Alfacalcidol
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Alfacalcidol
Alfacalcidol is a vitamin D analog widely prescribed in the management of conditions caused by impaired calcium metabolism, including osteoporosis, renal osteodystrophy, and hypocalcemia. As a prodrug of calcitriol, it is rapidly metabolized in the liver to the active form, ensuring clinical efficacy.
Manufactured under WHO-GMP standards, D.K. Pharmachem supplies Alfacalcidol with strict quality controls, regulatory documentation, and global compliance support, making it a preferred choice for leading pharmaceutical companies worldwide.
Product Specifications
| Attribute | Details |
|---|---|
| Pharmacopoeia Standard | JP / EP |
| CAS Number | 41294-56-8 |
| Molecular Formula | C₂₇H₄₄O₂ |
| Molecular Weight | 400.64 g/mol |
| Therapeutic Application | Vitamin D analog (bone & calcium disorders) |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | White / off-white crystalline powder |
| Purity | ≥99% |
Diverse Applications
Osteoporosis Treatment
Key API for formulations improving bone strength
Nephrology
Used in managing renal osteodystrophy and hypocalcemia in CKD
Endocrinology
Prescribed for hypoparathyroidism-related disorders
Generics Market
High global demand as an affordable vitamin D analog
Our Alfacalcidol Manufacturing Facility in India
As a WHO-GMP certified manufacturer, We are equipped for high-purity pharmaceutical intermediate production. Our Alfacalcidol manufacturing line is purpose-built for controlled synthesis, ensuring batch-to-batch consistency and compliance with international pharmacopoeial standards.
WHO-GMP Certified Infrastructure
DK Pharmachem operates a dedicated WHO-GMP certified manufacturing facility in India, equipped for high-purity pharmaceutical intermediate production. Our Alfacalcidol manufacturing line is purpose-built for controlled synthesis, ensuring batch-to-batch consistency and compliance with international pharmacopoeial standards.
Facility highlights to list as bullet points below this paragraph:
- Dedicated synthesis and processing units
- In-house HPLC and analytical quality control laboratory
- ISO-compliant raw material storage and handling
- ETP (Effluent Treatment Plant) for safe waste management
- Validated cleaning and production procedures
Production Capacity & Bulk Supply Capabilities
As a bulk Alfacalcidol supplier in India, DK Pharmachem maintains scalable production capacity to meet both regular and high-volume procurement requirements. Our supply chain is designed to support uninterrupted manufacturing operations for our clients.
Supply capabilities to list as bullet points:
- Consistent monthly output to meet bulk order requirements
- Flexible packaging: HDPE drums, fiber drums, bulk options
- Shelf-stable formulation with documented storage guidelines
- Batch traceability from raw material to finished product
- COA, MSDS, and EDMF documentation provided with every shipment
Certifications & Regulatory Compliance
Every batch of Alfacalcidol manufactured at our India facility is backed by:
- WHO-GMP Certification
- European Pharmacopoeia (EP) compliance
- British Pharmacopoeia (BP) compliance
- EDMF (European Drug Master File) registration
- Certificate of Analysis (COA) per batch
- Material Safety Data Sheet (MSDS) available on request
As one of the established Alfacalcidol manufacturers in India, we ensure uninterrupted supply chains and strict adherence to global quality standards.
We supply bulk Alfacalcidol from India
DK Pharmachem serves clients across pharmaceuticals, agrochemicals, water treatment, and contract manufacturing sectors. We maintain consistent stock availability to support both spot orders and long-term supply agreements.
As an established Alfacalcidol exporter, we ship to regulated markets including Europe, North America, Southeast Asia, and the Middle East. All export shipments are accompanied by full documentation - COA, MSDS, EDMF, and country-specific regulatory filings where required.
Request a Quote
Partner with DK Pharmachem for consistent pharmaceutical-grade quality, reliable bulk supply, and comprehensive regulatory documentation. Get in touch with our team today to discuss your requirements, timelines, and pricing.
Packaging, Handling & Storage Guidelines
Alfacalcidol powder is packed to maintain stability and ensure safe handling throughout the supply chain.
