Suppliers and packagers for generic pharmaceutical drug: acetaminophen

acetaminophen

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aspiro	ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	216617	ANDA	Camber Pharmaceuticals, Inc.	31722-205-24	24 VIAL, SINGLE-DOSE in 1 CARTON (31722-205-24) / 100 mL in 1 VIAL, SINGLE-DOSE (31722-205-31)	2022-07-27
B Braun Medical	ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	204957	NDA	B. Braun Medical Inc.	0264-4050-80	24 CONTAINER in 1 CASE (0264-4050-80) / 50 mL in 1 CONTAINER	2021-02-18
B Braun Medical	ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	204957	NDA	B. Braun Medical Inc.	0264-4050-90	24 CONTAINER in 1 CASE (0264-4050-90) / 50 mL in 1 CONTAINER	2021-02-18

Suppliers for the Pharmaceutical Drug Acetaminophen: A Comprehensive Analysis

Last updated: April 19, 2025

Acetaminophen, a widely used analgesic and antipyretic, remains one of the most critical active pharmaceutical ingredients (APIs) in global healthcare. The supply chain for this essential drug involves a complex network of manufacturers, distributors, and regulatory frameworks. This report examines the current landscape of acetaminophen suppliers, focusing on key players, regional dynamics, regulatory challenges, and supply chain strategies.

---

Global Supply Landscape of Acetaminophen

Dominance of Western and Asian Manufacturers

Mallinckrodt Pharmaceuticals stands out as the only Western supplier of acetaminophen, leveraging over 125 years of expertise in API manufacturing[1][4][7]. The company operates facilities in Raleigh, North Carolina, and Greenville, Illinois, supplying acetaminophen to over 100 countries[10]. Its product portfolio includes diverse formulations such as Compap™, a direct-compression acetaminophen line designed for seamless blending with other APIs[10]. Mallinckrodt’s commitment to supply continuity is reinforced by redundant equipment, strategic warehousing, and long-term raw material contracts, such as its acetic anhydride agreement dating to 1996[7][11].

In contrast, China and India dominate the Asian acetaminophen market, with Zhejiang Kangle Pharmaceutical, Anqiu Lu’an Pharmaceutical, and Granules India Limited leading production[6][9][12]. Chinese suppliers like Guangdong Taoteng Chemical offer bulk acetaminophen at competitive prices (USD 25–100/kg), catering to global demand for cost-effective APIs[8][11]. India’s IOL Chemicals and Pharmaceuticals and Granules India also play pivotal roles, exporting to over 80 countries with facilities compliant with U.S. FDA and EMA standards[3][9].

Regional Supplier Networks in the United States

The U.S. market features a mix of manufacturers and distributors. Pharm-RX Chemical Corporation and SAE Manufacturing Specialties Corp supply acetaminophen in powder and direct-compression forms, serving industries ranging from nutraceuticals to aerospace[2]. Spectrum Chemical Mfg. Corp., an ISO 9001-certified manufacturer, provides ultra-pure acetaminophen for laboratories and pharmaceutical facilities[2]. Mallinckrodt’s dominance is further cemented by its role as the sole Western producer, ensuring supply stability during disruptions, such as the 2008 Chinese manufacturing shutdowns[7].

---

Regulatory and Quality Considerations

Compliance Challenges and FTC Oversight

The FTC has previously flagged mislabeling issues among U.S. suppliers, including Leiner Health Products and LNK International, underscoring the importance of regulatory vigilance[5]. These cases highlight risks associated with private-label agreements, where third-party manufacturers produce acetaminophen for retailers like Walmart and Costco[5]. To mitigate such risks, suppliers like Mallinckrodt adhere to Good Manufacturing Practices (GMP) and hold certifications from 56 countries, ensuring global compliance[10][12].

Quality Assurance in API Production

Chinese manufacturers face scrutiny over quality control, though companies like Humanwell PuraCap Pharmaceuticals have achieved FDA approval for their facilities[6]. Anqiu Lu’an Pharmaceutical emphasizes “top-quality” raw materials, while Zhejiang Kangle integrates R&D with large-scale production[6][9]. Mallinckrodt’s investments in particle size optimization and micronization technologies further demonstrate the industry’s focus on enhancing product uniformity[4][10].

---

Supply Chain Resilience and Risk Mitigation

Strategic Sourcing and Redundancy

Mallinckrodt’s supply chain strategy includes dual sourcing for critical raw materials and maintaining safety stock across U.S. and U.K. warehouses[7][11]. This approach proved vital during the 2008 Beijing Olympics, when Chinese API production halted, and Mallinckrodt scaled up output to meet global demand[7]. Similarly, Chinese suppliers like Xi’an Haoze Biotechnology prioritize JIT delivery and custom formulations to adapt to market fluctuations[8][11].

