingly tightening.
The crisis has reinforced the importance of having a strong supply chain and a risk-management and business-continuity plan. How can you mitigate your raw-material risk, especially during a pandemic?
Risks When Choosing a Raw Material Supplier
How do you select your critical raw-material suppliers? What selection criteria and which risks have you identified? To understand risks related to supply, demand, material supplier capacities, and so on, you need information that can come only from communicating with your supplier about the stability of supply, production capacity, and transportation and distribution chain.
A large organisation such as Novo Nordisk Pharmatech can secure a continued source of raw materials. The past year they have experienced significantly increased freight fees and limited availability of transportation for both recombinant human insulin and quaternary ammonium compounds (also known as Quats) APIs. Despite that, and thanks to close cooperation with the customers, Novo Nordisk Pharmatech has been delivering their products as promised and without disrupting planned manufacturing processes.
A transparent communication is essential. To best manage unforeseen situations such as a pandemic, contingency planning is performed based on the customers’ needs. Furthermore, the company´s supply chain is secured by building partnerships, exchanging forecasts, and discussing foreseen changes, and performing joint planning. Sometimes, doing so is easier said than done. One way to facilitate those processes is by creating supply agreements. Entering into numerous supply agreements and Quality Assurance Agreements (QAAs) with our customers, has helped maintaining clear expectations from both sides and provide peace of mind.
Minimising Raw Material Variability
The customers want to source materials from reliable sites that deliver as agreed on quality, purity, and consistency between batches and shipments. Delivering a high level of consistency in both the quality and supply of pharmaceutical grade Quats and Human Insulin AF, Novo Nordisk Pharmatech helps the customers reduce their risk. The cornerstone of the organisation is an effective quality management system, which helps to achieve that goal. The comprehensive documentation package and tailored support, which continues through the whole product life cycle, gives you total peace of mind.
Novo Nordisk Pharmatech is monitored stringently by international regulatory authorities and customers. The company has an outstanding track record of compliance and customer satisfaction because they learn from each audit, monitor compliance requirements, and strive for continuous improvement.
One-Stop Regulatory Compliance
If you manufacture products for markets beyond your own, ensuring regulatory compliance can be a particular challenge: from staying up to date with changes, to navigating language barriers, or even meeting requirements above the official guidelines. While many countries are working towards harmonising regulations, experiences show that some customers still require more documentation than officially specified.
Audits can cover the Good Manufacturing Practice (GMP) level of a supplier, but supplier qualification consists of many aspects. Those include regulatory requirements and available risk assessments as well as a supplier’s overall compliance, noncompliance, and recall history.
Novo Nordisk Pharmatech takes pride in providing a simple, hassle-free, ‘one-stop’ compliance and regulatory package. All Novo Nordisk Pharmatech activities including dedicated QA and regulatory affairs teams are gathered at one site in Europe (Denmark), making supply chain audits easy. The customers are issued up-front access to a full package of certificates from authorities (e.g., current GMP as well as International Organisation for Standardisation (ISO) 9001, 14001, and 45001); qualification dossiers, statements, and declarations; change notifications, questionnaires, stability and analysis documents; and more.
Being qualified as a supplier is only the beginning of a journey. The support of the customers lasts throughout the whole product life cycle, with premium service and documentation. This is part of the ambition to remain a preferred supplier and contribute to improving pharma and biopharma processes.
Insulin Human AF
Novo Nordisk Pharmatech´s high purity, nontherapeutic 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 mammalian cells and enhances the yield and is a key component in serum free growth media. The Insulin Human AF is used for manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drug products approved by regulatory bodies worldwide, including FDA and EMA.
Novo Nordisk Pharmatech’ s 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.
Insulin Human AF has a shelf life of 60 months and the company has enough packed off-the-shelf Insulin Human AF in stock for at least five months of consumption, to be able to respond immediately to your specific requirements.
With Insulin Human AF 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.
Pharmaceutical Grade Quats
As the world’s leading supplier of pharmaceuticalgrade quaternary ammonium compounds (Quats), Novo Nordisk Pharmatech provides only the best and safest ingredients for the pharmaceutical and personal care industries. The Quats products are sold globally in more than 70 countries across Europe, Asia, North America, South America, and Africa.
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 Quats product range (including Benzalkonium Chloride, Cetrimide and Cetrimonium Bromide/CTAB) is suited for a wide range of pharmaceutical applications that require high purity and quality, 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 Pharmatech’ s Quats have excellent antimicrobial and surface-active properties, and are active against a broad spectrum of microorganisms, such as gram + and – & acid-fast bacteria, yeasts, moulds 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 to the highest regulatory guidelines, including ICH Q7, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). 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 have made the company an approved supplier to many of the world’s leading pharmaceutical companies. With more than 70 years of experience in producing Quats and more than 30 years CGMP manufacturing, Novo Nordisk Pharmatech deliver the same high-quality products batch after batch.
The Company´s History and Structure
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. 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 Køge, south of Copenhagen.
The entire value chain from Research and Development, Manufacturing, Quality Assurance, Quality Control to Sales and Marketing is located on site in Køge giving the company significant advantages in terms of agility.
More than 70 years of experience have given Novo Nordisk Pharmatech the know-how to ensure maximum product purity and keeping impurities to even lower levels than pharmacopeial standards. This has made the company a leading global supplier of high-quality ingredients - enabling the customers to make even better medicines.
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