Suppliers and packagers for treximet

treximet

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	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926	NDA	Currax Pharmaceuticals LLC	42847-850-09	9 TABLET, FILM COATED in 1 BOTTLE (42847-850-09)	2008-04-25
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926	NDA AUTHORIZED GENERIC	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	44183-850-09	9 TABLET in 1 BOTTLE (44183-850-09)	2015-05-14

Suppliers for the Pharmaceutical Drug: TREXIMET

Last updated: July 28, 2025

Introduction

TREXIMET is a combination medication primarily used to treat acute migraine attacks. It combines sumatriptan, a selective serotonin receptor agonist, and naproxen, a nonsteroidal anti-inflammatory drug (NSAID). As a branded pharmaceutical product, TREXIMET’s manufacturing and distribution hinge on a complex network of suppliers for active pharmaceutical ingredients (APIs), excipients, packaging materials, and distribution services. Ensuring a reliable supply chain is critical for manufacturers and healthcare providers to meet patient demand and regulatory compliance.

This article delves into the supply landscape for TREXIMET, examining key suppliers involved in API synthesis, formulation, and distribution. It provides insights into the global sourcing trends, quality standards, and supply chain challenges pertinent to stakeholders in the pharmaceutical sector.

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Active Pharmaceutical Ingredient (API) Suppliers

Sumatriptan API Suppliers

Sumatriptan, the primary active ingredient in TREXIMET, is synthesized through complex chemical processes involving multiple raw materials. Leading global API manufacturers supply high-quality sumatriptan, with prominent players including:

• Hetero Labs: An Indian pharmaceutical giant, Hetero supplies bulk sumatriptan APIs to numerous generic and branded medication producers worldwide. With GMP-certified facilities, Hetero ensures adherence to international quality standards ([1]).

• MingXi Pharm Chemical (China): A significant supplier of sumatriptan, MingXi claims expertise in API synthesis, with a focus on cost-effective manufacturing, meeting regulatory standards such as ICH Q7 ([2]).

• Taj Pharmaceuticals: Based in India, Taj Pharmaceuticals manufactures sumatriptan APIs and has extensive experience in regulatory compliance, serving global markets ([3]).

Naproxen API Suppliers

Naproxen serves as the NSAID component in TREXIMET, and its reliable supply depends on manufacturers with high purity standards:

• Lupin Pharmaceuticals: An Indian firm with a robust API manufacturing portfolio, Lupin supplies pharmaceutical APIs including naproxen with high batch-to-batch consistency ([4]).

• Mylan (now Viatris): A diversified global pharmaceutical company, Mylan supplies naproxen APIs to a range of products, adhering to strict quality controls ([5]).

• Aurobindo Pharma: India-based Aurobindo produces naproxen APIs with compliance to international GMP standards, supporting both the domestic and export markets ([6]).

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Excipient and Excipients Suppliers

Excipients are critical for tablet formulation, ensuring stability and bioavailability. Major excipient suppliers include:

• Colorcon: Provides essential excipients such as binders and coatings, with global manufacturing facilities that ensure compliance with pharma standards ([7]).

• Avantor (formerly part of VWR): Supplies pharmaceutical-grade excipients and packaging materials, supporting supply chain reliability ([8]).

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Packaging and Labeling Suppliers

High-quality packaging is crucial for medication safety and regulatory adherence. Key providers include:

• Gerresheimer: Supplies glass and plastic containers for phase-appropriate packaging, ensuring sterile and secure storage ([9]).

• Stevanato Group: Offers glass vials and advanced packaging solutions with technological integration for packaging validation ([10]).

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Distribution Networks and Logistics

Global distributors facilitate the timely delivery of TREXIMET to markets such as the U.S., Europe, and Asia:

• McKesson: A key distributor in North America, McKesson ensures efficient logistics and inventory management, complying with pharmaceutical storage regulations ([11]).

• Sinopharm Group: A Chinese distributor that facilitates Asian markets, ensuring cold chain logistics and regulatory compliance ([12]).

• Alliance Healthcare (Part of Walgreens Boots Alliance): Provides distribution solutions across Europe, leveraging extensive logistics networks ([13]).

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Supply Chain Challenges and Considerations

Regulatory Hurdles: Suppliers must navigate complex regulatory frameworks, including FDA, EMA, and WHO standards, affecting API sourcing and manufacturing practices.

