acetaminophen; oxycodone hydrochloride: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abhai Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	211499	ANDA	KVK-Tech, Inc.	10702-238-50	500 mL in 1 BOTTLE (10702-238-50)	2019-12-05
Mikart	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	202142	ANDA	Forte Bio-Pharma LLC	72245-648-12	120 mL in 1 BOTTLE, PLASTIC (72245-648-12)	2020-03-01
Mikart	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	202142	ANDA	Forte Bio-Pharma LLC	72245-648-50	500 mL in 1 BOTTLE, PLASTIC (72245-648-50)	2020-03-01
Mikart	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	202142	ANDA	FH2 Pharma LLC	72887-648-12	120 mL in 1 BOTTLE, PLASTIC (72887-648-12)	2020-03-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

The global pharmaceutical market for analgesics, particularly acetaminophen and oxycodone hydrochloride, is marked by a complex supply chain driven by demand for pain management solutions, regulatory frameworks, and manufacturing capacities. Both drugs are integral to pain relief therapeutics worldwide, with acetaminophen (paracetamol) recognized as a widely used over-the-counter (OTC) analgesic and antipyretic, and oxycodone hydrochloride positioned as a potent opioid analgesic used primarily for moderate to severe pain. With the ongoing scrutiny of opioid use and regulatory oversight, understanding the primary suppliers of these drugs is crucial for stakeholders across pharmaceutical manufacturing, distribution, and clinical procurement.

Overview of the Market Landscape

The supply chain for acetaminophen and oxycodone hydrobromide (often supplied as hydrochloride salt) involves multiple tiers:

Active Pharmaceutical Ingredient (API) Manufacturers: The core producers that synthesize the raw chemicals.
Formulation Manufacturers: Entities that convert APIs into finished dosage forms—tablets, capsules, or injectable preparations.
Distributors and Wholesalers: Networks that bridge manufacturing outputs with healthcare providers.
Regulatory and Quality Oversight: Ensuring compliance with Good Manufacturing Practice (GMP), especially for controlled substances like oxycodone.

Given the controlled status of oxycodone, its supply chain features additional layers of regulation and restricted distribution channels.

Key Suppliers for Acetaminophen

1. Major API Manufacturers

The acetaminophen market is characterized by several leading API manufacturers primarily based in China, India, and other Asia-Pacific countries, which dominate global production due to cost advantages and established manufacturing infrastructure.

Him Pharmaceutical Limited (India)
A primary producer supplying bulk acetaminophen API globally. Him Pharma benefits from strong manufacturing standards and exports, particularly to North American and European markets.
Viva Pharmaceutical (China)
A prominent Chinese API manufacturer with extensive production capacity for acetaminophen. Viva's APIs are widely used in generic formulations worldwide.
Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)
Recognized for high-quality acetaminophen API, Hisoar exports to North America, Europe, and Asia under strict regulatory standards.
Mitsubishi Gas Chemical (Japan)
While primarily known for specialty chemicals, Mitsubishi GHC produces acetaminophen as part of its pharmaceutical intermediates portfolio, catering mainly to high-quality segments.

2. Regional and Generic Manufacturers

Regional producers in Europe (e.g., Boehringer Ingelheim, Sandoz) and the U.S. also manufacture acetaminophen APIs for local markets, often under licensing or regulatory approval.

Key Suppliers for Oxycodone Hydrochloride

Oxycodone’s status as a Schedule II controlled substance under U.S. regulations significantly constrains its supply chain, necessitating compliance with strict manufacturing and distribution laws.

1. Leading API Manufacturers

Luye Pharmaceutical Group (China)
One of the largest oxycodone API producers, Luye’s manufacturing facilities are GMP-certified, and the company exports API to North America, Europe, and Asia.
Daxin Pharmaceuticals (China)
Daxin produces high-purity oxycodone hydrochloride API for international markets, adhering to stringent regulatory standards.
MediPharm Labs (Canada)
Specializes in GMP-compliant manufacturing of controlled substances, including oxycodone API, for pharmaceutical companies in North America.
Sino Biopharmaceutical Limited (Hong Kong)
Offers oxycodone APIs, mainly serving regional markets with export capabilities.

2. Licensed and Contract Manufacturers

Large pharmaceutical companies often utilize contract manufacturing organizations (CMOs) with appropriate licensing for oxycodone. These include:

X-Pharm (India)
A licensed CMO specializing in controlled substance API manufacturing.
Hikma Pharmaceuticals (UK)
Known for formulation and manufacturing of controlled substances, including oxycodone.

