HYDROCODONE BITARTRATE AND ACETAMINOPHEN: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	040894	ANDA	Genus Lifesciences Inc.	64950-343-16	473 mL in 1 BOTTLE (64950-343-16)	2020-11-20
Mikart	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	040881	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0843-63	473 mL in 1 BOTTLE (0054-0843-63)	2025-06-02
Pharm Assoc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	040838	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1544-40	4 TRAY in 1 CASE (0121-1544-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1544-10)	2013-07-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Hydrocodone Bitartrate and Acetaminophen is a widely prescribed combination analgesic used primarily for moderate to severe pain relief. Due to its high demand and potential for misuse, the supply chain for this medication is highly regulated and involves multiple key players. Understanding the landscape of suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to finished drug producers—is crucial for stakeholders in the pharmaceutical, healthcare, and regulatory sectors.

This article provides a comprehensive overview of the primary suppliers involved in the production and distribution of Hydrocodone Bitartrate and Acetaminophen, examines the regulatory environment shaping the supply chain, and discusses implications for market stakeholders.

1. Overview of Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate is an opioid analgesic derived from codeine, combined with Acetaminophen to enhance pain relief. The combination formulation is widely marketed under brands like Vicodin, Norco, and Lortab. The drug's manufacturing involves high complexity, especially concerning hydrocodone synthesis—an controlled substance subject to strict regulations in jurisdictions such as the U.S.

Supply chain components include:

API manufacturing for hydrocodone and acetaminophen.
Formulation and finished drug production.
Distribution channels compliant with pharmaceutical regulations.

2. Key API Suppliers for Hydrocodone Bitartrate

2.1. Major API Manufacturers

The production of hydrocodone Bitartrate hinges on specialized API producers, predominantly located in countries with established pharmaceutical manufacturing sectors, such as India, China, and certain European nations.

Sun Pharmaceutical Industries Ltd. (India):
Known as one of the world’s largest generic pharmaceutical companies, Sun Pharma produces hydrocodone APIs as part of its portfolio, primarily for its own manufacturing plants and for export. Its compliance with cGMP standards ensures regulatory acceptance globally.
Macleods Pharmaceuticals (India):
A significant player with integrated API and formulation capabilities, Macleods supplies hydrocodone APIs primarily for the North American and European markets.
Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
This Chinese API producer focuses on opioid raw materials, including hydrocodone, meeting both domestic and international regulatory standards.
Indivior Plc (UK):
Known more for formulations, Indivior is involved in the distribution of APIs for opioid-based therapies, although not a direct supplier.

2.2. Regulatory Considerations

API suppliers must adhere to the stringent guidelines of regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO). Certifications like cGMP are mandatory to ensure quality, safety, and consistency in APIs.

2.3. Challenges in API Supply

Supply chain disruptions, political factors, and regulatory changes (e.g., U.S. Drug Enforcement Administration (DEA) scheduling) impact API production and availability. Manufacturers face limitations due to the controlled nature of hydrocodone, which imposes strict import/export controls.

3. Acetaminophen Suppliers

3.1. Leading Raw Material Providers

Acetaminophen (paracetamol) is a widely synthesized non-opioid analgesic, produced at scale by numerous global manufacturers.

Mallinckrodt Pharmaceuticals:
With global manufacturing sites, Mallinckrodt supplies pharmaceutical grade acetaminophen for both API and finished products.
Mitsubishi Gas Chemical Company (Japan):
A key producer of acetaminophen with high purity standards, serving markets worldwide.
Sun Pharmaceutical Industries Ltd.:
Not only a producer of hydrocodone APIs but also a significant supplier of acetaminophen raw materials or finished formulations, ensuring control over supply chain margins.
Kao Corporation (Japan):
Supplies pharmaceutical-grade acetaminophen, adhering to rigorous quality standards.

3.2. Manufacturing and Quality Assurance

Acetaminophen production involves complex chemical synthesis that requires high-quality raw materials and strict process controls to meet pharmacopeial standards (USP, EP, JP).

3.3. Market Dynamics

Supply-demand fluctuations have been observed, especially during global events like the COVID-19 pandemic, which strained supply chains for raw materials and finished drugs.

4. Finished Drug Manufacturers and Distributors

4.1. Leading Pharmaceutical Companies

Pfizer:
Pfizer has marketed formulations like Norco, sourcing APIs from certified suppliers and ensuring compliance with regulatory standards.
Mallinckrodt Pharmaceuticals:
Produces and distributes hydrocodone-acetaminophen formulations, aligning with DEA class II schedules in the U.S.
Amneal Pharmaceuticals:
A prominent generic drug manufacturer, supplying hydrocodone-acetaminophen products nationally and internationally.
Mylan (now Viatris):
Has historically been a significant supplier, producing both branded and generic hydrocodone-acetaminophen formulations.

