Suppliers and packagers for TYLENOL

TYLENOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Kenvue Brands LLC	50580-309-01	1 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	2016-01-18
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Kenvue Brands LLC	50580-309-02	1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE	2016-01-18
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Kenvue Brands LLC	50580-783-10	1 BOTTLE, PLASTIC in 1 CARTON (50580-783-10) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	2015-07-13
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Kenvue Brands LLC	50580-783-24	1 BOTTLE, PLASTIC in 1 CARTON (50580-783-24) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	2015-07-13

Last updated: August 14, 2025

ppliers for the Pharmaceutical Drug: TYLENOL

Introduction

TYLENOL, a widely recognized over-the-counter medication primarily containing acetaminophen (paracetamol), is a staple analgesic and antipyretic used globally. Its widespread consumption underscores the importance of understanding its supply chain, particularly the suppliers involved in raw material procurement and manufacturing. This analysis explores the key suppliers, manufacturing dynamics, sourcing strategies, and market influences shaping TYLENOL’s supply chain, providing business professionals with insights to inform procurement and risk management decisions.

Raw Material Suppliers: Acetaminophen Production

1. Acetaminophen Raw Material Suppliers
At the core of TYLENON’s production is acetaminophen, a chemical compound synthesized through specific chemical processes. Several specialized chemical suppliers worldwide provide high-quality raw materials and intermediates used in the synthesis of acetaminophen. These include chemical producers in North America, Europe, and Asia, notably China, India, and South Korea, which dominate API (Active Pharmaceutical Ingredient) manufacturing.

2. Key Chemical Suppliers and Producers

• Mitsubishi Chemical (Japan): Supplies pharmaceutical-grade chemicals used in acetaminophen synthesis.
• Siegfrieds (Germany): Offers intermediates and specialized chemicals for API manufacturing.
• Hubei Sinopharm Chemical Reagent (China): One of the largest producers of pharmaceutical intermediates, including raw materials for acetaminophen.
• Shandong Xinhua Pharmaceutical (China): Engages in the synthesis of APIs including acetaminophen intermediates.

3. Raw Material Quality and Regulatory Compliance
For pharmaceutical products like TYLENOL, raw material suppliers must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP) and certifications such as ISO 9001. These standards ensure the safety, purity, and efficacy of the active pharmaceutical ingredients, providing assurance to downstream manufacturers.

API Manufacturers and Contract Manufacturing Organizations

4. Major API Manufacturers for Acetaminophen
The transition from raw chemical intermediates to finished API involves large-scale manufacturing facilities specializing in synthesis, purification, and quality control. Leading API manufacturers include:

• BASF (Germany): Produces pharmaceutical-grade APIs, including acetaminophen, under stringent quality controls.
• Huangshi Lingling Chemical (China): Significant producer of acetaminophen API serving global markets.
• GSK (GlaxoSmithKline): Engages in API manufacturing through subsidiaries and contracts with third-party manufacturers.
• Alpheus Pharmaceuticals (India): Supplies acetaminophen API to various pharmaceutical companies worldwide.

5. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource API production to CMOs to optimize cost-efficiency and capacity. CMOs such as Patheon (Thermo Fisher Scientific), Catalent, and Recipharm provide outsourced manufacturing of acetaminophen, often under strict quality and regulatory standards.

Formulation and Final Product Manufacturing

6. Tablet and Liquid Formulation Suppliers
Once the API is obtained, the final step involves production of TYLENOL formulations — tablets, liquids, and capsules. Key players in formulation and finished product manufacturing include:

• McNeil Consumer Healthcare (a Johnson & Johnson subsidiary): Responsible for the global production of TYLENOL.
• Sanofi and GSK: Contract out some formulations to regional manufacturers, depending on market needs.

7. Contract Packagers and Distributors
Final packaging and distribution often involve third-party specialists. These companies ensure compliance with regulatory packaging standards, including child-resistant features and tamper-evident seals.

Market Dynamics and Supply Chain Risks

8. Geographic Concentration and Dependence
The concentration of API manufacturing in China and India introduces geopolitical and supply chain risks. Any disruption — such as trade tensions, manufacturing shortages, or regulatory changes — could impact TYLENOL’s availability. US and European companies increasingly diversify supply sources to mitigate risk.

