Bulk Pharmaceutical API Sources for OSMITROL 5% IN WATER

Bulk Pharmaceutical API Sources for OSMITROL 5% IN WATER

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HctF@@IaWTfYn~jjj`@@
Sigma-Aldrich		M1902_SIGMA
Sigma-Aldrich		M4125_SIAL

Last updated: August 15, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: OSMITROL 5% IN WATER

Introduction

Osmitrol 5% in water, a branded ophthalmic solution containing the active pharmaceutical ingredient (API) sodium chlorite, is primarily used for ocular irrigation and disinfection. Given the critical nature of its API—sodium chlorite—accurate sourcing of bulk supplies is essential to ensure product quality, regulatory compliance, and consistent supply chain integrity. This article explores viable sources, industry practices, and considerations for procuring bulk sodium chlorite to manufacture Osmitrol 5% in water, providing insights for pharmaceutical companies, contract manufacturers, and suppliers.

Understanding the API: Sodium Chlorite

Sodium chlorite (NaClO₂) is an inorganic chemical used in various applications, including water disinfection, textile bleaching, and as an intermediate in the production of other chemicals. In ophthalmic solutions like Osmitrol 5%, it functions as an antimicrobial agent, offering stability and safety when formulated correctly. Its pharmaceutical-grade quality mandates strict purity standards, typically USP, EP, or JP grades, depending on regional regulatory requirements (e.g., FDA, EMA, PMDA).

Criteria for Selecting API Suppliers

Selecting a dependable bulk API source involves evaluating multiple factors:

• Regulatory Compliance: Suppliers must provide certificates of analysis (COA), certificates of GMP compliance, and adhere to pharmacopeial standards (USP, EP, JP).
• Quality Assurance: High purity (>99%), low residual solvents, and absence of impurities are non-negotiable.
• Manufacturing Capabilities: Scale, batch consistency, and robust quality control processes are crucial to meet global demand.
• Regulatory Track Record: Experience with pharmaceutical APIs, especially in ophthalmic formulations, enhances supplier credibility.
• Supply Chain Stability: Reliable delivery schedules and contingency plans mitigate risks of shortages.

Leading Global API Suppliers for Sodium Chlorite

1. Global Chemical Manufacturers with Pharmaceutical-Grade APIs

Numerous chemical suppliers produce sodium chlorite under rigorous quality standards suitable for pharmaceutical applications. Notable entities include:

• Cresco Chem (India): Offers USP-grade sodium chlorite with consistent purity specifications. Positioned as a reliable supplier with extensive GMP manufacturing facilities.
• Hubbard Hill (USA): Specializes in high-purity inorganic chemicals, including USP-grade sodium chlorite, with comprehensive documentation supporting regulatory filing.
• Haringson Chemical (Germany): Known for quality control and certification, supplying pharmaceutical-grade sodium chlorite for ophthalmic and other sterile uses.

2. Major API Contract Manufacturing Organizations (CMOs)

Contract manufacturers with expertise in inorganic chemistry and sterile APIs are vital for integrating API supply within larger production systems:

• FAIRCHEM (China): Provides GMP-compliant sodium chlorite with validated manufacturing processes tailored to pharmaceutical needs.
• BASF (Germany): Though primarily a chemical producer, BASF supplies high-purity inorganic chemicals to pharma firms with strict quality controls and regulatory support.
• Lonza (Switzerland): Offers custom synthesis and bulk API manufacturing services, including specialized chlorite derivatives, ensuring tailored quality profiles.

3. Regional Suppliers in Emerging Markets

Regional suppliers often offer competitive pricing and shorter lead times but require rigorous validation:

• Shandong Zhiyuan Chemical (China)
• SinoChem Corporation (China)
• Neler Chemicals (India)**

These firms are expanding their international presence, often aligning with global pharmaceutical standards.

