Novo Nordisk Pharmatech Insulin Human for Cell Culture Media and cGMP-Manufactured Quaternary Ammonium Compounds
Novo Nordisk Pharmatech is a Novo Nordisk company specialising in the supply of ingredients for the biopharmaceutical and pharmaceutical industries, such as human insulin for cell culture media and current good manufacturing practices (cGMP) manufactured quaternary ammonium compounds (usually referred to as quats), including benzalkonium chloride, cetrimide, and cetrimonium bromide.
Novo Nordisk Pharmatech’s insulin products include:
- Insulin from the largest manufacturer worldwide
- European Pharmacopoeia (Ph Eur) and United States Pharmacopeia (USP) compliance
- Comprehensive documentation
- Full traceability
- Supply guarantee
cGMP-manufactured quats offered include:
- Global regulatory compliance
- Manufacture in accordance with the highest good manufacturing practice (GMP) standards on the market, the ICH Guide Q7 for active pharmaceutical ingredients (API)
- High-purity products
- Analysis according to multicompendial pharmacopoeias: British Pharmacopoeia (BP), Ph Eur, United States Pharmacopeia and National Formulary (USP-NF) and Japanese Pharmacopoeia (JP)
- Regulatory documentation
As an approved supplier by a large number of global leading pharmaceutical companies, Novo Nordisk Pharmatech can assure full traceability and reliability of raw materials. The company has a well-developed management system, allowing traceing of where raw materials are used. Novo Nordisk Pharmatech also has close contact with suppliers and can meet customer-requested specifications.
Quality assurance and cGMP compliance
Consciousness in quality is an integrated part of Novo Nordisk Pharmatech’s work, enabling the company to offer outstanding products and services. By regular internal and external staff training and education, it always follows the latest guideline requirements.
Novo Nordisk Pharmatech’s quality system meets DS/EN ISO 9001 and ICH’s cGMP guide for API (ICH Q7). Uniform quality of finished products is ensured by the firm’s efficient quality control systems, computerised materials planning, and rigorous laboratory quality control. In-process samples and finished products are carefully analysed in a modern, well-equipped laboratory.
Customised pharmaceutical products
Novo Nordisk Pharmatech is supporting innovation by offering customised solutions to meet specific requirements.
Fast and reliable services in documentation, analyses, and manufacturing, fulfilling local and international regulatory requirements are key to securing customer satisfaction.
Novo Nordisk Pharmatech’s delivery and stock policy for pharmaceutical products is determined to meet the most demanding and urgent requirements and pharmaceutical products can be shipped within a week. The company’s range of products is also offered in a variety of packing solutions, meeting demands for small and large packaging.
As a chemical manufacturer, Novo Norisk Pharmatech’s considerations for the surrounding environment takes a very high priority.
The company continuously focus on improving its environmental efforts and it has implemented a management system according to DS/EN ISO 14001. Novo Nordisk Pharmatech also acts in accordance with environmental legislation and other declarations of intent.
Novo Nordisk Pharmatech continuously aims to reduce its environmental impact by optimising effective resource utilisation and minimising discharge and waste. As a Novo Nordisk company, Novo Nordisk Pharmatech works with the Triple Bottom Line concept, conducting activities in a financially, environmentally, and socially responsible way.
Quaternary ammonium compounds (quats) for the pharmaceutical industry
Novo Nordisk Pharmatech focuses on manufacturing quaternary ammonium compounds for the pharmaceutical and personal care industries. Its own innovative synthesis process makes the company a leading supplier of crystalline quats. This ensures a very high level of purity of our crystalline products such as cetrimide, cetrimonium bromide (CTAB) and myristalkonium chloride (MKC).
By using raw materials of high purity and following its stringent quality system, Novo Nodisk pharmatech’s products are particularly suited for applications within the pharmaceutical industry. They act as preservatives in many ophthalmic, nasal, and oral drugs, as well as for active ingredients in a variety of topical and antiseptic solutions, ointments and creams. For the cosmetic industry, our quats’ purity and characteristics provide ideal conditioning, emulsifying and preserving effects in hair and cream products.
Thanks to Novo Nordisk Pharmatech’s closely-controlled production process, reducing batch variation to a minimum, the company is highly valued by diagnostic reagent sector. Combined with their high purity, this makes our quats significantly superior to other less pure compounds.
If the required product is not in the standard assortment, we can design customised products. Our flexible production process can meet customer demands for special chain length distribution and / or solutions of quats mixed in various ratios.
Regulatory documentation for pharmaceutical compliance
As a supplier to the pharmaceutical, personal care and cosmetic industries, Novo Nordisk Pharmatech emphasises on the importance of offering quality products with the appropriate and necessary documentation. The company is fully aware of the importance of the drug registration phase within the pharmaceutical industry.
Novo Nordisk Pharmatech offers an extensive range of documentation on its pharmaceutical grade products, such as multicompendial analysis and access to regulatory documentation.
