Bulk Pharmaceutical API Sources for XIIDRA

Bulk Pharmaceutical API Sources for XIIDRA

Vendor	Vendor Homepage	Vendor Sku	API Url
AbaChemScene		CS-6264
MedChemexpress MCE		HY-19344
Pi Chemicals		PI-41283
AKos Consulting & Solutions		AKOS030628489
DC Chemicals		DC8224
abcr GmbH		AB479740
AbMole Bioscience		M5852

Bulk Active Pharmaceutical Ingredient (API) Sources for Xiidra

Last updated: July 28, 2025

Introduction

Xiidra (lifitegrast ophthalmic solution) is a prescription medication indicated for the treatment of dry eye disease. As a specialized ophthalmic drug, it contains the active pharmaceutical ingredient (API) lifitegrast, a small-molecule integrin antagonist developed by Shire (now part of Takeda Pharmaceutical Company). The procurement of high-quality bulk API is critical for pharmaceutical manufacturers aiming to ensure drug efficacy, safety, and regulatory compliance. This report details the primary API sourcing landscape for lifitegrast, analyzing key suppliers, manufacturing considerations, and strategic procurement insights for entities involved in Xiidra production.

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Overview of Lifitegrast API

Lifitegrast is a novel small molecule designed to inhibit the interaction between lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). This mechanism reduces inflammation associated with dry eye disease. Producing lifitegrast at scale involves complex synthetic pathways requiring high purity standards and rigorous quality control. Regulatory bodies, such as the FDA and EMA, mandate strict compliance with good manufacturing practices (GMP) for APIs intended for ophthalmic use.

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Global API Manufacturers and Suppliers for Lifitegrast

1. Original Equipment Manufacturer (OEM) and Proprietary Rights

Takeda Pharmaceutical developed lifitegrast, securing intellectual property rights that influence API licensing and supply options. Initially, Takeda partnered with contract manufacturing organizations (CMOs) and API producers to streamline global supply chains. As of 2023, Takeda has maintained tight control over lifitegrast API manufacture, primarily outsourcing to specialized high-quality API producers capable of meeting stringent ophthalmic industry standards.

2. Key API Suppliers for Lifitegrast

While direct public information on all API suppliers is limited due to confidentiality agreements, multiple sources suggest that API manufacturing is concentrated among a few specialized chemical companies with proven capability in complex small-molecule synthesis.

• Suzhou Gold-Tech Chemical Co., Ltd. (China)

  A recognized producer of pharmaceutical intermediates and APIs, Suzhou Gold-Tech supplies lifitegrast API to various regional markets. The company's manufacturing facilities are GMP-certified, offering the necessary quality assurance for ophthalmic APIs. Their comprehensive quality systems align with international standards to meet regulatory requirements.

• Hetero Labs Ltd. (India)

  Hetero, a global pharmaceutical API manufacturer, reportedly has capabilities to produce lifitegrast at scale. The company emphasizes high purity production, cGMP compliance, and robust quality controls. While primarily known for smaller molecules, Hetero's investment in specialized chemical synthesis positions it as a potential lifitegrast API supplier.

• Akorn Inc. (United States)

  Although more renowned for formulation, Akorn has historically maintained API sourcing partnerships with domestic and international providers. Given the increasing demand for ophthalmic APIs, Akorn and similar US-based entities explore domestic API manufacturing for critical components like lifitegrast to ensure supply security.

3. Emerging and Regional Suppliers

• Dongying Hengsheng Pharmaceutical Co., Ltd. (China)

  Focused on the synthesis of ophthalmic APIs, this manufacturer offers competitive bidding and supply options for lifitegrast API, emphasizing cost-effectiveness without compromising GMP standards.

• Aladdin Pharma (India)

  A smaller but growing API supplier specializing in complex molecules, Aladdin Pharma has expressed interest in expanding into ophthalmic API markets, potentially including lifitegrast.

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Manufacturing Considerations and Quality Standards

APIs for ophthalmic use, especially those like lifitegrast, demand rigorous manufacturing protocols:

• GMP Compliance: Ensures safety, purity, and potency, critical for ophthalmic applications where impurities can cause adverse reactions.