9. Regulatory and Quality Assurance
Suppliers must navigate complex regulatory pathways, including compliance with the US FDA, European EMA, and other regulatory agencies. Quality lapses can lead to recalls, affecting supply continuity.

10. Cost and Pricing Influence
Raw material costs are subject to volatility driven by global demand, raw material scarcity, or geopolitical events. These fluctuations influence the final cost structure of TYLENOL, affecting pricing and profitability for manufacturers and retailers.

Emerging Trends and Strategic Implications

11. Supply Chain Resilience
Companies are investing in supply chain resilience by establishing diversified supplier networks, increasing inventory buffers, and localizing certain manufacturing steps. These strategies mitigate risks associated with reliance on a handful of Asian-based suppliers.

12. Sustainability and Regulatory Changes
Increasing emphasis on sustainability influences sourcing strategies. Suppliers adopting greener manufacturing practices and transparent supply chains are favored, aligning with corporate social responsibility goals and regulatory expectations.

Conclusion

The TYLENOL supply chain is a complex ecosystem comprising raw material suppliers, API manufacturers, contract manufacturers, formulation specialists, and distributors. The primary raw materials originate mainly from chemical suppliers in Asia, with manufacturing hubs in China, India, and Europe. While cost advantages exist, reliance on geographically concentrated suppliers introduces inherent risks. Global regulatory compliance and quality standards ensure product safety but also pose challenges that necessitate ongoing risk management strategies.

Business professionals must monitor geopolitical, regulatory, and market developments to maintain resilient supply chains for TYLENOL, ensuring uninterrupted availability and competitive positioning.

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Key Takeaways

• Major raw material suppliers for acetaminophen reside mainly in Asia, specifically China and India, necessitating diversified sourcing strategies.
• Leading API manufacturers like BASF, Huangshi Lingling, and Alpheus Pharmaceuticals are integral to TYLENOL’s supply chain, often supplemented by CMOs for scaling production.
• Geopolitical risks and regulatory compliance significantly influence supply chain stability and costs.
• Companies are prioritizing supply chain resilience through diversification, strategic stockpiling, and monitoring geopolitical developments.
• Sustainability and quality assurance are becoming central to supplier selection and ongoing compliance efforts.

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FAQs

1. Who are the primary raw material suppliers for acetaminophen in TYLENOL?
The main raw material suppliers are chemical producers in China, India, and South Korea, notably Shandong Xinhua Pharmaceutical and Hubei Sinopharm Chemical Reagent, providing pharmaceutical-grade intermediates that meet international GMP standards.

2. Which companies manufacture the API used in TYLENOL?
Leading API manufacturers include BASF (Germany), Huangshi Lingling Chemical (China), and Alpheus Pharmaceuticals (India). These firms focus on large-scale, GMP-compliant production of acetaminophen API.

3. How does geopolitical risk impact TYLENOL’s supply chain?
Heavy reliance on Asian API suppliers exposes TYLENOL’s supply chain to risks stemming from trade tensions, regulatory changes, and manufacturing disruptions, prompting companies to diversify sourcing and increase inventory buffers.

4. What role do contract manufacturing organizations play in TYLENOL’s production?
CMOs facilitate large-scale formulation, packaging, and distribution, helping companies optimize costs, ensure regulatory compliance, and scale production capacity.

5. How are sustainability considerations influencing suppliers for TYLENOL?
Sustainability is increasingly vital, prompting suppliers to adopt greener manufacturing practices and transparent supply chains, aligning with regulatory requirements and corporate social responsibility initiatives.

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Citations

[1] U.S. Food and Drug Administration. (2022). Active Pharmaceutical Ingredient (API) Manufacturing: Regulatory Framework.
[2] European Medicines Agency. (2021). Good Manufacturing Practices for APIs.
[3] PharmSource. (2022). API Market Overview: China and India’s Dominance in Pharmaceutical Intermediates.
[4] GlobalData. (2023). Supply Chain Risks and Strategies in Pharma Manufacturing.
[5] Johnson & Johnson. (2022). TYLENOL Production and Supply Chain Overview.