ADVIL ALLERGY SINUS: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441	NDA	Haleon US Holdings LLC	0573-0188-10	20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK	2002-12-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Advil Allergy Sinus, a combination medication designed to relieve symptoms related to allergies and sinus congestion, is a popular over-the-counter (OTC) drug produced primarily by Pfizer Consumer Healthcare. Its active ingredients typically include ibuprofen, chlorpheniramine maleate, and pseudoephedrine, offering analgesic, antihistamine, and decongestant effects. The production and distribution of Advil Allergy Sinus involve a complex supply chain, comprising raw material suppliers, contract manufacturers, and distributors. This analysis provides a comprehensive overview of the key suppliers involved in the manufacturing of this pharmaceutical product, highlighting their roles, sourcing strategies, and the implications for stakeholders.

Raw Material Suppliers

1. Ibuprofen Raw Materials

Ibuprofen, a core component in Advil Allergy Sinus, is synthesized predominantly from propionic acid derivatives. Suppliers of the various chemicals involved, such as isobutylbenzene and acetic anhydride, are integral to the supply chain.

Major Suppliers:
Companies like BASF, Novartis (via Novartis Consumer Health, now part of GSK), and LJ Basic Chemicals supply high-quality raw materials for ibuprofen synthesis. For instance, BASF provides phenylpropionic acids and intermediates sourced globally, ensuring consistent quality compliant with pharmacopeia standards (USP, EP).
Supply Dynamics:
The procurement of raw chemicals depends on the global availability of petrochemical feedstocks, geopolitical stability, and compliance with Good Manufacturing Practices (GMP). Suppliers often maintain multiple manufacturing sites across Europe and Asia to mitigate supply chain risks.

2. Chlorpheniramine Maleate

Chlorpheniramine maleate, an antihistamine, is sourced from specialty chemical producers producing active pharmaceutical ingredients (APIs).

Leading Suppliers:
Ube Industries (Japan), Jiangsu Hengrui Medicine (China), and TCI Chemicals (Japan) are notable for supplying chlorpheniramine maleate API. These firms maintain stringent quality controls adhering to regulatory standards like FDA approvals and EDQM certifications.
Supply Stability:
Given the global demand for antihistamines, these suppliers operate large-scale manufacturing facilities to ensure a reliable supply chain, especially amid increased allergy medication consumption prompted by pollen seasons or environmental factors.

3. Pseudoephedrine

Pseudoephedrine, a decongestant, is subject to stringent regulatory control due to its potential use in illicit methamphetamine synthesis.

Suppliers and Regulations:
Major pharmaceutical manufacturers like Johnson Matthey, Sepracor (now part of Sanofi), and Indian generics producers suppliers pseudoephedrine API under strict regulatory oversight. In the US and EU, pseudoephedrine transactions are monitored through laws such as the Combat Methamphetamine Epidemic Act (CMEA), influencing sourcing strategies.
Legal and Supply Chain Considerations:
This regulation necessitates secure, licensed facilities and reporting requirements, often leading to diversified supplier bases to ensure consistent availability for OTC formulations.

Contract Manufacturing and Packaging

4. Contract Manufacturing Organizations (CMOs)

The complexity of pharmaceutical production warrants the engagement of CMOs to assemble finished formulations.

Key Players:
Companies like Piramal Enterprises (India), Aenova Group (Germany), and Catalent (US) act as CMOs, manufacturing both the active ingredients and final dosage forms.
Services Provided:
These CMOs handle formulation, granulation, filling, packaging, and quality testing, ensuring compliance with regulatory standards like cGMP. Their strategic locations enable rapid scaling and distribution, especially in Asia and Europe.

5. Packaging and Labeling Suppliers

Suppliers such as WestRock and DS Smith provide secondary packaging materials, including bottles, cartons, and safety seals vital for maintaining product integrity and compliance with labeling regulations.

Distribution and Supply Chain Considerations

6. Wholesale Distributors and Retail Channels

Pharmaceutical wholesalers, like McKesson, Cardinal Health, and AmerisourceBergen, serve as primary distributors for Advil Allergy Sinus in the US. These entities facilitate stock replenishment at pharmacies and retail outlets, ensuring product availability.

