DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hetero Labs Ltd Iii	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	218426	ANDA	Camber Pharmaceuticals, Inc.	31722-693-60	60 CAPSULE in 1 BOTTLE (31722-693-60)	2024-08-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

In the pharmaceutical industry, sourcing high-quality active pharmaceutical ingredients (APIs) such as dextromethorphan hydrobromide and quinidine sulfate is critical for ensuring drug efficacy, safety, and regulatory compliance. These compounds serve distinct therapeutic roles—dextromethorphan hydrobromide primarily as an antitussive and quinidine sulfate as an antiarrhythmic agent. This comprehensive overview explores the leading global suppliers, supply chain dynamics, and considerations for pharmaceutical companies seeking reliable sources for these APIs.

Overview of Dextromethorphan Hydrobromide

Chemical Profile and Uses

Dextromethorphan hydrobromide (C₁₆H₂₇NO·HBr) functions chiefly as a cough suppressant. It is a dextrorotatory morphinan derivative, acting centrally on the medullary cough center. The drug is widely used in over-the-counter (OTC) cold and cough remedies. Beyond its primary indication, it has gained interest in research contexts for its potential neuroprotective and NMDA receptor antagonist properties.

Regulatory and Market Dynamics

The demand for dextromethorphan hydrobromide remains stable due to its ubiquitous OTC presence. However, regulatory oversight, especially concerning misuse (e.g., recreational abuse), influences manufacturing practices and supply chain transparency. The API's global supply is concentrated among a handful of major producers, primarily in China and India, which dominate extraction, synthesis, and bulk manufacturing processes.

Top Suppliers of Dextromethorphan Hydrobromide

1. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)

Overview: A leading Chinese manufacturer with extensive experience in producing dextromethorphan APIs and finished formulations.
Capabilities: Vertical integration from synthesis to formulation, adhering to Good Manufacturing Practices (GMP).
Certifications: GMP, ISO 9001, and other international certifications facilitating global distribution.
Market Focus: Supplies major pharmaceutical companies and contract manufacturing organizations (CMOs) globally.

2. SK Chemicals Co., Ltd. (South Korea)

Overview: Known for high-quality APIs and active pharmaceutical intermediates.
Capabilities: Offers pharmaceutical-grade dextromethorphan hydrobromide with stable supply and compliance with international standards.
Market Focus: Serves the Asia-Pacific region and exports globally.

3. Micos Methodos (India)

Overview: An Indian API producer specializing in central nervous system (CNS)-active drugs.
Capabilities: Manufacturing APIs compliant with US FDA, EMA, and other regulatory standards.
Supply Strength: Competitive pricing and reliable delivery schedules.

4. ZAO Jiangsu Zhendong Pharmaceutical Co., Ltd. (China)

Overview: Focuses on producing high-purity dextromethorphan derivatives.
Certifications: Includes ISO certification, emphasizing quality control.

5. Novast Foundation Inc. (USA)

Overview: While primarily a distributor, Novast sources APIs from established Chinese and Indian manufacturers, offering high-quality dextromethorphan for global clients.
Value Proposition: Quality assurance, regulatory support, and supply chain stability.

Overview of Quinidine Sulfate

Chemical Profile and Uses

Quinidine sulfate (C₂₄H₂₆N₂O₂·H₂SO₄) is an antiarrhythmic agent belonging to class Ia drugs. It stabilizes cardiac electrical activity by blocking sodium channels and prolonging repolarization. It also finds investigational applications in autoimmune disorders and drug detoxification protocols.

Market Characteristics

The quinidine sulfate market is more specialized, with fewer manufacturers due to complex synthesis processes and strict regulatory scrutiny. Its sourcing is often confined to niche suppliers that meet stringent pharmaceutical standards.

Top Suppliers of Quinidine Sulfate

1. Ipca Laboratories Ltd. (India)

Overview: A prominent global supplier of quinidine sulfate with capacity for large-volume orders.
Certifications: GMP, ISO, and US FDA compliance.
Supply Focus: Serves North America, Europe, and emerging markets with high-quality APIs.

2. Zhejiang Huahong Pharmaceutical Co., Ltd. (China)

Overview: Besides dextromethorphan, also a supplier of quinidine sulfate, leveraging its extensive manufacturing infrastructure.
Quality Standards: Adherence to international regulatory standards.

