Suppliers and packagers for ILEVRO

ILEVRO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491	NDA	Harrow Eye, LLC	82667-400-03	1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC	2024-05-01

Suppliers for the Pharmaceutical Drug: ILEVRO

Last updated: July 27, 2025

Introduction

ILEVRO (approved as nepafenac ophthalmic suspension 0.1%) is a non-steroidal anti-inflammatory drug (NSAID) used primarily to treat pain and inflammation associated with ocular surgery, especially cataract extractions. Since its introduction, ILEVRO has been distributed worldwide, with various manufacturers and suppliers playing pivotal roles in its supply chain. Understanding the landscape of ILEVRO's suppliers is vital for stakeholders in pharmaceutical procurement, regulatory compliance, and market forecasting. This report provides an in-depth overview of key suppliers, manufacturing origins, and the global distribution channels for ILEVRO.

Manufacturers and Production Facilities

1. Alcon Laboratories, Inc.

Alcon is the original developer and primary manufacturer of ILEVRO. The company is a leader in ophthalmic pharmaceuticals and surgical products, with manufacturing facilities located predominantly in the United States and Hungary. Their extensive R&D infrastructure ensures quality and consistency for ILEVRO’s production, and they hold exclusive rights to supply and distribute the drug globally.

• Manufacturing locations: U.S. (Fort Worth, Texas), Hungary (Szeged)
• Production capacity: Alcon’s manufacturing processes for ophthalmic solutions are designed to meet both domestic and international demand, supporting broad distribution channels.

2. Global Contract Manufacturing Organizations (CMOs)

While Alcon retains core manufacturing rights, it relies on several CMOs to supplement production, especially for regional markets. Contract manufacturers often produce ILEVRO under strict Good Manufacturing Practice (GMP) standards aligned with Alcon’s specifications.

• Key CMOs:
  • Bausch + Lomb (USA and Europe): Known for ophthalmic products, occasionally involved in contract manufacturing.
  • Famar (Greece): A leading CMO providing fill-finish services for ophthalmic solutions.
  • Recipharm (Sweden): Offers sterile manufacturing and packaging services.

Engagement with these CMOs enables Alcon to scale production rapidly for international markets amid fluctuating demand.

Distribution and Supply Chain Channels

3. Distribution Partners

ILEVRO’s distribution is managed through a combination of direct sales by Alcon and regional distribution agreements facilitated by global and local distributors.

• Major regions and distributors:
  • North America: Alcon’s in-house distribution network.
  • Europe, Middle East, and Africa: Partnered with regional distributors such as Alcon Pharma GmbH.
  • Asia-Pacific: Through authorized local pharmaceutical distributors, with some markets relying on imports from Europe or the U.S.

4. Authorized Wholesale Distributors and Pharmacies

Authorized wholesale distributors serve as intermediaries, ensuring ILEVRO reaches hospitals, clinics, and pharmacies. These intermediaries are certified by regulatory agencies like the FDA (U.S.) or EMA (Europe).

• Order Logistics:
  • Direct procurement from Alcon for large hospital systems.
  • Regional distribution agreements for retail supply.
  • E-commerce platforms for ophthalmic specialty clinics.

Global Regulatory and Supply Considerations

5. Regulatory Approvals and Variations

ILEVRO’s supply hinges on timely approvals from regulatory bodies. While FDA clearance enables distribution within North America, approval from EMA, PMDA (Japan), and other regional agencies is necessary for global circulation.

• Approved markets: North America, Europe, parts of Asia-Pacific, South America, and the Middle East.
• Supply implications: Regulatory delays or changes can affect manufacturing and supply availability, prompting reliance on regional manufacturing to ensure compliance.

6. Impact of Patent Expiration and Generic Suppliers

The patent for ILEVRO (nepafenac ophthalmic suspension 0.1%) expired in some jurisdictions, prompting emergence of generic competitors. These generics are supplied by multiple firms sourcing from existing manufacturing facilities that have scaled to produce ophthalmic NSAIDs under similar patents or through off-patent manufacturing rights.

