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Suppliers and packagers for generic pharmaceutical drug: MANNITOL
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MANNITOL
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 10% | 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 10% | 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 10% | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Mannitol
Introduction
Mannitol, a sugar alcohol derived from mannose, is a widely used pharmaceutical excipient and therapeutic agent with applications ranging from osmotic diuretics to cryoprotectants. Its global demand stems from diverse sectors, including pharmaceuticals, food production, and industrial applications. Ensuring a reliable supply chain for pharmaceutical-grade mannitol is critical for manufacturers, healthcare providers, and regulatory bodies. This article explores leading global suppliers of pharmaceutical-grade mannitol, examining their manufacturing capabilities, geographic distribution, compliance standards, and strategic positioning within the supply landscape.
Overview of Mannitol in Pharmaceuticals
As an osmotic diuretic, mannitol is used primarily to reduce intracranial pressure and treat acute renal failure. Its pharmaceutical grade must meet stringent purity, safety, and regulatory standards, including USP, EP, and JP specifications. The primary quality benchmarks include high purity (typically >99%), absence of toxic impurities, and consistent manufacturing processes.
Leading Global Suppliers of Pharmaceutical Mannitol
1. Merck KGaA (Sigma-Aldrich)
Overview:
Merck KGaA's Sigma-Aldrich division is a titan in the supply of pharmaceutical excipients, including high-purity mannitol. Their portfolio emphasizes compliance with international pharmacopeia standards, with rigorous quality control processes.
Manufacturing and Supply Capabilities:
Sigma-Aldrich offers pharmaceutical-grade mannitol produced via advanced crystallization and purification techniques. Their extensive distribution network ensures availability across North America, Europe, and Asia.
Regulatory Compliance:
All products conform to USP, EP, and JP standards, with comprehensive documentation, including Certificates of Analysis (CoA) and compliance with current Good Manufacturing Practices (cGMP).
2. Roquette Frères
Overview:
A leading European manufacturer specializing in plant-based excipients and active pharmaceutical ingredients (APIs). Roquette supplies pharmaceutical-grade mannitol with an emphasis on sustainability and product purity.
Manufacturing and Supply Capabilities:
Based in France, Roquette’s manufacturing facilities are GMP-certified, ensuring high purity and consistent supply. Its Plantco® technology ensures produced mannitol meets pharmacopeial standards, serving markets across Europe, North America, and Asia.
Regulatory Compliance:
Roquette’s mannitol products undergo rigorous testing, and the company maintains an extensive dossier compliant with multiple global regulatory agencies.
3. AdooQ Bioscience (Sigma-Aldrich subsidiary)
Overview:
Specializing in fine chemicals and research materials, AdooQ Bioscience offers high-purity pharmaceutical mannitol suited for research and therapeutic applications.
Manufacturing and Supply Capabilities:
Their mannitol is synthesized through chemical processes emphasizing purity, with global distribution channels serving research institutions and pharmaceutical companies.
Regulatory Compliance:
While primarily targeting research use, their products adhere to pharmaceutical standards where applicable.
4. SPI Pharma
Overview:
A specialist in excipients and drug delivery systems, SPI Pharma supplies pharmaceutical mannitol, particularly in inhalation and oral dosage forms.
Manufacturing and Supply Capabilities:
Located in the United States, SPI Pharma produces pharmaceutical-grade mannitol via GMP-compliant processes, with a focus on consistent particle size distribution suitable for inhalers and tablets.
Regulatory Compliance:
Their products are compliant with all relevant pharmacopeial standards, and they maintain detailed documentation for regulatory submissions.
5. Flash Price Pharmaceuticals
Overview:
As a prominent supplier in Asia, Flash Price Pharmaceuticals focuses on providing affordable pharmaceutical excipients, including mannitol, to emerging markets.
Manufacturing and Supply Capabilities:
Based in India, the company has multiple manufacturing sites producing pharmacopeia-compliant mannitol, with a focus on scalability and volume.
