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Doxercalciferol | CAS No: 54573-75-0 | GMP-certified suppliers
A medication that treats secondary hyperparathyroidism in chronic kidney disease patients on dialysis or stages 3–4, supporting calcium balance and bone health.
Therapeutic categories
Primary indications
- Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, as well as for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease
Product Snapshot
- Doxercalciferol is available as oral capsules and intravenous injections
- It is primarily used in managing secondary hyperparathyroidism associated with chronic kidney disease in dialysis patients and stages 3 or 4 CKD patients
- The product is approved for use in the US and Canadian markets
Clinical Overview
Pharmacologically, doxercalciferol itself is inactive and requires metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), the biologically active metabolite. This metabolite functions similarly to calcitriol (1α,25-(OH)2D3), the active form of vitamin D3, by regulating calcium homeostasis through multiple physiological mechanisms. These include enhancing intestinal calcium absorption, promoting renal tubular calcium reabsorption, and cooperating with PTH to mobilize calcium from bone tissue. The active metabolite also acts on osteoblasts to support skeletal growth and suppresses excessive PTH synthesis and secretion within the parathyroid glands via specific receptor interactions.
The pathological context addressed by doxercalciferol involves impaired renal conversion of vitamin D precursors to active metabolites, a deficiency commonly seen in CKD patients which contributes to secondary hyperparathyroidism and subsequent metabolic bone disease. By restoring biologically active vitamin D levels, doxercalciferol helps mitigate these complications.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics reflect hepatic conversion to the active metabolite and its systemic actions on multiple target tissues, though detailed pharmacokinetic parameters are not specified here.
Safety considerations include monitoring for hypercalcemia and hyperphosphatemia due to vitamin D analog activity. Given its modulation of calcium and phosphorus metabolism, careful dosing and patient-specific titration are essential to minimize adverse effects.
Doxercalciferol is marketed under the brand name Hectoral by Genzyme Corporation and manufactured by Catalent Pharma Solutions, Inc. When sourcing the API, attention should be paid to compliance with pharmacopeial standards, purity criteria, and consistent manufacturing processes to ensure batch-to-batch reliability critical for therapeutic efficacy and safety in CKD patient populations.
Identification & chemistry
| Generic name | Doxercalciferol |
|---|---|
| Molecule type | Small molecule |
| CAS | 54573-75-0 |
| UNII | 3DIZ9LF5Y9 |
| DrugBank ID | DB06410 |
Pharmacology
| Summary | Doxercalciferol is an active vitamin D analog that binds to vitamin D3 receptors to regulate calcium homeostasis by enhancing intestinal calcium absorption, renal calcium reabsorption, and bone calcium mobilization. It modulates parathyroid hormone synthesis and secretion, thereby addressing secondary hyperparathyroidism associated with chronic kidney disease. The pharmacodynamic effects involve direct actions on bone cells and parathyroid glands to maintain calcium balance and support skeletal integrity. |
|---|---|
| Mechanism of action | Calcitriol (1α,25-(OH)2D3) and 1α,25-(OH)2D2 regulate blood calcium at levels required for essential body functions. Specifically, the biologically active vitamin D metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney and, in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton. They act directly on bone cells (osteoblasts) to stimulate skeletal growth, and on the parathyroid glands to suppress PTH (parathyroid hormone) synthesis and secretion. These functions are mediated by the interaction of these biologically active metabolites with specific receptor proteins in the various target tissues. In patients with chronic kidney disease (CKD), deficient production of biologically active vitamin D metabolites (due to lack of or insufficient 25-hydroxyvitamin D-1-alpha-hydroxylase activity) leads to secondary hyperparathyroidism, which contributes to the development of metabolic bone disease. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Vitamin D3 receptor | Humans | suppressor |
ADME / PK
| Half-life | 32 to 37 hours. |
|---|---|
| Metabolism | Doxercalciferol is absorbed from the gastrointestinal tract and activated by CYP 27 in the liver to form 1α,25-(OH)2D2 (major metabolite) and 1α,24-dihydroxyvitamin D2 (minor metabolite). Activation of doxercalciferol does not require the involvement of the kidneys. |
Formulation & handling
- Doxercalciferol is a small molecule vitamin D analogue available for oral and intravenous administration, requiring formulation in capsules or injectable solutions.
- Due to its low water solubility and high lipophilicity (LogP 5.75), lipid-based or solubilizing excipients may be necessary to enhance bioavailability and stability.
- Avoid co-administration with magnesium-containing antacids to prevent increased risk of hypermagnesemia during handling and dosing considerations.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient has multiple expired patents in the United States as of 2023, indicating a mature market with generic competition primarily in the US and Canada. Market activity is expected to continue under established regulatory frameworks. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Doxercalciferol is primarily marketed in the US and Canada with multiple branded products originating from likely a limited number of originator companies. Several patents related to Doxercalciferol have expiration dates spanning from 2010 to 2023, indicating that some patents have already expired while others are recent, suggesting the presence of established generic competition alongside ongoing branded product availability. |
|---|
Doxercalciferol is a type of Vitamin D analogues
Vitamin D analogues belong to the pharmaceutical category of active pharmaceutical ingredients (APIs) and are widely used in the medical field. These analogues are synthetic compounds designed to mimic the effects of natural vitamin D, a vital nutrient for human health. Vitamin D plays a crucial role in maintaining proper bone health, regulating calcium and phosphorus levels, and supporting the immune system.
Pharmaceutical companies produce various types of vitamin D analogues, each with distinct properties and applications. These analogues are designed to target specific receptors in the body, mimicking the actions of natural vitamin D. By interacting with these receptors, vitamin D analogues can effectively regulate calcium absorption and metabolism, promoting optimal bone health.
One of the significant advantages of using vitamin D analogues as APIs is their enhanced stability and bioavailability compared to natural vitamin D. This allows for better control over dosage and ensures consistent therapeutic effects. Moreover, pharmaceutical-grade analogues undergo rigorous quality control measures to guarantee their purity, safety, and efficacy.
Medical professionals prescribe vitamin D analogues to patients with vitamin D deficiencies, osteoporosis, psoriasis, and other related conditions. These APIs are available in various formulations, including oral tablets, capsules, and topical creams, allowing for flexible and convenient administration.
In summary, vitamin D analogues are a vital category of pharmaceutical APIs widely used to address vitamin D deficiencies and related health conditions. Their synthetic nature, enhanced stability, and targeted actions make them an effective option for maintaining bone health and supporting overall well-being.
Doxercalciferol API manufacturers & distributors
Compare qualified Doxercalciferol API suppliers worldwide. We currently have 9 companies offering Doxercalciferol API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Cerbios-Pharma | Producer | Switzerland | Switzerland | CoA, USDMF | 9 products |
| ChemExpress | Producer | United States | China | CoA, ISO9001, MSDS, WC | 197 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Heron (Shanghai) Pharmace... | Producer | China | China | CoA, GMP | 9 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Polymed Therapeutics | Producer | United States | United States | CoA, USDMF | 11 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
When sending a request, specify which Doxercalciferol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Doxercalciferol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
