Suppliers and packagers for qulipta

qulipta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7094-04	4 TABLET in 1 BOTTLE (0074-7094-04)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7094-30	30 TABLET in 1 BOTTLE (0074-7094-30)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7095-30	30 TABLET in 1 BOTTLE (0074-7095-30)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7096-04	4 TABLET in 1 BOTTLE (0074-7096-04)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7096-30	30 TABLET in 1 BOTTLE (0074-7096-30)	2021-09-30

Suppliers for the Pharmaceutical Drug: Qulipta

Last updated: July 29, 2025

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Introduction

Qulipta (atogepant) is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) in September 2021 for the preventive treatment of episodic migraine in adults. As a novel oral medication, Qulipta’s manufacturing and distribution depend heavily on a complex supply chain involving multiple suppliers for Active Pharmaceutical Ingredients (APIs), excipients, formulation, packaging, and distribution. This analysis provides a comprehensive overview of the key suppliers involved in Qulipta’s production, emphasizing sourcing strategies, market competition, supply chain risks, and potential implications for stakeholders.

Overview of Qulipta’s Manufacturing Components

Qulipta’s manufacturing process involves several critical components:

• Active Pharmaceutical Ingredient (API): Atogepant
• Excipients: Inactive ingredients that facilitate drug stability, bioavailability, and manufacturability
• Formulation and Packaging Materials
• Distribution Logistics

Among these, the API procurement is the most complex and vital component, often dictating supply stability and pricing.

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API Suppliers for Qulipta (Atogepant)

Manufacturers of Atogepant API

The API for Qulipta, atogepant, is produced primarily by pharmaceutical contract manufacturing organizations (CMOs) specializing in complex synthetic processes. As of its approval and subsequent commercialization, key API suppliers include:

• AbbVie’s In-House API Manufacturing:
  It is common for pharmaceutical companies to vertically integrate or outsource API manufacturing. Given AbbVie’s size and expertise, it is likely that the primary API production occurs within the company’s manufacturing facilities or through dedicated CMOs under strict quality agreements. There are reports suggesting that AbbVie relies on multiple, globally located CMOs to mitigate supply risks.

• Contract Manufacturing Organizations (CMOs):
  The specific CMOs for atogepant API have not been publicly disclosed in detail. However, based on industry standards, leading global API producers such as Samsung Biologics, Fujifilm Diosynth, and Lonza often serve as API suppliers for CNS-active compounds, including CGRP antagonists.
  Also, Hikal Ltd. and Hovione are known suppliers of similar peptidomimetic and small-molecule APIs, potentially implicated in the supply chain.

Supply Chain Risks and Challenges

• Complex Synthesis:
  The synthesis of atogepant involves multi-step chemical processes with specialized intermediates, making manufacturing sensitive to disruptions.

• Regulatory Scrutiny:
  API suppliers are subject to rigorous cGMP compliance, and any lapses can endanger supply continuity.

• Global Supply Chain Disruptions:
  COVID-19-related disruptions and geopolitical issues affect raw material sourcing and manufacturing output, increasing supply chain volatility.

Excipients and Formulation Components

While the focus lies primarily on API sources, excipients and formulation materials are often sourced from specialized chemical companies. Companies like Dow, Merck, and BASF provide pharmaceutical excipients involved in drug formulation. The robustness of these supply chains influences overall manufacturing stability.

Packaging and Distribution Suppliers

• Packaging Suppliers:
  Pharmaceutical-grade packaging is procured from firms such as Gerresheimer, West Pharmaceutical Services, and Nipro, providing components like blisters, bottles, and caps with strict quality standards.

• Logistics Providers:
  Major logistics companies such as DHL, FedEx, and UPS manage temperature-controlled distribution, critical for maintaining drug stability across the supply chain.

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Market Dynamics and Supplier Competition

The limited pool of high-quality API manufacturers for complex small molecules like atogepant generates competition-based pricing and supply constraints. Collaborations or sole-source arrangements heighten dependency risks, emphasizing the importance of diversified sourcing strategies. Industry consolidation and manufacturing capacity limitations pose ongoing risks to manufacturing continuity.

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Regulatory Implications and Supply Chain Transparency

Regulatory authorities increasingly demand transparency on supply sources to ensure product integrity. Suppliers with strong regulatory compliance histories, proven quality systems, and robust capacity are preferred. Manufacturers and licensors typically conduct rigorous audits and monitor supplier performance periodically.

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Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Should foster multiple supplier relationships or in-house capabilities to prevent shortages.
• Investors: Must consider potential supply chain bottlenecks when evaluating market entry and growth prospects.
• Patients and Healthcare Providers: Rely on supply chain stability to ensure uninterrupted access to Qulipta.

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Conclusion

Qulipta’s production hinges on a sophisticated, multi-layered supply chain involving specialized API manufacturers, excipient providers, packaging firms, and logistics providers. While specific supplier identities are closely guarded for strategic reasons, industry insights suggest reliance on top-tier CMOs for high-quality API synthesis and diversified sourcing to mitigate risks. The ongoing global supply chain challenges necessitate vigilant management and strategic partnerships to sustain Qulipta’s availability in the competitive migraine treatment landscape.

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Key Takeaways

• API sourcing for Qulipta relies heavily on CMOs specializing in complex small-molecule synthesis, with no exclusive supplier publicly confirmed.
• Diversification of API and excipient supply sources is critical to mitigate manufacturing disruptions.
• Global supply chain volatility, regulatory scrutiny, and capacity constraints heighten risks for pharmaceutical supply continuity.
• Strategic collaborations and robust quality assurance practices underpin the stability of Qulipta’s supply chain.
• Transparency and regulatory compliance are increasingly essential for maintaining market approval and patient trust.

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FAQs

1. Who are the primary API suppliers for Qulipta?
The specific API manufacturer for atogepant remains undisclosed publicly; however, global CMOs such as Samsung Biologics, Fujifilm Diosynth, and Lonza are typical suppliers for complex small-molecule APIs in the industry.

2. Can supply chain disruptions impact Qulipta availability?
Yes. Disruptions in raw material sourcing, manufacturing capacity, or regulatory issues can lead to shortages or delays in availability.

3. Are there multiple sources for the excipients used in Qulipta?
While detailed ingredient sourcing is proprietary, pharmaceutical excipients are generally sourced from established chemical suppliers like Dow or BASF to ensure quality and supply stability.

4. How do regulatory agencies oversee supply chain integrity for Qulipta?
Regulatory bodies such as the FDA mandate rigorous cGMP compliance and conduct audits of manufacturing sites to certify supply chain integrity and product quality.

5. How might supply chain issues affect the market dynamics for Qulipta?
Supply limitations can impact pricing, market penetration, and patient access, potentially encouraging companies to seek alternative suppliers or develop in-house manufacturing capabilities.

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Sources

[1] FDA Approval Announcement for Qulipta (2021).
[2] Industry reports on CGRP antagonist manufacturing.
[3] Public disclosures from AbbVie regarding API manufacturing partnerships.
[4] Leading pharmaceutical excipient supplier global data.
[5] Supply chain risk analyses for small-molecule pharmaceuticals.