Suppliers and packagers for GUAIFENESIN

GUAIFENESIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Walgreens	0363-0832-14	14 BLISTER PACK in 1 CARTON (0363-0832-14) / 1 TABLET in 1 BLISTER PACK	2018-08-31
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Walgreens	0363-0832-28	28 BLISTER PACK in 1 CARTON (0363-0832-28) / 1 TABLET in 1 BLISTER PACK	2018-08-31
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Walgreens	0363-0931-10	100 BLISTER PACK in 1 CARTON (0363-0931-10) / 1 TABLET in 1 BLISTER PACK	2018-08-31
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Walgreens	0363-0931-20	20 BLISTER PACK in 1 CARTON (0363-0931-20) / 1 TABLET in 1 BLISTER PACK	2018-08-31
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Walgreens	0363-0931-40	40 BLISTER PACK in 1 CARTON (0363-0931-40) / 1 TABLET in 1 BLISTER PACK	2018-08-31
Amneal Pharms	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	207342	ANDA	Rugby Laboratories, Inc.	0536-1163-61	100 BLISTER PACK in 1 CARTON (0536-1163-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2018-08-31

Guaifenesin Drug Suppliers: Market Overview and Key Players

Last updated: February 19, 2026

Guaifenesin, an expectorant used in cough and cold medications, has a stable global supply chain primarily driven by active pharmaceutical ingredient (API) manufacturers in Asia. Key producers are located in China and India, with a smaller but significant presence in Europe. The market is characterized by established manufacturers with long-term supply agreements and a focus on quality control and regulatory compliance. Pricing is competitive, influenced by raw material costs and production volumes.

What is the Global Supply Landscape for Guaifenesin API?

The global supply of guaifenesin API is concentrated among a limited number of large-scale manufacturers, predominantly in China and India. These regions benefit from lower manufacturing costs and established infrastructure for chemical synthesis.

Major Manufacturing Regions

• China: Holds the largest share of global guaifenesin API production. Manufacturers in China have scaled production to meet significant international demand. Examples of key Chinese suppliers include:
  • Hebei Jiheng Pharmaceutical Co., Ltd.
  • Shandong Xinhua Pharmaceutical Co., Ltd.
  • Chongqing Yutai Pharmaceutical Co., Ltd.
• India: A significant secondary producer, contributing a substantial portion of the global supply. Indian manufacturers often focus on meeting stringent regulatory standards for export markets. Key Indian players include:
  • Laurus Labs Limited
  • Divi's Laboratories Limited
  • Lupin Limited
• Europe: A smaller but notable presence exists, primarily serving regional markets and specialized pharmaceutical needs. European manufacturers often emphasize higher purity standards and specific certifications.

Production Capacity and Volume

Global production capacity for guaifenesin API is estimated to be in the tens of thousands of metric tons annually. Actual production volume fluctuates based on demand from pharmaceutical formulators. The market is characterized by consistent demand due to the widespread use of guaifenesin in over-the-counter (OTC) and prescription medications.

Who are the Leading Guaifenesin API Manufacturers?

Several companies dominate the global supply of guaifenesin API. These companies possess significant manufacturing capabilities, adhere to international quality standards, and have established distribution networks.

Key Global Suppliers and Their Profiles

Manufacturer Name	Primary Location	Key Products/Focus	Regulatory Approvals (Examples)
Hebei Jiheng Pharmaceutical Co., Ltd.	China	Guaifenesin API, other pharmaceutical intermediates	US FDA, EDQM, WHO GMP
Shandong Xinhua Pharmaceutical Co., Ltd.	China	Wide range of APIs including guaifenesin	US FDA, EDQM, KFDA
Chongqing Yutai Pharmaceutical Co., Ltd.	China	Guaifenesin, other APIs	US FDA, EDQM
Laurus Labs Limited	India	APIs, including guaifenesin, for global markets	US FDA, EMA, PMDA
Divi's Laboratories Limited	India	Custom synthesis, APIs (including guaifenesin potential)	US FDA, EMA, PMDA
Lupin Limited	India	Diverse API portfolio, including guaifenesin	US FDA, EMA
Altan Pharma S.A.	Greece	Pharmaceutical manufacturing, potential guaifenesin supply	EU GMP

Note: Product portfolios can evolve; direct verification of guaifenesin supply is recommended.

What are the Quality Standards and Regulatory Requirements for Guaifenesin API?

Suppliers must adhere to rigorous quality control measures and meet diverse international regulatory standards to supply guaifenesin API to pharmaceutical companies.

Key Pharmacopoeial Standards

• United States Pharmacopeia (USP): Sets standards for identity, strength, quality, and purity of medicines, including guaifenesin.
• European Pharmacopoeia (Ph. Eur.): Provides similar standards for the European market.
• Japanese Pharmacopoeia (JP): Relevant for suppliers targeting the Japanese market.
• British Pharmacopoeia (BP): Another widely recognized standard.

Manufacturing and Quality Certifications

• Good Manufacturing Practices (GMP): Essential for API production. Certifications from regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) are critical.
• ISO Certifications: Indicate adherence to international quality management system standards.
• Drug Master Files (DMFs): Submitted to regulatory agencies (e.g., FDA) by API manufacturers, containing confidential detailed information about facilities, processes, and quality controls.

Impurity Profiling and Control

Manufacturers are required to identify and control impurities within specified limits as defined by pharmacopoeias and regulatory guidelines. This includes residual solvents, related substances, and elemental impurities.

How is Guaifenesin API Priced and What Influences Costs?

The pricing of guaifenesin API is determined by several factors, including raw material costs, production scale, regulatory compliance expenses, and market competition.

Key Cost Drivers

• Raw Materials: The synthesis of guaifenesin relies on precursor chemicals. Fluctuations in the cost of these raw materials directly impact API production costs.
• Manufacturing Scale: Larger production volumes generally lead to lower per-unit costs due to economies of scale.
• Regulatory Compliance: Meeting GMP standards and obtaining necessary certifications involve significant investment in quality systems, testing, and documentation.
• Energy and Labor Costs: Vary by region and influence overall production expenses.
• Geopolitical Factors: Supply chain disruptions, trade policies, and currency exchange rates can affect landed costs.

Pricing Trends

Guaifenesin API pricing is generally considered stable but can exhibit minor volatility. Long-term supply agreements between API manufacturers and pharmaceutical formulators often involve fixed or formula-based pricing to ensure supply chain stability. The competitive landscape among major Asian producers helps to maintain price levels.

What are the Supply Chain Risks and Mitigation Strategies for Guaifenesin?

Pharmaceutical companies sourcing guaifenesin API face several supply chain risks, which can be mitigated through proactive planning and supplier diversification.

Identified Risks

• Single-Sourcing Dependency: Reliance on a single supplier creates vulnerability to production issues, quality failures, or geopolitical disruptions.
• Quality Control Failures: Non-compliance with pharmacopoeial standards or GMP can lead to batch rejections, regulatory actions, and product recalls.
• Geopolitical Instability: Tensions or trade disputes in key manufacturing regions can impact production and logistics.
• Raw Material Shortages: Disruptions in the supply of precursor chemicals can halt API production.
• Logistical Challenges: Transportation delays, customs issues, or changes in shipping regulations can affect timely delivery.

Mitigation Strategies

• Supplier Diversification: Establishing relationships with multiple qualified suppliers across different geographic regions.
• Auditing and Qualification: Conducting thorough audits of potential and existing suppliers to ensure compliance with quality and regulatory standards.
• Inventory Management: Maintaining adequate safety stock of API to buffer against unexpected supply interruptions.
• Long-Term Contracts: Securing supply through stable, long-term agreements with clear quality and delivery clauses.
• Geographic Risk Assessment: Monitoring geopolitical and economic conditions in key sourcing regions.
• Supply Chain Transparency: Working with suppliers to understand their sub-tier supplier relationships for critical raw materials.

How does Guaifenesin Demand Evolve with Market Trends?

Demand for guaifenesin is primarily driven by the pharmaceutical industry's production of cough and cold remedies. Market trends affecting these finished products directly influence API demand.

