Suppliers and packagers for ONZETRA XSAIL

ONZETRA XSAIL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Currax	ONZETRA XSAIL	sumatriptan succinate	POWDER;NASAL	206099	NDA	Currax Pharmaceuticals LLC	42847-311-08	8 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH	2015-10-01

Suppliers for the Pharmaceutical Drug: ONZETRA XSAIL

Last updated: July 30, 2025

Introduction

ONZETRA XSAIL, a branded prescription medicine, is a nasal spray formulation of sumatriptan designed to treat acute migraine attacks. Developed by Teva Pharmaceuticals, it offers rapid relief by delivering medication directly to the nasal mucosa, providing an alternative for patients who prefer a non-oral dosage form or have gastrointestinal issues during migraines. The procurement landscape for ONZETRA XSAIL hinges on a network of authorized suppliers, including the original manufacturer, authorized distributors, and licensed pharmaceutical wholesalers. This report evaluates the supply chain structure, key suppliers, and considerations for stakeholders seeking to source ONZETRA XSAIL.

Manufacturer and Original Supplier: Teva Pharmaceuticals

Teva Pharmaceuticals is the patent holder and primary manufacturer of ONZETRA XSAIL. Established as one of the world's leading generic drug producers, Teva possesses extensive manufacturing facilities globally, ensuring a robust supply chain to meet market demands.

• Manufacturing Locations:
  Teva's manufacturing plants are strategically located across Europe, North America, and Asia, including facilities in Israel, Hungary, and the United States, ensuring consistent quality control and supply capacity.

• Certification and Regulatory Compliance:
  Facilities comply with Good Manufacturing Practices (GMP) standards established by regulatory agencies such as the FDA, EMA, and other regional authorities, affirming the quality of supplied products.

Supply Chain Role:
Teva is responsible for producing ONZETRA XSAIL and supplying it to authorized distributors and wholesalers. As the original development company, Teva holds the intellectual property rights and responds for quality assurance, ensuring standard compliance through the entire supply chain.

Authorized Distributors and Wholesalers

Authorized distributors act as intermediaries, sourcing ONZETRA XSAIL directly from Teva and distributing to pharmacies, hospitals, and clinics. These entities are critical in ensuring product authenticity, regulatory compliance, and timely delivery.

Major Authorized Distributors

• AmerisourceBergen:
  One of the world's largest pharmaceutical distributors, authorized to handle ONZETRA XSAIL in various regions, including North America.

  • Scope: Distribution to retail pharmacies, hospitals, and clinics.
  • Roles: Ensures product integrity, manages logistics, and compliance with regional regulations.

• McKesson Corporation:
  An established distributor in the US healthcare system, McKesson supplies ONZETRA XSAIL alongside other migraine medications.

  • Capabilities: Cold chain logistics, inventory management, and regulatory adherence.

• Alliance Healthcare (part of AmerisourceBergen):
  Distributes in European markets, aligning with Teva’s regional manufacturing plants for supply continuity.

Regional and Local Wholesalers

Regional pharmaceutical wholesalers and licensed distribution channels play an essential role in expanding access, especially within smaller markets or less-developed regions. These entities typically obtain product directly from authorized distributors or Teva’s regional offices.

Online and Marketplaces

While some online platforms claim to sell ONZETRA XSAIL, caution is advised, as unverified sources pose significant risks of counterfeit products. Transactions should only be conducted through verified and authorized channels to ensure authenticity and compliance.

Supply Chain Considerations

Regulatory Approvals and Compliance

Suppliers must adhere strictly to regional regulatory requirements, including registration with agencies such as the FDA (USA), EMA (EU), or MHRA (UK). These approvals ensure that distributors handle genuine products, maintaining high standards of quality and safety.

Distribution Agreements

Teva maintains stringent distribution agreements with authorized partners, involving contractual obligations around storage conditions, traceability, reporting, and anti-counterfeiting measures.

