Suppliers and packagers for generic pharmaceutical drug: SUMATRIPTAN SUCCINATE

SUMATRIPTAN SUCCINATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080	NDA	GlaxoSmithKline LLC	0173-0478-00	2 SYRINGE in 1 CARTON (0173-0478-00) / .5 mL in 1 SYRINGE	1997-01-27
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080	NDA	GlaxoSmithKline LLC	0173-0479-00	2 SYRINGE in 1 PACKAGE (0173-0479-00) / .5 mL in 1 SYRINGE	1997-01-23
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080	NDA	GlaxoSmithKline LLC	0173-0739-00	2 SYRINGE in 1 PACKAGE (0173-0739-00) / .5 mL in 1 SYRINGE	2006-04-06
Glaxosmithkline	IMITREX	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080	NDA	GlaxoSmithKline LLC	0173-0739-02	2 SYRINGE in 1 CARTON (0173-0739-02) / .5 mL in 1 SYRINGE	2006-04-06

Suppliers for the Pharmaceutical Drug: Sumatriptan Succinate

Last updated: July 29, 2025

Introduction

Sumatriptan succinate is a widely prescribed medication primarily used for the acute treatment of migraine attacks and cluster headaches. As a triptan medication, it functions as a selective serotonin receptor agonist, effectively constricting cranial blood vessels to alleviate headache symptoms. Its global demand, combined with strict regulatory standards, underscores the importance of a reliable supply chain comprising numerous manufacturers and suppliers. This report examines the landscape of suppliers for sumatriptan succinate, detailing key players, manufacturing capacities, regulatory considerations, and supply chain dynamics vital for pharmaceutical companies, healthcare providers, and stakeholders seeking consistent sourcing options.

Global Manufacturing Landscape

The production of sumatriptan succinate involves complex chemical synthesis and stringent quality control, making it a specialized niche within the pharmaceutical API (Active Pharmaceutical Ingredient) sector. Several prominent pharmaceutical companies and generic API manufacturers dominate this landscape, primarily located in India, China, and Europe, reflecting the global distribution of pharmaceutical manufacturing expertise.

1. Major API Manufacturers

India

India's pharmaceutical industry, known for its generics and API manufacturing prowess, is a dominant supplier of sumatriptan succinate. Firms such as Sun Pharmaceutical Industries, Aurobindo Pharma, Cipla, and Lupin produce both APIs and finished dosage forms. Their manufacturing facilities are often compliant with ISO, WHO-GMP, and USFDA standards, facilitating global export compliance.

China

Chinese API manufacturers like Huangshan Huahong Pharmaceutical Co., Ltd. and North China Pharmaceutical Group Corp. have developed significant capacities for sumatriptan succinate synthesis, leveraging cost advantages and advanced process technologies. Regulatory oversight varies, but many factories have achieved certifications aligning with international standards.

Europe

While European firms predominantly focus on formulation and finished products, certain companies such as Teva Pharmaceuticals and Sandoz source APIs globally, including from Indian and Chinese manufacturers, due to the complex and capital-intensive nature of API synthesis.

2. Contract Manufacturing Organizations (CMOs) and API Suppliers

CMOs play a critical role in expanding production capacities, especially during supply shortages or increased demand. Companies like Famar, Patheon, and Recipharm have the technological infrastructure to produce sumatriptan succinate under strict quality controls, often working on a contractual basis with brand and generic pharmaceutical companies.

3. Key Considerations in Supplier Selection

• Regulatory Compliance: Ensuring suppliers possess relevant certifications (USFDA, EMA, WHO-GMP)
• Manufacturing Capacity: Capacity to meet global demand, especially amid surges
• Quality Control Procedures: Rigorous testing protocols for purity, stability, and consistency
• Supply Chain Security: Ability to provide uninterrupted supply and transparent logistics
• Cost and Lead Time: Competitive pricing and dependable delivery schedules

Supply Chain Dynamics and Challenges

The supply chain for sumatriptan succinate is influenced by geopolitical factors, intellectual property rights, raw material availability, and regulatory landscapes. Recent disruptions, such as the COVID-19 pandemic, have underscored vulnerabilities, prompting companies to diversify sourcing strategies. Additionally, increasing regulatory scrutiny demands adherence to Good Manufacturing Practices (GMP) and comprehensive documentation, adding to the complexity of supplier qualification.

