MANNITOL 5% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	MANNITOL 5% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006	NDA	B. Braun Medical Inc.	0264-7578-10	24 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINER	1993-07-26
B Braun	MANNITOL 5% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006	NDA	B. Braun Medical Inc.	0264-7578-20	24 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINER	1993-07-26
Otsuka Icu Medcl	MANNITOL 5% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	019603	NDA	ICU Medical Inc.	0990-7715-02	24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12)	2019-05-31
Otsuka Icu Medcl	MANNITOL 5% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	019603	NDA	ICU Medical Inc.	0990-7715-03	12 POUCH in 1 CASE (0990-7715-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0990-7715-13)	2019-05-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Mannitol 5% solution in plastic containers is a widely used pharmaceutical product primarily as an osmotic diuretic for cerebral edema, glaucoma, and during surgical procedures. As a vital pharmaceutical ingredient, its manufacturing, packaging, and supply chain involve numerous stakeholders, including active pharmaceutical ingredient (API) producers, formulation manufacturers, and packaging providers. Ensuring consistent supply and quality adherence is critical for healthcare providers, regulators, and pharmaceutical companies alike. This article provides an in-depth overview of key suppliers globally engaged in producing Mannitol 5% solutions in plastic containers, examining the landscape, key players, and procurement considerations.

Global Market Overview

The global pharmaceutical-grade mannitol market is driven by increasing clinical applications, demand for intravenous fluids, and growing awareness of its therapeutic uses. The industry involves both raw material suppliers producing API-grade mannitol and finished drug product manufacturers packaging the solution in various formats, including single-use plastic containers.

The supply chain for Mannitol 5% solutions requires adherence to stringent quality standards such as USP, EP, or JP certifications, FDA compliance, and Good Manufacturing Practices (GMP). Plastic container suppliers and pharmaceutical contract manufacturers (CDMOs) often collaborate to ensure the end product's integrity, sterility, and stability.

Major Suppliers of Mannitol API

1. Roquette Frères

Overview: A leading global supplier of pharmaceutical excipients and APIs, Roquette offers pharmaceutical-grade mannitol primarily used for oral and injectable formulations. Their manufacturing facilities comply with GMP standards and are certified for international markets.
Capabilities: Custom manufacturing, extensive regulatory support, and supply chain reliability.
Relevance: While primarily an API manufacturer, Roquette supplies raw material to formulation companies that produce Mannitol 5% solutions.

2. Anhui Biochem Group (formerly Anhui Bright Moon Biotechnology)

Overview: An established Chinese manufacturer specializing in pharmaceutical ingredient production, including mannitol.
Certifications: GMP, ISO-certified, with international registration and compliance.
Market: Supplies API to both domestic and international pharmaceutical companies, supporting formulations in various presentations.

3. SPI Pharma (now part of West-Ward Pharmaceuticals)

Overview: A North-American player in excipient and API production, providing high-purity mannitol for detailed formulations.
Certifications: FDA-approved facilities; compliant with GxP standards.
Application: Supplies API used in injectable formulations, including Mannitol 5% solutions.

4. Roekyo Corporation

Overview: A Japan-based pharmaceutical excipient producer offering mannitol suitable for sterile injectable applications.
Market Position: Serves Asian and global markets with high-quality standards.

5. Other Notable API Producers

Pangbo Chemical Co. (China)
Shandong Bright Pharmaceutical Co., Ltd. (China)

These organizations produce pharmaceutical-grade mannitol meeting international regulatory requirements.

Manufacturers of Mannitol 5% Solution in Plastic Containers

Following API procurement, the final formulation's production involves several key players specializing in sterile processing, aseptic filling, and packaging.

1. Baxter International Inc.

Overview: A global leader in sterile injectable manufacturing, Baxter produces intravenous solutions, including Mannitol 5% in plastic bags and bottles.
Facilities: Operate GMP-compliant manufacturing plants globally.
Supply Scope: Supplies to hospitals, clinics, and distributors.

2. Hospira (a Pfizer company)

Overview: Known for sterile injectable products, Hospira offers Mannitol in pre-filled or bag formats.
Packaging: Uses high-quality plastic containers, including polyolefins suitable for infusion therapy.

3. Fresenius Kabi

Overview: Specializes in intravenous solutions and sterile drug products.
Product Range: Provides Mannitol 5% in plastic infusion bags, with strict quality controls.

4. Sandoz (Novartis Group)

Overview: A global generics and biosimilars company that manufactures sterile solutions, including Mannitol formulations.
Packaging: Uses advanced aseptic filling technologies to ensure safety and sterility.

5. Local Contract Manufacturing Organizations (CMOs)

Regional players in Europe, India, and the Middle East include:

Biocon Limited (India)
Siam Bioscience (Thailand)
Fresenius Kabi India

These organizations often work under licensing agreements or contract manufacturing arrangements.

