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Novo Nordisk Pharmatech A/S

Supplier of Quaternary Ammonium Compounds and Recombinant Insulin Human AF

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Novo Nordisk Pharmatech A/S

Novo Nordisk Pharmatech A/S is a global and leading manufacturer of pharmaceutical ingredients for the pharmaceutical and biopharmaceutical industries.

Novo Nordisk Pharmatech A/S is a global and leading manufacturer of pharmaceutical ingredients for the pharmaceutical and biopharmaceutical industries. The company is specialized 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 helps the world´s largest pharmaceutical and biopharmaceutical industries reducing 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 through innovative and customised solutions.

 Product: Insulin Human AF

Novo Nordisk Pharmatech’s high purity, non-therapeutic 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 and enhances the yield and is a key component in serum-free growth media for mammalian cells. Human Insulin AF is used for the 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.

Product: Pharmaceutical grade Quats

As the world’s 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. 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. Their 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 with 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 over 30 years in CGMP manufacturing, Novo Nordisk Pharmatech delivers the same high-quality products batch after batch.

Quality and control

Being cGMP certified, Novo Nordisk Pharmatech ensures that every aspect of the manufacturing process is in control – from its own suppliers to the finished product.

All manufacturing is carried out in accordance with 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 organisation is a stringent Quality Management System (QMS) which ensures the right 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 both customers and authorities, including the FDA and EMA.

A comprehensive documentation package and tailored support, which continues through the whole product life cycle, gives you total peace of mind. The company provide 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 and declarations, stability, and analysis documents, and much more. They also support their customers well after supplier qualification and delivery and through their whole product lifecycle in case of any problems or issues.

Environment

Environmental challenges have never been more critical or more urgent than they are today, and 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.

Novo Nordisk Pharmatech is also a part of Novo Nordisk´s bold environmental strategy, Circular for Zero. The ambition is Zero environmental impact by 2030. To achieve zero impact, both up and down our supply chain, working with our suppliers is paramount. With both current and future suppliers, they will collaborate proactively to embed circular thinking across the value chain and switch to circular sourcing and procurement.

History and structure

Novo Nordisk Pharmatech A/S was established in 1949 as Ferrosan Fine Chemicals, part of the Ferrosan Group, which 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.

Contact

Novo Nordisk Pharmatech A/S
Koebenhavnsvej 216
4600
Koege
Denmark

Phone: +45 5667 1000
Fax: +45 5667 1001
Email: nnprinfo@novonordiskpharmatech.com
Website: www.novonordiskpharmatech.com

Insulin

Novo Nordisk Pharmatech lives up to the company's high-quality standards, providing pure, efficacious and safe products. Its entire supply chain, manufacturing and quality control takes place in Denmark. The company's recombinant Insulin Human AF is manufactured in accordance with Novo Nordisk Pharma's quality systems, which are based on ISO: 9001 standards and meet the requirements of…

Pharmaceutical-Grade Quaternary Ammonium Compounds

As one of the world's leading suppliers of quarternary ammonium compounds (Quats), Novo Nordisk provides high-quality and safe ingredients for the pharmaceutical and personal care industries. Its ingredients are produced according to current good manufacturing practices (cGMP) standards and backed by complete regulatory documentation. This combination of high-purity products and regulatory services has made the…

Strong Cetrimide Solution 40% BP Pharma with Ethanol

Also known as Cetrimide, Cetrimoni bromidum and Tetradecyl trimethyl ammonium bromide (TTAB), Strong Cetrimide Solution 40% BP Pharma with ethanol (CAS No. 1119-97-7.) consists of dodecyl trimethyl ammonium bromide (approximately 20%), trimethyl tetradecyl ammonium bromide (approximately 70%) and hexadecyl trimethyl ammonium bromide (approximately 10%). It also contains around 7.5% volume/volume (v/v) ethanol. Manufactured in accordance…

Benzalkonium Chloride (Regular Grade)

