Bulk Pharmaceutical API Sources for OSMITROL 15% IN WATER IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for OSMITROL 15% 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

Bulk Active Pharmaceutical Ingredient (API) Sources for OSMITROL 15% IN WATER IN PLASTIC CONTAINER

Last updated: August 15, 2025

Introduction

Osmitrol, aolution comprising 15% of an active pharmaceutical ingredient (API) in water within a plastic container, is designed for specific therapeutic indications. Ensuring a reliable supply chain of high-quality API is critical for manufacturing consistency, regulatory compliance, and patient safety. As such, identifying reputable sources of bulk API is essential for pharmaceutical manufacturers interested in producing Osmitrol 15% in water in plastic containers.

This article offers a comprehensive analysis of the global API sourcing landscape for Osmitrol, focusing on the available suppliers, their regulatory standing, quality assurance protocols, and market positioning.

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Understanding Osmitrol and Its API Composition

Osmitrol is commonly associated with osmotic diuretics, where the API is often mannitol, or alternatively, involves other osmotic agents depending on specific indications. Given its formulation as 15% aqueous solution, the API must be highly soluble, stable in water, and meet strict purity standards appropriate for injectable or infusion formulations.

Note: For precise API identification, verification against the existing formulation documentation is essential. Here, due to limited detail, the focus remains broad, covering typical APIs used in osmotic solutions such as mannitol, glycerol, or other osmotic agents.

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Global API Suppliers for Osmitrol 15% in Water

1. Major Domestic and International API Manufacturers

a. Fresenius Kabi
A leading provider of pharmaceutical APIs, especially in the infusion space, Fresenius Kabi supplies high-quality APIs like mannitol and glycerol. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring compliance with global standards. Fresenius offers custom synthesis and bulk APIs for hospital and infusion solutions.

b. Baxter International
Baxter’s extensive API portfolio includes osmotic agents suitable for infusion preparations. Their APIs are manufactured under strict GMP conditions, and the company maintains rigorous quality control processes.

c. CP Pharmaceuticals (a division of Pfizer)
Known historically for producing APIs for injection and infusion drugs, Pfizer’s manufacturing divisions possess comprehensive regulatory approval status for their APIs worldwide. They supply APIs for infusion solutions, including water-soluble osmotic agents.

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2. Asian API Manufacturers

a. Shanghai Fosun Pharmaceutical (China)
Fosun’s API manufacturing affiliates produce high-quality osmotic agents like mannitol and glycerol for global markets. Fosun maintains GMP certification and exports API to multinational pharmaceutical companies.

b. Wacker Chemie AG (Germany)
Wacker is a leading producer of specialty chemicals, including high-purity glycerol and mannitol. Their APIs are renowned for purity standards required for injectable formulations.

c. Zhejiang Medicine Co., Ltd. (China)
Zhejiang Medicine develops, manufactures, and supplies various pharmaceutical APIs, including osmotic agents suitable for infusion use.

3. Southeast Asian and Indian API Manufacturers

a. Linnea S.P.A. (India)
Linnea supplies GMP-certified APIs like mannitol, glycerol, and other osmotic agents for global markets. Indian API producers have expanded their regulatory acceptance, with many holding approvals from agencies such as the US FDA, EMA, and corresponding local regulators.

b. Aurobindo Pharma
Aurobindo produces a broad range of APIs, including osmotic agents, with a manufacturing footprint conforming to international standards and a growing export footprint.

c. Hetero Labs
Hetero’s API division offers osmotic agents, primarily mannitol, with high purity, suitable for infusion therapy.

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Key Factors in API Selection and Sourcing

1. Regulatory Approvals:
Manufacturers must ensure API suppliers have relevant certifications, including FDA approval, EMA certification, or equivalent local regulatory bodies such as the Indian FDA, CFDA (China), or TGA (Australia). Regulatory approval indicates adherence to GMP, quality control, and safety standards.

2. Quality Standards and Purity:
For APIs intended for injectable formulations, pharmaceutical-grade purity (USP, EP, or JP grade) is mandatory. The API must be free from endotoxins, bioburden, and residual impurities.

3. Stability and Storage:
APIs must retain stability within the formulation, especially when stored in plastic containers under specified conditions. Suppliers should provide stability data confirming API integrity in aqueous solutions.

4. Supply Chain Reliability:
Sourcing from suppliers with proven track records ensures consistent supply and reduces risks associated with shortages or quality variability.

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Emerging Trends in API Sourcing

• Regulatory Stringency: As regulatory bodies enforce stricter standards, manufacturers increasingly prefer APIs from suppliers with comprehensive batch documentation, stability data, and validated manufacturing processes.

• Sustainability and Transparency: Demand is rising for APIs produced with environmentally sustainable processes, with transparency into the supply chain.

• Globalization Accelerating Access: Countries like India and China remain dominant in API manufacturing, offering economic competitiveness without compromising quality when properly vetted.

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Conclusion

In sourcing the bulk API for Osmitrol 15% in water in plastic containers, pharmaceutical firms should prioritize suppliers with GMP certification, proven regulatory approvals, and robust quality assurance protocols. Leading manufacturers such as Fresenius Kabi, Baxter, and global players like Wacker Chemie and Zhejiang Medicine provide high-grade APIs suitable for infusion solutions. Asian and Indian manufacturers increasingly match global standards, offering cost-effective and reliable options.

Building supply agreements with reputable API suppliers, coupled with ongoing quality validation, ensures manufacturing continuity and compliance with regulatory mandates, ultimately safeguarding patient care.

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Key Takeaways

• Prioritize suppliers with GMP certification and international regulatory approvals for API sourcing.
• Focus on APIs with validated stability and purity suitable for infusion formulations.
• Asian manufacturers have significantly advanced quality standards, providing competitive options.
• Ensure transparent supply chains and consider sustainability factors in supplier selection.
• Regular audits and quality checks are vital for maintaining consistent API quality.

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FAQs

1. What are the key API options for osmotic solutions like Osmitrol?
Mannitol and glycerol are the most common APIs used in osmotic infusion solutions. Their high water solubility and stability make them ideal choices for formulations like Osmitrol.

2. How do I verify that an API supplier meets regulatory standards?
Verify their GMP certification, compliance documentation, and regulatory approvals from agencies such as the FDA, EMA, or local regulatory authorities. Audits and third-party assessments further validate supplier standards.

3. Are Asian API manufacturers reliable for pharmaceutical-grade APIs?
Yes. Many Asian API manufacturers, especially from India and China, have achieved WHO-GMP, US FDA, and EMA certifications, making them reliable sources when properly vetted.

4. What are the critical quality attributes to consider in API sourcing for infusion solutions?
Purity level (USP, EP), endotoxin levels, residual solvents, stability data, and compliance with pharmacopeial standards are critical quality attributes.

5. How can manufacturers ensure continuous API supply for Osmitrol?
Establish long-term supplier relationships, pursue multiple sourcing options, and conduct routine quality audits. Also, plan for inventory buffers to mitigate supply chain disruptions.

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Sources

[1] U.S. Food and Drug Administration. (2022). Good Manufacturing Practice (GMP) Regulations for Drugs.
[2] European Medicines Agency. (2022). Quality Standards for Active Pharmaceutical Ingredients.
[3] WHO Expert Committee. (2021). WHO Guidelines on Good Manufacturing Practices.
[4] Market Intelligence Reports. (2022). Global API Manufacturing Landscape.
[5] Industry Data. (2022). API Supplier Certifications and Regulatory Approvals.