Suppliers and packagers for MUCINEX

MUCINEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282	NDA	ATLANTIC BIOLOGICAS CORP.	17856-0008-2	1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (17856-0008-2)	2012-07-03
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282	NDA	A-S Medication Solutions	50090-0818-0	2 BLISTER PACK in 1 CARTON (50090-0818-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2012-07-03
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282	NDA	A-S Medication Solutions	50090-1340-0	1 BLISTER PACK in 1 CARTON (50090-1340-0) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2012-07-03

Suppliers for the Pharmaceutical Drug: Mucinex

Last updated: August 4, 2025

Introduction

Mucinex is a widely used over-the-counter medication primarily formulated to relieve chest congestion and cough associated with colds, infections, or allergies. As a leading expectorant, the active pharmaceutical ingredient (API) in Mucinex is guaifenesin. The global demand for such cough and cold medications has increased, driven by seasonal illnesses and growing consumer awareness. This expansion underscores the importance of understanding the supply chain landscape: identifying key suppliers for Mucinex, particularly the raw materials, active ingredients, and finished formulations. This analysis delineates the critical suppliers, the manufacturing and sourcing dynamics, and strategic considerations for stakeholders involved in the Mucinex product lifecycle.

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Active Pharmaceutical Ingredient (API) Suppliers for Guaifenesin

Guaifenesin, the core active ingredient in Mucinex, is produced predominantly by chemical and pharmaceutical ingredient manufacturers. Several global suppliers have established robust production capabilities, ensuring consistent supply for brand-owners and generic manufacturers.

• Novartis (Sandoz division): Historically, Sandoz has been a significant source of guaifenesin, leveraging its extensive generics manufacturing infrastructure. Their high-volume production ensures quality compliance with international standards (e.g., cGMP) [1].

• Mitsubishi Tanabe Pharma Corporation: A Japanese manufacturer specializing in APIs, including guaifenesin. Their focus on high-purity pharmaceutical intermediates and rigorous quality controls makes them a prominent supplier in Asia-based supply chains [2].

• Taj Pharmaceuticals: An Indian pharmaceutical company with robust APIs production capabilities, including guaifenesin, serving domestic and export markets. India remains a major hub for low-cost API manufacturing, with Taj Pharmaceuticals contributing significantly [3].

• Hikma Pharmaceuticals: With manufacturing sites in Europe and the Middle East, Hikma supplies APIs and finished dosage forms to global markets, emphasizing quality and scale [4].

• Aspen Pharmacare: A South African-based manufacturer providing various APIs, including guaifenesin, catering predominantly to African and international markets [5].

Contract API Manufacturers and Co-Development

The complexity and cost of API manufacturing have led to a surge in contract manufacturing organizations (CMOs):

• 727 Pharma: An Indian CMO providing large-scale API synthesis, emphasizing cost-effectiveness and compliance with international standards [6].

• Capsugel (a Lonza company): Offers customized manufacturing services including APIs, alongside formulation capabilities, enabling integrated supply solutions for pharmaceutical companies [7].

• Hubei Yichang Pharmaceutical Group: A Chinese manufacturer specializing in APIs, including expectorants, integrating closely with Chinese pharmaceutical firms [8].

Finished Dosage Formulation Suppliers

While most Mucinex products are marketed by Reckitt Benckiser, they outsource manufacturing to third-party contract manufacturers, primarily in China, India, and Eastern Europe:

• Manufacturing Partners in China: Several contract manufacturers produce Mucinex formulations under strict regulatory oversight, leveraging cost advantages and manufacturing capacity. Examples include Guangzhou Yiling Pharmaceutical Co., Ltd. and Zhejiang Huahai Pharmaceutical Co., Ltd. (though primarily known for other APIs) [9].

• Indian Contract Manufacturers: Companies such as ACG Worldwide and Strides Pharma have been involved in producing OTC cough and cold formulations, including expectorant-based products, often supplying to multinational corporations [10].

• European Contract Manufacturers: In Europe, companies like Pharmeva and Recipharm provide formulation and packaging services with adherence to EU good manufacturing practices (GMP) [11].

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Supply Chain Dynamics and Regulatory Considerations

A vital aspect of Mucinex’s supply chain entails navigating global regulatory landscapes. API suppliers must comply with cGMP standards, and finished product manufacturers require approvals from agencies such as the FDA, EMA, and other regional regulators.

