DSM Obtains Drug Master File Number for Vitamin B in China

By: DSM Pharma Solutions Editors

DSM, a global science-based company focusing in nutrition, health and sustainable living, obtains a Drug Master File number for Vitamin B in China.

As biopharmaceutical quality standards continue to rise, so do expectations for purity, potency and value across the supply chain.

DSM recently submitted and obtained a Drug Master File (DMF) number in China for Vitamin B1 (thiamine hydrochloride) and Vitamin B6 (pyridoxine) Active Pharmaceutical Ingredients (APIs), thereby enabling DSM’s biopharmaceutical partners to use these ingredients in the development of proprietary drug products.

Conditions including, but not limited to, Crohn’s disease, anorexia nervosa, alcoholism and kidney dialysis may lead to Vitamin B1 (thiamine) deficiency. Emerging scientific evidence suggests the potential role of thiamine in cervical cancer prevention and chronic kidney disease progression in patients with type 2 diabetes.

Vitamin B6 (pyridoxine) has known applications in isoniazid-induced peripheral neuritis, idiopathic sideroblastic anemia and Vitamin B6 deficiency states. Vitamin B6 (pyridoxine) is also plays an important role in neurotransmission, with potential applications in Alzheimer’s disease, attention deficit-hyperactivity disorder (ADHD), Down syndrome and autism spectrum disorder (ASD).

Click HERE for more information about DSM's Vitamin API offerings

DSM is the first and only company in the world that can provide access to both US DMFs and Certificates of Suitability (CEPs) for all 13 vitamins, providing its pharmaceutical partners a competitive advantage by accelerating the registration and market entry process, enabling timelier patient access. DSM’s 400-strong R&D team and global network of regulatory specialists provide the foundation for a full suite of end-to-end service offerings.

DSM prides itself on having proven success in quality assurance and ensuring a reliable supply of products to customers worldwide. Our investment in China underscores our continued commitment to providing best-in-class product offerings across key biopharmaceutical markets. The company draws on its unique skills in chemical synthesis and biotechnology to ensure all products meet strict sustainability standards. DSM’s commitment to making substantial future investments in excellence and sustainability also means our global production network remains high quality and cutting edge.