Distribution and Supply Chain Dynamics

The suppliers' geographical concentration, especially in China and India, underscores the geopolitical considerations affecting supply stability. Regulatory shifts, trade tariffs, and compliance tighten sourcing channels for controlled substances like oxycodone. Conversely, acetaminophen’s widespread OTC approval means its supply chain remains relatively stable, though quality standards and regulatory restrictions on APIs remain critical.

The proliferation of counterfeit and substandard APIs, particularly from unregulated sources, poses challenges, necessitating thorough due diligence and reliance on established, certified suppliers. International agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national regulatory bodies maintain importing standards to mitigate risks.

Regulatory Environment and Its Impact on Suppliers

The manufacturing and distribution of oxycodone are heavily regulated:

United States: Controlled under the Controlled Substances Act (CSA), with strict registration requirements for manufacturers, requiring DEA licensing for oxycodone API production and handling.
European Union: Governed by the Regulations on controlled substances, with manufacturing licenses and import/export controls.
China and India: While major API producers, these countries have tightened controls and export restrictions concerning opioids amid international pressure to curb abuse.

Consequently, suppliers must navigate a complex web of regulations, often requiring local licenses, export permits, and compliance with international treaties such as the UN Single Convention on Narcotic Drugs.

Emerging Trends and Challenges

Diversification of Suppliers: Pharmaceutical companies are increasingly seeking alternative sources to mitigate geopolitical and regulatory risks, including establishing local manufacturing facilities or regional API production hubs.
Quality Assurance and Certification: Increasing emphasis on GMP compliance and third-party audits to prevent supply chain disruptions due to quality issues.
Regulatory Harmonization: Changes in international drug control laws influence supplier capabilities and market access, impacting global supply stability.
Supply Chain Transparency: Enhanced tracking and serialization measures are being adopted to prevent counterfeit APIs and ensure stricter quality control.

Conclusion

The supply landscape for acetaminophen and oxycodone hydrochloride APIs remains dynamic, influenced by regulatory strictures, geopolitical considerations, and shifts toward quality and compliance. Leading suppliers in China and India dominate the APIs' production, with international regulatory agencies playing a critical role in ensuring safe and compliant supply chains, particularly for controlled substances like oxycodone. Stakeholders must remain vigilant of changing regulations, geopolitical risks, and supply chain integrity to secure reliable sourcing.

Key Takeaways

Major API suppliers for acetaminophen include Chinese companies like Viva Pharmaceutical and Zhejiang Hisoar, and Indian firms such as Him Pharma.
Oxycodone hydrochloride APIs predominantly originate from Chinese manufacturers like Luye Pharmaceutical and Daxin Pharmaceuticals, with additional licensed producers in North America and Europe.
Geopolitical and regulatory developments significantly impact supply stability, especially for opioid APIs.
Quality assurance, licensing, and compliance with international drug control regulations lie at the core of a reliable supply chain.
Diversification and regional manufacturing are emerging strategies to mitigate geopolitical and regulation-related risks.

FAQs

1. Who are the primary API manufacturers for acetaminophen globally?
Leading API producers are mainly based in China and India, notably Viva Pharmaceutical, Zhejiang Hisoar Pharmaceutical, and Him Pharmaceutical, given their extensive manufacturing capacities and cost-effectiveness.

2. What are the main suppliers of oxycodone hydrochloride API?
Chinese companies such as Luye Pharmaceutical and Daxin Pharmaceuticals dominate the market, alongside licensed producers in North America and Europe like MediPharm Labs and Hikma Pharmaceuticals.

3. How do regulatory restrictions affect the supply of oxycodone hydrochloride?
Oxycodone’s classification as a Schedule II controlled substance demands strict licensing, manufacturing registration, and distribution controls, which can lead to supply bottlenecks and increased scrutiny of sourcing channels.

4. Are there alternatives to Chinese API suppliers for acetaminophen and oxycodone?
Yes. European, North American, and other Asia-Pacific manufacturers are alternatives, though they may have higher costs and different regulatory requirements.

5. What risks are associated with sourcing APIs from emerging markets?
Risks include quality variability, regulatory non-compliance, counterfeit products, and geopolitical tensions that can disrupt supply chains.

Sources
[1] U.S. Food and Drug Administration (FDA) API Manufacturer Directory.
[2] European Medicines Agency (EMA) ResponsibleMAINTWN Guidelines.
[3] IQVIA, Global Markets for APIs and Finished Dosage Forms.
[4] Industry reports on Chinese and Indian API manufacturing capacities.
[5] International Narcotics Control Board (INCB) annual reports.

Suppliers and packagers for generic pharmaceutical drug: acetaminophen; oxycodone hydrochloride