Bulk Pharmaceutical API Sources for CALCIFEDIOL

Bulk Pharmaceutical API Sources for CALCIFEDIOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		H4014_SIGMA
NovoSeek		5283731
NovoSeek		6433735

Bulk Active Pharmaceutical Ingredient (API) Sources for Calcifediol

Last updated: July 29, 2025

Introduction

Calcifediol, also known as 25-hydroxyvitamin D₃, is a crucial metabolite in vitamin D physiology, widely used in clinical research, diagnostics, and therapeutic applications. Its role in calcium homeostasis and bone health underscores the growing demand for high-quality bulk APIs in pharmaceutical manufacturing. As the market expands, identifying reputable sources of calcifediol is essential for pharmaceutical companies, researchers, and regulatory bodies aiming to ensure product quality, consistency, and compliance.

This article provides a comprehensive overview of bulk API sources for calcifediol, including key manufacturers, regional supply chains, quality standards, and considerations for sourcing.

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Global Market Overview for Calcifediol API

The global vitamin D derivatives market, including calcifediol, is gaining momentum driven by the rising prevalence of osteoporosis, chronic kidney disease, and elderly population. The market is characterized by a limited number of specialized manufacturers capable of producing pharmaceutical-grade calcifediol in bulk quantities.

While the market remains relatively niche compared to other vitamin D analogs, it benefits from a concentrated supply chain comprising pharmaceutical raw material suppliers, custom synthesis providers, and integrators with strict cGMP standards.

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Leading Manufacturers and Suppliers of Calcifediol API

1. MAM Company

MAM (Medical & Analytical Manufacturing) is recognized for producing high-purity calcifediol for pharmaceutical and nutritional applications. Based in Europe, MAM supplies both analytical-grade and pharmaceutical-grade calcifediol, adhering to stringent quality standards. Their offerings include custom synthesis with validated batch-to-batch consistency.

2. Zhejiang Medicine Co., Ltd.

Zhejiang Medicine is one of China's prominent pharmaceutical companies specializing in vitamin D derivatives, including calcifediol. Their manufacturing facilities comply with ISO and GMP regulations, and they serve global markets with bulk quantities compliant with international pharmacopoeias.

3. Zhejiang Aoke Biotechnology Co., Ltd.

Operational in China, Aoke Biotechnology focuses on the synthesis of vitamin D products, offering calcifediol API for pharmaceutical and supplement applications. Their production processes are aligned with WHO and cGMP standards, ensuring compliance and product integrity.

4. Xi’an Lvbao Pharmaceutical Co., Ltd.

A Chinese pharmaceutical manufacturer with expertise in vitamin D derivatives. Xi’an Lvbao supplies calcifediol API in bulk, emphasizing quality control and regulatory compliance for international markets, including the US and Europe.

5. Dr. Paul Lohmann GmbH & Co. KGaA

Germany-based Dr. Paul Lohmann supplies high-purity calcifediol for nutritional and pharmaceutical applications. Their products are manufactured under strict quality controls, with a focus on purity and traceability, serving European and global clients.

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Regional Considerations and Supply Chain Dynamics

Asia-Pacific

Suppliers in China and India dominate bulk manufacturing and export of calcifediol APIs, leveraging cost-effective production and extensive outsourcing capabilities. However, regulatory frameworks vary, emphasizing the importance of sourcing from suppliers with robust GMP certifications to ensure compliance.

Europe

European manufacturers emphasize high-quality, cGMP-compliant API production, often serving specialty pharmaceutical markets. Regulatory oversight in the EU ensures adherence to rigorous safety and quality standards, making European sources preferable for pharmaceutical applications requiring strict compliance.

North America

While fewer domestic suppliers exist in North America, companies like Dr. Paul Lohmann offer high-grade APIs catering to the US market, with compliance to FDA regulations and comparable quality standards.

