Bulk Pharmaceutical API Sources for VITAMIN K1

Bulk Pharmaceutical API Sources for VITAMIN K1

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		47773_SUPELCO
Sigma-Aldrich		V3501_SIGMA
Sigma-Aldrich		95271_SIGMA
Molport		MolPort-003-666-819
Amadis Chemical		A840928
AKos Consulting & Solutions		AKOS015841892
Finetech Industry Limited		FT-0603296

Bulk Active Pharmaceutical Ingredient (API) Sources for: Vitamin K1

Last updated: August 3, 2025

Introduction
Vitamin K1, also known as phylloquinone, is a fat-soluble vitamin essential for blood coagulation and bone health. As a crucial API in pharmaceutical formulations and nutraceuticals, its sourcing significantly influences manufacturing quality, regulatory compliance, and supply chain security. This article provides a comprehensive analysis of the key bulk API sources for Vitamin K1, highlighting global suppliers, manufacturing standards, and market dynamics.

Global Manufacturing of Vitamin K1 API

The production of Vitamin K1 API is concentrated among a limited number of manufacturers primarily located in China, India, and certain European countries. These regions benefit from established chemical manufacturing infrastructure, raw material access, and stringent quality standards.

Leading API Manufacturers and Suppliers

• China
  China dominates the global API production market for Vitamin K1, accounting for an estimated 70-75% of supply. Major companies include Sichuan Hetian Pharmaceutical Co., Ltd., and Zhejiang Kanger Pharmaceutical Co., Ltd. These firms operate state-of-the-art manufacturing facilities adhering to Good Manufacturing Practices (GMP) and WHO cGMP standards. Chinese suppliers typically offer competitive prices, rapid lead times, and comprehensive export capacities. However, supply stability and quality consistency are crucial considerations for buyers, necessitating robust qualification and audits.

• India
  Indian pharmaceutical companies like Molychem and Swati Spentose offer Vitamin K1 APIs that meet international standards. Indian manufacturers often focus on API development with high purity levels suitable for pharmaceutical use, aligned with ICH Q7 guidelines. The Indian market is recognized for cost-effective manufacturing, aligning with global demand for affordable APIs.

• European Countries
  European API suppliers, including CordenPharma (Germany) and PhytoTech Labs (France), emphasize high purity, compliance with stringent regulatory frameworks, and sustainability. These suppliers cater primarily to regulated markets such as the U.S. and Europe, ensuring adherence to EMA and FDA quality standards. Their APIs are characterized by consistent quality, traceability, and comprehensive documentation.

Raw Material Sources and Synthesis

Vitamin K1 production involves the chemical synthesis of the phylloquinone structure, derived from plant sources such as green leafy vegetables, notably spinach, kale, and broccoli. The synthesis process typically involves the extraction of plant oils rich in plant-derived quinones, followed by chemical modifications and purification. Some suppliers engage in botanical extraction of quinones as an additional or alternative method, ensuring supply diversification.

Quality Standards and Regulatory Compliance

Sourcing Vitamin K1 API demands rigorous compliance with pharmacopeial standards such as USP, EP, and JP to ensure safety and efficacy. Suppliers often provide Certificates of Analysis (CoA), GMP certificates, and stability data. The API's purity generally exceeds 99%, with low levels of residual solvents, heavy metals, and impurities, aligning with strict regulatory requirements.

Supply Chain Considerations

Supply chain resilience for Vitamin K1 APIs hinges on geographic diversification and quality assurance. Over-reliance on Chinese suppliers may pose risks related to geopolitical issues, customs delays, or quality variability. Engaging diversified suppliers from India or Europe can mitigate these risks. Additionally, buyers should verify supplier audits, batch consistency, and traceability practices.

