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

Subscribe to access the full database, or Start Trial
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
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Otsuka America Pharmaceutical, Inc	59148-053-16	60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16)	2023-01-03
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Otsuka America Pharmaceutical, Inc	59148-053-98	4 CARTON in 1 BOX (59148-053-98) / 1 BOTTLE in 1 CARTON (59148-053-07) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE	2023-01-03
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Avanir Pharmaceuticals, Inc.	64597-301-13	1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE	2010-12-01
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879	NDA	Avanir Pharmaceuticals, Inc.	64597-301-60	60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60)	2010-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

What are the Key Suppliers for Dextromethorphan Hydrobromide and Quinidine Sulfate?

The pharmaceutical supply chain for dextromethorphan hydrobromide (DXM HBr) and quinidine sulfate is characterized by a concentrated number of manufacturers, particularly for the active pharmaceutical ingredients (APIs). These APIs are critical for the production of medications used in treating conditions such as cough suppression and certain cardiac arrhythmias. The market dynamics are influenced by regulatory requirements, manufacturing complexity, and global demand.

Dextromethorphan Hydrobromide (DXM HBr) Suppliers

DXM HBr is a widely used antitussive agent. Its synthesis involves multiple steps, and several companies specialize in its production. Key suppliers include:

Hubei Biocause Pharmaceutical Co., Ltd.: This Chinese company is a significant producer of DXM HBr. They operate large-scale manufacturing facilities and adhere to international quality standards. Their production capacity is substantial, serving both domestic and international markets. Hubei Biocause holds Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for DXM HBr, indicating compliance with European regulatory standards. [1]
Anqiu Lu'an Pharmaceutical Co., Ltd.: Another prominent Chinese manufacturer, Anqiu Lu'an Pharmaceutical is a key supplier of DXM HBr. The company emphasizes quality control and regulatory compliance in its production processes. They also export their products globally.
Shandong Xinhua Pharmaceutical Co., Ltd.: This established Chinese pharmaceutical company produces a range of APIs, including DXM HBr. Xinhua Pharmaceutical is known for its extensive experience in API manufacturing and its commitment to Good Manufacturing Practices (GMP).
Encay S.A.: Based in Argentina, Encay S.A. is a supplier of pharmaceutical ingredients, including DXM HBr. They cater to markets in Latin America and beyond, focusing on quality and reliability.
Novartis AG: While not exclusively an API manufacturer for DXM HBr, major pharmaceutical companies like Novartis may have internal production or strategic partnerships for key APIs used in their finished drug products, such as those containing dextromethorphan. However, dedicated API suppliers are more common for this ingredient.

The global production of DXM HBr is largely concentrated in China, with manufacturers benefiting from economies of scale and a robust chemical industry infrastructure. Pricing for DXM HBr can fluctuate based on raw material costs, production capacity, and global demand.

Quinidine Sulfate Suppliers

Quinidine sulfate is an antiarrhythmic drug used to treat certain types of irregular heartbeats. Its production is more specialized, and the supplier base is more limited compared to DXM HBr.

Taipei Pharmaceutical Co., Ltd.: This Taiwanese company is a recognized supplier of quinidine sulfate API. They have a history of manufacturing high-quality pharmaceutical ingredients and are a notable player in the global quinidine market.
Siegfried AG: Siegfried is a Swiss company that offers contract manufacturing and API development. While they may not be a primary listed supplier of quinidine sulfate, their capabilities in complex API synthesis mean they could be a producer or have the capacity to produce it for specific clients. Siegfried operates globally, with manufacturing sites in Europe and North America.
Major Pharmaceutical Companies (Internal Production/Partnerships): Similar to DXM HBr, large pharmaceutical companies that market quinidine sulfate-containing products may have internal manufacturing capabilities or exclusive supply agreements. However, for the broader market, dedicated API manufacturers are crucial.

The supply of quinidine sulfate is more constrained due to the specific manufacturing processes and lower overall global demand compared to widely used antitussives. Regulatory scrutiny for cardiac drugs is typically high, requiring manufacturers to maintain rigorous quality standards.

What are the Regulatory Considerations for These APIs?

Regulatory compliance is paramount for both DXM HBr and quinidine sulfate API manufacturers. Key regulatory bodies and requirements include:

Food and Drug Administration (FDA) - United States: Manufacturers supplying to the US market must comply with FDA’s Current Good Manufacturing Practices (cGMP) regulations. APIs must be registered with the FDA, and Drug Master Files (DMFs) are often submitted to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. [2]
European Medicines Agency (EMA) - Europe: For the European market, APIs must comply with EU GMP guidelines. Manufacturers can obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM). A CEP certifies that the quality of a substance is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia. [3]
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH guidelines, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), provide a harmonized approach to API GMP, which is adopted by regulatory authorities in many countries. [4]
Other National Regulatory Authorities: Manufacturers must also adhere to the specific regulations of other countries where their products are marketed, including those set by agencies in Japan (PMDA), Canada (Health Canada), and others.

The complexity of regulatory filings and the ongoing need for compliance create barriers to entry and necessitate significant investment in quality systems for API manufacturers.

What are the Market Dynamics and Trends?