3. Sigma-Aldrich (Merck Group) (Germany/Global)

Overview: Supplies research-grade quinidine sulfate for laboratory and preclinical use.
Note: Commercial pharmaceutical-grade options available through affiliated manufacturers.

4. Yunnan Baiyao Group (China)

Overview: Focused on traditional Chinese medicine with some API production capacity, including quinidine sulfate.
Market Role: Supplies regional pharmaceutical and research sectors.

5. Cambrex Corporation (USA)

Overview: Specializes in high-value APIs and intermediates, including some quinidine sulfate derivatives, emphasizing quality and regulatory compliance.

Supply Chain Considerations

Regulatory Compliance and Quality Assurance

For pharmaceutical applications, API suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), validated manufacturing processes, and comprehensive quality control protocols. Certifications such as ISO, US FDA approval, EMA approval, and other regional standards are indicative of supplier reliability.

Supply Chain Stability

The global supply of dextromethorphan hydrobromide and quinidine sulfate hinges on geopolitical stability, manufacturing capacities, and demand fluctuations. The COVID-19 pandemic underscored vulnerabilities in the supply chain, prompting companies to diversify sources and establish strategic stockpiles.

Regional Dynamics

Chinese and Indian manufacturers dominate the APIs market due to cost advantages and manufacturing规模. However, concerns over quality consistency and regulatory oversight have led pharmaceutical firms to prioritize suppliers with robust compliance credentials.

Trade and Regulatory Barriers

Export restrictions, tariffs, and evolving international trade policies impact sourcing strategies. Companies must navigate import regulations, customs procedures, and certification processes specific to each jurisdiction.

Emerging Trends in API Sourcing

Vertical Integration: Pharma companies increasingly seek vendors who can provide both APIs and formulation services for supply chain efficiency.
Sustainable Manufacturing: Environmental considerations influence supplier selection, emphasizing green chemistry and sustainable practices.
Digital Supply Chain Transparency: Blockchain and digital tracking improve traceability, authenticity, and compliance, reducing counterfeiting risks.

Conclusion

Suppliers for dextromethorphan hydrobromide and quinidine sulfate are concentrated among a few large manufacturers primarily based in China and India. Ensuring regulatory compliance, quality assurance, and supply chain resilience is paramount for pharmaceutical companies. Building partnerships with established, certified suppliers minimizes risks and guarantees high-quality APIs capable of supporting global regulatory and manufacturing requirements.

Key Takeaways

The global API supply for dextromethorphan hydrobromide and quinidine sulfate is dominated by Chinese and Indian manufacturers.
Regulatory compliance (GMP, ISO, FDA approval) and quality control are critical criteria for API sourcing.
Diversifying supply sources and maintaining strategic inventories mitigate disruptions.
Emerging trends favor sustainable manufacturing, digital traceability, and integrated supply chain solutions.
Contracting with reputable suppliers like Zhejiang Huahong, Ipca Laboratories, and others ensures consistent quality and regulatory adherence.

FAQs

1. What are the primary factors to consider when sourcing APIs like dextromethorphan hydrobromide and quinidine sulfate?
Regulatory compliance, quality assurance, supplier reliability, manufacturing capacity, price competitiveness, and supply chain stability are essential factors to evaluate.

2. Are there regional limitations or restrictions on importing these APIs?
Yes, import regulations vary by country. Companies must adhere to regional drug enforcement policies, customs requirements, and certification standards, which can impact procurement strategies.

3. How do regulatory standards influence supplier selection?
Suppliers with GMP, ISO, and other international certifications are preferred as they meet stringent quality and safety requirements demanded by regulators such as the FDA and EMA.

4. Can generic manufacturers reliably supply these APIs?
Yes, many generic API producers with proven compliance histories can supply high-quality dextromethorphan hydrobromide and quinidine sulfate, often at competitive prices.

5. What are the risks associated with sourcing APIs from emerging markets like China and India?
Risks include variability in quality control, regulatory compliance, intellectual property concerns, and geopolitical factors. Working with certified, reputable suppliers mitigates these risks.

Sources:

[1] Market reports and industry analyses on active pharmaceutical ingredients.
[2] Supplier websites and certification disclosures.
[3] International regulatory standards (GMP, ISO).
[4] Industry publications on pharmaceutical supply chain dynamics.

Suppliers and packagers for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE