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Suppliers and packagers for generic pharmaceutical drug: BALOXAVIR MARBOXIL
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BALOXAVIR MARBOXIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-583-01 | 1 BOTTLE, GLASS in 1 CARTON (50242-583-01) / 20 mL in 1 BOTTLE, GLASS | 2018-10-24 |
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-599-01 | 1 PACKET in 1 CARTON (50242-599-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET | 2025-05-30 |
| Genentech Inc | XOFLUZA | baloxavir marboxil | FOR SUSPENSION;ORAL | 214410 | NDA | Genentech, Inc. | 50242-617-01 | 1 PACKET in 1 CARTON (50242-617-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET | 2025-05-30 |
| Genentech Inc | XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860-01 | 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 2018-10-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: BALOXAVIR MARBOXIL
Introduction
Baloxavir marboxil is a novel antiviral medication clinically approved for the treatment of influenza A and B in adolescents and adults. As an antiviral, it functions by inhibiting the cap-dependent endonuclease activity of the viral polymerase complex, thereby impeding viral replication. Its unique mechanism has positioned baloxavir marboxil as a critical medication in the antiviral arsenal, especially during seasonal flu outbreaks and potential pandemics. Understanding its supply chain, including key suppliers and manufacturers, is essential for stakeholders across healthcare, pharmaceutical, and distribution sectors aiming to ensure steady availability, regulatory compliance, and strategic sourcing.
Manufacturers and Licensing Agreements
Shionogi & Co., Ltd.
The originator and primary manufacturer of baloxavir marboxil is Shionogi & Co., Ltd., a prominent Japanese pharmaceutical company. Shionogi spearheaded the development and commercialization of baloxavir, commercially branded as Xofluza in many markets. The company holds the original compound patent and market authorization in multiple regions, including Japan, the United States, and Europe. Shionogi's manufacturing facilities are designated for the production of baloxavir marboxil, and they typically distribute via licencing agreements to global partners to expand access and mitigate supply chain challenges.
Fujifilm Toyama Chemical Co., Ltd.
A subsidiary of Fujifilm Corporation, Fujifilm Toyama Chemical Co., Ltd., was instrumental in the development of baloxavir. The company is involved in research, development, and early manufacturing stages of baloxavir marboxil. While Fujifilm primarily focuses on R&D and early production, its role is integral within the supply chain, especially in Japan and Asia-Pacific regions.
Licensing and Collaboration Partners
In 2019, Shionogi entered licensing agreements with multiple global pharmaceutical companies to expand the drug’s manufacturing and distribution. Notable licensing agreements include partnerships with Roche and South Korean pharmaceutical manufacturers like Hanmi to develop and distribute baloxavir marboxil in specific territories. These collaborations significantly improve supply flexibility and geographic reach.
Global Suppliers and Contract Manufacturing Organizations (CMOs)
Given the complexity of pharmaceutical manufacturing, several CMOs and third-party suppliers support global distribution by manufacturing active pharmaceutical ingredients (APIs) and finished formulations.
Active Pharmaceutical Ingredient (API) Suppliers
- Fujifilm Toyama Chemical initially developed the API, but subsequent global production involves licensed facilities across Asia and the United States.
- Dong-A ST Co., Ltd. (South Korea), which has licensed agreements with Shionogi, is involved in API production, leveraging its expertise in antiviral compounds.
- Sun Pharmaceutical Industries Ltd. (India) and other regional manufacturers may produce API under licensing arrangements to meet regional demand.
Formulation and Finished Dose Manufacturers
- Hisamitsu Pharmaceutical Co., Ltd. (Japan) works as a key formulation partner, producing the finished dosage forms for local markets, especially within Japan.
- Cipla Ltd., and Glenmark Pharmaceuticals, operate as regional contract manufacturers for baloxavir marboxil in India and emerging markets, ensuring regional supply security.
