Bulk Pharmaceutical API Sources for MANNITOL 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MANNITOL 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HctF@@IaWTfYn~jjj`@@
ZINC		ZINC02041302
Sigma-Aldrich		15719_RIEDEL
Sigma-Aldrich		17781_FLUKA
Sigma-Aldrich		33440_RIEDEL
Sigma-Aldrich		63559_FLUKA

Bulk Active Pharmaceutical Ingredient (API) Sources for Mannitol 5% in Plastic Container

Last updated: August 8, 2025

Introduction

Mannitol, a sugar alcohol, is widely used in pharmaceutical applications, notably as an osmotic diuretic and excipient in formulations such as Mannitol 5% in plastic containers. The demand for high-quality Mannitol API hinges on reliable sourcing from globally recognized manufacturers adhering to stringent quality standards, regulatory compliance, and consistent supply chains. This report evaluates the key sources of Mannitol API tailored to injectable and suitable formulations stored in plastic containers, emphasizing suppliers' capabilities, geographical distribution, and industry reputation.

Overview of Mannitol API and Its Pharmaceutical Use

Mannitol functions predominantly as an osmotic diuretic to reduce intracranial and intraocular pressure and as a stabilizer and diluent in various pharmaceutical preparations. The purity, stability, and compliance with pharmacopeial standards (such as USP, EP, or JP) form critical parameters for API suppliers. For injectable Mannitol (5%), the API must conform to stringent sterility and endotoxin limits, demanding suppliers with validated manufacturing processes and robust Quality Control (QC).

Global API Suppliers for Mannitol 5%

1. Major Manufacturers in India

India is a leading producer of Mannitol API, with prominent companies recognized for their stringent quality standards and cost competitiveness.

a. Roquette India Pvt Ltd

• Overview: A subsidiary of Roquette Frères, France, specializing in pharmaceutical excipients. Roquette supplies high-purity Mannitol, complying with USP and EP standards.
• Capabilities: Manufacturing in GMP-compliant facilities with extensive stability and sterility testing for injectable-grade Mannitol.
• Supply Chain: Reliable, backed by global distribution channels.

b. Finetech Biotech Pvt Ltd

• Overview: An India-based API manufacturer with a focus on pharmaceutical excipients, including Mannitol.
• Standards: Offers API meeting USP, EP, and BP monographs with validated processes.
• Availability: Suitable for both bulk and adapted formulations, including sterile grades.

c. D D Pharmaceutical Ltd

• Overview: Established manufacturer with a focus on excipients and APIs such as Mannitol.
• Certifications: GMP, ISO, and other international standards ensuring compliance for injectable APIs.
• Advantages: Cost-effective, high-volume production capacity.

2. Chinese API Manufacturers

China remains a significant source of Mannitol API, leveraging scale and cost advantages.

a. Hebei Xinbai Biotechnology Co., Ltd

• Overview: Specializes in pharmaceutical excipients like Mannitol, adhering to ISO and GMP standards.
• Certifications: Compliance with cGMP, CN-GMP, and international pharmacopoeias.
• Product Range: Offers various grades suitable for injections, including sterile Mannitol.

b. Jinan Chengbang Pharmaceutical Co., Ltd

• Overview: Produces high-quality Mannitol API with formulations suitable for medical use.
• Quality Assurance: Emphasizes purity, endotoxin testing, and sterility requirements for injectable applications.

3. European and North American API Producers

European and North American companies supply premium-grade Mannitol API, emphasizing rigorous quality systems.

a. Roquette (France/Global)

• Overview: A leading global excipient manufacturer with a longstanding reputation for quality and regulatory compliance.
• API Quality: Ensures high-purity Mannitol suitable for parenteral applications; provides documentation supporting GMP and regulatory compliance.

b. SPI Pharma Inc. (United States)

• Overview: Offers pharmaceutical-grade Mannitol with comprehensive guarantees regarding endotoxin levels and sterility for injectable use.
• Standards: Meets USP, EP, JP, and other global standards for pharmaceutical ingredients.

Criteria for Selecting API Suppliers for Mannitol 5% in Plastic Containers

Quality Standards and Regulatory Compliance

• Suppliers must demonstrate compliance with pharmacopoeial standards (USP, EP, JP), especially for injectable formulations.
• Certification of Good Manufacturing Practice (GMP) is essential.
• Comprehensive QC testing for purity, residual solvents, endotoxin levels, microbiological contamination, and sterility.

