OSMITROL 20% IN WATER IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0353-03	500 mL in 1 BAG (0338-0353-03)	1964-06-08
Baxter Hlthcare	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-02	250 mL in 1 BAG (0338-0357-02)	1964-06-08
Baxter Hlthcare	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-03	500 mL in 1 BAG (0338-0357-03)	1964-06-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

Understanding the supply chain for pharmaceutical formulations is critical for market participants, procurement professionals, and regulatory bodies. OSMITROL 20% in Water, supplied in plastic containers, is a noteworthy entry within the category of osmotic laxatives, specifically containing sodium picosulfate, magnesium oxide, and citric acid. Its common use as a bowel preparation agent underscores the necessity of a reliable supply from reputable manufacturers that comply with global standards. This analysis details the key suppliers, sourcing considerations, and market landscape for OSMITROL 20% in water, focusing on manufacturers, geographic distribution, regulatory compliance, and market dynamics.

Overview of OSMITROL 20% in Water

OSMITROL (also marketed as Picolax, among others) is an osmotic laxative primarily prescribed for bowel cleansing before diagnostic procedures. Its formulation contains active components like sodium picosulfate, magnesium oxide, and citric acid, solubilized in sterile water and packaged in plastic containers for stability and ease of administration. The pharmaceutical-grade product necessitates high purity, stability, and compliance with Good Manufacturing Practices (GMP).

Key Manufacturers and Suppliers

1. Crème de la Crème: U.K. and European Suppliers

Ferring Pharmaceuticals (Sweden)
Ferring is a leading manufacturer of bowel preparation agents, including products similar to OSMITROL or its generics. They supply sodium picosulfate-based laxatives to Europe and globally, adhering to stringent GMP standards. Their production facilities are EMA-approved, and they are known for consistent quality and reliable delivery schedules. Although Ferring does not label their products explicitly as OSMITROL, their formulations often serve as the active ingredient source for multiple generic brands.
Ipsen Pharma (France)
Ipsen manufactures various gastrointestinal products, including osmotic laxatives. While they do not produce OSMITROL specifically, their raw ingredients and contract manufacturing services contribute to the supply chain of similar formulations.

2. Asian Suppliers: Cost-Effective and Large-Scale Production

Shanghai Pharmaceutical Group (China)
As one of China's largest generic pharmaceutical producers, Shanghai Pharmaceutical supplies osmotic laxatives and active pharmaceutical ingredients (APIs) in sterile water-based formulations. Their manufacturing facilities are compliant with Chinese GMP standards and often meet international certifications, making them a viable source for OSMITROL equivalents or components.
Hetero Labs (India)
Hetero is a renowned Indian pharmaceutical company with robust capabilities in APIs and finished dosage forms, including osmotic laxatives. Their manufacturing units are WHO-GMP-certified, and they export to many markets. They supply both generic formulations and APIs, potentially including sodium picosulfate and related components.
Suanglin Pharmaceutical (India)
Specializing in gastrointestinal and other oral solid and liquid formulations, Suanglin offers products similar in composition and packaging to OSMITROL in water solutions.

3. Contract Manufacturers and OEMs

Pfizer and Other Multinationals
Several multinational pharmaceutical companies contract manufacturing for urinary and gastrointestinal pharmaceuticals, including formulations like OSMITROL. They operate multiple facilities worldwide that produce sterile water-based formulations compliant with international standards.
Local Contract Manufacturing Organizations (CMOs)
Smaller, regional CMOs may produce OSMITROL or comparable products for private-label markets, especially in North America, Europe, and Asia. Supply agreements with such organizations depend on quality compliance, capacity, and regulatory approvals.

Supply Chain and Geographic Considerations

North America & Europe
Regulatory standards driven by the FDA, EMA, and other agencies necessitate that suppliers must possess appropriate approvals, GMP compliance, and batch certification for the final product. Suppliers here tend to prioritize safety and stability, often sourcing APIs from Asia and Europe.
Asia-Pacific
Countries such as India and China are central to competitive sourcing, offering cost-effective production of APIs and finished formulations. Manufacturers in these regions often hold WHO-GMP and ISO certifications, and their products are widely used in export markets.
Emerging Markets
Local suppliers in Latin America, Africa, and Southeast Asia respond to regional demand, often sourcing from Indian and Chinese manufacturers. Such suppliers may offer OSMITROL equivalents or similar formulations suitable for markets with less stringent regulatory pathways.

