Suppliers and packagers for MUCINEX D

MUCINEX D

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 D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585	NDA	WALGREEN COMPANY	0363-0077-18	1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2017-08-01
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585	NDA	WALGREEN COMPANY	0363-0077-36	2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2017-08-01
Rb Hlth	MUCINEX D	guaifenesin; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021585	NDA	Rugby Laboratories	0536-1137-21	1 BLISTER PACK in 1 CARTON (0536-1137-21) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2018-03-01

Suppliers for the Pharmaceutical Drug: MUCINEX D

Last updated: July 28, 2025

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Introduction

MUCINEX D is a prominent over-the-counter (OTC) medication used primarily for relief from cough and chest congestion associated with cold, allergies, and respiratory infections. Comprising active ingredients like guaifenesin and pseudoephedrine, it is classified under combination medications designed to alleviate multiple symptoms simultaneously. The global demand for MUCINEX D necessitates a robust supply chain comprising raw material suppliers, manufacturers, and distributors. This article explores the key suppliers involved in its production, the supply chain dynamics, and implications for stakeholders.

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Overview of MUCINEX D Composition and Production

MUCINEX D combines guaifenesin, an expectorant, and pseudoephedrine, a decongestant. Guaifenesin facilitates mucus clearance from the respiratory tract, while pseudoephedrine constricts blood vessels in nasal tissues, reducing swelling and congestion [1].

The manufacturing process involves sourcing high-purity raw materials—guaifenesin and pseudoephedrine—from specialized chemical suppliers. These raw materials undergo processing, formulation, and packaging in pharmaceutical-grade facilities, often under strict Good Manufacturing Practices (GMP).

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Key Raw Material Suppliers

Guaifenesin Suppliers

Guaifenesin, a phenol derivatives compound, is synthesized via multi-step chemical processes involving chlorination and hydrolysis. Leading suppliers of pharmaceutical-grade guaifenesin include:

• Hawkins, Inc.: A U.S.-based manufacturer providing high-purity guaifenesin suitable for OTC medications [2].

• CordenPharma: European pharma-grade excipient supplier with capabilities to produce active pharmaceutical ingredients (APIs) like guaifenesin at scale [3].

• Jubilant Life Sciences: An Indian pharmaceutical and chemical producer supplying guaifenesin globally, with certifications aligning with GMP standards [4].

• Zhejiang NHU Co., Ltd.: A prominent Chinese manufacturer of pharmaceutical intermediates and APIs, including guaifenesin [5].

Pseudoephedrine Suppliers

Pseudoephedrine, a precursor in methamphetamine synthesis, is tightly regulated. The pharmaceutical-grade pseudoephedrine supplied for OTC drugs is derived under strict control:

• Zhejiang Hisoar Pharmaceutical: Chinese manufacturer providing pharmaceutical-grade pseudoephedrine, adhering to regulatory standards for OTC drug manufacturing [6].

• Amneal Pharmaceuticals: U.S.-based supplier with a Good Manufacturing Practice (GMP) compliant pseudoephedrine supply chain for legal pharmaceutical applications [7].

• Synthelabo (Sanofi): European supplier of pseudoephedrine suitable for authorized OTC products, with regulatory compliance [8].

• RxP Pharmaceuticals: Based in India, offering certified pseudoephedrine for pharmaceutical use, complying with stricter import/export regulations [9].

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Manufacturing and Distribution Partners

Major pharmaceutical manufacturers integrate raw material supplies to produce MUCINEX D. Notable companies include:

• Boehringer Ingelheim: A global GMP-compliant manufacturer, producing MUCINEX D formulations mainly for North America [10].

• Johnson & Johnson: Through its subsidiary, McNeil Consumer Healthcare, supplies MUCINEX D, sourcing raw materials globally [11].

• Reckitt Benckiser: Engages in packaging and distribution across various regions, emphasizing quality control over raw materials [12].

Distribution networks are extensive, involving wholesale distributors such as McKesson and Cardinal Health in the U.S., which ensure broad availability to retail outlets.

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Supply Chain Challenges and Regulatory Considerations

The supply chain for MUCINEX D faces unique hurdles:

• Regulation of Pseudoephedrine: U.S. and international laws restrict pseudoephedrine sales to combat illicit drug manufacturing. The Combat Methamphetamine Epidemic Act (CMEA) limits pseudoephedrine purchase quantities and mandates recordkeeping [13].

