Calcitriol
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Calcitriol
Calcitriol is the hormonally active form of vitamin D3, essential in calcium regulation and bone metabolism. It is prescribed in conditions such as hypocalcemia, osteoporosis, hypoparathyroidism, and chronic kidney disease.
D.K. Pharmachem manufactures Calcitriol in WHO-GMP facilities, offering regulatory documentation, high purity, and stable global supply to leading pharmaceutical partners.
Product Specifications
| Attribute | Details |
|---|---|
| Pharmacopoeia Standard | USP / EP |
| CAS Number | 32222-06-3 |
| Molecular Formula | C₂₇H₄₄O₃ |
| Molecular Weight | 416.64 g/mol |
| Therapeutic Application | Vitamin D Hormone (Calcium & bone metabolism) |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | White crystalline powder |
| Purity | ≥99% |
Diverse Applications
Osteoporosis Therapy
Key API in calcium-regulating treatments
CKD Treatment
Prescribed to manage hypocalcemia in dialysis patients
Endocrinology
Used in hypoparathyroidism treatment
Pharma Industry
High demand in global generic vitamin D formulations
Our Calcitriol Manufacturing Facility in India
As a WHO-GMP certified manufacturer, We are equipped for high-purity pharmaceutical intermediate production. Our Calcitriol 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 Calcitriol 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 Calcitriol 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 Calcitriol 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 Calcitriol manufacturers in India, we ensure uninterrupted supply chains and strict adherence to global quality standards.
We supply bulk Calcitriol 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 Calcitriol 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
Calcitriol 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 Calcitriol sourcing?
Choosing the right sourcing partner for Calcitriol 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 Calcitriol products and services
What is Calcitriol used for?
Calcitriol is the hormonally active form of vitamin D3, used as an active pharmaceutical ingredient (API) in formulations for calcium regulation and bone metabolism disorders. It is used in generic drug manufacturing for conditions such as hypocalcemia, osteoporosis, hypoparathyroidism, and chronic kidney disease (CKD). DK PharmaChem supplies it as a bulk API to formulators producing these finished dosage forms.
What pharmacopoeial standards does DK PharmaChem manufacture Calcitriol to?
DK PharmaChem manufactures Calcitriol to United States Pharmacopeia (USP) and European Pharmacopoeia (EP) standards. The product has a minimum purity of 99% and is supplied as a white crystalline powder. Certificates of Analysis (CoA) confirming compliance are provided with each shipment.
Is Calcitriol manufactured under WHO-GMP conditions?
Yes, Calcitriol is manufactured in a World Health Organization Good Manufacturing Practice (WHO-GMP) certified facility. This applies to the full manufacturing process, not just final testing, which supports buyers who need to document supplier compliance for their own regulatory filings. Facility and quality system details are available on request for audit or vendor qualification purposes.
What regulatory documentation is available for Calcitriol?
DK PharmaChem provides a Drug Master File (DMF) or European Drug Master File (EDMF) for Calcitriol, along with a Certificate of Analysis (CoA) and Material Safety Data Sheet (MSDS) with each shipment. This documentation supports buyers filing their own regulatory submissions or import registrations. Specific document versions and country-specific filings can be confirmed directly with the DK PharmaChem team.
What is the CAS number of Calcitriol?
The CAS number for Calcitriol is 32222-06-3. Its molecular formula is C₂₇H₄₄O₃ with a molecular weight of 416.64 g/mol. These identifiers can be used to cross-check the product against pharmacopoeial monographs and your own specification sheets.
What is the minimum order quantity (MOQ) for Calcitriol?
Minimum order quantities for Calcitriol vary by grade and intended use. DK PharmaChem accommodates both development-stage requirements, such as small quantities for trials or regulatory filings, and commercial-scale orders. Contact the DK PharmaChem team directly with your required quantity for a firm MOQ and quote.
How can international buyers request a quote or samples for Calcitriol?
International buyers can request pricing, samples, or technical documentation by contacting DK PharmaChem directly through the website’s “Get in Touch” page or by email. Requests are typically handled by the technical and export sales team, who can also advise on documentation needed for your specific market. This is the fastest route to confirm current lead times and pricing.
Does DK PharmaChem export Calcitriol internationally?
Yes, DK PharmaChem exports Active Pharmaceutical Ingredients (APIs), including Calcitriol, to regulated and semi-regulated markets across Asia, Europe, Latin America, and the Middle East. The company is recognized as a Two Star Export House by India’s Directorate General of Foreign Trade (DGFT). For confirmation of export history or documentation applicable to your specific country, contact the DK PharmaChem team directly.