Packaging Options
- HDPE drums
- Fiber drums with inner liners
- Bulk packaging options available
Handling & Storage
- Store in a cool, dry, and well-ventilated area
- Protect from moisture and direct sunlight
- Keep containers tightly closed
- Follow standard safety precautions during handling
Proper storage preserves product quality and performance.
Why Choose DK Pharmachem for Alfacalcidol sourcing?
Choosing the right sourcing partner for Alfacalcidol means evaluating quality, regulatory standing, supply reliability, and long-term partnership capability. DK Pharmachem has been a trusted name in pharmaceutical intermediates for over four decades, built on a foundation of manufacturing excellence and customer trust.
Direct Manufacturer, Not a Trader
WHO-GMP Certified Manufacturing
EDMF Registration Support
EP/BP Compliant Product Quality
Comprehensive Technical & Export Documentation
Bulk Supply & Long-Term Contract Support
D.K. Pharmachem is trusted by pharmaceutical companies for consistent quality and dependable supply.
Frequently Asked Questions
Find answers to common questions about Alfacalcidol products and services
What is Alfacalcidol used for?
Alfacalcidol is a vitamin D analog used as an active pharmaceutical ingredient (API) in formulations for bone and calcium metabolism disorders, including osteoporosis, renal osteodystrophy, and hypoparathyroidism-related conditions. As a prodrug of calcitriol, it is used by formulators developing generic and branded vitamin D analog products. DK PharmaChem supplies this API to pharmaceutical manufacturers, not to end users.
What pharmacopoeial standards does DK PharmaChem manufacture Alfacalcidol to?
DK PharmaChem manufactures Alfacalcidol to Japanese Pharmacopoeia (JP) and European Pharmacopoeia (EP) standards, with a minimum purity of 99%. The product is supplied as a white to off-white crystalline powder, with a molecular formula of C27H44O2 and a molecular weight of 400.64 g/mol. Buyers requiring other pharmacopoeial grades can confirm compatibility with our technical team before ordering.
Is Alfacalcidol manufactured under WHO-GMP conditions?
Yes, DK PharmaChem manufactures Alfacalcidol under World Health Organization Good Manufacturing Practice (WHO-GMP) certified conditions. This covers process controls, quality checks, and documentation practices expected by regulated and semi-regulated pharmaceutical markets. Facility and quality system details are available on request for buyer audits and vendor qualification.
What regulatory documentation is available for Alfacalcidol?
A Drug Master File / European Drug Master File (DMF/EDMF) is available for Alfacalcidol, supporting regulatory filings in destination markets. DK PharmaChem also provides a Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS) with each shipment. Buyers can request these documents in advance for internal qualification and vendor approval processes.
What is the CAS number of Alfacalcidol?
The CAS (Chemical Abstracts Service) number for Alfacalcidol is 41294-56-8. This number can be used to verify product identity across regulatory filings, safety data sheets, and customs documentation. It corresponds to the molecular formula C27H44O2.
What is the minimum order quantity (MOQ) for Alfacalcidol?
MOQ for Alfacalcidol depends on the packaging format and destination market requirements. DK PharmaChem accommodates both trial and sample quantities for qualification, as well as bulk commercial orders. Contact our team with your required quantity and timeline to get an exact MOQ and pricing.
What packaging options are available for export?
Alfacalcidol is packed to protect this light-sensitive, temperature-sensitive active ingredient during international transit, using export-standard containers suited to air and sea freight. Packaging can be adapted to buyer specifications, including drum size, labeling, and secondary packaging for customs and cold-chain handling where required. Specify your logistics requirements when requesting a quote so packaging can be confirmed accordingly.
How can international buyers request a quote or samples for Alfacalcidol?
International buyers can request a quote or samples through the “Get in Touch” contact form on the DK PharmaChem website or by emailing dkc@dkpharmachem.com. Include your required quantity, pharmacopoeial grade, and destination country so the team can respond with accurate pricing and documentation. Sample requests are handled by the same team alongside technical and regulatory queries.