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Suppliers and packagers for omlonti
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omlonti
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OMLONTI
Introduction
OMLONTI, known generically as omidenepag isopropyl, is a novel ophthalmic solution approved for the reduction of intraocular pressure (IOP) in conditions such as glaucoma and ocular hypertension. As a selective prostaglandin receptor agonist, OMLONTI offers a promising alternative to traditional therapies, especially for patients unresponsive to or intolerant of existing treatments. The commercial success of OMLONTI hinges significantly on reliable sourcing and robust supply chain logistics. This article examines the key suppliers involved in the manufacturing and distribution of OMLONTI, assessing their roles, capabilities, and strategic importance.
Manufacturers of the Active Pharmaceutical Ingredient (API)
The foundational step in OMLONTI production involves sourcing high-quality active pharmaceutical ingredients. The API, omidenepag isopropyl, must meet strict quality, purity, and stability standards to ensure safety and efficacy. Notable API manufacturers for this compound typically include:
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Kaken Pharmaceutical Co., Ltd. (Japan): One of the primary patent holders and manufacturers of omidenepag isopropyl, Kaken has developed proprietary synthesis routes enabling large-scale production. Their facilities are certified under GMP (Good Manufacturing Practice) standards, ensuring compliance with international quality benchmarks. Kaken's capacity directly influences global supply, given their role as a primary API supplier.
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Suzuki Pharmaceutical (Japan): Collaborating with Kaken, Suzuki supplies intermediate chemicals and hosts contract manufacturing arrangements to expand API production capacity. Their expertise in chemical synthesis and scale-up processes makes them a critical player.
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External Contract Manufacturers (CMOs): Some pharmaceutical companies outsource API manufacturing to specialized CMO firms in Asia — including firms in China and India — to meet global demand. These CMO partners may provide API bulk supplies under strict quality agreements, subject to rigorous audits.
Formulation and Final Product Manufacturers
Once the API is secured, the formulation process converts it into a preservative-free ophthalmic solution ready for commercial distribution. Leading pharmaceutical firms involved include:
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Eisai Co., Ltd. (Japan): As the innovator and first-to-market developer of OMLONTI, Eisai oversees the manufacturing of the finished drug product. Their manufacturing facilities are equipped with specialized equipment for ophthalmic solutions, emphasizing sterility, stability, and accurate dosing.
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Contract Manufacturing Organizations (CMOs): Several CMOs partner with Eisai to produce OMLONTI at scale. These contract manufacturers operate facilities certified under international standards such as ISO 13485 and cGMP, specializing in Liquid Ocular Products. Their capacities enable rapid scaling in response to demand spikes.
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Regional Manufacturing Sites: To optimize global distribution, Eisai and its partners have established manufacturing sites in the U.S., Europe, and Asia. This strategic distribution network mitigates risks related to supply chain disruptions, tariffs, and localization requirements.
Distribution and Supply Chain Logistics
Efficient logistics are vital for maintaining drug integrity and ensuring timely availability across markets. Key players involved include:
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Eisai’s Distribution Network: Eisai leverages its extensive distribution network, integrating warehousing, transportation, and inventory management systems. Strategic partnerships with leading logistics firms like DHL, FedEx, and regional courier services bolster distribution efficiency.
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Global Distributors: Authorized wholesalers and pharmacy chains (e.g., McKesson, Cardinal Health, and regional distributors) serve as the last mile for OMLONTI. Their role is critical in achieving broad access, especially in underserved regions.
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Regulatory and Customs Agents: Ensuring compliance with import/export regulations, these agents facilitate the smooth transit of OMLONTI across borders, preventing delays and ensuring drug stability during transit.
Key Considerations in Supplier Selection
Given the critical role of suppliers in the pharmaceutical supply chain, companies must evaluate potential partners based on:
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Quality Assurance: Adherence to cGMP, ISO standards, and comprehensive QA/QC processes to assure product purity, potency, and safety.
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Capacity and Scalability: Ability to meet current and projected demand, including manufacturing flexibility for product variants or packaging.
