Bulk Pharmaceutical API Sources for PHOSPHOLINE IODIDE

Bulk Pharmaceutical API Sources for PHOSPHOLINE IODIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-941-436
AKos Consulting & Solutions		AKOS015967621
BOC Sciences		513-10-0

Bulk Active Pharmaceutical Ingredient (API) Sources for: PHOSPHOLINE IODIDE

Last updated: August 2, 2025

Introduction

Phospholine Iodide, known chemically as echothiophate iodide, is a potent choline ester used primarily in ophthalmology for the treatment of glaucoma. Its mechanism involves inhibiting acetylcholinesterase, thereby increasing acetylcholine levels to facilitate aqueous humor outflow. As a specialized API, sourcing high-quality Phospholine Iodide demands meticulous attention to manufacturer credibility, quality standards, and regulatory compliance. This analysis identifies key bulk API suppliers, evaluates their market stance, and offers strategic insights to pharmaceutical developers and distributors interested in procurements.

Market Landscape of Phospholine Iodide API Suppliers

1. Industry Overview

Phospholine Iodide remains a niche API with limited widespread manufacturing. The pharmaceutical industry's focus on its use in ocular treatments sustains a specialized supply chain characterized by few dominant manufacturing entities. As an older drug, its API production has stabilized within a handful of regional producers adhering to strict quality controls under GMP (Good Manufacturing Practice).

2. Key API Manufacturers and Suppliers

A. International Pharmaceutical Contract Manufactures and Suppliers

1. Synthesis and Contract Manufacturing Leaders in Asia

   • Wockhardt Ltd. (India): Wockhardt is a prominent pharmaceutical manufacturer with capabilities spanning contract manufacturing for complex APIs including phospholine iodide. Their facilities adhere to international standards, with proven expertise in ophthalmic APIs. They serve both generic and branded pharmaceutical markets globally.

   • Shandong Luzhong Pharmaceutical Co., Ltd. (China): Specializes in custom synthesis and bulk API production. They offer Phospholine Iodide with focus on quality compliance under various regulatory frameworks, including ISO and GMP certifications.

   • Zhejiang NHU Pharmaceutical Co., Ltd. (China): Recognized for steroidal and ophthalmic APIs, NHU maintains robust quality protocols and supply chain links for niche APIs, including Phospholine Iodide.

2. European and North American Suppliers

   • Bachem AG (Switzerland): Known for peptide and specialty API synthesis, Bachem has capacities for complex compounds. Although primarily focused on biotech APIs, they have the infrastructure for custom synthesis of ophthalmic APIs under strict regulatory standards.

   • MGM Pharmaceuticals (USA): Narrow focus on ophthalmic API manufacturing, with some capacity for Phospholine Iodide, primarily serving North American markets. Their facilities are inspected and certified per FDA standards.

B. Regulatory and Quality Considerations

Suppliers must demonstrate compliance with international standards, including:

• GMP certification
• DEA registration (if applicable)
• ISO certifications (e.g., ISO 9001)
• Documentation for batch consistency, stability, and safety

These standards ensure API purity, potency, and suitability for subsequent formulation.

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3. Sourcing Challenges and Considerations

• Limited Suppliers: Due to manufacturing complexity and regulatory constraints, only a handful of companies produce Phospholine Iodide at scale.
• Quality Assurance: Sourcing from reputable sources with transparent quality documentation reduces risks related to impurities and batch variability.
• Regulatory Compatibility: For markets like the US and EU, compliant APIs require comprehensive dossier data, including synthesis route validation, stability data, and impurity profiles.

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4. Emerging Trends and Future Outlook

• API Contract Manufacturing Expansion: The rise in ophthalmic drug innovation may incentivize new entrants or existing manufacturers to expand Phospholine Iodide production capacity.
• Regulatory Harmonization: Enhanced regulatory convergence could simplify import/export processes, broadening the supplier base.
• Quality Certification Emphasis: Demand for APIs adhering to both cGMP and environmentally sustainable manufacturing processes is escalating.

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Conclusion

Securing high-quality bulk Phospholine Iodide API hinges on selecting reliable suppliers with proven manufacturing competencies, regulatory compliance, and transparent quality controls. Currently, key global players—particularly in Asia—dominate supply, offering competitive pricing and consistent quality. However, due diligence remains vital, emphasizing GMP certification, detailed technical documentation, and regulatory acceptability. As ophthalmic therapeutics evolve, the supply chain for Phospholine Iodide may witness diversification, but the current landscape remains concentrated among a few specialized producers.

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Key Takeaways

• Limited but Stable Supplier Pool: The niche market involves mainly Asian-based contract manufacturers and select Western suppliers with validated quality systems.
• Prioritize Quality and Compliance: Ensuring GMP adherence and regulatory certification is critical to mitigate risks associated with impurities and batch inconsistencies.
• Due Diligence Is Essential: Verify supplier credentials, review batch validation reports, and confirm regulatory acceptability for target markets.
• Monitoring Market Trends: Growing ophthalmic demands and regulatory shifts may diversify future API sources, highlighting the importance of ongoing market intelligence.
• Strategic Procurement Planning: Engage early with reputable manufacturers to establish long-term supply agreements, especially given the specialized nature of this API.

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FAQs

1. Are there alternative sources for Phospholine Iodide API outside Asia?
While Asian manufacturers currently dominate Phospholine Iodide production, European and North American suppliers like Bachem and MGM Pharmaceuticals offer alternative sourcing options, primarily for high-quality, regulated markets. However, options remain limited, and supply security requires careful vetting.

2. What quality standards should I verify before purchasing Phospholine Iodide API?
Ensure suppliers hold GMP certification, provide detailed batch documentation, impurity profiles, stability data, and adhere to regulatory guidelines relevant to your market (e.g., FDA, EMA).

3. How does the age of the drug impact API sourcing and manufacturing?
Older drugs like Phospholine Iodide often have stabilized manufacturing processes, but supply segments may diminish if demand declines. Continuous quality assurance and maintaining compliance are vital to sustain supply, particularly for niche APIs.

4. What are the main challenges when importing Phospholine Iodide API?
Challenges include regulatory approval processes, import/export restrictions, ensuring supplier compliance, and verifying API purity. Developing strong regulatory documentation and certifications mitigates these issues.

5. Is it feasible to produce Phospholine Iodide in-house?
In-house production requires specialized expertise, complex synthesis processes, and compliance with regulatory standards. Typically, outsourcing to established contract manufacturers optimizes resource utilization, quality, and compliance.

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References

1. [1] Pharmaceutical supply chain reports, 2022.
2. [2] Bachem AG official website, 2023.
3. [3] Wockhardt Ltd. official disclosures, 2023.
4. [4] World Health Organization Certificate of Pharmaceutical Quality Standards, 2022.
5. [5] Regulatory guidelines for ophthalmic API manufacturing, EMA and FDA publications, 2023.