Solutions
Benzalkonium Chloride
10 reasons why
High GMP quality
Our pharmaceutical BKC is manufactured in accordance with cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard.
We analyse according to relevant multicompendial pharmacopoeias (e.g., Ph.Eur., USP/NF, JP and BP).
Our quality performance is continuously monitored by both customers and authorities, and we strive to continuously improve based on audit feed-back and customer centricity.
High purity
An innovative synthesis process resulting in high levels of purity make them particularly suited for pharmaceutical applications.
- Proven record of efficacy against a broad spectrum of microorganisms.
- Effective through a wide pH range.
- Odourless and colourless in your formulation.
- Surface active /adhesive cationic agent.
- Very stable, proven under ICH Q1 conditions.
Consistency
Our stable and well-established manufacturing, analytical and quality processes ensure continuous product consistency and availability. Therefore we deliver as promised, on-spec and on time.
The cornerstone of a quality organisation is an effective quality management system. Novo Nordisk Pharmatech’s quality management system is in compliance with DS/EN ISO 9001 in all of our activities.
We operate under the highest available standards, the ICH Q7 guideline for APIs, and we comply with all relevant quality ICH guidelines such as Q1, Q2, Q3A, Q9, Q10, & Q11.
Reliability
We offer an extensive range of documentation to help you meet the registration and regulatory requirements for your products. This includes multicompendial analysis and access to regulatory documentation.
We ensure the best possible service and fats preparation of documentation, such as Drug Master Files. To further facilitate your drug registration requirements, we offer access to our Certificate of Suitability according to the Monographs of the European Pharmacopoeia for benzalkonium chloride and cetrimide.
Global regulatory compliance
Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency.
Our comprehensive documentation and services include:
- ISO 9001 Certificate
- GMP Certificate from the Danish Medicine Agency
- Certificate of Analysis (current version of pharmacopoeias)
- Customer audits
- Declarations, statements (stability, residual solvents, TSE/BSE, GMO, allergens, elemental impurities, etc.)
- Change Notification
- Answering of questionnaires
- Process flowchart
- Packaging details
- Quality assurance agreements on Novo Nordisk Pharmatech template
Wide range of applications
A proven record of efficacy against a broad spectrum of microorganisms makes our Benzalkonium Chloride very effective through a wide pH range.
Proven under ICH Q1 conditions, the products are very stable and can therefore be used in a wide range of applications such as ophthalmic, nasal sprays, topical products, oral/dental products, vaccines, medical devices, veterinary, and other applications that require high purity and quality.
Embracing a circular mindset
Our environmental strategy, Circular for Zero, sets out targets and milestones for the next 10 years of this journey. Our ambition is bold and simple: to have zero environmental impact.
We will collaborate proactively with suppliers to embed a circular mindset for reduced environmental impact across our value chain and switch towards circular sourcing and procurement.
We will eliminate the environmental footprint from our operations and drive a circular transition across the company to achieve our zero environmental impact ambition.
We will upgrade existing and design new products based on circular principles and solve the end-of-life product waste challenge to close the resource loop.
Sustainability and triple bottom line
Novo Nordisk is a member of the UN Global Compact and World Business Council for Sustainable Development (WBSCD). As a fully owned subsidiary, we follow the general policies of Novo Nordisk for sustainability, business ethics and code of conduct.
We believe that a healthy economy, environment and society are fundamental to long-term business success. This is why we manage our business in accordance with the Triple Bottom Line (TBL) business principle, conducting activities in a financially, environmentally and socially responsible way.
More than 70 years of experience
More than 70 years in the manufacturing of quats guarantees the best solution for your application.
Our own highly qualified personal work continuously on product development and improving documentation to suit your needs.
This expertise – together with product and documentation availability and global compliance – has made Novo Nordisk Pharmatech a preferred supplier leading pharmaceutical companies worldwide.
Want to learn more?
For more information about our Quats products, please contact us or visit our Quats product page.
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