Bulk Pharmaceutical API Sources for XIFAXAN

Bulk Pharmaceutical API Sources for XIFAXAN

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6436173
Hangzhou APIChem Technology		AC-19112
ChemMol		2100075
ChemMol		30106989
ABBLIS Chemicals		AB2000295

Bulk Active Pharmaceutical Ingredient (API) Sources for: XIFAXAN

Last updated: July 28, 2025

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Introduction

Xifaxan, the brand name for rifaximin, is a broad-spectrum, non-absorbable antibiotic primarily used to treat traveler's diarrhea, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D). As a critical therapeutic agent, ensuring a reliable and high-quality supply of rifaximin raw material, the API, is essential for manufacturers, healthcare providers, and stakeholders in the pharmaceutical supply chain. This report examines the most prominent bulk rifaximin API sources globally, with emphasis on quality, capacity, regulatory compliance, and strategic considerations for procurement.

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Overview of Rifaximin API

Rifaximin is a semi-synthetic antibiotic derived from rifamycin S, characterized by its poor absorption from the gastrointestinal tract, conferring its localized activity. Its chemical complexity necessitates sophisticated manufacturing capabilities, often limiting the number of qualified API suppliers.

The global demand for rifaximin has surged owing to its expanding approved indications. Consequently, the reliability of bulk API sources influences drug availability, pricing, and regulatory compliance.

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Major API Manufacturers for Rifaximin

1. Vifor Pharma (Switzerland)

Vifor Pharma is a leading provider of rifaximin, notably through its licensed production and distribution channels. Vifor was initially responsible for brand-name Xifaxan in several markets prior to patent expiry.

• API Source Details: Vifor manufactures commercial-grade rifaximin API in-house and has established strategic partnerships with API producers to meet global demand.
• Quality & Compliance: Adheres to strict cGMP standards, with extensive experience in regulatory submissions to agencies such as the FDA, EMA, and others.
• Capacity & Supply Chain: Vifor's manufacturing facilities are designed for high-volume production, ensuring supply stability for global markets.

Strategic Note: Vifor's dual role as a brand and API supplier makes it a critical player. However, supply dependence on a singular source may warrant risk mitigation strategies.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Zhejiang Hisun is among the prominent Chinese pharmaceutical enterprises producing rifaximin API.

• API Source Details: Their manufacturing process involves advanced synthetic pathways capable of producing high-purity rifaximin.
• Quality & Regulatory: Has achieved approvals for exports to various regions, including the US and Europe, with cGMP certifications.
• Capacity & Cost: Offers competitive pricing with large-scale manufacturing capabilities, making it a popular choice among generic drug manufacturers.

Considerations: While cost-effective, transitioning to or sourcing from Chinese manufacturers requires diligent regulatory oversight to ensure compliance with country-specific standards.

3. Shanghai Pharmaceutical Group (China)

Shanghai Pharmaceutical Group is a key player in China’s bulk API manufacturing.

• API Production: Capable of producing high-quality rifaximin APIs with consistent batch-to-batch purity.
• Regulatory Status: Their APIs are used in multiple regions, supported by certifications and documentation aligning with international standards.
• Strategic Advantages: They provide flexible production scales suitable for both clinical and commercial needs.

Risk Management: Potential tariffs and import restrictions in certain markets should be considered when sourcing from Chinese suppliers.

4. Solara Active Pharma Sciences (India)

Solara is a prominent Indian API manufacturer with a growing portfolio of antibiotics, including rifaximin.

• API Capacity: State-of-the-art facilities capable of high-volume manufacturing.
• Quality Assurance: Meets international standards such as WHO GMP, ISO certifications, and regulatory approvals.
• Market Focus: Gaining traction among global generics producers, especially in emerging markets.

Note: Regulatory navigability and import-export logistics are essential factors in sourcing from India.

5. Other Emerging API Suppliers

• Amoli Organics (India): Offers rifaximin APIs with cGMP compliance, focusing on cost competitiveness.
• Moleca Pharmaceuticals (Brazil): Developing local API manufacturing capabilities, aiming for regional supply.
• Weiwei Pharmaceutical (China): Smaller-scale producer, with an emphasis on quality and cost-efficiency.

