Alfacalcidol

In the progression of metabolic bone diseases such as chronic kidney disease and osteoporosis, disordered calcium and phosphorus metabolism is the core pathological feature. Conventional calcium supplementation regimens often fail to address the abnormal bone metabolism caused by active vitamin D deficiency. Alfacalcidol is a vitamin D analog. As a prodrug, it is converted into active calcitriol after hydroxylation in the liver after entering the body, without the involvement of renal 1α-hydroxylase, which greatly reduces the medication burden on patients with renal insufficiency. It is clinically mainly used to treat renal osteodystrophy associated with chronic renal insufficiency, osteoporosis, hypoparathyroidism, vitamin D-dependent rickets, etc. The applicable population covers elderly patients with osteoporosis, the long-term follow-up population of chronic kidney disease, and patients of all ages with abnormal parathyroid function. Compared with ordinary vitamin D preparations, it has a faster onset of action and easier regulation of dosage.

The global market size of alfacalcidol was approximately USD 420 million in 2023, with the Chinese market accounting for nearly 38%, and the compound annual growth rate in the past three years has remained at 5.1%. The growth drivers mainly come from the rising prevalence of osteoporosis in the elderly and the popularization of early screening for chronic kidney disease. At present, generic drugs account for more than 85% of the domestic market, and the share of original research products is declining year by year. After the implementation of volume-based procurement, the terminal price of preparations has dropped by more than 60%. The upstream API supply side has formed a pattern dominated by domestic manufacturers and supplemented by imports. There are 12 domestic API enterprises that have completed registration with the CDE, and their production capacity can fully meet the domestic preparation production demand.

The original research enterprise of alfacalcidol is Teijin Pharma Limited of Japan, with the trade name "Alfarol". Its core compound patent expired in 1999 in major markets such as Japan and the United States, and the Chinese compound patent also expired in 1999. The original research dosage forms include soft capsules and small-volume injections. The specifications of soft capsules cover 0.25μg and 0.5μg, and the specification of injection is 1μg/1ml. The original research soft capsules have been included in the China Listed Medicines Catalogue as the reference preparation, and are also included in the FDA Reference Listed Drug Directory. Up to now, there are 17 alfacalcidol preparations approved for marketing in China. The CDE API registration platform has included 31 valid registration information, 19 of which are in "A" status and can be used for associated preparation declaration. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of alfacalcidol impurity reference standards, covering all quality control nodes such as starting materials, intermediates and degradation impurities in the synthesis process. The products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most impurities are available from stock, and stock orders paid before 16:00 can be shipped on the same day, which can fully meet the full-scenario needs of API research and development, quality research and routine production quality control.