Manufacturing Capacity and Lead Time

• Adequate capacity to meet continuous supply demands.
• Proven track record of timely deliveries critical for injection-based formulations.

Traceability and Documentation

• Reliable lot traceability, Certificates of Analysis (CoA), and Regulatory Compliance documentation.
• Support for regulatory submissions, including DMFs (Drug Master Files).

Cost and Contract Flexibility

• Competitive pricing aligned with quality standards.
• Flexibility in order quantities and lead times.

Sustainability and Ethical Standards

• Adherence to environmental regulations.
• Ethical sourcing and corporate social responsibility policies.

Regulatory Considerations and Quality Certification

Sourcing Mannitol API for injectable formulations necessitates compliance with international pharmacopoeial standards and regulatory agencies such as the U.S. FDA, EMA, and PMDA. Suppliers should furnish detailed documentation, including stability data, validation reports, endotoxin testing procedures, and microbial limits. Additionally, for products in plastic containers, compatibility testing and container-closure integrity documentation are necessary.

Emerging Trends and Future Outlook

The global pharmaceutical market's emphasis on sourcing high-quality, validated APIs continues to grow, especially for injectables requiring sterile Mannitol. Manufacturers investing in advanced purification, sterile filling capabilities, and accelerated compliance with evolving standards stand to maintain competitive advantages. As Pareto solutions for global supply chains improve, a diversification of sourcing options is emerging, reducing dependency on specific regions and enhancing supply resilience.

Conclusion

Securing reliable sources of Mannitol 5% API for plastic container formulations relies on evaluating multiple factors: quality assurance, regulatory compliance, manufacturing capacity, and supply stability. Leading manufacturers such as Roquette (France/India), Finetech Biotech (India), Hebei Xinbai (China), and SPI Pharma (USA) present robust options, each with unique strengths. Due diligence, including verification of certification, quality control protocols, and supply chain reliability, remains paramount. Strategic partnerships with established API suppliers enable pharmaceutical companies to uphold product integrity, regulatory compliance, and uninterrupted supply.

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Key Takeaways

• Indian, Chinese, European, and North American manufacturers are primary sources, with varying degrees of cost, quality, and regulatory compliance.
• Trustworthy vendors must demonstrate adherence to GMP and pharmacopoeial standards suitable for injectable APIs in plastic containers.
• Robust documentation, including CoA, stability data, endotoxin levels, and sterility assurance, is essential for regulatory approval.
• Diversifying suppliers mitigates risks associated with geopolitical, logistical, and quality issues.
• Ongoing innovation in manufacturing processes and stricter regulatory standards favor experienced, certified API producers.

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FAQs

1. What are the critical quality parameters for Mannitol API intended for injections?
Key parameters include purity (>99%), endotoxin levels, microbiological safety, sterility, residual solvent residues, and proper stability profiles compatible with plastic containers.

2. How does API source impact the quality and regulatory approval of Mannitol 5% injections?
Sourcing from certified, GMP-compliant manufacturers ensures consistent quality, facilitates regulatory approval, and minimizes risks of contamination or stability issues.

3. Can Mannitol API from China be considered reliable for pharmaceutical injections?
Yes. Several Chinese manufacturers are certified and compliant with international standards (GMP, ISO). Due diligence involving audits and documentation review is essential.

4. What role do certifications like USP and EP play in sourcing Mannitol API?
These pharmacopoeial standards define the quality benchmarks for pharmaceutical APIs; suppliers meeting these are preferred for injectable formulations to ensure compliance and patient safety.

5. Are there advantages to choosing global suppliers like Roquette over regional manufacturers?
Global suppliers like Roquette offer extensive validation, consistent quality, regulatory support, and robust supply chains. Regional manufacturers may offer cost benefits but require thorough validation of standards and compliance.

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Sources

1. USP–NF. United States Pharmacopeia–The National Formulary. USP Convention.
2. European Pharmacopoeia. European Directorate for the Quality of Medicines & HealthCare (EDQM).
3. Jinan Chengbang Pharmaceutical Co., Ltd. Official Website.
4. Hebei Xinbai Biotechnology Co., Ltd. Product Information.
5. Roquette Corporate Website and API Quality Documentation.