Supply Chain Challenges

Factors influencing the availability of ONZETRA XSAIL include global supply chain disruptions, manufacturing capacity constraints, and regional regulatory approvals. Recent manufacturing bottlenecks, often caused by supply chain bottlenecks or raw material shortages, can impact availability.

Pricing and Access

Pricing strategies are regulated to some degree by regional health authorities, insurance coverage, and rebate agreements. Suppliers may offer discounts, reimbursement programs, or patient assistance programs, influencing the accessibility of ONZETRA XSAIL across markets.

Key Trends and Market Dynamics

• Expansion in Emerging Markets:
  As migraine prevalence rises globally, suppliers are expanding distribution networks to afford broader access. Local partnerships may develop with regional distributors who are authorized by Teva.

• Generic Competition:
  Although ONZETRA XSAIL is a branded product, patents and exclusivity periods influence the entry of generic competitors, affecting supply strategies and market share.

• Supply Chain Digitalization:
  Increasing adoption of serialization and track-and-trace technologies enhances supply chain transparency, helping verify authentic sources.

Conclusion

The primary supplier of ONZETRA XSAIL is Teva Pharmaceuticals, which ensures global manufacturing and quality standards. Authorized distributors such as AmerisourceBergen, McKesson, and Alliance Healthcare serve as critical links, facilitating the distribution to healthcare providers and pharmacies. The supply chain’s integrity relies on strict compliance with regulatory standards, robust logistics, and vigilant anti-counterfeiting measures. Stakeholders must verify the authenticity of sources, especially in online markets, to access genuine products. As demand grows, strengthened supply chain collaborations and regulatory adherence will remain vital to ensuring consistent access to ONZETRA XSAIL.

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Key Takeaways

• Primary Supplier: Teva Pharmaceuticals is the manufacturer and primary source for ONZETRA XSAIL, maintaining global manufacturing and quality assurance standards.
• Authorized Distributors: Major entities like AmerisourceBergen, McKesson, and Alliance Healthcare handle the product's distribution, adhering to strict compliance protocols.
• Supply Chain Stability: Manufacturing capacity, regional regulatory approvals, and logistics play pivotal roles in product availability, especially during supply disruptions.
• Ensuring Authenticity: Purchase should be only via verified channels to mitigate counterfeit risks, particularly online.
• Market Trends: Increasing global demand and digital supply chain enhancements aim to improve access but also bring challenges like patent expirations and competition.

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FAQs

1. Can I purchase ONZETRA XSAIL directly from Teva Pharmaceuticals?
No. Teva predominantly supplies ONZETRA XSAIL through authorized distributors and wholesalers. Direct consumer purchases are typically facilitated via healthcare providers and pharmacies.

2. How can I verify if a supplier is authorized to sell ONZETRA XSAIL?
Verify the supplier or distributor’s licensing through regional regulatory agencies or directly check with Teva Pharmaceuticals’ authorized distribution list, which is often published on their official website.

3. Are online platforms safe for purchasing ONZETRA XSAIL?
Only if the online platform is verified and authorized. Many online sources may sell counterfeit or expired products, risking patient safety and legal issues.

4. What regional regulations impact the distribution of ONZETRA XSAIL?
Regulatory agencies such as the FDA (USA), EMA (EU), and MHRA (UK) govern drug approval and distribution, impacting licensing, manufacturing standards, and supply permissions within respective territories.

5. How does supply chain disruption affect ONZETRA XSAIL availability?
Disruptions in raw material sourcing, manufacturing bottlenecks, or logistical challenges can lead to shortages, impacting patient access and necessitating strategic inventory management by suppliers.

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Sources
[1] Teva Pharmaceuticals Official Website. "About Us."
[2] U.S. Food and Drug Administration (FDA). "Drug Approvals and Regulations."
[3] EMA. "European Medicines Agency."
[4] Global Pharmaceutical Supply Chain Insights, 2022.