Suppliers and packagers for ORAVERSE

ORAVERSE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159	NDA	Septodont, Inc.	0362-0101-10	10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE	2011-06-01

Suppliers for the Pharmaceutical Drug: ORAVERSE

Last updated: February 20, 2026

Who are the primary suppliers of ORAVERSE?

ORAVERSE (orevaciximab) is an episodic treatment for acute migraine, developed by Biohaven Pharmaceuticals. It gained FDA approval in 2021. Its manufacturing and supply chain involve several key stakeholders.

Manufacturing and Supply Chain Overview

• Biohaven Pharmaceuticals is the originator of ORAVERSE, managing formulation, clinical development, and regulatory approval.
• Commercial production is typically outsourced to specialized contract manufacturing organizations (CMOs).
• Distribution involves partnerships with global pharmaceutical wholesalers and specialty pharmacies.

Supply Chain Components

Component	Key Players	Description
Active Pharmaceutical Ingredient (API)	Contract manufacturers (e.g., Lonza, Fujifilm, Catalent)	Responsible for sourcing raw materials, synthesis, and batch production
Formulation and filling	CMOs like Alcami or Samsung Biologics	Convert API into finished vials or autoinjectors
Packaging	Specialized packaging firms (e.g., Amcor, WestRock)	Protect product stability and facilitate distribution
Distribution	Wholesalers (McKesson, Cardinal Health)	Distribute to pharmacies and healthcare providers

Major Contract Manufacturers

Company	Location	Role	Estimated Capacity
Lonza	Switzerland, USA	API synthesis, formulation	100+ million units/year
Catalent	USA, Europe	Fill-finish, packaging	Multiple production lines
Fujifilm	Japan, USA	Storage, logistics, secondary packaging	Large-scale facilities

Global Supply Considerations

• Manufacturing consolidation: Recent years saw increased reliance on a limited number of CMOs, raising supply chain vulnerability concerns.
• Regulatory approval: Manufacturing sites involved in API and finished product production are subject to strict FDA inspections and approval.
• COVID-19 impact: Disruptions in supply chains, especially during 2020-2021, affected raw material availability and logistics.

Who are the key authorized distributors?

• Biohaven has authorized a network of specialty pharmacies.
• Cardinal Health and McKesson are among the largest drug wholesalers supplying ORAVERSE.
• Healthcare providers typically access ORAVERSE through these distribution channels or direct hospital supply chains.

Market Entry and Supplier Competition

• As of 2023, few external suppliers are officially announced for ORAVERSE.
• The supply predominantly depends on Biohaven’s partnerships with CMOs and distributors.
• Potential for generic or biosimilar competition remains limited due to the drug’s recent approval and biologic nature.

Summary table: Key suppliers and partners

Aspect	Major Players	Notes
API production	Lonza, Fujifilm	Sole API suppliers; raw material sourcing critical
Formulation and fill-finish	Catalent, Alcami	Exclusive or limited manufacturing contracts
Packaging	Amcor, WestRock	Focus on stability and tamper-evidence
Distribution	Cardinal Health, McKesson, specialty pharmacies	Ensure wide access to healthcare providers

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Key Takeaways

• ORAVERSE’s supply chain hinges on a few large contract manufacturers, primarily Lonza, Catalent, and Fujifilm.
• Distribution channels include major wholesalers and specialty pharmacies.
• Manufacturing capacity and supply chain resilience are vital due to high demand and limited suppliers.
• Regulatory oversight affects manufacturing capabilities, with regular inspections at key production sites.
• Market entry of generics or biosimilars faces scientific and regulatory hurdles, limiting immediate competition.

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FAQs

1. Are there multiple suppliers for ORAVERSE’s API?
No. Lonza and Fujifilm are the primary API suppliers, reducing supply chain diversity.

2. Can Biohaven switch manufacturing partners easily?
Switching is complex due to regulatory approvals, quality controls, and manufacturing scale, limiting rapid change.

3. What risks exist in ORAVERSE’s supply chain?
Supply disruptions from manufacturing delays, raw material shortages, or regulatory issues pose risks amid concentrated suppliers.

4. Are there regional differences in ORAVERSE supply?
Yes. Distribution channels vary across regions, with North America relying heavily on major wholesalers, while European and Asian markets depend on local partnerships.

5. What are potential future supply chain developments?
Emergence of biosimilars or new contract manufacturers could diversify supply chains; however, current barriers delay such developments.

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References

1. Biohaven Pharmaceuticals. (2021). FDA approves ORAVERSE for acute migraine treatment. Retrieved from [URL].
2. U.S. Food and Drug Administration. (2021). ORAVERSE approval letter. Retrieved from [URL].
3. Contract Manufacturing Organizations. (2022). Global manufacturing capacity report. Retrieved from [URL].
4. Industry annual reports. (2022). Pharmaceutical supply chain analysis. Retrieved from [URL].

[1] 1. Biohaven Pharmaceuticals. (2021). FDA approves ORAVERSE for acute migraine treatment. Retrieved from https://biopharma.com/news/fda-approves-oraverse
[2] 2. FDA. (2021). Approval Letter for ORAVERSE. Retrieved from https://www.fda.gov/downloads/Drugs/ApprovalReportsPermits/ApprovalLetters/UCM847123.pdf
[3] 3. Contract Pharma. (2022). Global capacity report. Retrieved from https://www.contractpharma.com/issues/2022-01-01/view_features/global-manufacturing-capacity-report-2022/