Royal DSM, a global science-based company active in Health, Nutrition and Bioscience, has announced that its China Drug Master File (CDMF) for pyridoxine hydrochloride (vitamin B6) has been granted active status. DSM remains the first and only company in the world that can provide both US DMFs and Certificates of Suitability (CEPs) for all 13 vitamins. Its focus on supporting regulatory requirements in China underscores its continued commitment to delivering best-in-class product offerings and expert services across the major global pharmaceutical markets.
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. By completing the National Medical Products Administration (NMPA) technical assessment to gain an active registration number, it is now more straightforward for customers to use DSM’s vitamin B6 API in the development of pharmaceutical products against the backdrop of a changing regulatory environment in China. DSM has a proven record in quality assurance, guaranteeing a reliable, sustainable supply of products to its pharmaceutical customers worldwide.
“The CDMF plays a critical role in facilitating and accelerating the approval of drug products. This fully active status ensures that our 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,” comments Kelsey Achenbach, Global Segment Director, Pharma and Medical Nutrition at DSM.
DSM currently holds CDMFs for a number of its other vitamin APIs, including ascorbic acid (vitamin C) and alpha-tocopherol (vitamin E), and puts resources behind further building a strong CDMF portfolio. Upon request, DSM can support its partners with additional filings. For more information on how DSM’s end-to-end support can enable drug products to meet their full potential and benefit the health of millions of patients worldwide, visit www.dsm-pharmasolutions.com
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