DSM Receives US Drug Master Files For Essential Vitamins

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Overig advies 03/10/2016 12:00
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, 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 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.

The company claims they now offer an unparalleled reliability of supply and speed to market, stating that DSM’s full regulatory, scientific and quality expertise ensures that projects are both safe and compliant.


Source: Nutrition Horizon



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