Suppliers and packagers for generic pharmaceutical drug: SORBITOL

SORBITOL

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

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

Suppliers for the Pharmaceutical Drug: Sorbitol

Last updated: August 1, 2025

Introduction

Sorbitol, a sugar alcohol derived from glucose, is a key ingredient in the pharmaceutical and nutraceutical industries. Its applications range from excipients in tablets to sweeteners in syrups and chewables. The demand for sorbitol has surged with a growing focus on oral healthcare, diabetic-friendly products, and oral care formulations. Ensuring reliable sourcing of pharmaceutical-grade sorbitol is critical for manufacturers and healthcare providers alike. This analysis explores the global suppliers of pharmaceutical-grade sorbitol, their production capacities, quality standards, and market dynamics.

Global Market Overview of Sorbitol

The worldwide sorbitol market is projected to reach approximately USD 2.5 billion by 2027, with a compound annual growth rate (CAGR) of around 4.5% (source: MarketsandMarkets). The pharmaceutical sector constitutes a significant segment, driven by increasing demand in OTC products, oral care, and health supplements. Key manufacturing regions include China, Europe, North America, and India, with China being the dominant producer due to large-scale carbohydrate processing industries.

Major Suppliers of Pharmaceutical-Grade Sorbitol

1. Roquette Frères

Headquarters: France
Overview: Roquette is a leading global manufacturer of pharmaceutical excipients, including sorbitol. Their pharmaceutical-grade sorbitol meets USP, EP, and FCC standards.
Capabilities: The company offers both sorbitol syrup and crystalline products with high purity (>99%), ensuring suitability for parenteral use and oral formulations. Roquette emphasizes product consistency, regulatory compliance, and supply reliability.
Market Position: Roquette’s extensive R&D and manufacturing infrastructure enable it to serve global pharmaceutical companies. Their products are supplied across North America, Europe, and Asia.

2. SPI Pharma (part of Kerry Group)

Headquarters: United States
Overview: SPI Pharma is a recognized supplier of pharmaceutical excipients, including sorbitol, with a focus on high-quality, pharmaceutical-certified products.
Capabilities: Offers sorbitol solutions and powders meeting USP, EP, and JP standards. Their sorbitol is extensively used in chewable tablets, syrups, and topical formulations. They emphasize on batch-to-batch consistency and purity.
Market Position: SPI Pharma’s global distribution network and focus on regulatory compliance make it a preferred supplier for pharmaceutical manufacturers.

3. Cargill, Inc.

Headquarters: United States
Overview: Cargill produces various food and pharmaceutical grade sorbitol, incorporating strict quality controls to satisfy pharmaceutical standards.
Capabilities: Supplies high-purity sorbitol syrups used in medicated confectionery and oral care products. Their manufacturing facilities in North America and Asia enable broad market reach.
Market Position: Cargill’s integrated supply chain ensures reliable delivery and competitive pricing.

4. Merck KGaA (EMD Millipore)

Headquarters: Germany
Overview: Merck supplies a range of pharmaceutical excipients, including sorbitol, with adherence to pharmacopeial standards.
Capabilities: Their sorbitol products are used in minimally invasive pharmaceuticals, oral formulations, and dental products. The company emphasizes strict quality and regulatory adherence.
Market Position: Merck’s extensive global distribution and reputation for quality support its leadership position.

5. Ingredion Incorporated

Headquarters: United States
Overview: Ingredion offers sorbitol solutions suitable for pharmaceutical and food applications, with quality certifications aligned with international standards.
Capabilities: Their sorbitol is available as syrup, granular, or crystalline, tailored for pharmaceutical use.
Market Position: Ingredion’s innovation focus and large-scale production underpin its global supply security.

6. Finorit (China)

Headquarters: China
Overview: Finorit is a key regional player, producing pharmaceutical-grade sorbitol primarily for the Asian market.
Capabilities: The company supplies high-purity sorbitol meeting USP and EP standards, with cost-effective manufacturing.
Market Position: As a prominent Chinese supplier, Finorit serves local and export markets, supported by stringent quality controls.

Quality Standards and Regulatory Compliance

Pharmaceutical-grade sorbitol must adhere to rigorous standards, such as USP, EP, JP, and FCC. These standards specify purity (>99%), low residual water, and minimal impurities to ensure safety and efficacy. Suppliers must provide Certificates of Analysis (CoA), stability data, and compliance documentation. Suppliers like Roquette and Cargill demonstrate robust quality assurance, facilitating smooth regulatory approvals globally.

Supply Chain Dynamics and Considerations

The sorbitol supply chain is influenced by factors such as raw material availability, regional production capacities, and geopolitical considerations. China dominates global production, but supply disruptions—due to policies, environmental constraints, or pandemics—can impact availability. Diversification of suppliers aids in mitigating risks. Cold chain logistics are also critical, especially for sensitive formulations.

Emerging trends include sustainable sourcing and improved extraction technologies, which aim to reduce environmental impact and enhance purity. Suppliers investing in green manufacturing processes are likely to gain a competitive edge.

Market Trends Affecting Supplier Selection

• Increased Regulation & Quality Assurance: Stringent regulatory requirements compel pharmaceutical companies to select suppliers with proven compliance records.
• Innovation & Product Differentiation: Suppliers offering specialized grades, such as ultra-pure sorbitol, enable product differentiation.
• Global Supply Chain Stability: The COVID-19 pandemic highlighted vulnerabilities; thus, resilient supplier networks are critical.
• Sustainability: Green manufacturing practices influence procurement decisions, favoring suppliers with eco-friendly policies.

Conclusion

The procurement of pharmaceutical-grade sorbitol entails evaluating suppliers based on quality, capacity, compliance, and supply stability. Leading global players such as Roquette, SPI Pharma, and Cargill offer dependable sources, supported by extensive regulatory adherence and advanced manufacturing processes. Regional suppliers like Finorit expand the available options, especially for Asian markets. As demand for sorbitol grows in medicinal, oral care, and dietary sectors, supply chain resilience and sustainable practices will become increasingly vital in supplier selection.

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Key Takeaways

• Reliable sourcing from established global suppliers ensures product quality and regulatory compliance.
• Diversification across regional suppliers mitigates supply disruptions.
• Environmental sustainability and green manufacturing practices are influencing procurement decisions.
• Supplier capabilities must align with specific pharmaceutical applications, emphasizing purity and consistency.
• Keeping abreast of geopolitical developments and regulatory updates is critical for supply chain stability.

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FAQs

1. What are the main regulatory standards that pharmaceutical-grade sorbitol must meet?
Pharmaceutical sorbitol must comply with standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and Food Chemical Codex (FCC), which specify purity levels, residual impurities, and manufacturing practices.

2. Which regions dominate the production of pharmaceutical sorbitol?
China leads global production due to its extensive carbohydrate processing industry. Other significant regions include North America, Europe (notably France and Germany), and India.

3. How does supplier selection impact pharmaceutical product safety?
Selecting suppliers with stringent quality controls, regulatory certifications, and transparent documentation minimizes contamination risks and ensures patient safety.

4. Are regional suppliers a viable alternative to global corporations?
Yes, regional suppliers such as Finorit in China often offer cost advantages and tailored logistics solutions, but must meet the same strict quality standards and regulatory compliance to serve pharmaceutical applications.

5. What future trends are influencing the sorbitol supply chain?
Growing emphasis on sustainability, advancements in green extraction technologies, and supply chain diversification are shaping the future, alongside increasing regulatory scrutiny and market demand.