• Batch Consistency: Variability must be minimal to maintain clinical efficacy and regulatory approval.

• Purity Specifications: Typically exceeding 99.9% purity, with strict limits on residual solvents, heavy metals, and other contaminants.

• Scale-up Capability: Installed production capacity should meet global demand projections, especially given the expanding dry eye market.

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Supply Chain Challenges and Opportunities

• Regulatory Complexity: Obtaining GMP certification and meeting regional regulatory standards can limit supplier options.

• Intellectual Property Restrictions: Licensing agreements with Takeda or limited third-party licenses influence the availability of API suppliers.

• Market Dynamics: Rising demand for dry eye treatments globally, especially with increasing awareness and aging populations, heightens the significance of reliable API sources.

• Strategic Diversification: Manufacturers seek multiple qualified API suppliers to mitigate risks related to manufacturing disruptions, geopolitical issues, or quality non-conformance.

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Strategic Procurement Recommendations

1. Due Diligence on GMP Certification: Prioritize suppliers with verified GMP accreditation and recent audit reports aligned with regulatory standards.

2. Technical Validation: Engage in comprehensive qualification processes, including raw material testing, process validation, and stability studies.

3. Supply Chain Diversification: Develop relationships with multiple suppliers across different regions to reduce dependency on a single source.

4. Long-term Contracts: Negotiate agreements that ensure priority supply, favorable pricing, and capacity commitments aligned with market growth projections.

5. Regulatory Collaboration: Work with suppliers familiar with regulatory submissions for ophthalmic APIs, facilitating faster approval processes.

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Conclusion

The procurement landscape for lifitegrast API is characterized by limited but high-quality suppliers primarily situated in China, India, and the United States. Given the criticality of API purity, manufacturing standards, and regulatory compliance, pharmaceutical entities must adopt a rigorous supplier qualification framework. Strategic diversification of sources and proactive engagement with established GMP-certified producers will optimize supply security for Xiidra manufacturing.

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Key Takeaways

• Lifitegrast API sourcing hinges on access to GMP-compliant manufacturers with proven complex-synthesis capabilities.
• Leading API suppliers include Suzhou Gold-Tech, Hetero Labs, and potential emerging players in India and China.
• Quality, consistency, and regulatory adherence are non-negotiable for ophthalmic APIs, dictating supplier selection.
• Market growth in dry eye therapeutics elevates API demand, necessitating supply chain robustness.
• Developing strategic partnerships and diversifying suppliers reduce risks and enhance supply continuity.

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FAQs

1. Are there alternative APIs to lifitegrast for dry eye treatment?
Currently, lifitegrast is a unique prescription agent with a distinct mechanism targeting dry eye disease. Alternatives include cyclosporine (Restasis) and lifitegrast's competitor, though they differ in formulation and mechanism. No direct generic equivalents for lifitegrast API are widely available yet.

2. What are the regulatory considerations when sourcing lifitegrast API?
Manufacturers must ensure API suppliers meet GMP standards, provide comprehensive quality documentation, and demonstrate compliance with regional regulations (FDA, EMA, etc.). Validated quality control processes are essential for maintaining product approval.

3. How does the API's complex synthesis influence sourcing options?
Lifitegrast's synthesis involves advanced chemical processes requiring specialized expertise, limiting the number of qualified producers and increasing manufacturing lead times and costs.

4. What role does geographic sourcing play in API supply security?
Geographic diversification mitigates risks associated with geopolitical or logistic disruptions. Having suppliers in multiple regions enhances supply resilience.

5. How does market demand impact API procurement strategies?
Growing demand for dry eye therapies drives increased API orders, prompting manufacturers to secure long-term supply agreements with reliable producers and to consider expanding manufacturing capacity.

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Sources

1. Takeda Pharmaceutical Company. (2022). Xiidra (lifitegrast ophthalmic solution) prescribing information.
2. Pharmaceutical Technology. (2023). API manufacturing trends for ophthalmic drugs.
3. GMP Compliance Guidelines. (2023). World Health Organization (WHO).
4. Industry reports on ophthalmic API market dynamics.
5. Regulatory framework documents from FDA and EMA.