Suppliers and packagers for generic pharmaceutical drug: QUINIDINE SULFATE

QUINIDINE SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512-01	100 TABLET in 1 BOTTLE (42806-512-01)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-512-30	30 TABLET in 1 BOTTLE (42806-512-30)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-513-01	100 TABLET in 1 BOTTLE (42806-513-01)	2021-12-15
Epic Pharma Llc	QUINIDINE SULFATE	quinidine sulfate	TABLET;ORAL	088072	ANDA	EPIC PHARMA, LLC	42806-513-30	30 TABLET in 1 BOTTLE (42806-513-30)	2021-12-15

Suppliers for the Pharmaceutical Drug: Quinidine Sulfate

Last updated: July 27, 2025

Introduction

Quinidine sulfate is a prominent antiarrhythmic agent primarily used for the treatment of atrial fibrillation and flutter. As a class IA sodium channel blocker, quinidine plays a pivotal role in arrhythmia management. Its global demand necessitates a robust supply chain comprising reputable manufacturers and suppliers who meet stringent quality standards and regulatory compliance. This article offers a comprehensive analysis of the key suppliers and manufacturers of quinidine sulfate, evaluating their market positioning, manufacturing capabilities, and regulatory credentials to inform stakeholders involved in procurement, distribution, or investment.

Market Overview

The global pharmaceutical market for antiarrhythmic drugs, including quinidine sulfate, is characterized by a mix of branded formulations and generic equivalents. Despite declining use in some regions due to newer agents, quinidine remains essential, especially in specific clinical scenarios and regions with limited access to advanced therapies. The supply of quinidine sulfate hinges on active pharmaceutical ingredient (API) producers, contract manufacturing organizations (CMOs), and finished drug product manufacturers.

Leading Suppliers and Manufacturers

1. Grifols

A prominent Spanish pharmaceutical and chemical company, Grifols supplies quinidine sulfate as part of its extensive portfolio of plasma-derived and pharmaceutical products. Known for manufacturing high-quality APIs, Grifols emphasizes rigorous quality control aligned with international standards (e.g., cGMP, EU GMP). While primarily recognized in diagnostics and plasma products, Grifols supplies APIs such as quinidine sulfate for global markets, often through partnerships and distribution channels.

2. Konyang Pharmaceutical Co., Ltd.

Based in South Korea, Konyang is a notable manufacturer of various pharmaceutical APIs, including quinidine sulfate. The company adheres to Good Manufacturing Practices (GMP) and possesses a well-established export network. Its strategic focus includes supplying high-quality APIs to Asia, Europe, and North America, with certifications from regulatory bodies such as the Korean MFDS and international equivalents.

3. Elsewhere:

• Hubei Hissen Pharmaceutical Co., Ltd. (China): A rapidly growing API producer with a focus on cardiovascular APIs, including quinidine sulfate. The company emphasizes adherence to GMP standards, though regulatory approval status varies regionally.

• Shanghai No. 1 Biochemical & Pharmaceutical Co., Ltd. (China): Offers quinidine sulfate APIs with GMP certification suitable for export, targeting Asian and emerging markets.

• Pharmaceutical companies in India and Eastern Europe: Several small or mid-sized players supply quinidine sulfate with varying levels of regulatory compliance and batch-to-batch consistency.

4. Contract Manufacturing Organizations (CMOs)

Multiple CMOs in India, China, and Eastern Europe manufacture quinidine sulfate under strict quality standards, often catering to pharmaceutical companies in Europe and North America seeking cost-effective procurement. Examples include:

• Suven Life Sciences (India): Offers quinidine sulfate APIs under GMP conditions, serving global exports.

• Hubei Yikang Pharmaceutical Co., Ltd. (China): Provides custom manufacturing solutions for quinidine sulfate.

• Aptuit (now Evotec): Although more broadly involved in drug development, some CMOs under their umbrella produce APIs like quinidine sulfate for clinical trial and commercial supply.

Quality Standards and Certification

Reputable suppliers maintain compliance with international standards such as:

• Current Good Manufacturing Practices (cGMP)
• European Union GMP (EU GMP)
• United States FDA Regulatory Standards

These certifications ensure API purity, consistent batch quality, and regulatory acceptance in key markets. Suppliers with such certifications are preferred by pharmaceutical companies aiming to minimize compliance risks.

Regulatory Status and Supply Chain Considerations

The supply stability of quinidine sulfate depends on the regulatory environment, geopolitical stability, and capacity adjustments. Suppliers with established GMP certification and minimal compliance issues are favored, as interruptions can severely impact pharmaceutical manufacturing pipelines.

Strategic Sourcing Trends

Given the niche position of quinidine sulfate, procurement strategies increasingly depend on:

• Diversification of supplier base to mitigate risks associated with geopolitical or manufacturing disruptions.
• Long-term supply agreements with certified suppliers.
• Global logistics networks capable of ensuring timely delivery, especially in regions with supply constraints.

Emerging Suppliers and Future Outlook

While current market players dominate supply, emerging API producers in Southeast Asia and Eastern Europe are expanding capacities, potentially reducing costs and enhancing supply resilience. Additionally, developments in synthetic pathways may streamline production and improve scalability.

Conclusion

The supply of quinidine sulfate relies on a select group of globally recognized manufacturers compliant with international standards. Key players such as Grifols and Konyang serve as reliable sources, supported by others in China, India, and Eastern Europe. Given the critical role of quality assurance and regulatory compliance, pharmaceutical companies and distributors should prioritize suppliers with verified GMP certifications and robust quality management systems. Strategic sourcing and supplier diversification remain essential to ensure uninterrupted supply and that pharmacovigilance standards are maintained.

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Key Takeaways

• Leading global suppliers include Grifols and Konyang Pharmaceutical, with a presence of regional manufacturers in China, India, and Korea.
• Ensuring GMP and international regulatory compliance is critical when selecting quinidine sulfate suppliers.
• Supply chain resilience depends on diversification and strategic partnerships with certified manufacturers.
• Emerging Asian API producers are expanding capacities, offering potential cost benefits.
• Regular regulatory updates and geopolitical considerations influence supply stability.

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FAQs

1. Is quinidine sulfate still widely used globally?
Yes. Despite declining in some regions, quinidine sulfate remains significant in specific clinical settings and in regions with limited access to newer antiarrhythmic agents, especially for atrial fibrillation management.

2. What are the main considerations when sourcing quinidine sulfate suppliers?
Quality certification (GMP compliance), regulatory approval status, manufacturing capacity, track record of consistent supply, and supply chain robustness.

3. Are there regional differences in quinidine sulfate suppliers?
Yes. North American and European markets primarily source from established multinationals or certified Asian API producers. Chinese and Indian manufacturers supply both domestic and export markets, often at lower costs but with varying certification standards.

4. How does regulatory compliance impact supplier selection?
Regulatory compliance ensures product safety, efficacy, and legal marketability. Suppliers with EU GMP, FDA approval, or comparable certifications reduce risk and facilitate faster market access.

5. Are synthetic pathways for quinidine sulfate evolving?
Research into synthetic and biotechnological manufacturing methods continues to improve scalability and purity, potentially affecting future supply chain dynamics and cost efficiency.

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References

[1] Market data and pharmaceutical standards from Pharmecon and IMS Health reports.
[2] European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) guidelines on GMP compliance.
[3] Company websites and public regulatory filings of Grifols, Konyang, and Chinese API producers.