The market for DXM HBr and quinidine sulfate is influenced by several factors:

Demand for Finished Products: The primary driver of API demand is the market for prescription and over-the-counter (OTC) medications containing these active ingredients. For DXM HBr, demand is linked to the prevalence of cough and cold symptoms. For quinidine sulfate, demand is tied to the incidence of specific cardiac arrhythmias.
Generic Competition: Both DXM HBr and quinidine sulfate are available as generic drugs, which contributes to price competition among API suppliers. The expiration of patents for branded formulations has opened the market to generics, increasing the importance of cost-effective API production.
Supply Chain Resilience: Recent global events have highlighted the importance of supply chain resilience. Pharmaceutical companies are increasingly seeking diversified supplier bases and exploring regional manufacturing options to mitigate risks associated with single-source dependencies or geopolitical instability. This could lead to opportunities for suppliers outside of the historically dominant regions.
Quality and Compliance Focus: Regulatory bodies continue to increase scrutiny on API quality. Suppliers with strong compliance records and robust quality management systems are favored. Any instances of non-compliance or recalls can significantly impact a supplier's reputation and market access.
Cost Pressures: Pharmaceutical companies face ongoing pressure to reduce costs. This translates to API suppliers needing to optimize their manufacturing processes and supply chains to offer competitive pricing without compromising quality.

What are the Potential Risks and Considerations for Procurement?

Procuring these APIs involves several risks that businesses must manage:

Supplier Reliability and Quality: Ensuring consistent quality and reliable supply from manufacturers is critical. This requires thorough due diligence, including site audits, review of quality documentation (e.g., Certificates of Analysis, batch records), and assessment of regulatory compliance history.
Geopolitical and Regulatory Risks: Concentration of manufacturing in specific regions, such as China for DXM HBr, introduces geopolitical risks. Changes in trade policies, tariffs, or export restrictions can disrupt supply. Similarly, evolving regulatory requirements can impact manufacturing processes and market access.
Price Volatility: The prices of APIs can be subject to volatility due to fluctuations in raw material costs, energy prices, and changes in global supply and demand. Contractual agreements should account for potential price adjustments and include mechanisms for transparent pricing.
Lead Times and Inventory Management: Long lead times for API production and international shipping necessitate effective inventory management strategies to avoid stockouts or excessive holding costs.
Intellectual Property and Exclusivity: While DXM HBr and quinidine sulfate are off-patent for their basic chemical entities, specific manufacturing processes or polymorphic forms may be subject to patent protection. Understanding the IP landscape is important for both API manufacturers and finished product developers.

Key Takeaways

The supply landscape for dextromethorphan hydrobromide is dominated by a few large manufacturers, primarily in China, with Hubei Biocause Pharmaceutical and Anqiu Lu'an Pharmaceutical being significant players.
Quinidine sulfate suppliers are more limited, with Taipei Pharmaceutical Co., Ltd. being a notable manufacturer.
Strict adherence to GMP and regulatory requirements from bodies like the FDA and EMA is essential for API manufacturers.
Market dynamics are driven by generic competition, demand for finished products, and a growing emphasis on supply chain resilience and quality.
Procurement risks include supplier reliability, geopolitical factors, price volatility, and lead times, necessitating robust due diligence and contract management.

FAQs

Are there any alternative APIs that can substitute for dextromethorphan hydrobromide in cough formulations? While other antitussives exist (e.g., codeine, pholcodine), their regulatory status and pharmacological profiles differ. Dextromethorphan hydrobromide is widely favored for its efficacy and safety profile in OTC products. Substitution would require significant reformulation and regulatory re-approval.
What is the typical shelf life of these APIs? The typical shelf life for both dextromethorphan hydrobromide and quinidine sulfate APIs, when stored under recommended conditions, is generally between two to five years. Specific expiry dates are determined by the manufacturer and validated through stability studies.
How does the synthesis of quinidine sulfate differ from that of dextromethorphan hydrobromide? Dextromethorphan hydrobromide is synthesized from petrochemical precursors through a multi-step organic synthesis process. Quinidine sulfate is a naturally derived alkaloid, typically extracted from cinchona bark, and then further processed and purified. The extraction and purification process for quinidine is complex and dependent on botanical sourcing.
Are there any significant price differences between dextromethorphan hydrobromide and quinidine sulfate APIs? Generally, dextromethorphan hydrobromide APIs tend to be more competitively priced due to higher production volumes and a more concentrated manufacturing base with economies of scale. Quinidine sulfate APIs are typically more expensive due to lower production volumes, more specialized manufacturing processes, and a more limited supplier pool.
What is the typical minimum order quantity (MOQ) for these APIs from major suppliers? Minimum Order Quantities (MOQs) can vary significantly between suppliers and depend on packaging size, production batch sizes, and customer agreements. For bulk API purchases, MOQs can range from tens of kilograms to several metric tons, particularly for high-volume products like dextromethorphan hydrobromide. For less common APIs like quinidine sulfate, MOQs might be lower but priced at a premium.

Citations

[1] Hubei Biocause Pharmaceutical Co., Ltd. (n.d.). Product Information: Dextromethorphan Hydrobromide. Retrieved from [Manufacturer's website or relevant industry directory - specific URL not provided as it is proprietary information typically accessed through B2B platforms or direct contact].

[2] U.S. Food & Drug Administration. (2019). Guidance for Industry: Drug Master Files: A Report: Content and Format. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-master-files-report-content-and-format

[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificates of Suitability to the European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/certificates-suitability-european-pharmacopoeia

[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2000). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

Suppliers and packagers for generic pharmaceutical drug: DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE