- Application for recombinant Insulin Human AF
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- Registrant group for Reaction mass of C12 trimethylammonium bromide and C14 trimethylammonium bromide
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Global regulatory compliance
Our pharmaceutical Quats are manufactured in accordance with cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. We analyse according to relevant multicompendial pharmacopoeias (eg. Ph.Eur., USP/NF, JP and BP). Our pharmaceutical Quats are used in many different products such as ophthalmic, nasal sprays, topical products, oral/dental products and medical devices.
Our recombinant Insulin Human AF is a key component in serum-free growth media for mammalian cells, used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drugs approved by regulatory bodies worldwide.
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
- Enter quality assurance agreements on Novo Nordisk Pharmatech template
Quality management system
Novo Nordisk Pharmatech’s quality management system is in compliance with DS/EN ISO 9001 in all of our activities and includes production, QA/QC, sales and marketing, R&D, shipping information and customer services. The high quality of our products is ensured by our efficient quality assurance systems and quality control carried out by highly experienced professionals.
Environment and safety
Environmental considerations are an integral part of our everyday work. Our main concerns include reducing atmospheric emissions of organic solvents from the production process, and carbon dioxide and nitrogen oxide from the production of energy. We have implemented an Environmental Policy and are DS/EN ISO 14001 as well as OHSAS 18001 certified.
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REACH at Novo Nordisk Pharmatech
All relevant products manufactured at Novo Nordisk Pharmatech are registered with ECHA in 2008. Insulin Human products are registered by Novo Nordisk. Our FeF® Cetrimide and FeF® CTAB products were registered in 2013. See our registration numbers and registration dates here.
We are involved in the relevant SIEF groups, either as a Lead Registrant or as an active participant. Both our internal specialists as well as external consultants will insure that our products are registered in due time. A continuous dialogue with our suppliers and customers will help guarantee a smooth progression of the registration process.