Market Trends and Future Outlook

The demand for Vitamin K1 APIs continues to grow, driven by rising interest in nutraceuticals, functional foods, and pharmaceutical applications addressing osteoporosis and coagulation disorders. Market players are increasingly investing in sustainable sourcing, bio-based production methods, and advanced purification technologies to meet evolving regulatory and consumer expectations.

Key Players Summary

Country	Notable Suppliers	Key Attributes
China	Sichuan Hetian, Zhejiang Kanger	Cost-effective, large-scale, diverse supply
India	Molychem, Swati Spentose	Cost-efficient, GMP-compliant, reliable
Europe	CordenPharma, PhytoTech Labs	High purity, regulatory compliance, traceability

Quality and Certification Standards

Suppliers adhere to global standards such as:

• USP (United States Pharmacopeia)
• EP (European Pharmacopoeia)
• JP (Japanese Pharmacopoeia)
• ICH Q7 for active pharmaceutical ingredients production

Certifications such as ISO 9001, ISO 14001, and cGMP underpin their credibility, ensuring quality assurance.

Supply and Price Dynamics

Prices for Vitamin K1 API are influenced by raw material costs, manufacturing scale, and regulatory demands. Chinese suppliers often offer more competitive prices due to economies of scale, whereas European suppliers command higher premiums aligned with premium quality and stringent compliance. Buyers should execute thorough supplier evaluations, including site audits and testing, to assure quality and mitigate supply risks.

Conclusion

Sourcing Vitamin K1 API necessitates balancing cost, quality, regulatory compliance, and supply security. While Chinese manufacturers provide cost-effective solutions, ensuring quality through rigorous qualification is critical. Indian suppliers serve as reliable, cost-efficient options, increasingly aligned with international standards. European producers offer premium APIs with verified traceability and compliance, essential for highly regulated markets. Strategic sourcing, supplier diversification, and quality assurance are imperative for stakeholders aiming to optimize their supply chains of Vitamin K1 API.

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Key Takeaways

• The majority of Vitamin K1 API is produced in China, with India and Europe serving as notable alternatives.
• Quality standards such as USP, EP, and GMP compliance are critical for pharmaceutical and nutraceutical applications.
• Diversification of suppliers mitigates geopolitical and supply chain risks.
• Regulatory compliance and robust supplier qualification ensure product consistency and safety.
• Market growth in nutraceuticals and pharmaceuticals sustains demand for high-quality Vitamin K1 APIs.

FAQs

1. What are the primary raw materials used in Vitamin K1 API synthesis?
   Plant oils from green leafy vegetables like spinach and kale serve as the key raw materials, either extracted directly or used as starting points for chemical synthesis.

2. How do I evaluate the quality of a Vitamin K1 API supplier?
   Assess their GMP and ISO certifications, review Certificates of Analysis, conduct on-site audits if possible, and request stability and impurity profiles to ensure compliance with pharmacopeial standards.

3. Are there bio-based or environmentally sustainable methods for producing Vitamin K1 API?
   Emerging bio-refining and green chemistry approaches aim to improve sustainability; however, most commercial production still relies on chemical synthesis, with European suppliers increasingly emphasizing eco-friendly practices.

4. What are common quality issues to watch for when sourcing Vitamin K1 API?
   Potential issues include impurities, residual solvents, batch-to-batch variability, and deviations from purity standards. Rigorous testing and supplier qualification mitigate these risks.

5. Is there a significant price differential among suppliers?
   Yes, Chinese manufacturers typically offer lower prices driven by economies of scale, while European suppliers tend to be more expensive due to higher validation and quality assurance levels. Indian suppliers provide a balanced cost-quality profile.

Sources

[1] U.S. Pharmacopeia (USP) Monographs on Vitamin K1.
[2] European Pharmacopoeia (EP) Regulations.
[3] ICH Q7 Guideline for Pharmaceutical Manufacturing.
[4] Global Industry Analysts, "Market Report on Vitamins and Dietary Supplements."
[5] CordenPharma, "API Product Portfolio" (2023).