Bulk Pharmaceutical API Sources for RESTASIS MULTIDOSE

Bulk Pharmaceutical API Sources for RESTASIS MULTIDOSE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C3662_SIGMA
Sigma-Aldrich		C1832_SIGMA
Sigma-Aldrich		30024_SIGMA
Molport		MolPort-006-705-994
TCI (Tokyo Chemical Industry)		C2408

Bulk Active Pharmaceutical Ingredient (API) Sources for: RESTASIS MULTIDOSE

Last updated: November 13, 2025

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Introduction

Restasis Multi-Dose, developed by AbbVie, is a leading ophthalmic solution indicated for increasing tear production in patients with dry eye disease. The active pharmaceutical ingredient (API) in Restasis Multi-Dose is cyclosporine A, a potent immunosuppressant with anti-inflammatory properties. Ensuring reliable, high-quality API sourcing is critical for manufacturing, regulatory compliance, and maintaining supply chain integrity in the ophthalmic pharmaceutical sector.

This analysis explores the global sources for cyclosporine A, examining key suppliers, regional manufacturing capabilities, regulatory considerations, and supply chain factors influencing API procurement for Restasis Multi-Dose. A comprehensive understanding of API sourcing avenues is essential for stakeholders aiming to optimize costs, ensure stability, and adhere to strict quality standards.

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Global API Production and Supply Landscape

1. Major API Manufacturers

Cyclosporine A is produced predominantly by a handful of large-scale pharmaceutical ingredient manufacturers. Their manufacturing capacity, quality control systems, and regulatory compliance influence the robustness of the supply chain. Notable suppliers include:

• Chongqing Botai Pharmaceutical Co., Ltd. (China): One of the leading Chinese API manufacturers with significant export-volume to global pharmaceutical firms. They have USP and Ph. Eur. grades, adhering to cGMP standards suitable for ophthalmic applications.

• Jiangsu Hengrui Medicine Co., Ltd. (China): A prominent Chinese manufacturer with a diversified portfolio, including cyclosporine A, boasting strong GMP compliance and international regulatory approvals.

• Bend Research (United States): While primarily focused on drug delivery systems, Bend Research collaborates with high-quality API suppliers and may facilitate sourcing for complex formulations.

• Fujian Huarong Chemical Industry Co., Ltd. (China): Offers pharmaceutical-grade cyclosporine A, with capacity aligned to meet global demands.

• AbbVie (United States/Global): As the patent holder and original developer of Restasis, AbbVie supplies API via direct manufacturing or authorized suppliers meeting strict quality standards.

2. Regional Manufacturing Hubs

• China: The dominant source of bulk cyclosporine A globally, due to established industrial infrastructure, cost advantages, and significant export volume.

• India: Growing API industry, with several GMP-compliant APIs producers meeting global demand, focusing on cost efficiency and regulatory compliance for export.

• United States and Europe: Limited domestic production for cyclosporine A, predominantly due to high manufacturing costs, with reliance on imported APIs from China and India.

3. Regulatory Considerations

API sourced from China and India often meets international standards such as USP, EP, and JP, but regulatory scrutiny varies by jurisdiction. For Restasis, it is pivotal to validate API compliance through rigorous certificate of analysis (CoA), process validation, and supplier audits to meet FDA and EMA requirements. Recently, regulatory agencies emphasize traceability and quality assurance, necessitating partnerships with suppliers with proven compliance histories.

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Supply Chain Dynamics and Challenges

1. Quality Assurance and Certifications

Ensuring API purity, potency, and stability begins with selecting reputable suppliers who possess detailed documentation, are compliant with cGMP, and hold necessary certifications. For ophthalmic applications, API must meet stringent purity thresholds to prevent ocular toxicity.

2. Supply Chain Risks

• Geopolitical Factors: US-China trade tensions and import restrictions can disrupt supply chains, necessitating diversified sourcing strategies.

• Regulatory Changes: Stricter regulations or acts like the FDA's Drug Supply Chain Security Act (DSCSA) may impose additional verification requirements.

• Manufacturing Capacity and Lead Times: Growing global demand for cyclosporine A strains supply capacity, leading to lead times of several months and potential shortages.

3. Quality and Price Considerations

While Chinese API suppliers often offer cost advantages, some pharmaceutical companies prefer Indian or Western suppliers for perceived quality consistency and regulatory familiarity. Balancing cost and compliance is central in sourcing decisions for Restasis production.

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Emerging Trends in API Sourcing for Restasis

• Vertical Integration: Some pharmaceutical companies are developing in-house API manufacturing or engaging in strategic partnerships to secure supply chains.

• Advanced Quality Assurance (QA): Investment in advanced analytical techniques (e.g., HPLC, mass spectrometry) ensures batch-to-batch consistency.

• Supplier Qualification Programs: Rigorous due diligence, audits, and continuous monitoring are central to mitigating risks.

• Regulatory Harmonization: Increased cooperation among international regulators aims to streamline approval processes and validate API quality from global sources.

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Conclusion

Reliable sourcing of cyclosporine A API for Restasis Multi-Dose hinges on engaging reputable, GMP-compliant suppliers primarily located in China and India. Balancing cost, quality, and supply security requires meticulous supplier qualification, adherence to regulatory standards, and robust supply chain management. As demand for ophthalmic immunosuppressants grows, suppliers expanding manufacturing capabilities and achieving compliance will be critical to maintaining uninterrupted production.

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Key Takeaways

• The primary sources of API for Restasis Multi-Dose are Chinese and Indian manufacturers with extensive global exports.

• Ensuring quality compliance involves rigorous validation, certificates of analysis, and maintaining visibility over regulatory adherence.

• Diversification of suppliers mitigates geopolitical and regulatory risks, maintaining supply chain resilience.

• Continuous monitoring of manufacturing capacity and geopolitical developments informs sourcing strategies.

• Strategic collaborations and vertical integration are emerging trends that enhance supply reliability.

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FAQs

1. Are Chinese API suppliers suitable for ophthalmic pharmaceutical products like Restasis?
Yes, many Chinese API manufacturers produce high-quality cyclosporine A compliant with USP and Ph. Eur. standards. Due diligence, supplier audits, and comprehensive QA processes are essential to ensure suitability for ophthalmic applications.

2. How do regulatory standards impact API sourcing for Restasis?
Regulatory standards such as cGMP, USP, and EMA guidelines necessitate sourcing from approved suppliers who can demonstrate consistent quality, thorough documentation, and compliance. Non-compliance risks lead to regulatory refusal, product recalls, or supply disruptions.

3. What are potential supply chain risks for cyclosporine A API?
Geopolitical tensions, trade restrictions, capacity constraints, and regulatory changes can disrupt supply. Companies should develop diversified supplier networks and maintain strategic inventory.

4. Can I source API directly from the manufacturer for Restasis?
Yes, but it requires thorough qualification, validation of quality processes, and regulatory approval processes. Many pharmaceutical companies prefer established suppliers with known compliance records.

5. Is domestic API production feasible for Restasis manufacturing?
Currently, domestic production of cyclosporine A in the U.S. and Europe is limited due to high costs. Relying on imported APIs from GMP-compliant Chinese and Indian suppliers remains prevalent, but evolving manufacturing capabilities may alter this landscape.

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References

[1] Food and Drug Administration (FDA). Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Risk Management. 2020.
[2] European Pharmacopoeia. Monograph on Cyclosporine. 2021.
[3] AbbVie. Restasis Product Information. 2022.
[4] Ph. Eur. Monograph on Cyclosporine. 2022.
[5] IQVIA. Global API Market Report. 2022.