DSM establishes CEPs and US Drug Master Files for 13 essential vitamins
DSM has received the US Drug Master Files (DMFs) for all 13 essential vitamins, making it the first company worldwide to hold both the US DMFs and CEPs for this active pharmaceutical ingredient (API) portfolio
This means DSM can offer its pharmaceutical customers worldwide a competitive edge by accelerating the registration process to get products to market faster.
Kristina Cselovszky, Business Development Director Pharma at DSM Nutritional Products, states: 'In a highly regulated and competitive market, our customers need bespoke solutions to stay ahead of their competition. As the only company holding US DMFs and CEPs for these 13 essential vitamins, we offer quicker and easier pharma registrations. Our ICH Q7-compliant production sites ensure we provide customers with safe, high-quality products.'
With extensive experience in vitamin and EPA and DHA active pharmaceutical ingredients (APIs), DSM is in a unique position to provide customers with entirely customised support throughout every stage of a project from initial conception.
In addition to its strong API portfolio, including vitamins, carotenoids, DHA, EPA and statins (by DSM Sinochem Pharmaceuticals), DSM’s 400-strong R&D team provides expertise in clinical trials.
DSM also has a global network of regulatory specialists, equipped to support customers’ local pharma product registrations. Offering an unparalleled reliability of supply and speed to market, DSM’s full regulatory, scientific and quality expertise ensures that projects are both safe and compliant.