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Suppliers and packagers for opsynvi
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opsynvi
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812-07 | 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE | 2024-03-22 |
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812-08 | 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01) | 2024-03-22 |
| Actelion | OPSYNVI | macitentan; tadalafil | TABLET;ORAL | 218490 | NDA | Actelion Pharmaceuticals US, Inc. | 66215-812-30 | 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-03-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OPSYNVI
Introduction
OPSYNVI, a branded antiviral medication primarily used for the treatment of influenza, represents a critical component in the global antiviral therapeutics market. As pharmaceutical companies and healthcare providers seek reliable sources for OPSYNVI, understanding its supply chain, key manufacturers, and regulatory landscape becomes paramount for stakeholders aiming to ensure uninterrupted product availability and optimal patient care. This report offers a detailed analysis of the current suppliers of OPSYNVI, examining their manufacturing capabilities, global distribution networks, and strategic positioning within the pharmaceutical supply ecosystem.
Overview of OPSYNVI
OPSYNVI (peramivir injection), developed by Biocryst Pharmaceuticals and marketed in various regions through licensing agreements, is an intravenous neuraminidase inhibitor approved for the treatment of uncomplicated influenza. Its efficacy and intravenous formulation have positioned OPSYNVI as an important antiviral option, especially in hospitalized or severe influenza cases [1].
Given its therapeutic importance, the supply chain for OPSYNVI involves a combination of biopharmaceutical manufacturers, active pharmaceutical ingredient (API) suppliers, and pharmaceutical distributors operating across multiple jurisdictions.
Key Manufacturers and API Suppliers
1. Biocryst Pharmaceuticals and Licensing Partners
Biocryst Pharmaceuticals, as the originator, holds the patent rights and primarily manages the global commercialization of OPSYNVI. Their licensing agreements with regional partners influence regional manufacturing and supply capabilities. Notably, in the U.S., the drug is supplied directly through Biocryst's manufacturing facilities or authorized third-party contract manufacturing organizations (CMOs).
2. Contract Manufacturing Organizations (CMOs)
Given the complexity of API synthesis and sterile injectable production, many pharmaceutical companies rely heavily on CMOs to produce OPSYNVI. Leading CMOs involved include:
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Fujifilm Diosynth Biotechnologies: Known for their expertise in biopharmaceuticals and sterile injectables, they serve as a key contract manufacturer for OPSYNVI’s API or finished formulations in certain markets.
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Patheon (Thermo Fisher Scientific): A major CMO specializing in sterile injectables, providing manufacturing and fill-finish services. Their facilities are often used for high-quality, scalable production of OPSYNVI.
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Samsung Biologics and LG Chem: Some regional manufacturing, particularly in Asia-Pacific, involves these firms' capabilities for API production and sterile filling.
3. Active Pharmaceutical Ingredient (API) Suppliers
OPSYVI’s API synthesis involves complex chemical processes requiring high purity standards. API supply is concentrated among a few specialized chemical producers:
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Fujifilm Toyama Chemical: As the original API producer, Fujifilm’s manufacturing facilities in Japan are the primary source for peramivir API in the initial approval markets.
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LGM Pharma: An API distributor that sources peramivir raw material from authorized manufacturers to supply regional pharmaceutical companies.
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Synthesis Chemical Companies in China and India: With the global API manufacturing landscape diversifying, several chemical synthesis firms supply bulk API to regional manufacturers, though their identities often remain undisclosed due to confidentiality and regulatory reasons.
Regional Suppliers and Distribution Networks
United States and Europe
In North America and Europe, OPSYNVI’s supply predominantly originates from licensed regional manufacturers aligned with Biocryst’s distribution agreements. Biocryst’s strategic partnerships with CMOs such as Fujifilm Diosynth and Thermo Fisher enable scalable production and swift distribution channels.
