New vitamin D3 powder form accelerates product launches and makes DSM the only CEP holder

By: DSM Pharma Solutions Editors

Fast-evolving science on the beneficial role of vitamin D3 for immune health is gaining increasing interest among the medical communities. Moreover, the current COVID-19 pandemic has highlighted the strong market need for innovative prescription and over-the-counter therapies to be accessible fast. DSM is pleased to announce the approval of a new Certificate of Suitability (CEP) for a vitamin D3 powder form. The CEP helps our partners to accelerate the product development process through optimal content uniformity in oral solid dose formulations.  

With the support of the new CEP, the vitamin D3 active pharmaceutical ingredient (API) powder form is available for our partners worldwide, fully accepted in more than 50 countries globally, including all European Union countries, Canada, Argentina, Australia, and Singapore. Currently, DSM is the first and only CEP holder for powdered vitamin D3 forms. The new CEP will considerably facilitate the registration process and help accelerate market entry in compliance with the latest regulatory requirements. For DSM partners the CEP provides new opportunities to address growing market demand innovatively and in line with applicable regulatory and quality standards. 

Manufactured under pharma GMP-compliant conditions in the largest vitamin production site in the world in Sisseln, Switzerland, this vitamin D3 API can be reliably supplied long-term. The first commercial batches are expected to be available in the second half of 2021.  

Co-innovation brings new products to a growing market, fast 

The vitamin D therapy market is projected to have a compound annual growth rate of 11.6% by 2024.1 This development is mainly driven by the growing awareness of vitamin D insufficiency in up to 40% of the population.2-5 Analyses of the vitamin D therapy market project that the oral route of administration is expected to growth highest between now and 2024, due to the range of beneficial effects ascribed to vitamin D, its safety and ease of administration.1,6 The onset of the COVID-19 pandemic has further accelerated global vitamin D market growth. Vitamin D supplementation as an adjuvant therapeutic intervention could be of substantial clinical and economic significance.

The strong therapeutic potential of vitamin D is supported by a vast body of research. In addition to its well-established role in bone metabolism,6 studies have demonstrated a beneficial role of vitamin D3 as an immunomodulator, with effects on infections, autoimmune diseases, and other inflammatory conditions.8 Recent data have shown a protective effect of vitamin D on infection, hospitalization, and mortality rates in COVID-19 patients.9-11 There is a compelling argument for testing vitamin D as an adjuvant treatment to improve the clinical presentation and prognosis of COVID-19, especially in older adults in whom endogenous vitamin D synthesis is less efficient.7,12 Vitamin D may be an important, inexpensive, and safe adjuvant therapy for many diseases. 

DSM is your reliable, innovative, end-to-end partner 

DSM brings expertise and innovation to co-develop new over-the-counter products and prescription medicines in this ever-changing and competitive marketplace. Our commitment to quality, innovation, and reliable supply of API makes us your ideal end-to-end partner to address emerging therapeutic areas benefiting global patient health while helping our partners achieve long-term growth.

Partner with DSM for access to our broad portfolio of APIs, customized solutions, and expert services aimed at supporting your entire product life cycle – and to together grow in the fast-evolving vitamin D market. Contact us for more information.   

Published on

17 February 2021

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References

  1. Markets and Markets. Vitamin D Therapy Market by Route of administration (Oral, Parenteral), Age Group (Children, Adult, Senior Adult), Purchase Pattern (OTC, Prescription), Application (Osteoporosis, Rickets, Autoimmune Disorder, Skin Diseases) - Global Forecast to 2024. Available from: https://www.marketsandmarkets.com/Market-Reports/vitamin-d-therapy-market-32540026.html (accessed 5 February 2021) 
  2. Palacios, C. & Gonzalez, L. Is vitamin D deficiency a major global public health problem? J Steroid Biochem Mol Biol 144 Pt A, 138-145 (2014).
  3. Parva, N. R. et al. Prevalence of Vitamin D Deficiency and Associated Risk Factors in the US Population (2011-2012). Cureus 10, e2741 (2018).
  4. Cashman, K. D. et al. Vitamin D deficiency in Europe: pandemic? Am J Clin Nutr 103, 1033-1044 (2016).
  5. Hilger, J. et al. A systematic review of vitamin D status in populations worldwide. Br J Nutr 111, 23-45 (2014).
  6. Rizzoli, R. Vitamin D supplementation: upper limit for safety revisited? Aging Clin Exp Res (2020).
  7. Brenner, H. Vitamin D Supplementation to Prevent COVID-19 Infections and Deaths-Accumulating Evidence from Epidemiological and Intervention Studies Calls for Immediate Action. Nutrients, 2021;13(2).
  8. Vanherwegen, A. S., Gysemans, C. & Mathieu, C. Vitamin D endocrinology on the cross-road between immunity and metabolism. Mol Cell Endocrinol 453, 52-67 (2017).
  9. Ali, N. Role of vitamin D in preventing of COVID-19 infection, progression and severity. J Infect Public Health (2020).
  10. Laird, E., Rhodes, J. & Kenny, R. A. Vitamin D and Inflammation: Potential Implications for Severity of Covid-19. Ir Med J 113, 81 (2020).
  11. Kaufman, H. W., Niles, J. K., Kroll, M. H., Bi, C. & Holick, M. F. SARS-CoV-2 positivity rates associated with circulating 25-hydroxyvitamin D levels. PLoS One 15, e0239252 (2020).
  12. Kinyamu, H. K., Gallagher, J. C., Petranick, K. M. & Ryschon, K. L. Effect of parathyroid hormone (hPTH[1-34]) infusion on serum 1,25-dihydroxyvitamin D and parathyroid hormone in normal women. J Bone Miner Res 11, 1400-1405 (1996).

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