Bulk Pharmaceutical API Sources for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1902_SIGMA
Sigma-Aldrich		M4125_SIAL
Sigma-Aldrich		M8429_SIAL
Sigma-Aldrich		M9546_SIAL
Sigma-Aldrich		M9647_SIAL
Hangzhou Trylead Chemical Technology		TL806434

Bulk Active Pharmaceutical Ingredient (API) Sources for OSMITROL 5% in Water in Plastic Container

Last updated: August 9, 2025

---

Introduction

Osmitrol, the brand name for mannitol, is a critical therapeutic agent used primarily as an osmotic diuretic in the management of increased intracranial or intraocular pressure and to reduce cerebral edema. The formulation in question, a 5% solution in water housed within a plastic container, necessitates sourcing high-quality bulk active pharmaceutical ingredients (API) that meet stringent pharmaceutical standards. Ensuring the procurement of reliable, compliant API suppliers is vital for maintaining drug safety, efficacy, and regulatory adherence.

---

Regulatory Standards and API Quality Requirements

The API for Osmitrol 5% in water must conform to pharmacopoeial standards such as the United States Pharmacopoeia (USP), European Pharmacopoeia (EP), or other region-specific pharmacopeias. The API should demonstrate:

• Purity with minimal impurities and contaminants.
• Consistent potency and stability.
• Good Manufacturing Practice (GMP) compliance.
• Comprehensive documentation including Certificates of Analysis (CoA) and stability reports.

These standards are essential for APIs intended for human use, especially for injectables and infusion solutions, where sterility and low endotoxin levels are mandatory.

---

Global API Suppliers for Mannitol

Several global suppliers specialize in producing pharmaceutical-grade mannitol, offering APIs suitable for formulation into sterile solutions such as Osmitrol 5%. Below are prominent sources categorized based on manufacturing reputation, product quality, and regulatory compliance.

1. Merck KGaA (EMD Millipore)

• Overview: Merck is a leading supplier of pharmaceutical excipients and APIs, including pharmaceutical-grade mannitol.
• Capabilities: Offers both bulk mannitol USP/EP grade and customized specifications tailored for injectable solutions.
• Certifications: GMP-certified manufacturing sites with comprehensive quality assurance.
• Application: Widely used in pharmaceutical formulations, including infusion solutions.

2. Roquette Frères

• Overview: French-based global supplier specializing in plant-based pharmaceutical excipients and APIs.
• Product Range: Supplies pharmaceutical-grade mannitol with high purity suitable for parenteral use.
• Quality Assurance: GMP compliance, thorough documentation, and stability data.
• Reputation: Recognized for high-quality excipients and active ingredients with a focus on pharmaceutical safety.

3. Bio-Techne Corporation

• Overview: Global provider of research and clinical-grade APIs, including mannitol.
• Specialization: Offers pharmaceutical-grade mannitol powders meeting pharmacopeial standards.
• Regulatory: Supplies API with detailed certificate of analysis aligned with USP/EP standards.

4. Fuso Chemical (Fuso Pharmaceutical Industries)

• Overview: Japanese manufacturer with decades of experience producing high-purity pharmaceutical ingredients.
• API Offerings: Supplies pharmaceutical-grade mannitol suitable for sterile infusion solutions.
• Certifications: GMP-compliant, emphasizing quality and regulatory compliance.

5. Sigma-Aldrich (Merck KGaA Outlet)

• Overview: A well-established global supplier providing pharmaceutical-grade chemicals.
• Product: Offers mannitol APIs with detailed specifications, appropriate for sterile formulations.
• Delivery: Reliable supply chain with documentation supporting regulatory submissions.