7. Logistics Providers

Third-party logistics (3PL) companies, such as DHL Supply Chain and FedEx, manage the global distribution network, ensuring timely delivery while maintaining cold chain and regulatory compliance.

Supply Chain Challenges and Risks

Regulatory Compliance:
The sourcing of pseudoephedrine requires adherence to strict regulations, which can cause supply disruptions. Variability in regulatory environments globally impacts sourcing strategies.
Raw Material Price Fluctuations:
Petrochemical feedstocks for ibuprofen may experience volatility influencing cost structures, potentially affecting retail pricing and profit margins.
Geopolitical Risks:
Trade tensions and sanctions can impact the availability of key raw materials and finished APIs from specific regions (e.g., China, India, Europe).
Pandemic Impact:
COVID-19 highlighted vulnerabilities in global supply chains, prompting companies to diversify suppliers and increase inventory buffers.

Implications for Stakeholders

Pharmaceutical Companies:
Ensuring a diversified supplier base minimizes risks associated with geopolitical and regulatory changes. Establishing long-term contracts with multiple suppliers can stabilize costs and supply.
Suppliers:
Compliance with international standards and maintaining regulatory certifications are paramount to securing and sustaining business with major pharmaceutical firms.
Regulators:
Monitoring the distribution of pseudoephedrine remains critical considering its dual-use nature, prompting continued oversight and reporting requirements.
Consumers:
Availability and consistent quality of Advil Allergy Sinus depend on an intricate web of reliable suppliers across the supply chain.

Key Takeaways

The manufacturing of Advil Allergy Sinus involves a complex supply chain comprising multiple suppliers of raw materials, active pharmaceutical ingredients, and packaging components, primarily located in Europe, Asia, and North America.
Key raw material suppliers include BASF (ibuprofen), Ube Industries and Jiangsu Hengrui (chlorpheniramine maleate), and Sepracor (pseudoephedrine), all subject to regulatory scrutiny.
Contract manufacturing organizations globally support formulation, assembly, and packaging, enabling scalability and compliance.
Supply chain resilience hinges on diversified sourcing, strict regulatory adherence, and strategic logistics management.
External factors such as regulations on pseudoephedrine and geopolitical tensions pose ongoing risks to supply stability.

FAQs

1. Who are the primary raw material suppliers for Advil Allergy Sinus?
Major suppliers include BASF for ibuprofen intermediates, Ube Industries and Jiangsu Hengrui for chlorpheniramine maleate, and companies like Johnson Matthey for pseudoephedrine, all operating under stringent regulatory standards to ensure product quality.

2. How does regulation impact the sourcing of pseudoephedrine?
Because pseudoephedrine can be misused for illicit drug manufacturing, its procurement is tightly regulated globally, requiring licensed suppliers, secure facilities, and rigorous tracking, which can influence supply continuity.

3. Are there risks associated with raw material price fluctuations?
Yes. Fluctuations in petrochemical prices and global economic shifts can impact raw material costs, affecting the final product pricing and profitability for manufacturers and retailers.

4. How do supply chain disruptions affect Advil Allergy Sinus availability?
Disruptions in raw material sourcing, manufacturing delays, or regulatory issues can lead to shortages, impacting consumer access and sales performance.

5. What strategies do companies employ to mitigate supply chain risks?
Diversification of supplier bases, forming long-term agreements, maintaining safety stock, and geographic spread of manufacturing facilities are key strategies to ensure stable supply.

References

Pfizer Consumer Healthcare. "Advil Allergy Sinus Product Information," [Pfizer Press Release], 2022.
USP and EDQM pharmacopeias confirming ingredient standards and sourcing practices.
U.S. Drug Enforcement Administration (DEA). Pseudoephedrine regulations.
Industry reports on pharmaceutical supply chains, Deloitte, 2021.
Company filings and regulatory disclosures from BASF, Ube Industries, and Sepracor.

Suppliers and packagers for ADVIL ALLERGY SINUS