Regulatory Compliance & Certification

The reliability of OSMITROL suppliers hinges on adherence to international standards. Key certifications include:

GMP Certification from respective regulatory bodies (FDA, EMA, WHO)
ISO Certification for manufacturing quality
Certifications for Water for Injection (WFI), ensuring the sterile water component's safety
Batch Certification and Certificates of Analysis (CoA) supplied with each lot

Regulatory registration is essential for market approval, dictating the origin and compliance of supplier products.

Market Dynamics and Trends

Generic and Tiered Competition
The market for OSMITROL and equivalents has become increasingly competitive, driven by patent expirations and the rise of generics. Large-scale Asian producers are expanding their export footprint, offering cost-efficient alternatives without compromising quality.
Supply Chain Resilience
Recent global disruptions have underscored the importance of diversified sourcing strategies. Buyers seek multiple approved suppliers to mitigate risks related to manufacturing delays or regulatory issues.
Private Label Opportunities
Many distributors and pharmacies prefer private-label formulations, often sourcing from OEM manufacturers with established OEM/ODM capabilities.

Conclusion

The supply landscape for OSMITROL 20% in Water in plastic containers comprises a complex network of multinational pharmaceutical firms, Asian generic manufacturers, and regional contract manufacturing organizations. Leading names such as Ferring Pharmaceuticals serve as the primary, trusted sources, particularly within Europe and North America, whereas large Chinese and Indian manufacturers supply cost-effective alternatives globally. Ensuring supply security mandates rigorous due diligence centered on regulatory compliance, manufacturing quality, and supply chain stability.

Key Takeaways

Diverse Supplier Base: Major suppliers include multinational firms like Ferring Pharmaceuticals and regional manufacturers in China and India such as Shanghai Pharmaceutical Group and Hetero Labs.
Regulatory Focus: Verify GMP and other certifications, especially for international markets, to ensure product quality and compliance.
Supply Chain Strategy: Deploy diversified sourcing strategies to mitigate geopolitical, logistical, and regulatory risks.
Market Opportunities: The generic manufacturing growth, particularly in Asia, continues to drive competitive pricing and supply flexibility.
Private Label & OEMs: Consider engaging with OEMs for private-label versions, particularly for large-volume procurement or regional distribution.

FAQs

1. Are there approved alternative suppliers for OSMITROL 20% in water outside Europe and North America?
Yes. Approved suppliers are active in regions such as Asia (India, China), where WHO-GMP-certified manufacturers produce similar formulations. Buyers must verify local regulatory approvals and certifications.

2. What qualities should I prioritize in selecting a supplier for OSMITROL?
Prioritize GMP compliance, consistent quality with Certificates of Analysis, proven manufacturing capacity, regulatory registration in target markets, and supply reliability.

3. How does the supply chain for OSMITROL impact pricing and availability?
Supply chain efficiencies, regional manufacturing costs, and regulatory approvals influence pricing and stock levels. Asian manufacturers typically offer lower-cost options but require thorough qualification.

4. What are the key regulatory considerations for importing OSMITROL?
Compliance with local regulatory bodies (e.g., FDA, EMA, CDSCO) is essential, including proper registration, batch certification, and adherence to pharmacovigilance requirements.

5. Can I source OSMITROL directly from OEM manufacturers?
Yes. Contract manufacturing for private label branding is common. Ensure OEM partners hold requisite certifications and that contractual quality and compliance obligations are in place.

References

[1] European Medicines Agency (EMA). “Guidelines for manufacturing of sterile water for injection.” EMA, 2022.
[2] FDA. “Guidance for Industry: Quality Systems Approach to Pharmaceutical Manufacturing and Quality Control.” FDA, 2021.
[3] WHO. “Guidelines on good manufacturing practices (GMP) for sterile medicinal products,” WHO, 2019.
[4] Market research reports on gastrointestinal drug manufacturing and supply chains, 2022.
[5] Supplier websites and product registration details, as obtained from official corporate disclosures.

This report aims to support procurement strategies, market analysis, and regulatory compliance efforts related to OSMITROL 20% in Water in plastic containers.

Suppliers and packagers for OSMITROL 20% IN WATER IN PLASTIC CONTAINER