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Last Updated: April 1, 2026

Suppliers and packagers for ILEVRO


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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
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Ilevro

Last updated: February 20, 2026

Who Are the Main Suppliers of Ilevro?

Ilevro (nepafenac ophthalmic suspension 0.3%) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat ocular inflammation and pain after cataract surgery. It is marketed primarily by Alcon, a Novartis division. Its supply chain involves manufacturing, distribution partners, and authorized distributors globally.

Manufacturing and Distribution

Primary Manufacturer

  • Alcon:
    • Located in Switzerland.
    • Produces Ilevro under its global manufacturing facilities.
    • Approved by the FDA and EMA.

Authorized Distributors and Supply Chain Partners

  • Alcon's global network handles distribution.
  • Third-party logistics providers include major pharmaceutical distribution companies such as McKesson, Cardinal Health, and AmerisourceBergen.

Contract Manufacturing

  • Alcon may use contract manufacturing organizations (CMOs) for certain production processes.
  • Specific CMO details are proprietary but likely include companies with GMP-certified facilities specializing in ophthalmic pharmaceuticals.

Regulatory Approvals and Market Presence

Region Regulatory Agency Approval Status Estimated Distribution Volume
US FDA Approved (2016) High (widely prescribed)
EU EMA Approved (2016) High
Japan PMDA Approved (2017) Moderate
Other Various (Australia, Canada, etc.) Approved Variable

Supply Chain Challenges and Considerations

  • Manufacturing bottlenecks can lead to shortages.
  • Global distribution disruptions, such as those caused by COVID-19, affected delivery times.
  • Patent exclusivity protections limit the entry of generics, impacting supply flexibility.

Market Competition and Generics

While no generic versions of Ilevro are currently FDA-approved or marketed, other ophthalmic NSAIDs such as bromfenac (e.g., Bromsite) exist. The absence of generics limits supply diversity and keeps Alcon as the primary supplier.

Summary of Key Suppliers

Supplier Name Type Location Market Role
Alcon Proprietary Manufacturer Switzerland Primary developer and distributor
McKesson Distributor US Distributes in North America
Cardinal Health Distributor US Distributes in North America
AmerisourceBergen Distributor US Distributes in North America

Conclusion

Ilevro's supply chain centers around Alcon as the sole manufacturer, utilizing a global network for distribution. No generic suppliers are currently active due to patent protection. Supply stability depends on manufacturing capacities and regulatory approvals across markets.


Key Takeaways

  • Alcon is the exclusive producer and primary supplier of Ilevro.
  • Distribution occurs via authorized distributors, primarily in North America and Europe.
  • Patent protections and manufacturing capacity influence supply availability.
  • Disruptions in supply chains can impact drug availability.
  • No active generic competitors reduce market competition but may limit supply flexibility.

FAQs

1. Are there any generic versions of Ilevro?
No, as of 2023, no generic versions have received FDA approval or marketing authorization.

2. Which companies handle distribution for Ilevro?
McKesson, Cardinal Health, and AmerisourceBergen are key distribution partners in North America.

3. Can supply disruptions occur with Ilevro?
Yes. Manufacturing challenges and global supply chain issues can cause shortages.

4. Does Alcon outsource any manufacturing?
Yes. Alcon may use contract manufacturing organizations, but details are proprietary.

5. What regions approve Ilevro for use?
The US, the EU, Japan, Australia, and Canada have approved Ilevro, with regulatory processes managed by respective agencies.


References

[1] Alcon. (2022). Ilevro Product Information. Retrieved from https://www.alcon.com/products/clinical-opthalmology/ilevro

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