We manufacture Quats using only high purity tertiary amines with various alkyl chain lengths, normally ranging from C12 to C18. We keep one step ahead of the current, global regulatory requirements, both in manufacturing (GMP, ISO), analysis (multicompendial pharmacopoeia) and documentation (CEP/COS, DMF, declarations).
FeF Chemicals is a Novo Nordisk company that specialises in the supply of ingredients for the pharmaceutical and biopharmaceutical industries, such as and cGMP manufactured Quaternary Ammonium Compounds (usually referred to as Quats) e.g. Benzalkonium Chloride, Cetrimide and Cetrimonium Bromide and Insulin Human for cell culture media.
For our cGMP manufactured Quats we offer:
As an approved supplier by a large number of global leading pharmaceutical companies, FeF Chemicals can assure full traceability and reliability of the raw materials. We have a well-developed management system, allowing tracing where the raw materials are used. We also have close contact with our suppliers and can meet with customer requested specifications. For us, reliability is not just in the system but also in the mindset of our employees.
Our quality system meets DS/EN ISO 9001 and ICH’s cGMP Guide for Active Pharmaceutical Ingredients (ICH Q7). Uniform quality of finished products is ensured by our efficient quality control systems, computerised materials planning and rigorous laboratory quality control.
If the required product is not in the standard assortment, we can design customized products. Our flexible production process can meet customer demands for special chain length distribution and/or solutions of quats mixed in various ratios.