4.2. Regulatory Compliance and Distribution

Manufacturers must navigate regulatory jurisdictions, including DEA scheduling, FDA approval, and international export controls. Distribution is concentrated within highly regulated channels such as pharmacists, hospitals, and authorized distributors to prevent diversion and misuse.

5. Regulatory Environment Impacting Supply

5.1. Controlled Substance Regulations

Hydrocodone's classification as a Schedule II substance in the U.S. requires detailed record-keeping, secure storage, and limited manufacture licensing. The DEA's quotas directly influence production capacity and, consequently, supply availability. Similar regulations apply globally, notably in Canada, Australia, and the EU.

5.2. Global Regulatory Harmonization

Efforts by the International Narcotics Control Board (INCB) aim to balance medical necessity against potential abuse, influencing manufacturing licenses and export/import protocols.

5.3. Impact on Suppliers

Suppliers face accreditation and licensing barriers, stricter reporting requirements, and the necessity of robust compliance systems. These regulatory hurdles can result in supply delays, increased costs, or shortages.

6. Market and Supply Chain Challenges

6.1. Disruption Risks

Historical shortages in hydrocodone and acetaminophen have resulted from:

Regulatory shutdowns.
Manufacturing failures.
Supply chain disruptions during crises like COVID-19.
Political tensions affecting exports or raw material access.

6.2. Quality Assurance and Counterfeit Risks

The high demand and value of hydrocodone formulations attract counterfeit and substandard supplies, emphasizing the importance of quality control across the supply chain.

6.3. Future Outlook

The shift towards alternative pain management therapies and regulatory tightening may impact traditional supply chains. Diversification of API sources and insistence on supply chain resilience become key strategic considerations for stakeholders.

Key Takeaways

The supply of Hydrocodone Bitartrate and Acetaminophen hinges largely on API producers based in India and China, with stringent regulatory oversight ensuring quality but adding complexity.
Major formulators like Pfizer, Mallinckrodt, and Amneal rely on these APIs for multiple regional markets, navigating strict controlled substance regulations.
Disruptions due to regulation, geopolitical issues, or manufacturing challenges can impact the availability of these medications.
The global regulatory environment continuously evolves to balance legitimate healthcare needs against potential abuse, influencing supply chain structures and practices.
Stakeholders should prioritize supply chain risk management, regulatory compliance, and quality assurance to secure steady access to this high-demand medication.

FAQs

1. Who are the leading suppliers of hydrocodone API globally?
Major suppliers include Sun Pharmaceutical Industries (India), Macleods Pharmaceuticals (India), and Zhejiang Hisun Pharmaceutical (China), all of which produce APIs compliant with international quality standards.

2. How does regulation affect the supply of hydrocodone and acetaminophen?
Regulations like the DEA scheduling and GMP requirements impose licensing, production quotas, and security measures that restrict and regulate supply, potentially leading to shortages if compliance or licensing issues arise.

3. Can the supply of acetaminophen be unaffected by controlled substance regulations?
Yes; acetaminophen is a non-controlled OTC medication in most jurisdictions, making its supply less restrictive but still subject to manufacturing quality and raw material availability issues.

4. How are supply chain disruptions managed for regulated opioids?
Manufacturers buffer supply risks through inventory management, diversification of API sources, strategic stockpiling, and adherence to regulatory protocols that ensure continuous and compliant supply.

5. What is the outlook for the future supply of hydrocodone-bitartrate and acetaminophen?
While demand is poised to remain stable, regulatory tightening and the shift toward alternative therapies may influence supply dynamics, emphasizing the need for supply chain resilience and innovation.

References

[1] U.S. Food and Drug Administration (FDA). "Controlled Substance Schedules," https://www.fda.gov, accessed 2023.
[2] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice," https://www.ema.europa.eu, accessed 2023.
[3] International Narcotics Control Board (INCB). "Annual Reports," https://www.incb.org, 2022.
[4] IQVIA Institute. "The Global Use of Medicine," IQVIA, 2022.
[5] MarketWatch. "Opioid Market Analysis," https://www.marketwatch.com, 2023.

Suppliers and packagers for HYDROCODONE BITARTRATE AND ACETAMINOPHEN