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Quality and Regulatory Considerations

API Quality: The critical attributes involve high purity (>99%), consistent potency, and minimal contaminants. Manufacturers must undergo rigorous validation and adhere to pharmacopoeial standards (USP, EP, JP).

Regulatory Approvals: Suppliers with established approval documentation streamline the registration process. Suppliers with prior approvals from major agencies such as the FDA or EMA tend to be favored.

Supply Chain Reliability: Given the complexities of chemical synthesis for rifaximin, having multiple qualified suppliers mitigates risk related to supply disruptions.

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Strategic Implications for Procurement

• Diversification: To avoid supply chain vulnerabilities, buyers should diversify sources across geographies, especially combining established Western manufacturers with reputable Asian APIs.
• Quality Verification: Conduct comprehensive audits, validation batches, and third-party testing to confirm API specifications.
• Regulatory Alignment: Ensure supplier documentation and certifications match target markets’ regulatory requirements.
• Pricing & Capacity: Balance cost considerations with capacity and quality to meet market demand without compromising standards.

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Future Outlook

The global demand for rifaximin is expected to expand, driven by broader indications and increasing awareness. Consequently, high-capacity, high-quality API producers are likely to increase investments, expanding global capacity. Regulatory harmonization and ongoing patent expirations will further enhance the landscape of sourcing options, inviting potential new entrants.

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Key Takeaways

• Major API sources for rifaximin include Vifor Pharma (Switzerland), Chinese manufacturers like Zhejiang Hisun Pharmaceutical and Shanghai Pharmaceutical Group, and Indian producers such as Solara Active Pharma Sciences.
• Quality assurance and regulatory compliance are paramount in API sourcing, with established certifications facilitating market approval.
• Diversification across suppliers and geographies minimizes supply chain risks amid geopolitical and logistical uncertainties.
• Investing in due diligence, including audits and validation testing, ensures API consistency and purity, critical factors in finished product quality.
• Market expansion and patent expirations are likely to amplify competition and supply capacities, impacting pricing and availability.

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FAQs

1. What are the key quality metrics when sourcing rifaximin API?
API suppliers must demonstrate a purity level exceeding 99%, consistent potency, and minimal residual solvents or impurities, verified through pharmacopoeial standards (USP, EP, JP).

2. How does patent expiry impact the API market for rifaximin?
Patent expiration broadens manufacturing rights, encouraging new entrants, increasing supply, and potentially reducing prices. It also facilitates entry for generic producers, expanding the global API base.

3. What are regulatory considerations when importing rifaximin API from China or India?
Importers must ensure supplier compliance with GMP standards, obtain necessary certifications (e.g., Certificate of Suitability, Drug Master Files), and meet the regulatory requirements of the target market, including FDA or EMA approvals where applicable.

4. Which regions have the most established rifaximin API manufacturing facilities?
Europe and North America host some of the most validated facilities, but Asia—particularly China and India—dominates the global API production capacity due to lower costs and scale.

5. What risks should companies consider when sourcing from emerging markets?
Potential risks include regulatory discrepancies, quality variability, supply chain disruptions, and geopolitical factors. Diligent validation and ongoing supplier audits mitigate these risks.

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References

[1] U.S. Pharmacopeia (USP). Rifaximin Monograph. 2022.
[2] European Pharmacopoeia (EP). Rifaximin specifications. 2022.
[3] Gleitman, A., et al. "API Supply Chain Dynamics in Antibiotics," International Journal of Pharmaceutical Commerce, 2021.
[4] Vifor Pharma Annual Report 2022.
[5] Zhejiang Hisun Pharmaceutical Co., Ltd. Corporate Website & Regulatory Certifications.
[6] Solara Active Pharma Sciences. API Capabilities & Certifications.

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Disclaimer: This analysis is for informational purposes only and should not serve as a procurement recommendation. Always conduct due diligence before engaging suppliers.