Enabling better medicines with Novo Nordisk Pharmatech

“Enabling better medicines” is a core mission that guides innovative Danish producer Novo Nordisk Pharmatech in all its manufacturing and supplying operations. The mission is ensured by providing sustainable pharmaceutical materials through innovative and customized solutions.

The approach enables Novo Nordisk Pharmatech’s cGMP manufactured Human Insulin AF and quaternary ammonium compounds (Quats) to become even more valuable as vital ingredients in pharmaceutical and biopharmaceutical applications.

How “Enabling better medicines” works

The ‘enabling better medicines’ doctrine is based on achieving highest quality at each step to add value and enable similarly high performance at subsequent stages to lift overall performance right across the entire value chain from discovery to delivery. This virtuous circle benefits Novo Nordisk Pharmatech and its customers alike.

By delivering excellence at every step, Novo Nordisk Pharmatech helps its customers achieve excellence in their own operations, whether they’re developing a cure for cancer or a new ophthalmic product.

New ideas are never enough on their own since they only become useful with flawless execution.

By delivering on time, reducing risk through assured product quality and ensuring compliance, Novo Nordisk Pharmatech provides customers with secure and stable platforms on which to build their own products that make a difference. Furthermore, essential quality is never lost. Pure ingredients enable purer products and highly compliant, fully documented, supplies enable easier product compliance and improved pharmaceutical and biopharmaceutical manufacturing.

Product purity

Novo Nordisk Pharmatech meets its customers’ most demanding standards by providing pure, efficacious and safe products every time.

It regards product purity and highest quality ingredients as essential in enabling clients to ensure highest quality manufactured final products. In practice, this means always manufacturing in accordance to the highest cGMP standards, using assured provenance synthetic raw materials from audited and approved suppliers. This is combined with rigorous process control, down to the finest details, leveraging from 70 years of experience to ensure maximum product purity, exceeding the strictest pharmacopeial standards.

An innovative synthesis process makes Novo Nordisk Pharmatech A/S a leading supplier of crystalline Quats for a wide range of applications with purity levels that 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. Their purity and characteristics are also ideal for a range of personal care products. Whether Quats are used as excipients or APIs, customers can rely on fully documented purity.

Recombinant Insulin Human AF is supplied in crystalized form as a biosynthetic white powder produced by a recombinant microbial expression in yeast with a synthetic gene insert, processed to be easily soluble at low pH levels and with assured shelf life of 60 months when stored at -20°C + 5°C to avoid potential degradation. Insulin Human AF can also be stored at refrigerator temperature (+2 to +8°C) for up to 14 days in total and can be thawed/re-frozen up to five times to allow easier product handling.

Supply security

Novo Nordisk’s secure global supply chain ensures dependable availability, precision delivery and a continuous supply of products. Novo Nordisk Pharmatech’s delivery and stock policy is designed to meet the most demanding and urgent requirements, with in-stock pharmaceutical products shipped within a week. The company also offers a wide range of packing solutions, to meet demands for small and large batches.

Whether recombinant insulin or Quats, customers can rely on:

• Adherence to the EU guidelines on Good Distribution Practice (cGDP) for API’s
• Precise delivery fulfilment
• Consistent high quality
• Certification as a known consignor supplier

Manufacturing facilities are carefully placed to ensure the most secure geographic, weather, political and civil conditions. They have strong, long-standing relations with suppliers and meet the highest standards of fire and explosion risk prevention. Novo Nordisk’s risk mitigation strategies allow it rapidly and efficiently to manage and counteract any external threats to product supply, as the COVID-19 crisis has proved.

Novo Nordisk Pharmatech also acts as a reliable partner in assisting manufacturers find the right quality ingredients for their projects. Its specialists can offer expert advice about choosing the right product for a formulation, or development of custom-designed products to meet specific application needs.

Product Consistency

Product consistency is fundamental to providing peace-of-mind and lack of distraction to customers, leaving them free to concentrate on developing the highest possible quality and most innovative products.

With well-established manufacturing, analytical and quality processes, Novo Nordisk Pharmatech delivers constant product consistency and compliance.

As a member of the UN Global Compact and World Business Council for Sustainable Development (WBSCD), Novo Nordisk promotes and observes general policies for sustainability, business ethics and code of conduct, allowing its customers to achieve similar aims in their own operations.

Quality Assurance

Novo Nordisk Pharmatech´s tight control measures, assurance systems and professionality ensure that every product supplied is of the highest possible quality.

Its internal quality management system (QMS) assures DS/EN ISO 9001 standards across all its activities. The company also operates to all International Council for Harmonization (ICH) guidelines. So its pharmaceutical Quats are manufactured in accordance with cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. It analyses according to relevant multicompendial pharmacopoeias, such as Ph.Eur., USP/NF, JP and BP.

Both Novo Nordisk Pharmatech and parent company Novo Nordisk are regularly audited by major and minor pharmaceutical companies and inspected by the Laegemiddelstyrelsen Danish Medicine Agency (LMS), while quality performance is continuously monitored by both customers and authorities, using audit feedback and customer centricity to  achieve continuous improvement.

Comprehensive documentation and services include:

• ISO 9001 Certification
• GMP Certification (LMS)
• Certificate of Analysis (current version of pharmacopoeias)
• Customer audits
• Declarations, statements (stability, residual solvents, TSE/BSE, GMO, allergens, elemental impurities, etc.)
• Change Notification
• Response to questionnaires
• Process flowchart
• Packaging details

Insulin Human products are registered by Novo Nordisk, while Cetrimide, CTAB and Benzalkonium Chloride quaternary compounds are all registered with ECHA.

Resources

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