Press release

dsm-firmenich Builds China Drug Master File Portfolio, Achieving Active Status for Pyridoxine Hydrochloride (Vitamin B6)

Kaiseraugst (CH), 24 May 2022

Royal dsm-firmenich, 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-firmenich 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-firmenich’s vitamin B6 API in the development of pharmaceutical products against the backdrop of a changing regulatory environment in China. dsm-firmenich 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-firmenich.

dsm-firmenich 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-firmenich can support its partners with additional filings. For more information on how dsm-firmenich’s end-to-end support can enable drug products to meet their full potential and benefit the health of millions of patients worldwide, visit Pharma Solutions | DSM


dsm-firmenich – Bright Science. Brighter Living.™

Royal dsm-firmenich is a global, purpose-led company in Health, Nutrition & Bioscience, applying science to improve the health of people, animals and the planet. dsm-firmenich’s purpose is to create brighter lives for all. dsm-firmenich’s products and solutions address some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. The company was founded in 1902 and is listed on Euronext Amsterdam. More information can be found at dsm-firmenich - We bring progress to life.

For more information

Kelsey Achenbach

DSM Pharma Solutions

Eleanor Tarling

Barrett Dixon Bell
+44 746 778 3675

Forward-looking statements
This press release may contain forward-looking statements with respect to DSM’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is leading.