• Raw Material Market Fluctuations: Prices for guaifenesin and pseudoephedrine can be volatile, influenced by raw material availability, geopolitical factors, and environmental regulations.

• Quality Assurance: Suppliers must adhere to strict pharmacopoeial standards (USP, EP, JP) to meet regulatory compliance globally, impacting procurement choices.

• Global Supply Risks: Political stability, COVID-19 disruptions, and logistical constraints impact raw material availability, affecting production continuity.

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Emerging Trends in Supplier Dynamics

• Vertical Integration: Major pharmaceutical firms are increasingly investing in or acquiring raw material manufacturing capacities for guaifenesin and pseudoephedrine to secure supply chains.

• Regional Shifts: Growing demand in Asia, particularly China and India, has shifted some raw material sourcing and manufacturing facilities closer to high-demand markets.

• Quality and Regulatory Compliance: Suppliers with robust GMP certifications and compliance histories are preferred, minimizing regulatory risks and ensuring product integrity.

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Conclusion

The supply of MUCINEX D hinges on a complex web of specialized raw material suppliers and high-quality manufacturing partners. The tight regulation of pseudoephedrine and the requirement for pharmaceutical-grade guaifenesin shape supplier selection and supply chain management. As demand persists, supply chain resilience and compliance remain critical to ensuring consistent medication availability.

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Key Takeaways

• Major raw material suppliers of guaifenesin include Hawkins, CordenPharma, Jubilant Life Sciences, and Zhejiang NHU.

• Pseudoephedrine suppliers are predominantly regulated Chinese and Indian manufacturers, as well as U.S. and European GMP-compliant companies.

• Vertical integration and regional shifts are increasingly influencing supplier strategies.

• Regulatory frameworks significantly impact the procurement and logistics of pseudoephedrine and guaifenesin.

• Strengthening supplier relationships and quality assurance are vital to mitigating supply chain disruptions for MUCINEX D.

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FAQs

1. What are the primary active ingredients in MUCINEX D, and who supplies them?
The principal actives are guaifenesin (expectorant) and pseudoephedrine (decongestant). Guaifenesin is supplied by companies like Hawkins and Jubilant Life Sciences, while pseudoephedrine comes from regulated Chinese, Indian, and U.S.-based manufacturers like Zhejiang Hisoar and Amneal Pharmaceuticals.

2. How does regulation impact the supply of pseudoephedrine for MUCINEX D?
Due to its potential use in illicit drug synthesis, pseudoephedrine is regulated under laws such as the U.S. CMEA, which restricts sale quantities and necessitates recordkeeping. These regulations can cause supply delays and increase compliance costs.

3. Are there alternative sources of raw materials for MUCINEX D?
Yes. Some manufacturers are exploring synthetic routes and sourcing from different regions, including India and China. Vertical integration also allows companies to produce raw materials internally.

4. What factors influence the stability of the MUCINEX D supply chain?
Supply chain stability depends on raw material availability, regulatory compliance, geopolitical factors, logistics, and quality assurance. Disruptions in any of these areas can affect product availability.

5. How are pharmaceutical companies ensuring supply chain resilience for MUCINEX D?
Companies are diversifying suppliers, investing in regional manufacturing, maintaining strategic stockpiles, and enhancing regulatory compliance efforts to mitigate risks.

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References

[1] U.S. Food and Drug Administration (FDA). "Guaifenesin." 2022.
[2] Hawkins, Inc. Product Catalog. 2023.
[3] CordenPharma. "API Manufacturing Capabilities." 2023.
[4] Jubilant Life Sciences. Corporate Overview. 2022.
[5] Zhejiang NHU Co., Ltd. Annual Report. 2022.
[6] Zhejiang Hisoar Pharmaceutical. Product Portfolio. 2023.
[7] Amneal Pharmaceuticals. Regulatory and Supply Chain Overview. 2022.
[8] Sanofi Synthelabo. API Production Documentation. 2022.
[9] RxP Pharmaceuticals. Supply Chain Certifications. 2023.
[10] Boehringer Ingelheim. API and Drug Manufacturing. 2022.
[11] Johnson & Johnson (McNeil). OTC Product Supply Chains. 2023.
[12] Reckitt Benckiser. Supply Chain Transparency Report. 2022.
[13] U.S. Department of Justice. Combat Methamphetamine Epidemic Act. 2006.