EXCEDRIN (MIGRAINE RELIEF): Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2035-20	1 BOTTLE in 1 CARTON (0067-2035-20) / 20 TABLET, COATED in 1 BOTTLE	2011-09-13
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2035-80	1 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE	2011-09-13
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2039-02	2 TABLET, FILM COATED in 1 POUCH (0067-2039-02)	2010-02-15
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2039-24	1 BOTTLE in 1 CARTON (0067-2039-24) / 24 TABLET, FILM COATED in 1 BOTTLE	2010-02-15
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2039-30	1 BOTTLE in 1 CARTON (0067-2039-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2010-02-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

EXCEDRIN, a widely recognized over-the-counter (OTC) medication, is marketed primarily for migraine relief. Combining acetaminophen, aspirin, and caffeine, EXCEDRIN offers a multi-mechanistic approach to alleviating headache pain, especially migraines. Given its popularity, understanding its supply chain dynamics, including primary ingredients and manufacturing procurement sources, is essential for stakeholders assessing supply continuity, quality assurance, and regulatory compliance.

Manufacturing Overview and Supplier Landscape

1. Pharmaceutical Ingredients Composition and Key Suppliers

EXCEDRIN’s efficacy hinges on three core active ingredients:

Acetaminophen (Paracetamol)
Aspirin (Acetylsalicylic Acid)
Caffeine

Each ingredient’s supply chain involves multiple global suppliers, with procurement strategies balancing cost, quality, regulatory adherence, and reliability.

Acetaminophen Suppliers

a. Major Global Suppliers

Acetaminophen manufacturing is concentrated among a handful of large API (Active Pharmaceutical Ingredient) producers. Prominent suppliers include:

Hubei Guochuang Pharmaceutical (China): Offers high-volume acetaminophen APIs compliant with international standards, often supplying to major OTC medicinal producers [1].
Hoffmann-La Roche (Switzerland): Historically a key supplier, with a focus on high-quality APIs, operating under strict GMP standards.
Mitsubishi Chemical Holding Corporation (Japan): Supplies acetaminophen for various pharmaceutical applications, including OTC products like EXCEDRIN.
Xinhua Pharmaceutical (China): Supplies acetaminophen APIs to multiple OTC brands globally.

b. Supply Chain Considerations

Reliance on Chinese API manufacturers remains prominent due to cost advantages. However, geopolitical factors, regulatory scrutiny, and quality control practices influence procurement strategies. Companies often diversify suppliers to mitigate risks.

Aspirin Suppliers

a. Major Producers

Aspirin, synthesized from salicylic acid, is produced predominantly by:

BASF (Germany): Supplies pharmaceutical-grade aspirin, adhering to strict regulatory standards.
Bayer AG (Germany): Historical inventor of aspirin; continues to supply pharma-grade acetylsalicylic acid globally with rigorous quality controls.
Xinhua Pharmaceutical (China): A significant supplier for OTC formulations, including aspirin APIs for products like EXCEDRIN.

b. Procurement Trends

Manufacturers often source aspirin APIs from well-established, GMP-compliant suppliers to meet regulatory and quality standards essential for OTC products.

Caffeine Suppliers

a. Sources and Manufacturers

Synthetic caffeine is sourced from multiple suppliers, including:

Kinbasha Industries (Japan): Supplies pharmaceutical-grade caffeine with certifications suited for OTC formulations.
Jiangsu Xinguang Chemical (China): Offers caffeine APIs at competitive prices.
Mitsubishi Chemical (Japan): Also supplies caffeine with high purity standards for pharmaceutical manufacturing.

b. Market Dynamics

Caffeine’s global demand in OTC formulations fosters a competitive supplier landscape, with China and Japan being key sourcing regions.

Manufacturers of EXCEDRIN

1. Johnson & Johnson

The primary manufacturer and marketer of EXCEDRIN is Johnson & Johnson, which formulates and distributes the product globally. They source active ingredients from approved suppliers aligning with GMP standards to ensure product quality and safety.

2. Supply Chain Control

Johnson & Johnson maintains strict supplier qualification processes, including audits and quality assessments, aligning with regulatory requirements (e.g., FDA, EMA) for OTC drugs.

Regulatory and Quality Assurance

a. Supplier Qualification

Manufacturers must evaluate suppliers for compliance with Good Manufacturing Practices (GMP), ensuring API quality, potency, and purity.

b. Supply Chain Risks

Disruptions in API supply—be it geopolitical (e.g., US-China trade tensions), natural disasters, or regulatory changes—can impact EXCEDRIN availability.

c. Quality Certifications

Suppliers often possess certifications such as ISO 9001, GMP, and US FDA approval or equivalent, necessary for pharmaceutical APIs.

Emerging Trends and Strategic Sourcing

Diversification: To mitigate risks associated with supply chain disruptions, companies diversify sources across multiple regions.
Vertical Integration: Some pharmaceutical companies are investing in API manufacturing to secure supply and maintain quality control.
Sustainability and Ethical Sourcing: Increasing emphasis on environmentally responsible sourcing and ethical procurement practices is influencing supplier selection.

Conclusion

The supply chain for EXCEDRIN’s active ingredients hinges on a select group of global suppliers, primarily based in China, Europe, and Japan. The integrity and reliability of these suppliers are crucial, given the product’s OTC status and regulatory demands. Strategic sourcing, supplier qualification, and risk management remain pivotal for ensuring consistent product availability.

Key Takeaways

Major suppliers of EXCEDRIN’s ingredients are concentrated in China, Europe, and Japan. Diversification reduces risk and ensures procurement stability.
Regulatory compliance and GMP adherence are non-negotiable for suppliers providing APIs for OTC medications like EXCEDRIN.
Supply chain disruptions influence global OTC formulations, emphasizing the need for strategic supplier relationships.
Vertical integration and strategic diversification are trends that can enhance supply chain resilience.
Ongoing regulatory scrutiny necessitates rigorous supplier qualification and quality assurance protocols.

FAQs

1. Who are the leading suppliers of acetaminophen for OTC products like EXCEDRIN?
Hubei Guochuang Pharmaceutical, Mitsubishi Chemical, and Hoffmann-La Roche are among the primary suppliers, with most sourcing from Chinese and Japanese manufacturers.

2. How does Johnson & Johnson ensure the quality of ingredients sourced globally?
They employ rigorous qualification processes, audits, and enforce compliance with GMP, ensuring API quality and regulatory adherence.

3. Are there risks associated with sourcing APIs from China for OTC medications?
Yes. Risks include supply disruptions, regulatory scrutiny, and quality concerns; thus, many companies diversify sources.

4. What are the main trends affecting API suppliers for OTC drugs?
Key trends include diversification, vertical integration, focus on sustainability, and responding to global supply chain disruptions.

5. How does regulatory compliance influence supplier selection for EXCEDRIN?
Regulatory standards like FDA and 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recurse for incremental advantage.

Sources:

[1] Global Acetaminophen API Suppliers, Market Research Reports (2022).

Suppliers and packagers for EXCEDRIN (MIGRAINE RELIEF)