Suppliers and packagers for MANNITOL 15%

MANNITOL 15%

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	Henry Schein, Inc.	0404-9905-50	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2022-01-12
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	Hospira, Inc.	0409-4031-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)	2004-11-30
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1468-1	50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)	2019-12-13
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1468-3	25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSE	2019-12-13

Suppliers for the Pharmaceutical Drug: Mannitol 15%

Last updated: August 17, 2025

Introduction

Mannitol 15% solution remains a critical component in clinical settings due to its efficacy as an osmotic diuretic. Used primarily to reduce intracranial pressure and treat cerebral edema, Mannitol 15% is also employed in renal function testing and as a osmotic agent in various pharmaceutical formulations. Ensuring a reliable supply of high-quality Mannitol 15% is essential for healthcare providers, pharmaceutical manufacturers, and distributors. This article analyzes the leading suppliers, highlights supplier selection criteria, examines market dynamics, and provides actionable insights to industry stakeholders.

Overview of Mannitol 15%

Mannitol (C6H14O6) is a sugar alcohol derived chiefly through the hydrogenation of fructose or by fermentation processes. Pharmaceutical-grade Mannitol 15% solutions are sterile, pyrogen-free, and meet stringent purity standards, typically conforming to pharmacopeial specifications such as USP, EP, or JP.

The 15% concentration indicates 15 grams of Mannitol dissolved in 100 mL of solution, making it suitable for intravenous/injectable formulations and specific clinical applications. The global demand for Mannitol 15% is driven by hospitals, clinics, and pharmaceutical companies engaged in neurological and renal therapeutics.

Leading Suppliers of Mannitol 15%

1. Merck KGaA (Sigma-Aldrich)

Overview: Merck KGaA, through its Sigma-Aldrich brand, supplies pharmaceutical-grade Mannitol to the global market. Known for rigorous quality standards, Merck offers Mannitol suitable for injectable use, complying with international pharmacopoeias.

Supply Capabilities: Capable of large-scale production, Merck maintains extensive distribution channels worldwide, ensuring prompt delivery. Their Mannitol products meet FDA, EMA, and other regulatory standards.

Market Position: As a pioneer in pharmaceutical excipients and active ingredients, Merck’s reputation is underpinned by consistent quality and regulatory compliance.

2. Roquette Frères

Overview: Based in France, Roquette is a leading manufacturer of pharmaceutical and food-grade excipients, including Mannitol. Their pharmaceutical-grade Mannitol is produced under strict quality management systems.

Supply Capabilities: Roquette supplies both bulk sterile Mannitol 15% solutions and raw materials for formulation, with a focus on sustainability and quality assurance. Their manufacturing facilities adhere to cGMP standards.

Market Position: Recognized for innovation and supply reliability, Roquette caters primarily to European and North American markets.

3. SPI Pharma (a division of Harro Hofliger Group)

Overview: SPI Pharma specializes in pharmaceutical excipients, including Mannitol. They focus on sterile, injectable-grade Mannitol solutions.

Supply Capabilities: SPI offers customized packaging options and fulfills the demand for sterile, pyrogen-free Mannitol 15%. Their facilities are certified compliant with global regulatory agencies.

4. Qingdao Bright Moon Seaweed Group

Overview: A key Asian manufacturer, Bright Moon produces Mannitol primarily for industrial and pharmaceutical purposes. They have expanded their quality controls for pharmaceutical-grade Mannitol.

Supply Capabilities: While primarily catering to Asian markets, Bright Moon’s scale and quality control certifications facilitate exports to other regions.

5. RTP Company

Overview: Specializing in high-performance thermoplastics and specialty ingredients, RTP Company offers Mannitol used as an excipient and carrier in pharmaceuticals.

Supply Capabilities: Their focus is on innovative formulations and tailored supply solutions, including sterile Mannitol solutions.

6. Fosun Pharma & Other Regional Manufacturers

Regional pharmaceutical conglomerates such as Fosun Pharma (China), Nan Hua Pharmaceutical (India), and various local manufacturers also supply Mannitol 15%. Their offerings often serve domestic markets but are increasingly aiming for international standards.

