Bulk Pharmaceutical API Sources for SORBITOL 3.3% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for SORBITOL 3.3% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		47841_SUPELCO
Sigma-Aldrich		S0900_SIGMA
Sigma-Aldrich		S1876_SIGMA
Sigma-Aldrich		S3889_SIGMA
Sigma-Aldrich		S6021_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for Sorbitol 3.3% in Plastic Container

Last updated: August 12, 2025

Introduction

Sorbitol, a sugar alcohol derived from glucose, is widely used in pharmaceutical formulations as a humectant, stabilizer, and excipient. Specifically, Sorbitol at a 3.3% concentration in plastic containers is a common formulation component in oral and topical pharmaceuticals, as well as in dental care products like mouthwashes and toothpaste. The sourcing of high-quality bulk active pharmaceutical ingredients (APIs) like Sorbitol is critical for pharmaceutical manufacturers aiming for safety, consistency, and regulatory compliance.

This analysis evaluates key suppliers worldwide, focusing on their reliability, quality standards, regulatory compliance, and market positioning for supplying Sorbitol at 3.3% concentration in plastic containers.

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Regulatory and Quality Standards for API Suppliers

Sorbitol APIs intended for pharmaceutical use must meet stringent standards, including:

• Quality Certifications: cGMP (current Good Manufacturing Practice) compliance is essential.
• Regulatory Approvals: Approved by agencies such as the FDA (USA), EMA (Europe), PMDA (Japan), and corresponding local authorities.
• Pharmacopoeia Compliance: Fulfills specifications outlined in USP, EP, BP, or JP pharmacopoeias.
• Verification of Purity: Typically > 99% purity, with low levels of sorbitol impurities and contaminants.
• ISO Certification: ISO 9001, ISO 22000, and other relevant certifications affirm quality management systems.

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Major Suppliers of Sorbitol API

1. Cargill, Inc.

Overview:
Cargill is a leading global supplier with a comprehensive portfolio of pharmaceutical-grade Sorbitol, approved for oral, topical, and parenteral applications.

Supply Capabilities:

• Manufactures pharmaceutical-grade Sorbitol (both crystalline and liquid forms).
• Flexible packaging options including plastic containers suitable for pharmaceutical use.
• Extensive distribution network across North America, Europe, and Asia.

Quality & Compliance:

• cGMP-certified manufacturing plants.
• Pharmacopoeia-compliant products.
• Regular audits and stringent quality control processes.

Market Position:
Cargill’s reputation in the pharmaceutical sector stems from consistent quality, product availability, and robust regulatory compliance.

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2. Roquette Frères

Overview:
Roquette is an established European API supplier known for its high-quality Sorbitol products serving the pharmaceutical industry.

Supply Capabilities:

• Offers pharmaceutical-grade Sorbitol with various specifications, including suitable for liquid formulations.
• Bottled and bulk packaging options, including plastic containers for direct-to-consumer packaging.

Quality & Compliance:

• GMP-certified manufacturing facilities.
• Certified according to USP and EP standards.
• Emphasizes product purity and traceability.

Market Position:
Strong presence in Europe and Asia, with a focus on innovation and quality assurance.

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3. Merck KGaA (Sigma-Aldrich / MilliporeSigma)

Overview:
As a leading life sciences and API supplier, Merck offers pharmaceutical-grade Sorbitol suitable for both research and manufacturing purposes.

Supply Capabilities:

• Provides pharmaceutical-grade Sorbitol in bulk quantities, supplied in suitable packaging including plastic bottles and drums.
• Tailored for formulations requiring specific concentrations, including 3.3%.

Quality & Compliance:

• Meets USP, EP, and other pharmacopoeia standards.
• cGMP manufacturing standards.
• Batch testing, purity assurance, and documentation.

Market Position:
Widely trusted for consistent quality, regulatory support, and global logistical capabilities.

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4. Cerestar (Part of IOI Group)

Overview:
Cerestar, a division of IOI Group, supplies Sorbitol APIs with extensive regulatory and quality certifications.

Supply Capabilities:

• Offers pharmaceutical-grade Sorbitol in various physical forms.
• Supports containerized packaging options ensuring stability and quality.

Quality & Compliance:

• GMP compliance and adherence to pharmacopoeia standards.
• Robust quality assurance programs.