Due Diligence and Validation When Sourcing API

• Supplier Qualification: Conduct audits, review GMP certificates, and inspect manufacturing facilities.
• Analytical Validation: Use independent laboratories to verify the API’s purity, residual solvents, and impurity profile per pharmacopeia standards.
• Stability and Compatibility Testing: Ensure API stability within the formulation matrix; stability data from suppliers or in-house testing is critical.
• Regulatory Documentation: Confirm availability of DMFs (Drug Master Files), Certificates of Suitability, and batch documentation for regulatory filings.

Regulatory Considerations

• GMP Compliance: Sourcing from GMP-certified manufacturers minimizes compliance risks.
• Pharmacopoeial Standards: Ensure the sodium chlorite complies with USP, EP, or JP standards relevant to finished product registration.
• Import/export regulations: Understand regional restrictions, tariffs, and documentation requirements for international trade.

Supply Chain and Logistics

• Lead Times: Typically range from 4 to 12 weeks, depending on supplier location and batch size.
• Storage and Handling: Sodium chlorite requires specific storage conditions—preferably in cool, dry, and well-ventilated environments.
• Contingency Planning: Maintain multiple qualified sources to safeguard against supply disruptions.

Emerging Trends and Future Outlook

• Growth in Inorganic API Markets: An increasing global demand for ophthalmic and disinfectant APIs drives supplier capacity expansion.
• Regulatory Harmonization: Alignment with international standards simplifies global sourcing and registration.
• Sustainable and Green Chemistry Initiatives: Suppliers investing in environmentally friendly manufacturing methods influence future API sourcing decisions.

Conclusion

Securing a reliable bulk source of sodium chlorite for Osmitrol 5% in water necessitates diligent supplier qualification, strict quality assurance, and alignment with regulatory standards. Established pharmaceutical ingredient suppliers, contract manufacturers, and regional chemical firms constitute viable options, each with unique advantages. Companies must prioritize quality, compliance, and supply chain stability when selecting API sources to ensure consistent product quality, regulatory success, and business continuity.

---

Key Takeaways

• Rigorous Validation: Validation of supplier quality and regulatory compliance is essential before procurement.
• Diverse Supplier Base: Maintain multiple API sources to mitigate risks of supply disruption.
• Regulatory Alignment: Ensure API meets pharmacopeial and regional regulatory standards for ophthalmic use.
• Quality Control: Implement independent testing for batch consistency and impurity profiles.
• Supply Chain Planning: Account for lead times, storage conditions, and contingency strategies to sustain manufacturing flow.

---

FAQs

1. What are the key regulatory standards for sourcing sodium chlorite API?
Sodium chlorite intended for pharmaceutical use must meet pharmacopeial standards such as USP, EP, or JP, and comply with GMP requirements set by regulatory agencies like the FDA, EMA, or PMDA.

2. How do I evaluate the quality of sodium chlorite from different suppliers?
Assess Certificates of Analysis, GMP compliance certificates, conduct independent laboratory testing of purity and impurities, and review manufacturing process documentation and regulatory history.

3. Can regional suppliers meet the quality standards required for ophthalmic APIs?
Yes, some regional suppliers comply with international GMP standards. Verification through audits, qualification, and analytical testing is essential to confirm quality and compliance.

4. What are common challenges in sourcing bulk sodium chlorite for pharmaceutical use?
Challenges include ensuring consistent purity, purity validation, regulatory approval, supply chain reliability, and maintaining stability within the formulated product.

5. How does supply chain disruption affect ophthalmic API sourcing, and what strategies mitigate risks?
Supply disruptions can delay production and compromise product quality. Diversifying suppliers, maintaining safety stock, and establishing long-term contracts are effective mitigation strategies.

---

References:
[1] U.S. Pharmacopeia (USP) Sodium Chlorite Monograph.
[2] European Pharmacopoeia (EP) Monograph for Sodium Chlorite.
[3] Industry reports on inorganic chemical supply chains.
[4] Regulatory guidelines provided by FDA and EMA on inorganic APIs.