Suppliers and packagers for generic pharmaceutical drug: OMIDENEPAG ISOPROPYL

OMIDENEPAG ISOPROPYL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092	NDA	Ocuvex Therapeutics, Inc.	84826-002-01	1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC	2022-09-23
Ocuvex Therap	OMLONTI	omidenepag isopropyl	SOLUTION;OPHTHALMIC	215092	NDA	Ocuvex Therapeutics, Inc.	84826-002-03	3 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC	2022-09-23

Suppliers for the Pharmaceutical Drug: Omidenepag Isopropyl

Last updated: August 2, 2025

Introduction

Omidenepag isopropyl is a groundbreaking ophthalmic agent primarily marketed for the reduction of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. As a selective prostaglandin EP2 receptor agonist, omidenepag isopropyl offers a novel mechanism distinct from traditional prostaglandin analogs, promising enhanced efficacy and reduced side effects. The growing clinical demand for this innovative therapy has heightened the importance of identifying reliable suppliers capable of meeting manufacturing, distribution, and regulatory standards. This article provides a comprehensive overview of the key suppliers and manufacturers involved in the omidenepag isopropyl supply chain, focusing on their roles, geographic presence, and strategic significance.

Manufacturers of Omidenepag Isopropyl

U.S.-Based Manufacturer: Santen Pharmaceutical

Santen Pharmaceutical, a leading ophthalmic-focused pharmaceutical company headquartered in Japan, is the primary developer and producer of omidenepag isopropyl. The company announced the commercialization of its novel drug, EYBELIS (OMIDEPAG), in various markets, including Japan and the United States, through subsidiaries and strategic partnerships ([1]). Santen maintains full control over the manufacturing processes of omidenepag isopropyl, ensuring adherence to Good Manufacturing Practices (GMP) and regulatory compliance.

Santen’s manufacturing facilities in Japan and international sites are equipped with advanced pharmaceutical production infrastructure, enabling large-scale synthesis of omidenepag isopropyl. Their vertical integration and investments in R&D solidify their position as the principal supply source across multiple regions.

Contract Manufacturing Organizations (CMOs) and Outsourcing Partners

While Santen retains primary manufacturing control, several CMOs may be involved in the supply chain for formulation, packaging, or regional distribution. These partnerships are often confidential due to commercial sensitivities; nonetheless, notable CMOs with ophthalmic manufacturing expertise include:

• Sterile pharmaceutical contract manufactories in Asia and Europe: These firms specialize in ocular formulations and sterile filling processes.
• Formulation service companies: Providing expertise in stabilizing and packaging omidenepag isopropyl into eye drops.

Such collaborations ensure flexibility in supply management, enabling rapid scale-up during high-demand periods and regional customization.

Geographic Supply Chain Dynamics

Japan and Asia-Pacific

Santen Pharmaceuticals leads production within Japan and the broader Asia-Pacific region, leveraging local regulatory approvals for rapid market access. Their extensive regional distribution network ensures timely supply to Asian markets, including China, South Korea, and Southeast Asia.

North America and Europe

In the United States, the Food and Drug Administration (FDA) approved EYBELIS in 2020, with Santen establishing regional subsidiaries to facilitate distribution. Santen's North American manufacturing facilities or approved CMOs supply the drug to meet FDA market requirements, maintaining strict compliance with US pharmaceutical standards.

In Europe, Santen has obtained marketing authorizations in certain countries, importing the drug from manufacturing sites compliant with EU regulations. European supply chains rely on regional CMOs under Santen’s oversight to meet local regulatory standards.

Distribution and Supply Chain Challenges

The relatively recent market entry of omidenepag isopropyl implies limited alternative suppliers; most supply is centralized under Santen’s control or through strategic partners. Challenges include:

• Supply Chain Disruptions: COVID-19 pandemic impacted manufacturing and logistics, emphasizing reliance on geographically concentrated facilities.
• Regulatory Approvals: Varying requirements across jurisdictions may hinder rapid scaling and flexibility.
• Formulation Stability and Packaging: Ophthalmic formulations are sensitive to environmental conditions, necessitating specialized packaging and storage solutions to ensure product integrity during transit.

Emerging and Future Suppliers

With the drug’s increasing approval footprint, potential future suppliers include:

• Regional CMO Expansion: New manufacturing agreements in Europe and North America could diversify the supply chain.
• Local Manufacturers: Market access may incentivize regional players to develop parallel manufacturing capacities, reducing dependency on core suppliers.
• Technology Transfer Initiatives: Santen and other stakeholders may establish licensing or technology transfer deals to accelerate local production in emerging markets.

Regulatory and Strategic Considerations

Manufacturers intending to enter or expand the supply of omidenepag isopropyl must navigate complex regulatory landscapes, requiring robust GMP compliance, stability data, and quality assurance protocols. Establishing diversified supply chains mitigates risks related to geopolitical tensions, natural disasters, and global health crises.

Key Takeaways

• Primary Manufacturer: Santen Pharmaceutical remains the dominant producer and regional distributor of omidenepag isopropyl, with integrated manufacturing facilities and strategic partnerships.
• Supply Chain Dependence: The current supply chain is concentrated, making it susceptible to disruptions; diversification through CMOs and regional manufacturing is critical.
• Regional Strategy: Santen’s localized manufacturing and regulatory pathways facilitate access in key markets like the US, Japan, and Europe.
• Emerging Suppliers: Growth in regional manufacturing, especially via licensing and technology transfer, will likely expand supply options and improve resilience.
• Supply Chain Challenges: Ensuring drug stability, dealing with logistics complexities, and navigating regulatory requirements remain key considerations for current and future suppliers.

FAQs

Q1: Who are the main suppliers of omidenepag isopropyl globally?
A1: Santen Pharmaceutical is the primary manufacturer and supplier globally, supported by a network of CMOs and regional distributors.

Q2: Are there alternative producers for omidenepag isopropyl outside Santen?
A2: Currently, no significant alternative producers are publicly identified. However, future licensing agreements could lead to additional manufacturing partners.

Q3: What regions are covered by Santen’s manufacturing and distribution of omidenepag isopropyl?
A3: Santen supplies the drug in Japan, North America, Europe, and Asia-Pacific regions, often through localized manufacturing and regulatory approvals.

Q4: What are the main challenges faced by suppliers in the omidenepag isopropyl supply chain?
A4: Challenges include supply chain disruptions, regulatory variations, formulation stability, and logistical issues, especially amid global disruptions like the COVID-19 pandemic.

Q5: How might future suppliers impact the availability of omidenepag isopropyl?
A5: Emerging regional manufacturers and licensing deals could diversify supply sources, reduce reliance on a single entity, and improve market resilience.

Conclusion

The supply landscape for omidenepag isopropyl is predominantly controlled by Santen Pharmaceutical, leveraging its technological expertise, manufacturing capacity, and regulatory acumen. While current reliance on core manufacturing centers presents risks, strategic partnerships, regional manufacturing initiatives, and emerging licensing agreements are poised to diversify supply sources. Stakeholders aiming to capitalize on this ophthalmic innovation should prioritize understanding the evolving supply chain dynamics, regulatory pathways, and regional production capabilities to ensure reliable access and distribution.

---

References:

[1] Santen Pharmaceutical Official Website. (2022). EYBELIS (Omidenepag).
[2] U.S. Food and Drug Administration. (2020). EYBELIS (Omidenepag Isopropyl) Approval.
[3] Santen Annual Report. (2022). Manufacturing & Supply Chain Strategy.