Market Position:
Advantageous for Asian markets and exporters seeking reliable bulk API sources.

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5. Jungbunzlauer

Overview:
Jungbunzlauer, a reputable Swiss producer, supplies high-purity Sorbitol APIs globally.

Supply Capabilities:

• Provides pharmaceutical-grade Sorbitol for oral and topical pharmaceuticals.
• Adequate packaging options, including plastics suitable for pharmaceutical storage.

Quality & Compliance:

• Certified according to GMP, ISO, and pharmacopoeia standards.
• Focus on sustainability and product consistency.

Market Position:
Known for premium quality, environmental consciousness, and strong European presence.

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Emerging and Regional API Suppliers

While global giants dominate, regional suppliers in India, China, and Southeast Asia offer cost-effective alternatives, provided they meet international standards:

• Shandong Lianwo Biotech Co., Ltd. (China): Focuses on pharmaceutical-grade Sorbitol with exports worldwide.
• Shreeji Chemicals (India): Offers Sorbitol APIs aligned with international standards and customized packaging.

Quality assurance and regulatory compliance are critical when sourcing from regional suppliers.

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Key Considerations When Selecting Sorbitol API Suppliers

• Regulatory Accreditation: Confirm cGMP compliance, and certification by relevant authorities.
• Quality Certifications: Ensure product specifications align with pharmacopeial standards.
• Supply Reliability: Evaluate supplier capacity, lead times, and logistical support.
• Packaging Options: Confirm availability of suitable packaging like plastic containers that prevent contamination and degradation.
• Customer Support: Assess technical support, documentation, and post-sales services.

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Conclusion

High-quality bulk sources of Sorbitol 3.3% in plastic containers are available from leading global API suppliers such as Cargill, Roquette, Merck KGaA, Cerestar, and Jungbunzlauer. These firms offer regulatory-compliant products with consistent quality, essential for pharmaceutical and consumer health applications.

Choosing the right supplier hinges on compliance, reliability, and support, especially considering the stringent nature of pharmaceutical manufacturing. Contracting established suppliers with robust quality systems mitigates risk and ensures product integrity in formulations.

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Key Takeaways

• Prioritize cGMP-certificated suppliers with proven compliance to international pharmacopoeia standards for pharmaceutical-grade Sorbitol.
• Assess supply chain reliability and manufacturing capacity, especially for bulk orders in plastic containers.
• Verify packaging options to ensure long-term stability and contamination prevention for Sorbitol APIs.
• Consider regional suppliers only if they meet or exceed international quality benchmarks, supported by documentation and certifications.
• Stay informed of regulatory developments to adapt supplier choices to evolving compliance standards.

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FAQs

1. What are the primary regulatory standards for pharmaceutical Sorbitol APIs?
Pharmaceutical-grade Sorbitol APIs typically must comply with USP, EP, BP, or JP pharmacopoeia standards, along with cGMP guidelines set by regulatory agencies like the FDA or EMA.

2. Can Sorbitol 3.3% in plastic containers be used directly in pharmaceuticals?
Yes, provided the API meets all necessary quality, purity, and stability standards and is approved for pharmaceutical use by relevant regulators.

3. How important is packaging in sourcing Sorbitol APIs?
Packaging is crucial to maintain API stability, prevent contamination, and ensure integrity during storage and transportation. Plastic containers should be inert and compliant with pharmaceutical standards.

4. Are regional suppliers reliable for sourcing Sorbitol API?
Regional suppliers can be reliable if they possess necessary certifications, quality controls, and have a track record of regulatory compliance, but due diligence is essential.

5. How do I verify the quality of Sorbitol API from a new supplier?
Request comprehensive documentation, including Certificates of Analysis (CoA), GMP certificates, regulatory approvals, and conduct independent testing if necessary before large-scale procurement.

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Sources:

[1] Cargill Pharmaceutical Solutions. Product Information and Quality Standards.
[2] Roquette Frères. Pharmaceutical Grade Sorbitol Specifications.
[3] Sigma-Aldrich (Merck KGaA). API Specifications for Sorbitol.
[4] Jungbunzlauer. Quality Certification and GMP Compliance.
[5] International Pharmacopoeia Standards and Regulatory Guidelines.