Suppliers and packagers for zomig

zomig

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA	Amneal Pharmaceuticals LLC	64896-083-12	6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY	2024-07-15
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA	Amneal Pharmaceuticals LLC	64896-084-12	6 BOTTLE, SPRAY in 1 CARTON (64896-084-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY	2024-07-15
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals NY LLC	69238-2351-6	6 BOTTLE, SPRAY in 1 CARTON (69238-2351-6) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY	2024-07-15
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals NY LLC	69238-2352-6	6 BOTTLE, SPRAY in 1 CARTON (69238-2352-6) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY	2024-07-15

Suppliers for the Pharmaceutical Drug: Zomig

Last updated: July 29, 2025

Introduction

Zomig (zolmitriptan) is a popular medication used for the acute treatment of migraine attacks, including those with aura. As a selective serotonin receptor agonist, Zomig constricts blood vessels in the brain and alleviates headache symptoms. Given its widespread use, understanding the suppliers behind Zomig is critical for stakeholders involved in procurement, distribution, and supply chain management. This analysis provides a comprehensive overview of the primary suppliers, manufacturing dynamics, and supply chain considerations for Zomig.

Manufacturers and Original Patent Holders

AstraZeneca’s Role in Zomig Production

Originally developed and marketed by AstraZeneca—one of the world's leading pharmaceutical companies—Zomig received approval in multiple markets starting in the early 2000s. AstraZeneca held the patent rights and was the principal manufacturer of Zomig until generic versions entered the market.

Patent Expiry and Generic Entrants

The expiration of AstraZeneca's patent rights in various regions has catalyzed the entry of generic manufacturers. The key patent expiries occurred around the early 2010s, enabling multiple pharmaceutical companies to produce bioequivalent versions.

Global Supply Landscape

Major Generics Manufacturers

Following patent expiry, several generic pharmaceutical companies gained approval to produce Zomig (zolmitriptan), significantly expanding the global supply chain. Notable generic producers include:

• Teva Pharmaceuticals (Israel): One of the largest generic drug manufacturers globally, Teva has obtained approvals for Zomig tablets, nasal sprays, and other formulations in various markets [1].

• Mylan (now part of Viatris): Has produced Zomig generics widely across North America and Europe, leveraging extensive manufacturing capabilities [2].

• Sandoz (Novartis division): Known for producing high-quality generics, Sandoz supplies Zomig formulations in several jurisdictions [3].

• Sun Pharma: An Indian pharmaceutical behemoth, Sun Pharma has been manufacturing zolmitriptan products for numerous markets [4].

• Lupin Limited: Another Indian company, Lupin has established a significant presence in the Zomig generic market [5].

Authorized Generics and Biosimilars

In addition to off-patent generics, AstraZeneca or other patent holders sometimes introduce authorized generics to maintain market control. While biosimilars are more relevant for biological products, traditional generics dominate the zolmitriptan supply chain.

Manufacturing Locations

Manufacturers operate facilities across North America, Europe, India, and China. These diversified manufacturing bases mitigate supply disruptions and enable broader market access.

Distribution and Supply Chain Dynamics

Distribution Channels

Zomig is distributed through pharmacies, hospitals, and clinics worldwide. Distribution partners include wholesale pharmaceutical distributors and specialty pharmacy chains. Regulatory approvals for each country influence distribution channels and supplier selection.

Supply Chain Risks

• Raw Material Availability: The active pharmaceutical ingredient (API) for zolmitriptan is synthesized in specialized facilities, often in India or China, complicating supply continuity during geopolitical or logistical disruptions.

• Manufacturing Capacity Constraints: Capacity limitations at manufacturing plants can lead to shortages, especially during sudden rises in demand or manufacturing setbacks.

• Regulatory Approvals: Variations in regulatory approval processes can delay the launch of generic versions or impact existing suppliers’ operational status.

Recent Trends and Market Dynamics

Market competition from multiple generics has driven prices down, facilitating wider accessibility. However, supply chain disruptions caused by pandemics, geopolitical tensions, or raw material shortages remain a concern. AstraZeneca’s exit from some markets and the rise of generics have shifted the supply landscape toward diversified sourcing.