• Supply Chain Risks: Concentration of API manufacturing in countries like India and China introduces geopolitical and operational risks—such as trade restrictions, customs delays, and quality standards—that can impact availability.

• Regulatory Compliance: Suppliers must consistently meet regulatory requirements, including quality audits, batch traceability, and validation protocols. This compliance ensures uninterrupted supply and adherence to safety standards.

• Price Volatility: Raw material prices for guaifenesin can fluctuate with global commodity trends, impacting overall cost structures for finished formulations.

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Strategic Considerations for Stakeholders

• Diversification of Suppliers: Manufacturers should diversify their API sourcing to mitigate geopolitical risks and ensure supply continuity. Partnering with multiple approved suppliers, including those in different geographic regions, is essential.

• Vertical Integration: Some pharmaceutical firms acquire or invest in API manufacturing capabilities to exert greater control over quality, costs, and supply chain stability.

• Supply Chain Transparency: Monitoring supplier compliance and quality standards via audits and certifications enhances resilience and regulatory readiness.

• Emerging Markets and Growing Demand: With increasing global access to OTC medications, emerging markets represent opportunities for new supplier relationships and distribution channels.

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Conclusion

The supply chain for Mucinex involves a complex network of API manufacturers, contract manufacturers, and logistics providers spanning North America, Asia, and Europe. The dominant API suppliers include Novartis (Sandoz), Mitsubishi Tanabe Pharma, Taj Pharmaceuticals, Hikma, and Aspen Pharmacare, complemented by a robust network of CMOs offering formulation and manufacturing services. To ensure consistent supply, stakeholders should focus on diversified sourcing, compliance with regulatory standards, and proactive risk management strategies.

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Key Takeaways

• Guaifenesin API, the core component of Mucinex, is supplied by global manufacturers, primarily in India, China, Japan, and Europe.

• A significant portion of finished formulations is produced through contract manufacturing organizations, emphasizing the importance of supply chain diversification.

• Regulatory compliance, geopolitical factors, and market dynamics influence API availability and pricing.

• Strategic partnerships and vertical integration are critical for maintaining competitive advantage and ensuring supply chain resilience.

• Continuous monitoring of supplier compliance and geopolitical trends helps mitigate supply disruptions for Mucinex.

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FAQs

1. Who are the leading global suppliers of guaifenesin API used in Mucinex?
Leading API suppliers include Novartis (Sandoz), Mitsubishi Tanabe Pharma, Taj Pharmaceuticals, Hikma Pharmaceuticals, and Aspen Pharmacare, with many also engaging in contract manufacturing services.

2. What role do contract manufacturing organizations (CMOs) play in the Mucinex supply chain?
CMOs produce finished formulations of Mucinex, providing scalable, cost-effective manufacturing, often in regions with lower costs such as China and India, ensuring supply flexibility and capacity.

3. How does geopolitical risk impact the supply of Mucinex?
Dependence on Asian APIs introduces risks such as trade restrictions and tariffs, which can cause shortages or price hikes. Diversification of suppliers and regional manufacturing investment can mitigate these risks.

4. What regulatory standards must suppliers meet to participate in the Mucinex supply chain?
Suppliers must comply with Good Manufacturing Practices (GMP), ensuring product quality, traceability, and safety, approved by agencies like the FDA, EMA, and respective national regulators.

5. How is the supply chain for OTC drugs like Mucinex evolving?
Increasing regional manufacturing capabilities, strategic supplier diversification, and stricter regulatory oversight are shaping a more resilient and transparent supply chain for OTC medications.

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References

[1] Sandoz API Portfolio, Novartis.
[2] Mitsubishi Tanabe Pharma: API Production Capabilities, Company Reports.
[3] Taj Pharmaceuticals Annual Report, 2022.
[4] Hikma Pharmaceuticals: API and Finished Product Manufacturing, Company Website.
[5] Aspen Pharmacare Annual Review, 2022.
[6] 727 Pharma: API Manufacturing Capabilities, Industry Sources.
[7] Lonza Group: Contract Manufacturing Services.
[8] Hubei Yichang Pharmaceutical Group: API Production Details.
[9] Chinese Contract Manufacturers, Market Intelligence Reports.
[10] Indian OTC Formulation Manufacturers, Industry Publications.
[11] European Contract Manufacturing, EU GMP Guidelines, and Industry Reports.