DSM Receives US Drug Master Files For Essential Vitamins

03 Oct 2016 --- DSM has received the US Drug Master Files (DMFs) for all 13 essential vitamins, meaning it can offer its worldwide pharmaceutical customers a competitive edge by accelerating the registration process to get products to market faster.

The news also means that DSM is the first company worldwide to hold both the US DMFs and CEPs for this Active Pharmaceutical Ingredient (API) portfolio.

Kristina Cselovszky, Business Development Director Pharma at DSM Nutritional Products, stated: “In a highly regulated and competitive market, our customers need bespoke solutions to stay ahead of their competition.”

Speaking with NutritionInsight Cselovszky added, "DSM is already serving other highly regulated markets, like EU-countries, Japan, Brazil and therefore commit to the highest quality standard of their APIs, meeting the latest regulatory requirements and standards."

"However," she continued, "we also had to introduce additional internal programs to address some additional aspects which are critical to get US DMFs approved by the US FDA," Cselovszky continued.

"The successful accomplishment of such programs was only possible due to the full commitment from different functions and overall company passion and belief for pharma segment."

"DSM can offer its pharmaceutical customers worldwide a competitive edge by accelerating the registration process to get products to market faster, now including the 13 essential vitamins as APIs in pharma products for the registrations in the US," Cselovszky stated.

With extensive experience in vitamin and EPA and DHA Active Pharmaceutical Ingredients (APIs), DSM is in a unique position to provide customers with entirely customized support throughout every stage of a project from initial conception.

In addition to its strong API portfolio, including vitamins, carotenoids, DHA, EPA and statins, 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.

by Hannah Gardiner