Benzalkonium Chloride 95% Regular (BKC/BAC/BAK)CAS No. 8001-54-5. Consists of Benzyl (dodecyl) dimethyl ammonium chloride (approx. 65%) and Benzyl (tetradecyl) dimethyl ammonium chloride (approx. 35%). Contains approx. 95% active ingredients.Packaging sizes:50kg drum - Item number: 8560002Documentation and services:Certificate of AnalysisDatasheetDeclarations (TSE/BSE, allergens, animal testing)Process flowchartMSDSISO 9001 CertificateBenzalkonium Chloride Solution 50% Regular (BKC/BAC/BAK)CAS No. 8001-54-5. Consists of…

Insulin Human SG (Standard Grade) ror Cell Culture Medium Use

Consists of human insulin crystals, a biosynthetic product produced by recombinant microbial expression in yeast.

For Further Manufacturing Use Only.Not for Therapeutic Use.Manufactured in accordance with ISO 9001.Analyzed according to the current European Pharmacopoeia (Ph.Eur.) and United States Pharmacopoeia (USP).Packaging sizes:1 g - Repack Item No.: 65000110 g - Repack Item No.: 65001050 g - Repack Item No.: 650050100 g - Repack Item No.: 6501001 kg - Repack Item No.:…

Benzalkonium Chloride 95% with Standard Chain Length (cGMP)

Benzalkonium Chloride Solution 50% (85/15) JP (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed product consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 85%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 15%). It also contains around 50% active ingredients. Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7…

Benzalkonium Chloride Solution with Standard Chain Length ( cGMP)

Benzalkonium Chloride Solution 50% Ph.Eur., USP/NF, JP (BKC/BAC/BAK) (CAS No. 8001-54-5.) consists of benzyl (dodecyl) dimethyl ammonium chloride (approximately 65%) and benzyl (tetradecyl) dimethyl ammonium chloride (approximately 35%). It also contains around 50% active ingredients. Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical…

Benzalkonium Chloride with Special Chain Length ( cGMP)

Benzalkonium Chloride Solution 50% (53/30/15/2) Ph.Eur., USP/NF (BKC/BAC/BAK) (CAS No. 8001-54-5.) is a custom-designed product consisting of benzyl (dodecyl) dimethyl ammonium chloride (approximately 53%), benzyl (tetradecyl) dimethyl ammonium chloride (approximately 30%), benzyl (hexadecyl) dimethyl ammonium chloride (approximately 15%) and benzyl (octadecyl) dimethyl ammonium chloride (approximately 2%). It also contains around 50% active ingredients. Manufactured in…

Myristalkonium Chloride ( cGMP)

Also known as benzalkonium chloride powder and myristyl dimethyl ammonium chloride, myristalkonium chloride (MKC) pharma (CAS No. 139-08-2) consists of benzyl (tetradecyl) dimethyl ammonium chloride. It also contains approximately 99% active ingredients. Manufactured in accordance with the current good manufacturing practices (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), this product…

Cetyl Trimethyl Ammonium Bromide (cGMP)

Also known as cetrimonium bromide and hexadecyl trimethyl ammonium bromide (HTAB), cetyl trimethyl ammonium bromide (CTAB) USP/NF (CAS No. 57-09-0.) consists of trimethyl hexadecyl ammonium bromide. It also contains approximately 99% active ingredients. Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical ingredients (API), it…

Cetrimide Ph.Eur and Strong Cetrimide (cGMP)

Also known as cetrimoni bromidum, tetradecyl trimethyl ammonium bromide (TTAB), myristyl trimethyl ammonium bromide (MTAB) and mytrimonium bromide, Cetrimide Ph.Eur (CAS No. 1119-97-7.) consists of trimethyl tetradecyl ammonium bromide. It also contains approximately 99% active ingredients. Manufactured in accordance with the current good manufacturing practice (cGMP) guideline International Conference on Harmonisation (ICH) Q7 for active pharmaceutical…
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