Through highly qualified support, the firm ensures the best possible service and fast preparation of documentation, such as drug master files for its pharmaceutical-grade products. To further facilitate the drug registration process, Novo Nordisk Pharmatech offers access to its certificates of suitability according to the monographs of the Ph Eur, for benzalkonium chloride solution 50% and benzalkonium.
Products and Services
Benzalkonium Chloride Ph.Eur., USP/NF, JP (BKC/BAC/BAK)
CAS No. 8001-54-5. Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). Contains approximately 95% active ingredients.
Benzalkonium Chloride (3% C16) USP/NF (BKC/BAC/BAK)
CAS No. 8001-54-5. Custom design product consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approximately 64%), Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 34%) and Benzyl (hexadecyl) dimethyl ammonium chloride (approximately 2%-3%). Contains approximately 95% active ingredients.
Benzalkonium Chloride Solution 17% USP/NF (BKC/BAC/BAK)
CAS No. 8001-54-5. Custom design solution consisting of Benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). Contains approximately 17% active ingredients.
Benzalkonium Chloride Solution 50% Ph.Eur., USP/NF, JP (BKC/BAC/BAK)
CAS No. 8001-54-5. Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). Contains approx. 50% active ingredients.
Other names: Cetrimoni bromidum / Tetradecyl trimethyl ammonium bromide (TTAB) / Myristyl trimethyl ammonium bromide (MTAB) / Mytrimonium bromide.
Myristalkonium Chloride (MKC) Pharma (Other names: Benzalkonium Chloride powder/Myristyl dimethyl ammonium chloride)
CAS No. 139-08-2. Consists of Benzyl (tetradecyl) dimethyl ammonium chloride. Contains approximately 99% active ingredients.
Novo Nordisk Pharmaceuticals High-Quality Ingredients
Every new idea needs great execution. Novo Nordisk Pharmaceuticals can help with a reliable supply of the highest quality ingredients for the biopharmaceutical and pharmaceutical industries.
Mammalian cells are one of the most widely used platforms in the production of biopharmaceuticals.
Novo Nordisk Pharmatech has announced it will be showcasing its innovative biologics and Insulin Human AF at the World Biosimilar Congress in Switzerland.Read more
Novo Nordisk Pharmatech has announced it will be attending this year's European Antibody Congress, which will be held in Congress Center Basel in Switzerland.Read more
Novo Nordisk has announced it will be present at CPhI Worldwide.Read more
Novo Nordisk Pharmatech Showcases Recombinant Insulin at BioProcess International Conference and Exhibition
Novo Nordisk has announced it will be attending the BioProcess International conference and exhibition.Read more
Novo Nordisk Pharmatech Selects Azelis to Distribute its Quaternary Ammonium Compounds in Germany, Spain, Portugal, the UK, and Ireland
Novo Nordisk Pharmatech has entered an agreement with Azelis for the distribution of quaternary ammonium compounds (quats) to the pharmaceutical and medical device markets in Germany, Spain Portugal, UK and Ireland.Read more
Novo Nordisk has announced it will be attending CPhI North America, the meeting place for those seeking powerful partnerships to illuminate the path towards high-growth in the pharmaceutical industry.Read more
Novo Nordisk Pharmatech has announced it will be attending the annual Cell Line Development and Engineering Asia at the Hilton Shanghai Hongqiao.Read more
Novo Nordisk Pharmatech has announced it will be returning for the annual World Vaccine Congress.Read more
Selectchemie expands its pharmaceutical, over the counter (OTC) and personal care product offering with Novo Nordisk Pharmatech's pharmaceutical-grade quaternary ammonium compounds for Switzerland, Austria, and Eastern European markets.Read more
Novo Nordisk Pharmatech has announced it will be attending CHPI Worldwide to showcase its product portfolio.Read more
Brenntag Specialties (BSI) has signed a distribution agreement for Novo Nordisk Pharmatech's Pharmaceutical Grade Quaternary Ammonium Compounds, to be marketed in the US and Peurto Rican personal care, over-the-counter (OTC), and pharmaceutical markets.Read more
Novo Nordisk Pharmatech will be attending the BioProcess International European Summit from 12-13 April in Vienna, Austria.Read more
To provide the best possible customer service, Novo Nordisk Pharmaceuticals now offers distribution from two separate warehouse locations that serve a global client base. One is located in Plainfield, Indiana, US, and the other facility is located near Copenhagen, Denmark.Read more
Novo Nordisk Pharmatech will host a booth at this week's Biosimilars Asia.Read more
The Danish Medicines Agency has recently renewed its cGMP certificate in accordance with EU GMP Part II (ICH Q7) for an additional three-year period.Read more
Quaternary ammonium compounds (Quats) have excellent antimicrobial and surface-active properties, and have a very wide range of applications.Read more
With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances.Read more