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Quality Standards and Regulatory Compliance

Sourcing calcifediol API demands stringent adherence to regulatory standards such as:

• USP (United States Pharmacopeia)
• EP (European Pharmacopoeia)
• CP (Chinese Pharmacopoeia)

Manufacturers complying with cGMP (current Good Manufacturing Practices) are preferred to ensure batch consistency, impurity profiling, and stability.

Certifications such as ISO 9001, ISO 13485, and specific pharmacopoeial monographs are indicative of quality assurance measures. Validation reports, stability data, and analytical documentation are critical when evaluating supplier credibility.

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Considerations for Selecting API Suppliers

• Regulatory Validity: Suppliers should demonstrate compliance with relevant pharmacopoeias and certifications.
• Quality Control: Analytical data, impurity profiles, and batch consistency are paramount.
• Supply Capacity: Capacity for large-scale production to meet demand.
• Pricing and Lead Time: Balancing cost-efficiency with reliable delivery schedules.
• Regulatory Support: Assistance with documentation, quality dossiers, and registration processes.

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Emerging Trends and Future Outlook

The increased focus on vitamin D's therapeutic potential and the management of vitamin D deficiency is likely to sustain demand for calcifediol. Innovation in synthesis methods, including greener processes and bio-based production, promises to improve sustainability and reduce costs. Additionally, the development of novel formulations and enhanced bioavailability suggests a diversifying market.

The regulatory landscape is evolving, emphasizing transparency, traceability, and comprehensive quality data, which will influence supplier selection strategies. As global health crises highlight the importance of vitamin D in immune function, the market for calcifediol APIs is expected to expand, further driving supply chain sophistication.

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Key Takeaways

• Limited but Concentrated Supply Chain: Major producers of calcifediol API are primarily based in Europe and Asia, with Chinese suppliers dominating in bulk manufacturing.
• Stringent Quality Standards: High-quality, cGMP-compliant APIs with comprehensive documentation are essential for pharmaceutical applications.
• Regional Supply Dynamics: European and North American suppliers emphasize compliance, whereas Chinese producers offer cost-competitive options with proper certifications.
• Future Market Drivers: Growing clinical evidence and public health initiatives targeting vitamin D deficiency are expected to sustain demand.
• Strategic Sourcing: Companies should prioritize suppliers with proven quality records, regulatory compliance, adequate capacity, and reliable logistics.

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FAQs

Q1: What are the main regions producing calcifediol API globally?
A1: Europe and China are the primary regions, with European manufacturers focusing on high-quality, regulated products, and Chinese suppliers offering cost-effective bulk production.

Q2: How do I verify the quality of calcifediol API from a supplier?
A2: Review their pharmacopoeial compliance, obtain analytical reports (HPLC, impurity profiles), certifications (cGMP, ISO), and validate batch data through audits or third-party testing.

Q3: Are there bio-based or greener synthesis methods for calcifediol API?
A3: Emerging technologies aim to develop more sustainable synthesis processes; however, most current commercial APIs are produced via chemical synthesis under strict quality controls.

Q4: Can calcifediol API be custom synthesized?
A4: Yes, several manufacturers offer custom synthesis services tailored to specific purity, quantity, or formulation requirements, provided the technical feasibility.

Q5: What regulatory considerations exist when sourcing calcifediol API?
A5: Suppliers must adhere to pharmacopoeial standards (USP, EP, CP), and the API must meet regulatory qualifications such as FDA or EMA approval, depending on the market.

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References

1. MarketWatch. "Vitamin D Derivatives Market Analysis." [Online]. Available: marketwatch.com
2. United States Pharmacopeia. USP monograph for calcifediol.
3. European Pharmacopoeia. Monograph on vitamin D derivatives.
4. Zhejiang Medicine Co., Ltd. Product brochure and certification documents.
5. Dr. Paul Lohmann GmbH & Co. KGaA. Product datasheet and quality assurance documentation.

Note: The supplier specifics are illustrative; potential buyers should conduct detailed due diligence before procurement.