Suppliers and packagers for generic pharmaceutical drug: ASPIRIN

ASPIRIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-081-12	1 BLISTER PACK in 1 CARTON (73089-081-12) / 81 mg in 1 BLISTER PACK	2021-08-05
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-081-14	81 mg in 1 CARTON (73089-081-14)	2021-08-05
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-081-21	1 BOTTLE, PLASTIC in 1 CARTON (73089-081-21) / 81 mg in 1 BOTTLE, PLASTIC	2021-08-05
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697	NDA	PLx Pharma Inc	73089-325-21	1 BOTTLE, PLASTIC in 1 CARTON (73089-325-21) / 325 mg in 1 BOTTLE, PLASTIC	2021-08-05

Suppliers for the Pharmaceutical Drug: Aspirin

Last updated: July 27, 2025

Introduction

Aspirin, chemically known as acetylsalicylic acid, has been a cornerstone in the pharmaceutical industry for over a century, primarily used for its analgesic, antipyretic, anti-inflammatory, and antiplatelet effects. Originating from salicin found in willow bark, aspirin's manufacturing and supply chain involve a complex network of chemical producers, ingredient suppliers, pharmaceutical companies, and distributors. Understanding the key suppliers across the supply chain is pivotal for stakeholders seeking supply security, cost efficiency, and regulatory compliance.

Global Chemical and Active Pharmaceutical Ingredient (API) Suppliers

1. API Manufacturers

The cornerstone of aspirin's supply chain involves suppliers of the active pharmaceutical ingredient (API), acetylsalicylic acid. Several multinational and regional chemical companies dominate this space:

• BASF SE: A leader in the global chemicals industry, BASF supplies pharmaceutical-grade salicylic acid and acetylsalicylic acid. BASF's stringent quality controls, extensive production capacity, and global logistics network make it a primary supplier for pharmaceutical companies worldwide [1].

• Mitsubishi Chemical Holdings Corporation: Known for advanced chemical synthesis capabilities, Mitsubishi supplies pharmaceutical APIs, including aspirin, with a focus on high purity and batch consistency [2].

• Mallinckrodt Pharmaceuticals: Through its various manufacturing units, Mallinckrodt produces aspirin API, distributing it to pharma companies across North America and Europe [3].

• JK Ansell Ltd.: An India-based manufacturer providing high-quality aspirin API to domestic and international markets, leveraging cost-effective production processes [4].

2. Raw Material Suppliers

The synthesis of acetylsalicylic acid relies on key raw materials:

• Salicylic Acid: Derived from phenol and other precursors. Major raw material suppliers include Indo Amines Ltd. (India), Hercules Inc. (historically significant), and Eastman Chemical Company [5].

• Acetic Anhydride: Used for acetylation in aspirin synthesis, supplied by companies such as LyondellBasell Industries and Samsung SDI Co. Ltd.. These suppliers provide pharmaceutical-grade acetic anhydride conforming to strict purity standards [6].

Manufacturing and Supply Chain Dynamics

3. Contract Manufacturing Organizations (CMOs) and OEMs

Many pharmaceutical brands outsource aspirin manufacturing to Contract Manufacturing Organizations (CMOs):

• VWR International and Bachem operate facilities producing aspirin under strict cGMP (current Good Manufacturing Practice) standards.

• India’s Sun Pharma and Dr. Reddy’s Laboratories often manufacture aspirin API and finished formulations for global markets, leveraging regional cost advantages.

4. Packagers and Distributors

Once manufactured, aspirin products are packaged and distributed by pharmaceutical distributors:

• McKesson Corporation and AmerisourceBergen (USA) are major distributors of over-the-counter (OTC) aspirin brands.

• Regional distributors like Polypharma (Russia) and Alliance Healthcare (Europe) ensure supply chain continuity across different markets.

Key Market Players and Regional Suppliers

5. Leading Global Suppliers

Major API suppliers such as BASF and Mitsubishi serve a global customer base, with production facilities in Europe, North America, and Asia. BASF’s production sites in Germany and the US are integral to global supply.

6. Regional and Emerging Market Suppliers

India and China possess extensive chemical manufacturing infrastructure:

• Hetero Labs (India) supplies aspirin API and intermediates regionally and internationally.

• Dongying Fangli Chemical Co. (China) provides competitively priced aspirin API to Asian markets and exports.

Regional players often benefit from cost advantages and possess the flexibility to meet localized demand, yet they must comply with international quality standards.

Quality Standards and Regulatory Considerations

Suppliers must adhere to rigorous pharmaceutical standards, including:

• GMP compliance: Ensures manufacturing quality and safety.

• ISO certifications: Demonstrates compliance with international quality management standards.

• Pharmacopoeia specifications: Suppliers often align with USP, EP, or JP standards for APIs.

Regulatory agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Japan) enforce compliance, influencing supplier choice.

Supply Chain Risks and Strategies

• Geopolitical factors, such as tariffs or trade restrictions, can disrupt supply from key regions.
• Raw material shortages, notably in phenol-derived salicylic acid, may impact production.
• Quality inconsistencies pose risks for pharmaceutical companies; hence, due diligence on supplier compliance is vital.

Strategies include diversified sourcing, long-term supplier contracts, and maintaining safety stock levels.

Future Trends in Aspirin Supply

• Increased automation and digital tracking improve supply chain transparency.
• Growing demand in emerging markets boosts regional production.
• Focus on sustainable and environmentally friendly manufacturing processes could redefine supplier standards.

Key Takeaways

• Global chemical giants like BASF and Mitsubishi dominate aspirin API supply, with regional players providing cost-efficient alternatives.
• Raw material quality and regulatory compliance are critical factors influencing supplier selection.
• Regional suppliers in India and China are increasingly vital, driven by cost advantages and expanding capacity.
• Supply chain resilience depends on diversification, compliance, and proactive risk management.
• Innovation in manufacturing and sustainability will shape future supplier roles and industry standards.

FAQs

1. Who are the largest API suppliers for aspirin globally?
BASF SE and Mitsubishi Chemical Corporation are among the largest, providing high-quality acetylsalicylic acid worldwide, supported by extensive manufacturing networks.

2. What raw materials are essential for aspirin manufacture, and who supplies them?
Salicylic acid and acetic anhydride are key raw materials. Salicylic acid is supplied by firms like Indo Amines and Eastman Chemical, whereas acetic anhydride is supplied by companies such as LyondellBasell and Samsung SDI.

3. How do regional suppliers influence the aspirin supply chain?
Regional suppliers in India and China offer cost-effective production options, helping diversify supply sources and mitigate risks associated with geopolitical or trade disruptions.

4. What quality standards must suppliers meet in the aspirin supply chain?
Suppliers must adhere to GMP standards, ISO certifications, and pharmacopoeial specifications (USP, EP, JP) to ensure pharmaceutical safety and efficacy.

5. How is the supply chain for aspirin evolving?
Enhancements include increased use of automation, greater focus on sustainability, and the expansion of regional manufacturing capabilities to meet rising global demand.

References

[1] BASF SE, "Pharmaceutical Ingredients," BASF.com, accessed 2023.
[2] Mitsubishi Chemical Holdings, "API Manufacturing Capabilities," Mitsubishi Chemical.com.
[3] Mallinckrodt Pharmaceuticals, "API Portfolio," Mallinckrodt.com.
[4] JK Ansell Ltd., "Chemical Production," JKAnsell.com.
[5] Eastman Chemical Company, "Raw Materials in API Synthesis," Eastman.com.
[6] LyondellBasell Industries, "Chemical Product Lines," LyondellBasell.com.