Criteria for Selecting Mannitol 15% Suppliers

Choosing the right supplier for Mannitol 15% involves multiple factors:

• Regulatory Compliance: Suppliers should adhere to cGMP, FDA, EMA, and pharmacopoeial standards.
• Quality Assurance: Certificates of analysis (COA), stability tests, and purity levels must meet pharmacopeial specifications.
• Supply Reliability: Capacity to fulfill large-volume orders consistently.
• Pricing and Payment Terms: Competitive pricing with transparent payment terms.
• Logistics & Delivery: Efficient cold-chain logistics (if necessary), timely delivery, and flexible packaging.
• Technical Support: Availability of technical data, formulation assistance, and post-sale support.

Market Dynamics and Trends

The global demand for Mannitol 15% is influenced by increasing neurological and nephrological healthcare needs. The market is also shaped by:

• Regulatory Stringency: Enhanced quality control standards have led to favoring suppliers with robust compliance histories.
• Supply Chain Disruptions: Factors such as geopolitical tensions, COVID-19 pandemic, and raw material shortages affect supply stability.
• Emerging Markets: Growing healthcare infrastructure in Asia and Africa presents both opportunities and supply chain challenges.
• Environmental & Sustainability Trends: Suppliers emphasizing eco-friendly manufacturing and reduced carbon footprints are gaining favor.

Challenges in the Mannitol 15% Supply Chain

Despite numerous suppliers, certain challenges persist:

• Raw Material Scarcity: Mannitol is derived from renewable resources, but fluctuations in raw material availability can disrupt supply.
• Quality Variability: Variations in purity and sterility standards among regional manufacturers require diligent qualification.
• Regulatory Barriers: Import/export restrictions and differing regulatory requirements complicate international procurement.
• Cost Fluctuations: Raw material costs and manufacturing expenses influence pricing structures.

Conclusion

The global supply landscape for Mannitol 15% features well-established players like Merck, Roquette, and SPI Pharma, complemented by regional manufacturers in Asia and India. Selecting a supplier demands rigorous evaluation of quality, compliance, logistics, and sustainability factors. With healthcare demands mounting and regulatory standards tightening, strategic supplier partnerships are essential to ensure uninterrupted, high-quality supply.

Key Takeaways

• Leading suppliers such as Merck KGaA and Roquette offer high-quality, regulatory-compliant Mannitol 15%, suitable for pharmaceutical applications.
• Supplier selection should prioritize regulatory compliance, quality assurance, supply stability, and technical support.
• Market dynamics are shifting toward sustainable manufacturing practices amidst fluctuating raw material availability and regulatory frameworks.
• Regional manufacturers expand options but require diligence concerning quality and compliance.
• Long-term supply security depends on diversified sourcing, rigorous qualification processes, and proactive engagement with suppliers.

FAQs

1. What are the primary criteria when selecting a supplier for Mannitol 15%?
Selection criteria include regulatory compliance (FDA, EMA standards), product purity, consistency in supply, quality certifications, logistics capabilities, and competitive pricing.

2. Are there regional differences in Mannitol 15% suppliers?
Yes. European and North American markets are dominated by firms like Merck and Roquette, whereas Asian markets include manufacturers such as Bright Moon. Regional manufacturers may have varying standards and certification levels.

3. How does regulatory compliance impact Mannitol supply?
Strict adherence to pharmacopeial standards and cGMP practices ensures product safety and efficacy, influencing supplier reputation and procurement feasibility.

4. What are the main challenges in sourcing Mannitol 15% internationally?
Challenges include raw material shortages, fluctuating shipping costs, import tariffs, differing certification requirements, and potential geopolitical barriers.

5. Is it advisable to diversify Mannitol suppliers?
Yes. Diversification reduces dependency on a single source, mitigates supply disruptions, and enhances negotiating leverage. Proper qualification of multiple suppliers is crucial for compliance and quality assurance.

---

Sources:

[1] Merck KGaA. "Pharmaceutical Ingredients – Mannitol." Merck.com.
[2] Roquette Frères. "Pharmaceutical Excipients & Raw Materials." Roquette.com.
[3] SPI Pharma. "Sterile Mannitol Solutions – Product Portfolio." Spipharmaceuticals.com.
[4] Pharmacopoeial Standards (USP, EP, JP).
[5] Industry Reports on Excipient Market and Supply Chain Dynamics.