Suppliers and packagers for OMIDRIA

OMIDRIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-00	1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-04	4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL	2023-07-01
Rayner Surgical	OMIDRIA	ketorolac tromethamine; phenylephrine hydrochloride	SOLUTION;IRRIGATION	205388	NDA	Rayner Surgical Inc.	82604-600-99	4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL	2023-07-01

Suppliers for the Pharmaceutical Drug: OMIDRIA

Last updated: July 30, 2025

Introduction

OMIDRIA (phenylephrine and ketorolac injection) is a pioneering ophthalmic solution approved by the U.S. Food and Drug Administration (FDA) in 2015. Manufactured by Valeant Pharmaceuticals International, Inc., now known as Bausch + Lomb, OMIDRIA has established itself as a critical addition to intraocular cataract and placement procedures. The drug combines a mydriatic agent, phenylephrine, with a non-steroidal anti-inflammatory drug (NSAID), ketorolac, to optimize surgical outcomes, reduce the need for additional intraoperative medications, and improve patient recovery.

This article examines the primary suppliers involved in the production and distribution of OMIDRIA, their roles within the supply chain, and the implications for stakeholders across the ophthalmic pharmaceutical landscape.

Manufacturing of OMIDRIA

The core manufacturing entity for OMIDRIA is Bausch + Lomb, a renowned leader in eye health products with extensive expertise in ophthalmic pharmaceuticals. The company maintains manufacturing facilities equipped with advanced pharmaceutical production capabilities compliant with Good Manufacturing Practices (GMP) standards, ensuring product safety, efficacy, and quality.

Supply Chain and Distribution

While Bausch + Lomb handles the formulation and primary manufacturing of OMIDRIA, the distribution network extends globally through multiple channels. These encompass authorized distributors, specialty pharmacies, hospital supply chains, and wholesale drug vendors. The distribution process involves several key players:

• Bausch + Lomb Direct Distribution: As the primary manufacturer, Bausch + Lomb manages the bulk production, packaging, and supply logistics of OMIDRIA. They maintain strict quality control measures and regulatory compliance to ensure product integrity during transit.

• Authorized Distributors and Wholesalers: Several large pharmaceutical distribution firms serve as authorized distributors for OMIDRIA. These include companies such as McKesson, Cardinal Health, and AmerisourceBergen, which supply hospitals, clinics, and specialty pharmacies. These distributors ensure efficient nationwide and global dissemination of the product, maintaining adequate inventory and regulatory documentation.

• Specialty and Hospital Pharmacies: OMIDRIA is primarily supplied through centralized hospital pharmacies and specialty surgical centers. These facilities procure the drug via distributor networks or direct procurement contracts with Bausch + Lomb, ensuring timely availability during surgical procedures.

• Global Suppliers: Outside North America, Bausch + Lomb collaborates with local subsidiaries or third-party logistics providers to navigate regional regulatory requirements and distribution channels, ensuring that OMIDRIA remains accessible in international markets.

Key Suppliers and Their Roles

1. Bausch + Lomb

   • Role: Exclusive manufacturer of OMIDRIA; controls formulation, quality assurance, and initial packaging.
   • Impact: Ensures supply stability, product quality, and compliance with regulatory standards. Bausch + Lomb’s manufacturing capacity directly influences global availability and pricing.

2. Pharmaceutical Distributors (McKesson, Cardinal Health, AmerisourceBergen)

   • Role: Distribute OMIDRIA to healthcare providers and pharmacies; manage logistics, warehousing, and regulatory compliance in their jurisdictions.
   • Impact: Critical for maintaining supply chain resilience, pricing strategies, and inventory management.

3. Regional and International Logistics Providers

   • Role: Handle transportation, customs clearance, and regional distribution logistics.
   • Impact: Ensure timely delivery, preserve drug stability, and manage regional regulatory hurdles.

4. Hospitals and Surgical Centers

   • Role: End-users and procurement points; influence demand volume and purchasing decisions.
   • Impact: Their purchasing patterns and volume purchasing agreements shape production planning and inventory levels.

Market Dynamics and Supply Chain Challenges

The supply of OMIDRIA hinges upon manufacturing capacity, global distribution efficiency, and regulatory compliance. Disruptions such as manufacturing delays, transportation issues (notably during the COVID-19 pandemic), or regulatory changes can impact supply continuity. Given OMIDRIA’s specialized clinical use, supply chain disruptions have heightened significance, affecting surgical scheduling and patient care.

Impact of Patent and Regulatory Environment

ONOIDEKARIA holds patents that protect the formula until 2033, influencing generic development and competitive entry. Consequently, Bausch + Lomb maintains a dominant position, with the supply chain predominantly centered around their manufacturing and distribution network. Regulatory environments in various regions further influence supply chain complexity and supplier roles.

Future Trends and Supply Chain Optimization

Emerging trends include potential manufacturing capacity expansion, adoption of digital supply chain tracking, and regional manufacturing facilities to mitigate geopolitical or logistical risks. Strategic partnerships and licensing agreements with regional distributors may further diversify supply sources and enhance resilience.

Key Takeaways

• Exclusive production by Bausch + Lomb is central to OMIDRIA’s supply chain, with their manufacturing capacity and quality controls directly impacting availability.

• Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen facilitate widespread distribution, ensuring healthcare facilities have access to OMIDRIA when needed.

• Regional logistics providers are vital in maintaining supply continuity across global markets, especially amid logistical challenges.

• Supply chain resilience depends on manufacturing agility, regulatory compliance, and geographic diversification to prevent shortages and ensure timely patient access.

• Emerging trends toward digital tracking and capacity expansion suggest future improvements in supply stability and response to market demand.

Conclusion

The global supply of OMIDRIA fundamentally depends on a tightly integrated network comprising Bausch + Lomb's manufacturing prowess, a cadre of major pharmaceutical distributors, and regional logistics providers. While the current supply chain demonstrates robustness, ongoing challenges necessitate strategic adaptations to sustain availability and optimize distribution efficiency. Stakeholders must monitor manufacturing capacity, regulatory developments, and logistical innovations to effectively navigate the evolving landscape of ophthalmic pharmaceuticals.

FAQs

1. Who are the primary manufacturers of OMIDRIA?
Bausch + Lomb is the exclusive manufacturer of OMIDRIA, overseeing its formulation, manufacturing, and quality assurance.

2. Which distributors supply OMIDRIA to hospitals and clinics?
Major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen serve as authorized suppliers for OMIDRIA across the United States and Globally.

3. How does international distribution of OMIDRIA work?
Bausch + Lomb collaborates with regional subsidiaries and logistic providers to navigate regional regulatory requirements and ensure timely delivery in international markets.

4. Are there any supply chain risks associated with OMIDRIA?
Yes. Manufacturing delays, transportation disruptions, and regulatory changes could impact supply. Strategic diversification and capacity expansion are ongoing mitigation strategies.

5. Is there potential for generic versions of OMIDRIA?
Currently, patent protections extend until 2033, limiting generic development. Post-expiration, generic competitors could influence supply dynamics and pricing.

Sources

1. FDA Approval for OMIDRIA. U.S. Food and Drug Administration.
2. Bausch + Lomb official website.
3. Pharmaceutical Supply Chain Reports. Healthcare Supply Chain Association.
4. Industry analysis on ophthalmic pharmaceuticals. MarketResearch.com.
5. Patent and regulatory environment reports. FDA, WHO.