Regulatory and Patent Landscape

Patent Status

Most key patents expired between 2010 and 2012 in major markets such as the US, the EU, and Japan. Consequently, a proliferation of generic manufacturers now supplies Zomig.

Regulatory Approvals for Generics

Generic companies require Abbreviated New Drug Applications (ANDAs) in the US, abbreviated as NBDS in Europe. These applications verify bioequivalence without extensive Clinical trials. Approval timelines and regulatory stringency influence supply timelines.

Emerging Considerations

• Supply Chain Transparency: Stakeholders increasingly demand transparency regarding manufacturing sites, ingredients sourcing, and quality standards.

• Sustainability Initiatives: Environmental sustainability in API manufacturing and packaging influences supplier selection.

• Innovation and Reformulation: Development of new formulations (e.g., nasal sprays, rapidly dissolving tablets) by various manufacturers expands the supplier base beyond traditional tablet producers.

Key Players Summary Table

Manufacturer	Market Presence	Notable Formulations	Geographic Focus
AstraZeneca	Original patentholder	N/A	Global (patent holder)
Teva	Leading generic producer	Tablets, nasal spray	North America, Europe, Asia
Mylan/Viatris	Extensive generics portfolio	Tablets	North America, Europe, Asia
Sandoz	High-quality generics	Tablets, nasal spray	Globally
Sun Pharma	Indian market leader	Tablets	India, emerging markets
Lupin	Growing presence	Tablets	Asia, Africa

Conclusion

The supply chain for Zomig (zolmitriptan) has transitioned from being primarily controlled by AstraZeneca to a broad network of generic manufacturers following patent expirations. Major players—Teva, Mylan/Viatris, Sandoz, Sun Pharma, and Lupin—dominate the generics landscape, augmented by regional manufacturers. While the broadening supplier base fosters competition and affordability, supply chain vulnerabilities persist, particularly related to API sourcing and manufacturing capacity. Continuous monitoring of regulatory changes, capacity expansions, and raw material availability is crucial for stakeholders involved in procurement and supply chain management.

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Key Takeaways

• Diversified Supplier Base: Multiple global manufacturers produce Zomig, reducing dependence on a single supplier but necessitating comprehensive supply chain oversight.

• Regulatory Dynamics: Patent expiries facilitated market entry for generics, but regulatory pathways and approval timelines impact supply stability.

• Supply Chain Risks: Raw material sourcing from Asia and manufacturing capacity constraints pose ongoing supply risks.

• Market Competition: Increased generic competition has driven price reductions and increased accessibility, but also requires vigilant monitoring to prevent shortages.

• Future Outlook: Emerging formulations and regional manufacturers may further diversify supply options while innovation and geopolitical factors influence market stability.

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FAQs

Q1: Who are the leading global suppliers of Zomig?

A: Key suppliers include Teva Pharmaceuticals, Mylan (Viatris), Sandoz (Novartis), Sun Pharma, and Lupin, among others.

Q2: How has patent expiry affected Zomig’s supply chain?

A: Patent expiries in the early 2010s led to a surge of generic manufacturers entering the market, broadening the supply base and reducing costs but also introducing supply chain complexities.

Q3: What are the main risks to Zomig supply stability?

A: Risks include raw material shortages from API-producing countries, manufacturing capacity limitations, geopolitical tensions, and regulatory delays.

Q4: Are there regional differences in Zomig suppliers?

A: Yes. While global companies dominate many markets, Indian firms like Sun Pharma and Lupin are significant regional suppliers, especially in Asia.

Q5: What future trends could impact Zomig supply?

A: Expansion of formulations (e.g., nasal spray options), increased regional manufacturing capacities, and evolving regulatory landscapes will shape future supply dynamics.

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References

[1] AstraZeneca Official Website. (n.d.). Zomig Product Details.

[2] Mylan Corporate Reports. (2021). Generic Zolmitriptan Approvals.

[3] Sandoz Product Portfolio. (2022). Neurology Generics.

[4] Sun Pharma Annual Report. (2022). API and Formulation Strategies.

[5] Lupin Limited. (2021). Market Approvals and Manufacturing Capabilities.