Key Packaging Suppliers for Plastic Containers

In addition to formulators, the supply of suitable plastic containers—typically polyethylene (PE), polypropylene (PP), or specialized medical-grade plastics—is critical.

1. Stevanato Group

Overview: Supplies premium sterile plastic containers, including bottles and bags, optimized for pharmaceutical injectable solutions.
Focus: Ensures compatibility, barrier properties, and sterilization compatibility.

2. Becton Dickinson (BD)

Overview: Prominent supplier of pre-sterilized plastic infusion bags and bottles.
Product Offering: Flexible, high-integrity packaging solutions suitable for Mannitol 5% infusion.

3. Terumo Corporation

Overview: Provides various sterile plastic containers, including infusion bags, suitable for pharmaceutical solutions.
Certifications: Compliant with ISO and GMP standards.

4. Nipro Corporation

Overview: Offers medical-grade plastic containers supporting international standards, ensuring regulatory compliance.

Supply Chain and Procurement Considerations

For pharmaceutical companies and distributors, selecting a reliable supply chain for Mannitol 5% in plastic containers involves these critical factors:

Regulatory Compliance: Suppliers must hold necessary certifications such as GMP, ISO, and meet regional agency standards (e.g., FDA, EMA, PMDA).
Quality Certifications: Certificates of Analysis (CoA), stability data, and batch consistency verify reliable supply.
Supply Capacity: Capacity to meet global demand fluctuations, especially in pandemic or emergency contexts.
Lead Times: Efficient logistics partnerships that ensure timely delivery without compromising sterility.
Price Stability: Competitive costing aligned with quality standards to maintain product affordability.

Emerging Trends and Market Dynamics

The market is trending toward increased outsourcing, with many pharmaceutical companies favoring contract manufacturing to reduce costs and leverage technological innovations. Additionally, the shift toward single-use technology in sterile processing facilitates scalable and contamination-free production of Mannitol solutions. Regulatory harmonization globally also simplifies cross-border procurement.

Conclusion

The procurement of Mannitol 5% in plastic containers involves a multi-tiered supply chain with distinguished API suppliers like Roquette and Anhui Biochem, complemented by contract manufacturers such as Baxter and Fresenius Kabi. Packaging standards are upheld by specialized suppliers like Stevanato and BD, ensuring product sterility, stability, and regulatory compliance. An integrated approach combining rigorous supplier qualification, quality assurance, and supply chain resilience is essential for uninterrupted delivery of this critical pharmaceutical product.

Key Takeaways

Global API Suppliers: Roquette, Anhui Biochem, and SPI Pharma are among the leading manufacturers providing pharmaceutical-grade mannitol suitable for injectable formulations.
Formulation and Packaging Vendors: Major pharmaceutical companies like Baxter, Fresenius Kabi, and Sandoz produce Mannitol 5% solutions, primarily in plastic infusion bags and bottles.
Packaging Players: Suppliers such as Stevanato and BD supply medical-grade plastic containers that meet stringent sterility and compatibility standards.
Supply Chain Strategy: Prioritize suppliers with GMP certifications, robust production capacity, and proven logistics capabilities to ensure continuous supply.
Market Trends: Increasing reliance on outsourcing and single-use technologies enhances manufacturing flexibility, while regulatory homogenization facilitates international procurement.

FAQs

1. What are the primary applications of Mannitol 5% in clinical settings?
Mannitol 5% solutions are mainly used as osmotic diuretics to reduce intracranial pressure in cerebral edema, manage ocular pressure in glaucoma, and serve as part of surgical protocols requiring controlled fluid therapy.

2. How do I verify the supplier’s regulatory compliance for Mannitol 5% solutions?
Ensure suppliers hold GMP certification, ISO standards, and regional approvals (FDA, EMA, PMDA). Request Certificates of Analysis, batch traceability data, and audits or inspection reports.

3. Are there regional suppliers for Mannitol 5% suitable for local markets?
Yes. Regional manufacturers in India, China, and Southeast Asia—such as Biocon, Anhui Biochem, and Siam Bioscience—provide high-quality Mannitol formulations aligning with international standards.

4. What packaging considerations are critical for Mannitol solutions?
Containers must maintain sterility, compatibility with the solution, barrier integrity, and ease of sterilization. Polypropylene and polyethylene materials are common choices subject to validation.

5. How can supply chain disruptions be minimized?
Establish diversified supplier bases, verify supplier certifications, maintain safety stock levels, and foster collaborative relationships with logistics providers committed to compliance and reliability.

References:

[1] Global Industry Analysts, Inc. "Mannitol Market Report," 2022.
[2] U.S. Pharmacopeia (USP). "Pharmaceutical Mannitol Monograph," 2021.
[3] Roquette Official Website. "Pharmaceutical Excipients and APIs," 2022.
[4] Baxter Annual Report. "Sterile Injectable Products Portfolio," 2022.
[5] Becton Dickinson. "Infusion Therapy Solutions," 2022.

Suppliers and packagers for MANNITOL 5% IN PLASTIC CONTAINER