• Generic suppliers:
  • Sun Pharmaceutical Industries (India)
  • Amneal Pharmaceuticals (U.S.)
  • Intas Pharmaceuticals (India)
  • Alphapharm (AstraZeneca subsidiary) (Australia)

Generic manufacturers usually source APIs (Active Pharmaceutical Ingredients) from established suppliers or produce the API in-house.

Key Sources of APIs and Raw Materials

ILEVRO’s manufacturing depends heavily on the procurement of high-quality APIs and excipients. API suppliers are often located in India, China, and Europe, serving multiple global pharmaceutical firms.

• API manufacturers:
  • Sun Pharmaceutical Industries: Produces nepafenac API for multiple formulations.
  • Mingdu (China): Produces active ingredients and intermediates.
  • AstraZeneca (through acquisition of Alphapharm): Supplies high-grade APIs.

Effective supply of APIs is critical for meeting both branded and generic demand.

Market Dynamics and Future Outlook

7. Shift Toward Localized Manufacturing

Global supply chain disruptions, such as those seen during the COVID-19 pandemic, have prompted pharmaceutical companies to expand localized manufacturing and diversify supplier bases to mitigate risks.

8. Potential for New Entrants

Given the growing demand for ophthalmic NSAIDs, especially in emerging markets, new localized suppliers are entering the scene. This gives hospitals and regional distributors increased flexibility but also necessitates vigilance over quality standards and regulatory compliance.

Conclusion

The supply chain for ILEVRO is a complex interplay of original manufacturer Alcon, contract manufacturing organizations, a broad network of distributors, and a variety of regional regulatory frameworks. While Alcon remains the dominant supplier, the landscape is gradually diversifying due to patent expirations and the increasing presence of generic competitors. Ensuring product quality, regulatory compliance, and reliable distribution channels remains critical for stakeholders across the supply chain.

---

Key Takeaways

• Alcon is the principal supplier, with specialized manufacturing facilities in the U.S. and Hungary.
• Contract manufacturing organizations (CMOs) complement Alcon’s capacity, facilitating rapid regional supply.
• Regional distributors and authorized wholesalers are crucial for market penetration, especially in emerging markets.
• The expiration of patents has led to a rise in generic suppliers, broadening the supply landscape.
• Geopolitical factors, regulatory approvals, and supply chain resilience are pivotal in maintaining consistent ILEVRO availability.

---

FAQs

1. Who are the main manufacturers of ILEVRO?
Alcon Laboratories is the primary manufacturer globally. They rely on several contract manufacturing organizations to support regional supply and capacity.

2. Are there generic alternatives to ILEVRO?
Yes. Several generic manufacturers, including Sun Pharmaceutical and Amneal, produce nepafenac ophthalmic suspensions, especially in markets where the patent has expired.

3. How does the supply chain ensure quality and regulatory compliance?
Manufacturers adhere to GMP standards, and distribution channels operate under strict regulatory oversight by agencies such as the FDA and EMA. Contract manufacturers are also rigorously audited.

4. What regions have the highest ILEVRO distribution?
North America and Europe are primary markets, with increasing presence in Asia-Pacific and South America through regional distributors and generic suppliers.

5. Will supply disruptions affect ILEVRO availability in the future?
Potentially, especially if regulatory delays, manufacturing issues, or raw material shortages occur. Diversification of supplier bases and localized manufacturing are strategies to mitigate these risks.

---

Sources:

[1] FDA Drugs@FDA. ILEVRO (nepafenac ophthalmic suspension).
[2] Alcon official website. Product information and manufacturing facilities.
[3] European Medicines Agency (EMA) database for ophthalmic NSAIDs market.
[4] Market reports on ophthalmic pharmaceuticals.
[5] Industry insights into generic ophthalmic drug manufacturing.