Market Drivers

• Prevalence of Respiratory Illnesses: Seasonal increases in cough and cold incidence, as well as the impact of pandemics, directly correlate with demand for guaifenesin-containing products.
• Growth in Over-the-Counter (OTC) Market: The accessibility of guaifenesin in OTC formulations contributes to consistent, high-volume demand.
• Combination Therapies: Guaifenesin is frequently formulated with other active ingredients (e.g., decongestants, antihistamines, cough suppressants), increasing its utility and demand.
• Emerging Markets: Increasing healthcare access and pharmaceutical consumption in developing economies can drive long-term demand growth.

Market Restraints

• Competition from Alternative Expectorants: While guaifenesin is dominant, other expectorants or cough suppressants may offer alternative treatment options.
• Regulatory Scrutiny: Any changes in regulatory opinions on the efficacy or safety of guaifenesin could impact its market position.
• Maturity of Developed Markets: Developed markets have well-established consumption patterns, limiting significant incremental growth beyond seasonal variations.

What are the Intellectual Property and Patent Landscapes for Guaifenesin?

Guaifenesin itself is a well-established compound with expired foundational patents. The intellectual property landscape now focuses on new formulations, delivery systems, and combination products.

Patent Status

• Compound Patents: The original patents covering the synthesis and use of guaifenesin have long expired. It is considered a generic API.
• Process Patents: While less common for such an established compound, specific novel or improved manufacturing processes could be patented.
• Formulation Patents: Patents are more likely to cover new formulations of guaifenesin, such as extended-release versions, combination products with other APIs, or novel dosage forms.
• Method of Use Patents: Patents could exist for specific therapeutic applications of guaifenesin, though its primary use as an expectorant is widely known.

Implications for API Suppliers

For API suppliers, the lack of compound patent protection means competition is based on cost, quality, regulatory compliance, and reliability. The focus is on supplying the generic API to a broad market of formulators.

Key Takeaways

• The global supply of guaifenesin API is dominated by manufacturers in China and India, with established players and significant production capacity.
• Adherence to pharmacopoeial standards (USP, Ph. Eur.) and GMP certifications (FDA, EMA) is critical for API suppliers.
• Pricing is influenced by raw material costs, manufacturing scale, and competitive pressures, generally remaining stable.
• Supply chain risks include single-sourcing and quality failures; mitigation involves supplier diversification and robust quality assurance.
• Demand for guaifenesin API is driven by the consistent need for cough and cold medications, particularly in the OTC segment, and is sensitive to seasonal respiratory illnesses.
• The intellectual property landscape for guaifenesin API is mature, with expired compound patents, shifting focus to novel formulations and combinations.

Frequently Asked Questions

1. Are there any significant emerging suppliers of guaifenesin API? While the market is mature, continuous capacity expansions by existing major players in Asia are observed. New entrants are rare due to high capital investment and stringent regulatory hurdles for API manufacturing.
2. What is the typical lead time for ordering guaifenesin API from major suppliers? Lead times can vary from 4 to 12 weeks, depending on the supplier, order volume, and current production schedules. Contracts often specify delivery timelines.
3. How do impurities in guaifenesin API affect finished drug products? Impurities can impact the safety, efficacy, and stability of the finished drug product. Regulatory agencies set strict limits for known and unknown impurities.
4. What are the primary quality control tests performed on guaifenesin API? Key tests include identification (e.g., IR spectroscopy), assay (purity determination), related substances (chromatographic analysis for impurities), heavy metals, residual solvents, and microbial limits.
5. Does the price of guaifenesin API vary significantly based on its intended market (e.g., US vs. Europe)? While the base API cost is global, landed costs can differ due to shipping, import duties, and specific market regulatory compliance requirements. However, the fundamental API price is largely standardized.

Citations

[1] United States Pharmacopeia. (n.d.). Guaifenesin Monograph. USP-NF Online. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia (Ph. Eur.). EDQM. [3] World Health Organization. (2010). WHO good manufacturing practices for pharmaceutical products. WHO. [4] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). FDA.gov.