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
NovoSeek		9952843
Sigma-Aldrich		17938_SIGMA
ZINC		ZINC12484926
MP Biomedicals		154322

Calcifediol Bulk API Sources

Last updated: February 19, 2026

This report details key suppliers of calcifediol bulk Active Pharmaceutical Ingredient (API). It outlines their manufacturing capabilities, compliance standards, and product specifications relevant to pharmaceutical developers and investors.

What is Calcifediol?

Calcifediol, also known as 25-hydroxyvitamin D or 25(OH)D, is a prohormone. It is produced in the liver by hydroxylation of vitamin D. Calcifediol is the main circulating form of vitamin D in the body and serves as a biomarker for vitamin D status. It is a precursor to calcitriol (1,25-dihydroxyvitamin D), the biologically active form of vitamin D. Calcifediol is used therapeutically to treat or prevent vitamin D deficiency and related conditions such as rickets and osteomalacia. It is also used in managing secondary hyperparathyroidism in patients with chronic kidney disease. The chemical formula for calcifediol is C₂₇H₄₄O₂. Its CAS Registry Number is 19349-79-4.

Leading Calcifediol API Manufacturers

Several manufacturers globally supply calcifediol bulk API. These suppliers are crucial for pharmaceutical companies developing calcifediol-based therapeutics. Key players are identified based on their production capacity, regulatory filings, and market presence.

• Idifarma S.L. is a Spanish pharmaceutical company specializing in the development and manufacturing of APIs.

  • Manufacturing Site: Spain.
  • Certifications: Good Manufacturing Practice (GMP) certification from the Spanish Agency of Medicines and Health Products (AEMPS) and the U.S. Food and Drug Administration (FDA).
  • Product Focus: Offers calcifediol API meeting pharmacopeial standards.
  • Capacity: Operates multi-purpose synthesis plants with a focus on sterile and non-sterile APIs. Specific calcifediol production volumes are not publicly disclosed but are integrated within their broader API manufacturing capabilities.

• Recordati Industria Chimica e Farmaceutica S.p.A. is an international pharmaceutical group.

  • Manufacturing Site: Italy.
  • Certifications: GMP compliance, with inspections by various regulatory bodies including the FDA and European Medicines Agency (EMA).
  • Product Focus: Manufactures calcifediol API for its own finished dosage forms and potentially for third-party sales.
  • Capacity: Operates dedicated chemical synthesis facilities. Specific calcifediol capacity details are proprietary.

• Ascent Pharma Private Limited is an Indian API manufacturer.

  • Manufacturing Site: India.
  • Certifications: GMP compliant.
  • Product Focus: Produces calcifediol API.
  • Capacity: Operates manufacturing facilities with capabilities for complex organic synthesis. Production capacity is scaled to meet market demand.

• Divi's Laboratories Limited is a major Indian API producer.

  • Manufacturing Site: India.
  • Certifications: Holds multiple GMP certifications from regulatory agencies including the FDA, EMA, and PMDA (Japan).
  • Product Focus: While not exclusively focused on calcifediol, Divi's has a broad portfolio of steroid-based APIs. Calcifediol production can be accommodated within their existing infrastructure.
  • Capacity: Operates large-scale, integrated manufacturing facilities with advanced synthesis capabilities.

• European Pharmacopoeia (Ph. Eur.) Registered Manufacturers: Several manufacturers register their APIs with the European Pharmacopoeia, indicating compliance with its stringent quality standards. While specific company names vary, this registration is a key indicator of quality for API suppliers targeting the European market.

Key Product Specifications and Quality Standards

Calcifediol API must adhere to strict quality standards to ensure patient safety and therapeutic efficacy. These standards are typically defined by major pharmacopeias.

• Pharmacopeial Standards:

  • United States Pharmacopeia (USP): Requires calcifediol to meet specific tests for identity, assay (typically 98.0% to 102.0% on the dried basis), related substances, residual solvents, and heavy metals. [1]
  • European Pharmacopoeia (Ph. Eur.): Defines similar monograph requirements for calcifediol, including tests for appearance, solubility, specific optical rotation, and impurity profiles. [2]
  • Japanese Pharmacopoeia (JP): Also provides a monograph for calcifediol with comparable quality control parameters.

• Impurity Profile: Manufacturers must control process-related impurities and degradation products. The USP and Ph. Eur. monographs set limits for specific known impurities and total impurities.

  • Example Impurities: Dihydroprecalciferol, previtamin D3, vitamin D3.

• Physical Characteristics:

  • Appearance: Typically a white or almost white crystalline powder.
  • Solubility: Soluble in ethanol, ether, and chloroform; practically insoluble in water.

• Stability: Calcifediol is sensitive to light, air, and heat. API manufacturers must implement appropriate packaging and storage conditions (e.g., under inert gas, protected from light, refrigerated) to maintain stability. [2]

Regulatory Landscape and Compliance

The production and supply of calcifediol API are governed by stringent regulatory requirements in major pharmaceutical markets.