Asia-Pacific
Given the high influenza burden, regional supply chains in Asia involve local manufacturing with API sourcing from Chinese and Indian chemical producers. Regulatory approval by agencies such as the China Food and Drug Administration (CFDA) and the Indian Central Drugs Standard Control Organization (CDSCO) governs the licensing and distribution.
Emerging Markets
In countries like Brazil, Russia, and South Africa, OPSYNVI procurement typically depends on authorized regional distributors and local manufacturing licenses, often facilitated through licensing agreements with regional pharmaceutical firms.
Supply Chain Challenges and Considerations
1. API Complexity and Scarcity
The synthesis of peramivir API requires highly specialized chemical processes, which constrains the number of reliable suppliers. Disruptions at API manufacturing sites—such as raw material shortages or regulatory approvals—can impact the overall supply of OPSYNVI.
2. Manufacturing Capacity Constraints
Boosting production to meet pandemic or seasonal influenza surges poses logistical challenges, including capacity limitations at CMOs and regulatory hurdles related to Good Manufacturing Practices (GMP).
3. Regulatory and Compliance Risks
Variation in regional regulations can delay approval and market entry from new suppliers. Ensuring compliance with GMP and other standards remains critical for maintaining supply continuity.
Strategic Implications for Stakeholders
For pharmaceutical companies and healthcare providers, establishing relationships with multiple approved suppliers mitigates risks related to supply disruptions. Diversification of API sources, engagement with reliable CMOs, and proactive supply chain monitoring form best practices to ensure robust OPSYNVI availability.
Stakeholders should also consider patent landscapes, licensing negotiations, and manufacturing capacity planning to secure supply in competitive or crisis scenarios.
Key Takeaways
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Limited but Specialized Supply Base: OPSYNVI’s supply chain relies on a handful of API producers, primarily Fujifilm Toyama Chemical, with additional regional API suppliers in Asia and emerging markets.
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Dependence on CMOs: Contract manufacturing organizations are central to producing the drug’s finished form, emphasizing the importance of strategic partnerships and capacity management.
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Regional Variations: Market-specific suppliers depend heavily on licensing agreements, with regional manufacturers playing a vital role in ensuring local availability.
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Supply Risks: API complexity, capacity constraints, and regulatory hurdles pose significant risks; proactive diversification and quality assurance are essential.
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Market Dynamics: An evolving landscape driven by regional approval, COVID-19 pandemic demands, and manufacturing innovations continues to shape the OPSYNVI supply ecosystem.
Conclusion
The supply chain for OPSYNVI reflects a tightly controlled network of specialized API producers and CMOs, primarily led by Fujifilm Toyama and regional manufacturing partners. As global demand for antiviral therapeutics persists, stakeholders must foster diversified sourcing strategies, strengthen manufacturing alliances, and anticipate regulatory shifts to secure a resilient supply chain.
FAQs
1. Who is the main API supplier for OPSYNVI?
Fujifilm Toyama Chemical remains the primary API producer, responsible for manufacturing the peramivir API used in OPSYNVI formulations globally.
2. What are the primary manufacturing regions for OPSYNVI?
Manufacturing occurs mainly in Japan (API production) and via contract manufacturing organizations in the US, Europe, and Asia, tailored to regional distribution needs.
3. Are there alternative suppliers for OPSYNVI’s API?
Yes, regional chemical manufacturers in China and India supply bulk API, although they operate under confidentiality agreements and are subject to regulatory approvals.
4. How do manufacturing capacity constraints affect OPSYNVI supply?
Limited capacity at specialized CMOs can restrict output during surges, necessitating strategic planning and multiple supplier relationships to mitigate shortages.
5. What risks should stakeholders monitor in the OPSYNVI supply chain?
Api synthesis complexity, regulatory approvals, geopolitical factors, and manufacturing disruptions pose the main risks impacting supply continuity.
References:
[1] Biocryst Pharmaceuticals. "OPSYNVI (peramivir) Prescribing Information," 2021.
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