SORBITOL 3% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	SORBITOL 3% IN PLASTIC CONTAINER	sorbitol	SOLUTION;IRRIGATION	017863	NDA	Baxter Healthcare Corporation	0338-0295-47	3000 mL in 1 BAG (0338-0295-47)	1980-05-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 10, 2025

Introduction

Sorbitol, a sugar alcohol used extensively in pharmaceutical formulations, especially for ophthalmic and topical applications, is widely supplied across the globe. For formulations such as Sorbitol 3% in plastic containers, sourcing reliable suppliers that adhere to pharmaceutical-grade standards is critical for maintaining product quality, regulatory compliance, and supply chain stability. This report provides a comprehensive overview of key suppliers for Sorbitol 3%, emphasizing their production capacity, certifications, and reputation within the pharmaceutical industry.

Market Overview of Sorbitol Suppliers

Sorbitol, chemically known as D-glucitol, is produced through the hydrogenation of glucose derived from corn, wheat, or other carbohydrate sources. The global market for sorbitol is dominated by several large-scale producers operating under strict Good Manufacturing Practices (GMP). For pharmaceutical-grade sorbitol, suppliers must meet stringent quality standards, including USP, EP, or JP certification, depending on the market.

In particular, the formulation of Sorbitol 3% in plastic containers necessitates suppliers capable of providing high-purity, stable, and safe excipient-grade sorbitol suitable for contact with pharmaceuticals.

Major Suppliers of Sorbitol 3% in Pharmaceutical-Grade

1. Merck KGaA (Sigma-Aldrich)

Overview: A global leader in chemicals and pharmaceuticals, Merck supplies high-quality sorbitol products, including USP/EP grade suitable for pharmaceutical formulations.
Product Range: Offers sorbitol solutions in various concentrations, including 70% aqueous solutions, which can be diluted to 3% in final formulations.
Certifications: USP, EP, and ISO certifications ensure compliance.
Supply Capabilities: Global distribution network supports large-scale needs, with strict quality control measures.
Packaging: Provides sorbitol solutions in durable, pharmaceutical-grade plastic containers suitable for direct formulation.

2. Roquette Frères

Overview: A French multinational specializing in plant-based excipients and ingredients, Roquette provides pharmaceutical-grade sorbitol.
Product Range: Supplies sorbitol solutions, including formulations suitable for ophthalmic and topical applications.
Certifications: Meets various pharmacopoeial standards, adhering to FDA and EMA regulations.
Supply Capabilities: Large-scale manufacturing facilities with reliable supply chain logistics.
Packaging: Offers sorbitol in plastic bottles optimized for pharmaceutical use, ensuring stability and contamination prevention.

3. Cargill, Inc.

Overview: A major agribusiness company providing a broad spectrum of excipients, including sorbitol solutions.
Product Range: Offers USP/EP-grade sorbitol solutions, tailored for pharmaceutical manufacturing.
Certifications: Obtains strict GMP and pharmacopoeial compliance.
Supply Capabilities: Robust global supply infrastructure with flexible MOQ (minimum order quantities) options.
Packaging: Delivers in high-quality plastic containers designed for pharmaceutical applications.

4. SPI Pharma

Overview: Specializes in pharmaceutical excipients, including sorbitol solutions for various delivery forms.
Product Range: Offers sorbitol 70% solutions that can be diluted to desired concentrations.
Certifications: Compliant with USP, EP, and other international standards.
Supply Capabilities: Customizable packaging and reliable supply chain management.
Packaging: Provides pharmaceutical-grade plastic containers suitable for hospital and commercial use.

5. Finetech Industry Limited

Overview: A leading Asian supplier specializing in pharmaceutical excipients, including sorbitol.
Product Range: Offers sorbitol solutions in various concentrations, with an emphasis on quality.
Certifications: GMP, ISO, and pharmacopoeial standards compliance.
Supply Capabilities: Competitive pricing and flexible delivery options.
Packaging: Uses high-quality plastic bottles designed for pharmaceutical storage and use.

Regional Suppliers and Distributors

For small to medium-scale needs, regional distributors and local manufacturers may provide sorbitol solutions. These entities often import from global suppliers or produce locally under GMP standards. Examples include:

Bremer Industrie Vertriebs GmbH (Germany)
China-based excipient manufacturers such as Guangzhou Shuangge Pharmaceutical Co., Ltd.
India-based Indian Drugs & Pharmaceuticals Ltd. (IDPL)

These regional suppliers often cater to local pharmaceutical companies, offering faster lead times and possibly lower costs.

Key Considerations When Selecting Suppliers

Pharmacopoeial Compliance: Suppliers must provide sorbitol conforming to USP/EP/Japanese Pharmacopoeia standards.
Quality Certifications: Ensure ISO 9001, GMP, and other relevant certifications.
Packaging Standards: Compatibility with plastic containers, stability, and contamination control.
Delivery & Lead Time: Reliable global and regional logistics.
Customer Support: Technical support and documentation.

Conclusion

The procurement of Sorbitol 3% in plastic containers demands rigorous evaluation of suppliers' quality standards, regulatory compliance, and supply chain robustness. Leading global suppliers such as Merck KGaA, Roquette, and Cargill possess the necessary certifications, manufacturing capacity, and experience to meet pharmaceutical requirements. The decision should align with specific formulation, volume, and regulatory needs, ensuring a consistent and compliant supply chain.

Key Takeaways

Global Leaders: Merck KGaA, Roquette, and Cargill dominate the pharmaceutical-grade sorbitol supply market.
Quality Assurance: Prioritize suppliers with GMP, ISO certifications, and pharmacopoeial compliance.
Packaging Compatibility: Confirm container standards meet pharmaceutical contact regulations.
Supply Chain Reliability: Evaluate logistical capabilities and lead times for consistent procurement.
Regional Options: Local distributors can be viable alternatives for smaller volumes, with a focus on quality and compliance.

FAQs

1. What are the main regulatory standards for pharmaceutical-grade sorbitol?
Pharmaceutical-grade sorbitol must comply with pharmacopoeial standards such as USP (United States Pharmacopoeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). These ensure safety, purity, and quality suitable for human use [1].

2. Can sorbitol in plastic containers be used directly in pharmaceuticals?
Yes. When supplied in pharmaceutical-grade containers, sorbitol is suitable for direct incorporation into formulations, provided it meets specified pharmacopoeial standards and compatibility requirements.

3. What quality certifications should I confirm before sourcing sorbitol?
Ensure suppliers hold GMP certification, ISO 9001, and quality compliance documentation aligned with relevant pharmacopoeial standards (USP, EP, JP).

4. Are there regional suppliers of pharmaceutical-grade sorbitol?
Yes, regional suppliers in India, China, and Europe provide quality sorbitol solutions. Verify their certifications and laboratory testing results for compliance.

5. What are the typical packaging options for Sorbitol 3% in plastic containers?
Suppliers generally provide sorbitol in HDPE or PET bottles, sealed to prevent contamination, with volumes ranging from 100 mL to 5 liters, tailored for pharmaceutical use.

References

[1] United States Pharmacopoeia (USP). Sorbitol Monograph.
[2] European Pharmacopoeia (EP). Sorbitol Monograph.
[3] CPhI Reports on Pharmaceutical Excipient Suppliers.
[4] Merck KGaA Product Catalog, Pharmaceutical Supplies.
[5] Roquette Official Website. Pharmaceutical Excipients Overview.

Suppliers and packagers for SORBITOL 3% IN PLASTIC CONTAINER