Suppliers and packagers for xiidra

xiidra

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073	NDA	Novartis Pharmaceuticals Corporation	0078-0911-12	12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE	2016-07-11
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073	NDA	Novartis Pharmaceuticals Corporation	0078-0911-94	4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE	2016-07-11
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073	NDA	Bausch & Lomb Incorporated	24208-911-12	12 POUCH in 1 CARTON (24208-911-12) / 5 AMPULE in 1 POUCH (24208-911-05) / .2 mL in 1 AMPULE	2024-01-02

Suppliers for the Pharmaceutical Drug: Xiidra

Last updated: July 29, 2025

Overview of Xiidra

Xiidra (lifitegrast ophthalmic solution 5%) is a prescription medication developed primarily for the treatment of dry eye disease (DED). Approved by the U.S. Food and Drug Administration (FDA) in 2016, Xiidra is marketed by Novartis Pharmaceuticals Corporation. It functions as a lymphocyte function-associated antigen-1 (LFA-1) antagonist, inhibiting the interaction that leads to inflammation associated with dry eye disease. As with many ophthalmic drugs, Xiidra’s supply chain relies on a network comprising active pharmaceutical ingredient (API) manufacturers, formulation facilities, packaging partners, and distribution channels.

Key Components of Xiidra Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Xiidra's manufacturing process is the procurement of high-quality lifitegrast API. While Novartis manufactures Xiidra in-house, the complexity of chemical synthesis and stringent quality requirements open avenues for multiple API suppliers. As of current data, production of lifitegrast is primarily centralized within Novartis; however, several potential vendors have been identified or speculated to contribute to API supply globally.

• Novartis API Manufacturing: Novartis's internal API production facilities in Switzerland and the United States are presumed to be primary sources, adhering to Good Manufacturing Practices (GMP). These in-house facilities enable tight control over API quality, a critical aspect for ophthalmic solutions.

• External API Suppliers: Although Novartis largely maintains proprietary manufacturing, market intelligence suggests that third-party API vendors in India and China could be involved in supply chains, particularly during scaled-up production phases. Companies specializing in complex small-molecule synthesis, such as Aurobindo Pharma, Hetero Labs, or Shilpa Medicans, may participate in API supply, given their experience with similar chemical entities.

2. Formulation and Final Product Manufacturing

Xiidra’s formulation involves precise compounding to create a sterile ophthalmic solution. Contract manufacturing organizations (CMOs) specializing in sterile ophthalmic preparations are often engaged for this step.

• Profile of Formulation Manufacturers: Global CMOs located in countries like India, Ireland, and the United States—such as Bausch + Lomb, AbbVie Contract Manufacturing, or Catalent—are likely candidates due to their expertise in ophthalmic drug formulations.

• Quality Control and Packaging: The final product undergoes rigorous testing and is packaged in unit-dose bottles. Packaging suppliers, such as Gerresheimer or Stevanato Group, may supply the primary containers and related components.

3. Distribution Channels

Post-manufacturing, Xiidra is distributed via wholesale drug distributors, specialty pharmacies, hospital systems, and directly through Novartis’s distribution network.

• Major Distributors: Cardinal Health, McKesson, and AmerisourceBergen are critical brokers in the ophthalmic drug domain, ensuring availability across retail pharmacies and healthcare providers.

• Market-Specific Dynamics: In regions outside the U.S., local distributors and licensing partners often play roles, especially in Europe, Asia, and emerging markets.

Strategic Supplier Considerations

Market Concentration and Risk

The reliance on Novartis’s internal API production reduces supply chain fragmentation but increases dependency on a limited number of high-capacity plants. Any disruption can impact product availability.

Global Supply Chain Challenges

Recent global events, including the COVID-19 pandemic, have highlighted vulnerabilities in pharmaceutical logistics. Supply chain resilience hinges on diversified sourcing, robust quality assurance, and strategic inventory management. Suppliers in India and China, while capable of scaling production, face geopolitical and logistical challenges, which companies must mitigate proactively.

Regulatory and Quality Assurance

All suppliers involved must comply with stringent GMP standards enforced by the FDA, EMA, and other regulatory bodies. The complexity of ophthalmic formulations further underscores the need for high standards in sterility and stability testing.

Emerging Trends in Supply Chain Management for Xiidra

• Supplier Diversification: Novartis and other stakeholders are increasingly engaging multiple API vendors to prevent supply disruptions.
• Vertical Integration: Larger pharmaceutical firms, including Novartis, are investing in their own manufacturing infrastructure to safeguard APIs critical to their portfolio.
• Strategic Stockpiling: To ensure uninterrupted supply, especially for chronic conditions like dry eye disease, inventory management strategies are being enhanced.

Conclusion

Xiidra's supply chain predominantly revolves around Novartis’s internal manufacturing capabilities, supplemented by strategic external suppliers of APIs and formulation services. The complex and highly regulated nature of ophthalmic drugs necessitates a meticulous, transparent supply chain with strong quality assurance protocols. Stakeholders must continuously monitor geopolitical, logistical, and regulatory factors impacting the suppliers involved to maintain consistent product availability globally.

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Key Takeaways

• Primary API Source: Novartis manufactures xiidra’s lifitegrast in-house, ensuring strict quality control.
• External Suppliers: Potential involvement of API vendors from India and China, amid ongoing diversification efforts.
• Formulation and Packaging: Contract manufacturers specializing in ophthalmic solutions and reputable packaging companies play pivotal roles.
• Supply Chain Risks: Global disruptions necessitate diversified sourcing and inventory strategies.
• Regulatory Compliance: Suppliers must adhere to GMP standards to sustain high-quality, safe ophthalmic products.

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Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for Xiidra?
While Novartis primarily produces lifitegrast internally, several third-party API vendors, especially in India and China, are likely involved to meet global demand, though specifics remain proprietary.

2. How does Novartis ensure the quality of Xiidra's supply chain?
Novartis enforces rigorous GMP compliance across its manufacturing facilities and works with certified contract manufacturers for formulation, packaging, and distribution to uphold high safety and efficacy standards.

3. Are there risks associated with relying on external API suppliers?
Yes. Geopolitical instability, supply chain disruptions, and quality assurance challenges can threaten API availability, prompting companies to diversify supplier bases and increase inventory buffers.

4. What role do contract manufacturing organizations play in Xiidra’s production?
CMOs handle formulation, sterile compounding, and packaging, leveraging expertise in ophthalmic drug manufacturing, and help scale production efficiently.

5. How might supply chain trends impact Xiidra availability?
Enhanced supplier diversification, geopolitical shifts, and pandemic-related disruptions underscore the need for resilient supply chains to ensure continuous Xiidra access globally.

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References

1. U.S. Food and Drug Administration. (2016). Xiidra (lifitegrast) ophthalmic solution, 5%. [FDA Label].
2. Novartis Pharmaceuticals. (2022). Annual Report and Corporate Statements.
3. SupplyChainBrain. (2021). Global Ophthalmic Drug Manufacturing Trends.
4. Pharma Intelligence. (2022). API Market Dynamics and Supplier Developments.
5. Global Supply Chain Insights. (2022). Risks and Strategies in Pharmaceutical Supply Chains.