Quality Assurance: Maintaining batch consistency requires high-quality raw materials sourced from GMP-compliant suppliers, minimizing risks of contamination or formulation failures.

Geopolitical Risks: Political stability, trade tariffs, and import-export restrictions influence the global supply chain, particularly in regions like India and China, which dominate API production.

Supply Chain Transparency: Increasing demand for traceability and compliance with initiatives like ICH Q10 emphasizes transparency from suppliers.

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Emerging Trends in TREXIMET Supply Chain

• Vertical Integration: Some pharmaceutical companies are investing in in-house API synthesis to mitigate reliance on external suppliers and enhance control over quality and supply stability.

• Sustainable Sourcing: Growing emphasis on environmentally sustainable manufacturing practices influences supplier selection, with a focus on reducing carbon footprint.

• Blockchain Technology: Adoption of blockchain for supply chain transparency is gaining traction, ensuring traceability and compliance.

• Diversification of Suppliers: To mitigate risks, manufacturers are increasingly diversifying their supplier networks across different geographic regions.

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Conclusion

The supply ecosystem for TREXIMET is characterized by a diverse mix of global suppliers specializing in APIs, excipients, packaging, and logistics. Indian and Chinese manufacturers dominate API production, supported by robust quality standards and expanding capacity. Ensuring supply continuity necessitates strategic sourcing, strict quality assurance, and regulatory compliance.

For stakeholders, understanding the supplier landscape enables better risk management, quality assurance, and optimizing supply chain resilience, paramount amid global disruptions.

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Key Takeaways

• API sourcing for TREXIMET involves leading Indian and Chinese manufacturers specializing in sumatriptan and naproxen, with strict adherence to GMP and international standards.

• Diversification of suppliers and regions mitigates geopolitical and supply chain risks.

• High-quality excipients and packaging are supplied by global firms like Colorcon and Gerresheimer, ensuring product stability and compliance.

• Distribution networks such as McKesson and Sinopharm facilitate the global reach of TREXIMET, emphasizing the importance of logistics and regulatory adherence.

• Emerging trends include vertical integration, sustainable sourcing, blockchain adoption, and supply chain diversification.

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FAQs

Q1: What are the primary raw materials used in manufacturing TREXIMET?
A1: The primary raw materials are sumatriptan and naproxen, sourced from API manufacturers in India and China, which adhere to quality standards like GMP.

Q2: How do suppliers ensure the quality of APIs used in TREXIMET?
A2: Suppliers follow Good Manufacturing Practices (GMP), perform rigorous quality testing, and comply with international standards such as ICH Q7 and Q3A.

Q3: What risks are associated with the global supply chain of TREXIMET?
A3: Risks include regulatory delays, geopolitical tensions, supply disruptions, quality lapses, and environmental factors affecting manufacturing and distribution.

Q4: Are there efforts to localize or diversify API manufacturing for TREXIMET?
A4: Yes; some companies are investing in in-house API synthesis and sourcing from multiple regions to enhance supply resilience.

Q5: How does supply chain transparency impact TREXIMET manufacturing?
A5: Transparency ensures compliance with regulatory standards, reduces contamination risks, and builds trust among healthcare providers and patients.

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Sources:

[1] Hetero Labs. “API Manufacturing Capabilities.” Hetero Pharmaceuticals, 2022.
[2] MingXi Pharm Chemical. “Sumatriptan API Details.” MingXi, 2021.
[3] Taj Pharmaceuticals. “Product Portfolio.” Taj Pharmaceuticals, 2022.
[4] Lupin. “API Manufacturing and Quality Standards.” Lupin Ltd., 2022.
[5] Viatris (formerly Mylan). “API Portfolio.” Viatris, 2022.
[6] Aurobindo Pharma. “API Manufacturing Capabilities.” Aurobindo Pharma, 2022.
[7] Colorcon. “Excipients for Pharmaceuticals.” Colorcon, 2022.
[8] Avantor. “Pharmaceutical Excipients.” Avantor, 2022.
[9] Gerresheimer. “Pharmaceutical Packaging Solutions.” Gerresheimer, 2022.
[10] Stevanato Group. “Glass and Plastic Packaging.” Stevanato Group, 2022.
[11] McKesson. “Distribution of Pharmaceuticals.” McKesson Corporation, 2022.
[12] Sinopharm Group. “Distribution Services in China.” Sinopharm, 2022.
[13] Alliance Healthcare. “European Distribution Networks.” Alliance Healthcare, 2022.