DSM secures active China Drug Master File for pyridoxine hydrochloride

By: DSM Pharma Solutions Editors

• DSM has announced that its China Drug Master File (CDMF) for pyridoxine hydrochloride (vitamin B6) has been granted active status. View press release here to read DSM's announcement.
• The CDMF plays a critical role in facilitating and accelerating the approval of drug products. With this news, DSM is now able to provide full regulatory support to customers developing pharmaceuticals for the Chinese market.
• China is the world’s second largest pharmaceutical market. DSM puts resources behind further building a strong CDMF portfolio and is dedicated to continuing to deliver a reliable supply of high-quality vitamin APIs to its global customer base, supported by best-in-class expert services.

DSM is continuing to build its CDMF portfolio, adding an active CDMF for pyridoxine hydrochloride to the documentation it already holds for a number of its other vitamin APIs, including ascorbic acid (vitamin C) and alpha-tocopherol (vitamin E). It remains the first and only company in the world that can provide both US DMFs and Certificates of Suitability (CEPs) for all 13 vitamins and is now putting resources behind supporting regulatory requirements in China. Upon request, DSM is also able to assist its partners with additional filings.

Benefiting patients’ heath worldwide

This fully active status ensures that DSM customers developing finished drug products for the Chinese market have access to a trusted partner for the supply of pyridoxine hydrochloride, produced under the high-quality standards of pharmaceutical GMP. Pyridoxine hydrochloride plays an important role in neurotransmission, with potential applications in drug products to support patients with idiopathic sideroblastic anemia and vitamin B6 deficiency states.

The regulatory environment in China continues to evolve. As an end-to-end partner, DSM works with its customers to enable drug products to meet their full potential – in this case, making it more straightforward for customers to use DSM’s pyridoxine hydrochloride API in the development of pharmaceutical products. DSM secured the active registration number for pyridoxine hydrochloride by completing the National Medical Products Administration (NMPA) technical assessment.

DSM has a proven record in quality assurance, guaranteeing a reliable, sustainable supply of products to its pharmaceutical customers worldwide. Contact us to learn more about how our expert team can support customers in navigating regulatory requirements across the major global pharmaceutical markets.