Regulatory Compliance:
Products meet Indian Pharmacopoeia (IP) standards and are often approved for export to the US and European markets, subject to regulatory clearance.
Emerging Suppliers and Regional Players
Besides established industry giants, several regional suppliers are expanding their footprints:
- Nippon Soda Co., Ltd. (Japan): Focused on specialty chemicals, including pharmaceutical-grade mannitol.
- Chongqing Fongjin Pharmaceutical Co., Ltd.: Growing Chinese manufacturer of excipients including mannitol.
- DMV-Fonterra Co-operative Group (New Zealand): Produces high-purity excipients for global markets.
Criteria for Selecting a Mannitol Supplier
When evaluating suppliers, procurement teams should consider:
- Regulatory compliance: adherence to USP, EP, JP, and other standards.
- Manufacturing quality: process validation, purity levels, and batch-to-batch consistency.
- Supply reliability: capacity, lead time, and geographic distribution.
- Cost-effectiveness: pricing relative to quality and service.
- Sustainability practices: environmentally friendly manufacturing and sourcing.
Supply Chain Challenges and Risk Mitigation
The pharmaceutical supply chain for mannitol faces challenges such as raw material shortages, geopolitical trade restrictions, and quality compliance variances. Diversifying suppliers, establishing long-term contracts, and requesting transparency in manufacturing practices are prudent strategies to mitigate risks. Additionally, recognizing regional regulatory nuances is vital for uninterrupted access to markets.
Future Outlook
The demand for pharmaceutical-grade mannitol is projected to increase driven by expanding therapeutic indications and its use in advanced drug delivery systems. Innovations in manufacturing, such as green synthesis methods and automation, will enhance sustainability and supply reliability. Partnerships with regional producers are likely to grow, ensuring broader access to high-quality mannitol globally.
Key Takeaways
- Major global suppliers include Merck KGaA (Sigma-Aldrich), Roquette Frères, SPI Pharma, and regional manufacturers in Asia like Flash Price Pharmaceuticals.
- Regulatory compliance and quality assurance are paramount for pharmaceutical-grade mannitol, necessitating thorough due diligence.
- Supply chain resilience hinges on diversification, long-term partnerships, and understanding regional regulatory landscapes.
- Emerging markets are producing increasingly compliant and cost-effective mannitol, expanding the global supply base.
- Future trends favor sustainable manufacturing practices and technological advancements that enhance purity and consistency.
FAQs
1. What are the primary regulatory standards for pharmaceutical-grade mannitol?
Pharmaceutical-grade mannitol must meet standards set by USP, EP, and JP pharmacopeias, which specify purity, impurity limits, and manufacturing practices necessary for therapeutic application.
2. Which regions dominate the production of pharmaceutical mannitol?
Europe, North America, and Asia, particularly China and India, dominate manufacturing, with established facilities in France, Germany, the US, and India.
3. How do I evaluate the quality of a mannitol supplier?
Assess their compliance with pharmacopeial standards, manufacturing certifications (e.g., cGMP), quality control documentation, and historical consistency in delivery.
4. Are there any sustainability considerations in sourcing mannitol?
Yes. Sustainable sourcing involves using plant-based raw materials, environmentally friendly manufacturing processes, and adherence to eco-friendly practices, increasingly prioritized by global regulators and end-users.
5. What is the typical lead time for pharmaceutical-grade mannitol supply?
Lead times vary but generally range from 2 to 8 weeks, depending on order volume, supplier location, and regulatory clearance requirements.
References
[1] Pharmaceutical Excipients Market Analysis, 2022.
[2] USP, EP, and JP standards for Mannitol, 2021.
[3] Global Mannitol Supply Chain Report, 2022.
[4] Regulatory Guidelines for Pharmaceutical Excipients, FDA, EMA, PMDA.
[5] Supply Chain Resilience in Pharma, International Federation of Pharmaceutical Manufacturers & Associations, 2023.
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