Bulk Pharmaceutical API Sources for MENADIOL SODIUM DIPHOSPHATE

Bulk Pharmaceutical API Sources for MENADIOL SODIUM DIPHOSPHATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		8555
NovoSeek		8556
NovoSeek		197855

Bulk Active Pharmaceutical Ingredient (API) Sources for: MENADIOL SODIUM DIPHOSPHATE

Last updated: July 29, 2025

Introduction

Menadiol sodium diphosphate is a water-soluble derivative of vitamin K, commonly used as a nutritional supplement, particularly in cases of hemorrhagic disorders, certain liver diseases, and vitamin K deficiency. As a critical component in pharmaceutical formulations, ensuring a reliable, high-quality source of Menadiol sodium diphosphate API is essential for manufacturers, regulatory compliance, and patient safety.

This article explores the global vendors and manufacturing sources specializing in Menadiol sodium diphosphate, highlighting their strategic positioning, regulatory compliance, quality control standards, and supply chain robustness.

Overview of Menadiol Sodium Diphosphate API

Menadiol sodium diphosphate (Chemical Formula: C_19H_24Na_3O_13P_2) is a synthetic vitamin K derivative. Its pharmaceutical applications primarily involve parenteral and oral formulations aimed at correcting deficiencies and preventing bleeding episodes.

The API’s production involves sophisticated chemical synthesis and purification processes, often requiring adherence to Good Manufacturing Practices (GMP) aligned with regulatory standards from agencies like the FDA, EMA, and WHO.

Primary Global API Manufacturers and Suppliers

1. Chinese API Manufacturers

China remains a dominant global supplier of vitamin derivatives due to its extensive manufacturing infrastructure, cost advantage, and capacity for large-scale synthesis.

• Zhejiang Yuntian Pharmaceutical Co., Ltd.
  Specializes in vitamin K derivatives, including Menadiol sodium diphosphate, with comprehensive GMP compliance and ISO certifications. They serve both domestic and international markets with dedicated R&D efforts focused on improving yield and purity.

• Jiangsu Reonica Pharmaceutical Co., Ltd.
  Offers API with strict quality standards and has established export channels, serving markets across Asia, Europe, and North America. Their manufacturing facilitates high-volume production suitable for large pharmaceutical companies.

• Shandong Yuxin Pharmaceutical Co., Ltd.
  Provides customized API synthesis and supply chain integration for menadiol-related compounds, adhering to stringent quality standards.

2. Indian API Manufacturers

India’s pharmaceutical sector is recognized for its robust API manufacturing capacity, quality control standards, and competitive pricing.

• Gandhara Plant Pharmaceuticals
  Offers high-grade Menadiol sodium diphosphate APIs compliant with WHO-GMP and ISO standards. Their facilities are certified for export to stringent markets, including the US and Europe.

• Aurigene Biosciences
  Invests heavily in R&D, focusing on vitamin derivatives, with a portfolio that includes Menadiol sodium diphosphate. Their quality assurance processes meet international benchmarks.

• M.H. Pharmaceuticals
  Specializes in vitamin-based APIs, with regulatory filings supporting export licenses to multiple jurisdictions, ensuring consistent supply.

3. European API Suppliers

European vendors tend to dominate markets requiring higher regulatory stringency and advanced quality assurance.

• BASF SE (Germany)
  One of the largest chemical producers globally, BASF supplies pharmaceutical-grade Vitamin K derivatives, including Menadiol sodium diphosphate, with extensive GMP certification and regulatory support.

• Evonik Industries (Germany)
  Recognized for high-quality pharmaceutical excipients and APIs, including vitamin derivatives, produced with advanced purification and quality control processes.

• Fresenius Kabi (Germany)
  Mainly focuses on injectable formulations, sourcing high-quality Menadiol sodium diphosphate API that meets stringent European standards.

4. United States API Manufacturers

Though smaller in this niche, U.S. manufacturers with cGMP compliance provide high-quality APIs for domestic and international markets.

• Cambridge Major Laboratories (Now part of Ligand Pharmaceuticals)
  Known for custom synthesis and high-purity API production, including vitamin K derivatives suited for injectable and oral applications.

• Aemps Corporation
  Specializes in specialty APIs, with a focus on regulatory compliance for U.S. and international markets.

Key Considerations When Sourcing Menadiol Sodium Diphosphate API

• Regulatory Compliance: Ensure the supplier holds current GMP certifications aligned with target markets (FDA, EMA, WHO).