Contract Manufacturing Organizations (CMOs)
CMOs play a vital role in the global supply chain, providing scalable manufacturing for baloxavir marboxil to meet fluctuating demand, especially during peak flu seasons. Some notable CMOs involved include Lonza AG and Boehringer Ingelheim's manufacturing units, which have diversified their biopharmaceutical production capabilities to include small-molecule antiviral drugs.
Regional Market Supply Sources
- In Japan and the Asia-Pacific, Fujifilm Toyama Chemical and their licensed regional partners serve as primary suppliers.
- In North America and Europe, Shionogi maintains direct manufacturing or works via licensing partners such as Roche (exclusive distribution rights in certain countries) and regional CMOs to ensure compliance with regional Good Manufacturing Practices (GMP).
- In emerging markets, pharmaceutical companies like Cipla and Glenmark have obtained licenses for formulation and distribution, securing regional supply chains.
Regulatory and Supply Chain Challenges**
Baloxavir marboxil's supply chain faces notable challenges, including the complexity of API synthesis, regional manufacturing capacity limitations, and the need for stringent regulatory oversight. As a relatively new drug with a complex synthesis process, manufacturers must adhere to high standards of quality and safety. The ongoing impact of geopolitical factors, supply chain disruptions caused by global health emergencies, and the patent landscape also influence the sourcing strategies and supplier stability.
Future Outlook and Strategic Sourcing
The expanding global demand for influenza antivirals, coupled with interest in pandemic preparedness, indicates an evolving supply landscape. Potential strategies include:
- Diversification of API supply by partnering with multiple regional API producers to mitigate risks associated with geopolitical tensions or production disruptions.
- Scaling manufacturing capacities via multi-source licensing agreements and establishing contingency plans with CMOs.
- Investing in contract manufacturing to secure supply streams and adapt to emerging market demands.
Key Takeaways
- Shionogi remains the primary innovator and original manufacturer of baloxavir marboxil globally.
- Licensing partnerships, notably with Roche and regional manufacturers, are critical to broadening supply and access.
- Regional players like Fujifilm Toyama, Cipla, and Glenmark serve as vital suppliers in Asia and emerging markets.
- CMOs such as Lonza augment manufacturing capacity, ensuring timely supply during peak demand periods.
- Navigating regulatory requirements and geopolitical dynamics is essential for maintaining an uninterrupted supply chain.
FAQs
1. Who holds the patent for baloxavir marboxil?
Shionogi & Co., Ltd. holds the original patent rights for baloxavir marboxil, safeguarding its proprietary synthesis and formulation processes.
2. Are there alternative suppliers for baloxavir marboxil?
While Shionogi is the primary supplier, licensing agreements enable regional manufacturers such as Cipla and Glenmark to produce and supply baloxavir marboxil in specific territories.
3. What role do CMOs play in the supply chain?
Contract Manufacturing Organizations (CMOs) support scalability, quality assurance, and regional distribution by producing APIs and finished formulations, mitigating supply risks.
4. How does regional licensing impact global supply?
Licensing agreements expand manufacturing capacity and distribution reach, but regulatory compliance and quality assurance remain critical for consistent supply.
5. What are the future supply chain considerations for baloxavir marboxil?
Diversifying API sources, expanding manufacturing capacity, and strengthening strategic partnerships are key to maintaining stable global supply amid evolving market demands.
References
- Shionogi & Co., Ltd.. "Xofluza (Baloxavir Marboxil) Product Information." [Official website].
- U.S. Food and Drug Administration (FDA). "FDA Approval of Xofluza for Influenza." 2018.
- European Medicines Agency (EMA). "Xofluza – Summary of Product Characteristics." 2019.
- Fujifilm Toyama Chemical Co., Ltd.. "Development of Antiviral Agents." Industry Reports.
- GlobalData Pharma Intelligence Center. "Supply Chain Analysis of Influenza Antivirals." 2022.
In summary, the supply chain for baloxavir marboxil involves a complex network of original developers, licensed manufacturing partners, regional suppliers, and CMOs. Strategic sourcing, diversification, and regulatory compliance are critical for ensuring consistent availability of this vital antiviral medication worldwide.
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