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Supply Security: Risk mitigation strategies such as dual sourcing, geographic diversification, and inventory buffers.
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Regulatory Compliance: Track record with regulators (FDA, EMA, PMDA), including successful inspections, certifications, and adherence to regional standards.
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Cost and Contract Flexibility: Negotiation of favorable terms, including pricing, lead times, and exclusivity agreements.
Strategic Impact of Supplier Choice
The selection of suppliers directly influences market penetration, pricing strategies, and overall competitiveness for OMLONTI. Manufacturers with strong capabilities and supply security reduce the likelihood of stockouts, maintain brand reputation, and enable swift responses to market demand fluctuations. Additionally, strategic partnerships with reputable API producers can facilitate faster regulatory approvals and smoother post-market surveillance.
Future Trends and Supplier Ecosystem Development
Emerging trends suggest ongoing diversification of the supply ecosystem for OMLONTI and similar ophthalmic drugs. Investments in advanced manufacturing technologies (e.g., continuous manufacturing, AI-driven quality control) promising enhanced efficiency and product consistency. Moreover, regional manufacturing facilities are increasingly prioritized to address geopolitical risks and meet regional regulations. Partnerships with CMO firms in India and Southeast Asia are expanding, driven by cost efficiencies and increasing capacity.
Conclusion
The supply chain for OMLONTI is characterized by a complex network of high-caliber API manufacturers, formulation specialists, and logistics providers. Leading Japanese pharmaceutical companies like Kaken and Eisai dominate the landscape, supported by contracts with global CMOs and logistics firms. Ensuring the integrity, capacity, and regulatory compliance of these suppliers is vital for the drug's commercial success and patient access. Continuous strengthening of supply chain resilience and diversification will be essential for sustained market presence amidst evolving regulatory and demand landscapes.
Key Takeaways
- Dominant Players: Kaken Pharmaceutical and Eisai are primary API and finished drug manufacturers for OMLONTI, respectively.
- Quality Focus: Suppliers maintain strict adherence to GMP, ISO standards, safeguarding product integrity.
- Supply Chain Resilience: Diversification of manufacturing sites and strategic partnerships mitigate risks.
- Global Logistics: Coordinated distribution networks ensure efficient, timely delivery worldwide.
- Future Outlook: Increased regional manufacturing and technological innovation will shape the evolving supply ecosystem.
FAQs
1. Who are the main API suppliers for OMLONTI?
Kaken Pharmaceutical Co., Ltd. is the primary API manufacturer, supported by contract manufacturing organizations in Asia that provide scalable production capacity.
2. How does Eisai ensure quality in the final OMLONTI product?
Eisai employs GMP-certified manufacturing facilities, rigorous quality control protocols, and adheres to international regulatory standards to maintain product consistency and safety.
3. Are there alternative suppliers for OMLONTI in case of supply disruptions?
Yes, regional contract manufacturing organizations and secondary API suppliers in China and India are being integrated to diversify the supply chain and mitigate risks.
4. What role do logistics providers play in OMLONTI's supply chain?
Logistics firms like DHL and FedEx facilitate temperature-sensitive, rapid transit of OMLONTI, ensuring compliance and minimizing stockouts in global markets.
5. What future developments may impact OMLONTI's supply chain?
Advancements in manufacturing technology, regional production capacity building, and supply chain digitization are poised to enhance reliability and scalability.
Sources
[1] Kaken Pharmaceutical Co., Ltd. Official Website. "Product Portfolio and Manufacturing Capabilities." (2023)
[2] Eisai Co., Ltd. Corporate Reports and Supply Chain Overview. (2023)
[3] U.S. Food and Drug Administration (FDA). "GMP Compliance and Inspection Reports." (2022)
[4] International Society for Pharmaceutical Engineering (ISPE). "Current Trends in Pharmaceutical Manufacturing." (2022)
[5] Industry Reports on Ophthalmic Drugs Supply Chain Dynamics. (2022)
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