Pricing Dynamics and Market Competition

Acetaminophen API prices vary significantly by region. Chinese suppliers offer wholesale rates as low as USD 3.8–4/kg for bulk orders, whereas U.S. and European manufacturers command premiums due to higher regulatory and labor costs[6][8]. For instance, Mallinckrodt’s Compap™ line is priced at a premium for its particle size advantages, appealing to formulation-specific applications[4][10].

---

Emerging Trends and Future Outlook

Shift Toward Vertical Integration

Companies like Granules India are vertically integrating API production with finished dosage forms (FDFs), streamlining supply chains and reducing dependency on external suppliers[3][9]. Similarly, Mallinckrodt’s expansion into custom formulations and contract manufacturing reflects a broader industry trend toward tailored solutions[4][10].

Sustainability and Green Manufacturing

Mallinckrodt emphasizes sustainable operations, including energy-efficient manufacturing and waste reduction initiatives[10]. Chinese suppliers like Anhui Sinotech Industrial are adopting greener synthesis methods for acetaminophen production, aligning with global environmental standards[6][9].

---

Conclusion

The acetaminophen supply chain is characterized by a delicate balance between cost-efficient Asian production and high-compliance Western manufacturing. While Mallinckrodt remains a cornerstone of reliability for U.S. and European markets, Chinese and Indian suppliers dominate bulk API trade. Regulatory compliance, supply chain redundancy, and technological innovation will continue to shape the industry, ensuring acetaminophen remains accessible amid growing global demand.

“As the only Western supplier of acetaminophen, Mallinckrodt Pharmaceuticals is a trustworthy, reliable source for the products your customers depend on.” — Mallinckrodt Pharmaceuticals[1]

---

Key Takeaways

1. Mallinckrodt Pharmaceuticals is the sole Western acetaminophen supplier, prioritizing supply chain resilience.
2. China and India lead bulk API production, offering competitive pricing but requiring rigorous quality checks.
3. Regulatory compliance remains critical, with historical mislabeling cases underscoring the need for oversight.
4. Vertical integration and sustainable practices are emerging as key industry trends.

---

FAQs

1. Why is Mallinckrodt considered a reliable acetaminophen supplier?
   Mallinckrodt ensures supply continuity through redundant manufacturing, strategic warehousing, and long-term raw material contracts[1][7][10].

2. What are the risks of sourcing acetaminophen from Chinese suppliers?
   While cost-effective, quality control and regulatory compliance vary, necessitating thorough vendor audits[6][8][11].

3. How do acetaminophen API prices differ between regions?
   Chinese suppliers offer lower bulk prices (USD 3.8–100/kg), whereas U.S./European APIs command higher rates due to compliance costs[6][8][10].

4. What strategies do suppliers use to mitigate supply chain disruptions?
   Dual sourcing, safety stock, and JIT delivery systems are common[7][8][11].

5. How is sustainability influencing acetaminophen production?
   Manufacturers are adopting energy-efficient processes and greener synthesis methods to meet environmental standards[6][10].

References

1. https://www.mallinckrodt.com/products/active-pharmaceutical-ingredients/our-core-four-values/supply-continuity/acetaminophen-risk-mitigation/
2. https://www.thomasnet.com/suppliers/usa/acetaminophen-200907
3. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/acetaminophen
4. http://mnk.com/products/active-pharmaceutical-ingredients/our-core-four-values/performance/particle-size-and-product-breadth/
5. https://www.ftc.gov/news-events/news/press-releases/2001/11/five-manufacturers-over-counter-analgesic-products-agree-settle-charges-mislabeling-certain-products
6. https://m.pharmasources.com/industryinsights/71743.html
7. https://www.mallinckrodt.com/globalassets/documents/products/core-four-values/supply-continuity/supply-acetaminophenriskmitigation.pdf
8. https://www.made-in-china.com/products-search/hot-china-products/Wholesale_Acetaminophen.html
9. https://www.pharmacompass.com/manufacturers-suppliers-exporters/acetaminophen
10. https://www.mallinckrodt.com/products/active-pharmaceutical-ingredients/acetaminophenparacetamol/
11. https://www.made-in-china.com/products-search/hot-china-products/Acetaminophen.html
12. https://pharmaoffer.com/api-excipient-supplier/analgesics/paracetamol