---

Regional API Suppliers and Considerations

While global suppliers provide high ISO certifications, regional API manufacturers in India, China, and Europe may offer cost-effective options. Key considerations include:

• India: Suppliers like Sun Pharma, Aurobindo Pharma, and Dr. Reddy's offer established API manufacturing facilities with GMP certification. They provide mannitol meeting international pharmacopeial standards.
• China: Major API producers such as North China Pharmaceutical Group Corporation (NCPC) and Zhejiang Huahai Pharmaceuticals are notable but require rigorous due diligence regarding quality assurance.
• Europe: Companies like Novartis and BASF produce high-purity APIs aligned with stringent European regulations.

When sourcing from regional suppliers, audit reports, quality certificates, and API validation are crucial.

---

Supply Chain and Quality Verification

To mitigate risks associated with API sourcing, implement rigorous supplier qualification processes:

• Regulatory Documentation: Confirm Certificates of Analysis, GMP certifications, and stability data.
• Audits: Conduct on-site inspections or third-party audits focusing on manufacturing practices.
• Traceability: Ensure full supply chain traceability for compliance and quality control.
• Quality Control Testing: Perform independent laboratory testing for purity, residual solvents, endotoxin levels, and sterility, especially critical for APIs used in injectable solutions.

---

Implications for Formulation and Container Compatibility

The API's characteristics influence formulation stability and compatibility with packaging. Mannitol's low hygroscopicity and stabilizing properties favor its use in sterile water solutions within plastic containers. Quality APIs minimize impurity-related interactions with plastic materials, reducing degradation risk and ensuring patient safety.

---

Supply Chain Challenges and Solutions

Supply chain disruptions, geopolitical factors, and regulatory changes can impact API availability. Strategies include:

• Establishing relationships with multiple suppliers.
• Maintaining safety stock of bulk API.
• Monitoring geopolitical and regulatory developments affecting API imports.
• Ensuring suppliers’ compliance with current Good Manufacturing Practices (cGMP).

---

Conclusion

Sourcing high-quality bulk API for Osmitrol 5% in water requires a strategic approach emphasizing regulatory compliance, supplier credibility, and supply chain robustness. Renowned global manufacturers like Merck KGaA, Roquette, and Bio-Techne consistently meet pharmaceutical standards and provide reliable supply channels. Regional suppliers may be suitable with diligent validation processes. Ensuring API quality and consistent supply safeguards product integrity, patient safety, and regulatory adherence.

---

Key Takeaways

• Prioritize APIs from reputable, GMP-certified global suppliers such as Merck KGaA, Roquette, and Bio-Techne.
• Verify documentation, including Certificates of Analysis and stability data, before procurement.
• Employ rigorous supplier qualification, auditing, and independent testing to mitigate risks.
• Consider regional API options but conduct thorough due diligence to ensure compliance.
• Maintain diversified sourcing strategies to buffer against supply chain disruptions.

---

FAQs

1. What are the critical quality attributes for API used in Osmitrol 5% formulation?
Key attributes include high purity, low endotoxin levels, sterility, consistent potency, and compliance with pharmacopeial standards such as USP or EP.

2. Can regional API suppliers meet global regulatory standards for injectable drugs?
Yes, many regional suppliers are GMP-certified and produce APIs that conform to international standards, provided proper validation, documentation, and quality checks are performed.

3. How important is batch-to-batch consistency in API sourcing?
Extremely important, as variability can impact formulation stability, efficacy, and safety, especially for sterile injectable APIs.

4. What challenges exist in sourcing mannitol API globally?
Challenges include regulatory differences, supply chain disruptions, quality assurance compliance, and geopolitical factors affecting trade.

5. How does the API quality influence the final product's shelf life?
High-quality APIs with minimal impurities enhance stability, reducing degradation pathways, and prolonging product shelf life when stored under recommended conditions.

---

Sources:
[1] USP Monograph for Mannitol.
[2] European Pharmacopoeia (EP) Standards.
[3] Merck KGaA Product Documentation.
[4] Roquette Pharmaceutical Excipients Portfolio.
[5] Industry reports on API manufacturing and supply chain dynamics.