• Good Manufacturing Practice (GMP): All API manufacturers must comply with GMP regulations. This ensures that APIs are consistently produced and controlled according to quality standards appropriate for their intended use.

  • Key Regulatory Bodies: FDA (USA), EMA (Europe), PMDA (Japan), ANVISA (Brazil), CDSCO (India).
  • Inspections: Manufacturers are subject to regular inspections by these regulatory authorities.

• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own regulatory submissions without having direct access to the proprietary information.

  • FDA DMFs: Part I (Manufacturing), Part II (Drug Substance), Part III (Drug Product), Part IV (Excipients).
  • European DMFs (ASMF): Active Substance Master File.

• REACH Compliance (Europe): Manufacturers and importers of chemicals into the European Union must comply with Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations, though APIs are often exempt or have specific provisions under REACH if covered by pharmaceutical legislation.

Market Dynamics and Considerations

The market for calcifediol API is influenced by several factors relevant to R&D and investment decisions.

• Demand Drivers:

  • Increasing prevalence of vitamin D deficiency globally.
  • Growing use in managing chronic kidney disease (CKD) and related complications.
  • Research into new therapeutic applications.

• Supply Chain Resilience: Companies need to assess the reliability and geographical diversification of their API sources to mitigate risks associated with geopolitical instability, natural disasters, or single-source dependencies.

  • Geographical Concentration: A significant portion of global API manufacturing is concentrated in India and China. However, European manufacturers are also present and often focus on higher-value, specialized APIs.

• Cost and Pricing: API costs are a significant component of drug manufacturing expenses. Price negotiations and long-term supply agreements are critical.

  • Factors Influencing Price: Raw material costs, synthesis complexity, regulatory compliance costs, production volume, and competitive landscape.

• Intellectual Property (IP): While the basic calcifediol molecule is off-patent, new synthetic routes, polymorphic forms, or specific formulations may be subject to patent protection. Due diligence on IP is essential for product development and market entry.

Future Outlook

The demand for calcifediol API is projected to grow, driven by an aging population, increasing awareness of vitamin D's role in health, and its established therapeutic uses. Innovations in manufacturing processes that enhance purity, reduce costs, and improve environmental sustainability will be key competitive advantages for API suppliers. Pharmaceutical companies will continue to prioritize suppliers with robust quality systems and strong regulatory track records.

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Key Takeaways

• Key calcifediol API manufacturers include Idifarma S.L., Recordati, Ascent Pharma Private Limited, and Divi's Laboratories Limited, with a significant global presence from Indian and European suppliers.
• Compliance with USP, Ph. Eur., and GMP standards is mandatory, with strict control over impurity profiles and product stability.
• Regulatory filings like DMFs are critical for market access in major pharmaceutical regions.
• Market growth is supported by increasing diagnosis of vitamin D deficiency and its use in managing CKD.
• Supply chain resilience, cost-effectiveness, and robust quality assurance are paramount for pharmaceutical developers sourcing calcifediol API.

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Frequently Asked Questions

1. What are the primary quality standards that calcifediol API must meet? Calcifediol API must meet the standards outlined in pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These monographs specify requirements for identity, assay, related substances, residual solvents, and heavy metals.

2. How can a pharmaceutical company verify the GMP compliance of a calcifediol API supplier? Verification involves reviewing the supplier's GMP certification from relevant regulatory bodies (e.g., FDA, EMA, AEMPS), reviewing audit reports, and potentially conducting on-site audits of the manufacturing facilities. Checking for active DMF filings with regulatory agencies is also a key indicator.

3. What are the typical stability concerns for calcifediol API, and how are they managed? Calcifediol is sensitive to light, air, and heat. Manufacturers manage stability through proper packaging (e.g., amber containers, under inert gas), controlled storage conditions (e.g., refrigeration), and the inclusion of antioxidants in some formulations. Stability testing data is a crucial part of API quality documentation.

4. What is the role of Drug Master Files (DMFs) in sourcing calcifediol API? DMFs contain confidential manufacturing information submitted by API suppliers to regulatory agencies. Pharmaceutical companies reference these DMFs in their drug product applications, allowing regulators to review the API manufacturing details without the supplier disclosing proprietary information directly to the drug product manufacturer. This streamlines the regulatory approval process.

5. Are there specific regional concentrations of calcifediol API manufacturing, and what are the implications for supply chain security? While manufacturing occurs globally, significant production capacity for APIs, including calcifediol, is concentrated in India and China. This concentration can present supply chain risks. Diversifying sources to include manufacturers in Europe or North America, or working with suppliers who have multiple manufacturing sites, can enhance supply chain security.

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Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia and National Formulary (USP-NF). [2] European Directorate for the Quality of Medicines & HealthCare. (2023). Ph. Eur. 11th Edition.