Regulatory and Quality Assurance

Manufacturers must comply with stringent regulatory requirements set by authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). These agencies periodically audit manufacturing facilities to ensure safety, efficacy, and quality standards. Supplier audits, certification status, and batch consistency records are critical data points for downstream procurement and risk management.

Market Trends and Future Outlook

The demand for sumatriptan succinate continues to grow due to increased migraine prevalence worldwide. Innovations in formulation, such as nasal sprays and autoinjectors, necessitate high-quality APIs from reliable suppliers. Furthermore, the evolution of biosimilar and generic markets may further diversify supplier options.

Emerging markets and the push for local manufacturing are likely to influence future supply dynamics, possibly leading to new entrants and expanded capacities in Asia and Eastern Europe. Additionally, factors like supply chain digitization and advanced serialization are increasingly impacting procurement strategies.

Key Suppliers Summary Table

Supplier	Country	Certification	Production Capacity	Notable Strengths	URL (if available)
Sun Pharmaceutical Industries	India	USFDA, WHO-GMP	High	Cost-effective manufacturing	sunpharma.com
Aurobindo Pharma	India	USFDA, EMA	Moderate	Robust quality management systems	aurobindo.com
Zhejiang Hisoar Pharmaceutical	China	GMP	Growing	Competitive pricing	N/A
Teva Pharmaceuticals	Israel/Global	USFDA, EMA	Large-scale	Extensive global distribution	teva.com
Recipharm	Sweden	GMP	Variable	Flexible manufacturing	recipharm.com

Regulatory Implications for Procurement

Potential buyers must ensure suppliers maintain compliance with evolving international standards. Regulatory approvals, inspection histories, and quality certificates serve as proxies for supplier reliability. Due diligence and supplier qualification processes are non-negotiable, especially when sourcing from emerging markets.

Conclusion

The supply of sumatriptan succinate hinges on a diverse ecosystem of manufacturers predominantly based in India and China, complemented by established European and global pharmaceutical players. Ensuring a resilient, compliant, and high-quality supply chain requires meticulous supplier qualification, continuous monitoring, and diversification strategies. As demand persists and formulations diversify, the supplier landscape is poised for evolution, emphasizing the importance of robust partner relationships and compliance.

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Key Takeaways

• Diverse Supplier Base: Indian and Chinese API manufacturers dominate the sumatriptan succinate market, supported by European and global contract manufacturers.
• Regulatory Compliance Critical: Certifications like USFDA, EMA, and WHO-GMP are vital indicators of supplier reliability.
• Supply Chain Resilience: COVID-19 highlighted vulnerabilities, urging companies to diversify sourcing and establish strategic partnerships.
• Quality Assurance Central: Rigorous testing, batch validation, and audit histories underpin procurement decisions.
• Market Growth and Innovation: Increasing global migraine prevalence fuels demand, while formulation innovations influence API sourcing requirements.

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FAQs

1. What are the main regions manufacturing sumatriptan succinate APIs?
Primarily India and China, with European and North American firms sourcing from these regions, provide the bulk of global API production for sumatriptan succinate.

2. How do regulatory standards impact supplier selection?
Suppliers must adhere to international GMP standards and maintain certifications such as USFDA approval or WHO-GMP compliance, ensuring product quality and facilitating market access.

3. What are the common challenges in sourcing sumatriptan succinate?
Supply chain disruptions, regulatory compliance, raw material availability, and fluctuations in manufacturing capacity pose ongoing challenges.

4. Are there alternative suppliers to major manufacturers?
Yes. Emerging manufacturers in Southeast Asia, Eastern Europe, and through CMOs enhance diversification, though due diligence regarding quality and compliance remains essential.

5. How is the market for sumatriptan succinate expected to evolve?
Demand is expected to grow steadily, prompted by increasing migraine prevalence. Technological advancements and regulatory shifts will influence supplier dynamics in the coming years.

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References

[1] U.S. Food and Drug Administration. (2022). API Manufacturers' Compliance Data.
[2] World Health Organization. (2021). Prequalification of Active Pharmaceutical Ingredients.
[3] Indian Pharmaceutical Industry Reports. (2022). API Production and Export Statistics.
[4] Chinese Pharmaceutical Market Analysis. (2022). API Manufacturing & Certification Trends.
[5] European Medicines Agency. (2022). Good Manufacturing Practice Guidelines.