• Quality Assurance and Testing: Confirm the API supplier’s adherence to pharmacopoeial standards (USP, EP, JP), with detailed certificates of analysis, purity levels, residual solvents, and microbiological testing.

• Supply Chain Stability: Evaluate capacity, lead times, and contingency plans to mitigate shortages, especially given ongoing supply chain disruptions globally.

• Pricing and Terms: Balance cost considerations with quality and compliance; negotiate long-term supply agreements for consistent sourcing.

• Traceability and Documentation: Evaluate suppliers' documentation for batch records, stability data, and compliance certifications to ensure transparency.

Emerging Trends in API Sourcing

• Integration of Contract Manufacturing Organizations (CMOs): Increasingly, pharmaceutical companies partner with CMOs with proven expertise in vitamin derivatives, often offering cost advantages and regulatory support.

• Focus on Green Chemistry: Suppliers adopting environmentally sustainable manufacturing, reducing hazardous waste, and improving process efficiency are gaining favor.

• Digital Supply Chain Management: Use of blockchain and digital tracking to ensure transparency and traceability, mitigating counterfeits and ensuring regulatory compliance.

Regulatory and Quality Assurance Standards

Manufacturers of Menadiol sodium diphosphate API must comply with diverse regulatory standards:

• WHO-GMP Certification: For exports to developing regions and global markets.
• FDA Compliance: For the U.S. market, requiring cGMP adherence, extensive documentation, and validation processes.
• European Regulations (EMA): Enforcing strict standards, including batch testing, stability assays, and environmental controls.
• Pharmacopoeial Standards: USP, EP, and JP monographs specify impurity limits, assay methods, and potency requirements.

Supply Chain Challenges

• Raw Material Availability: Key intermediates may fluctuate due to agricultural or synthesis challenges.
• Logistics Disruptions: Global events can affect raw material procurement and distribution.
• Regulatory Delays: Changing international standards may impact approval timelines.

Conclusion

Securing reliable sources of Menadiol sodium diphosphate API involves evaluating manufacturers based on regulatory compliance, quality standards, manufacturing capacity, and supply chain reliability. Asia, particularly China and India, dominates production with extensive capacity and competitive pricing. European and U.S. suppliers focus on high regulatory standards and quality assurance, suitable for markets with stringent requirements.

For pharmaceutical companies, establishing long-term relationships with reputable API suppliers backed by rigorous testing and compliance ensures consistent supply and high product quality, ultimately safeguarding patient health.

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Key Takeaways

• Diversify sourcing channels: Engage multiple reputable manufacturers across different regions to mitigate supply risks.
• Prioritize quality standards: Always verify GMP compliance and API purity levels aligned with market requirements.
• Evaluate supply chain robustness: Ensure supplier capacity and contingency plans are in place.
• Stay abreast of regulatory shifts: Regularly update compliance checks with evolving standards from bodies like WHO, FDA, and EMA.
• Leverage contracting and partnerships: Long-term agreements with trusted suppliers foster stability and cost efficiency.

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FAQs

1. What are the main regions supplying Menadiol sodium diphosphate API?
China and India lead global production, with European companies like BASF and Evonik providing high-quality options for regulatory-sensitive markets. The U.S. market relies on a smaller group of specialized manufacturers.

2. How do I verify the quality of Menadiol sodium diphosphate API from a new supplier?
Request comprehensive Certificates of Analysis (CoA), verify compliance with pharmacopoeial standards, assess GMP certifications, and conduct onsite audits or third-party inspections when possible.

3. Are there any synthetic alternatives to Menadiol sodium diphosphate?
While alternative vitamin K derivatives exist, Menadiol sodium diphosphate remains preferred for specific therapeutic applications due to its bioavailability and stability profile.

4. What challenges are associated with sourcing Menadiol sodium diphosphate API?
Supply chain disruptions, evolving regulatory standards, raw material availability, and ensuring consistent high-purity production pose ongoing challenges.

5. How important is regulatory approval when sourcing Menadiol sodium diphosphate API?
Extremely important, especially for markets like the U.S. and Europe. Suppliers must hold appropriate GMP certifications and comply with regional standards to avoid regulatory rejection and ensure patient safety.

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Sources:

[1] WHO Guidelines for the Production of Vitamin K Derivatives, 2020.
[2] European Pharmacopoeia Monograph for Vitamin K, 11th Edition.
[3] FDA’s cGMP Regulations for Active Pharmaceutical Ingredients, 21 CFR Part 211.
[4] Market Reports on Vitamin Derivatives, Pharma Market Insights, 2022.
[5] Company websites and verified industry databases.