OXYCODONE AND ACETAMINOPHEN: 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
Abhai Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210644	ANDA	KVK-Tech, Inc.	10702-184-01	100 TABLET in 1 BOTTLE (10702-184-01)	2018-02-09
Abhai Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210644	ANDA	KVK-Tech, Inc.	10702-184-10	1000 TABLET in 1 BOTTLE (10702-184-10)	2018-02-09
Abhai Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210644	ANDA	KVK-Tech, Inc.	10702-184-50	500 TABLET in 1 BOTTLE (10702-184-50)	2018-02-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report analyzes key suppliers for the active pharmaceutical ingredients (APIs) and finished drug products of oxycodone and acetaminophen, a combination analgesic. The analysis focuses on global manufacturing capabilities, regulatory compliance, and supply chain dynamics relevant to the U.S. market.

What are the primary active pharmaceutical ingredients (APIs) for oxycodone and acetaminophen combination drugs?

The primary APIs are oxycodone hydrochloride and acetaminophen. Oxycodone hydrochloride is a semi-synthetic opioid agonist used for pain relief. Acetaminophen, also known as paracetamol, is a non-opioid analgesic and antipyretic.

Oxycodone Hydrochloride API Suppliers

Manufacturing of oxycodone hydrochloride is highly regulated due to its Schedule II controlled substance status in the United States. The Drug Enforcement Administration (DEA) tightly controls quotas for its production and importation.

Specialty Manufacturers: Production is concentrated among a limited number of specialized chemical manufacturers with advanced security protocols and DEA licenses. These entities often have integrated supply chains to manage the sourcing of precursor chemicals, which are also regulated.
Key Global Players:
- Mallinckrodt Pharmaceuticals: A significant historical producer of opioid APIs in the U.S. The company has faced extensive litigation related to its role in the opioid crisis.
- Purdue Pharma L.P.: While historically a major player in oxycodone-based products (e.g., OxyContin), its API manufacturing operations have been subject to restructuring and legal challenges. Its status as a direct API supplier to the broader market has been significantly impacted.
- Teva Pharmaceutical Industries Ltd.: A large generic pharmaceutical company with API manufacturing capabilities. Teva produces a range of opioid APIs.
- Amneal Pharmaceuticals LLC: Through acquisitions, Amneal has expanded its API portfolio, including controlled substances.
- Ipsen Biopharmaceuticals Ireland Limited: A subsidiary of Ipsen, involved in API production for various therapeutic areas.
- Camargo Pharmaceutical Services: Operates as a contract development and manufacturing organization (CDMO) that can handle controlled substance APIs.
Regulatory Hurdles: U.S. manufacturers must comply with DEA regulations on production quotas, security, record-keeping, and diversion control. International suppliers must meet U.S. Food and Drug Administration (FDA) requirements for API quality and manufacturing practices (current Good Manufacturing Practices - cGMP) and secure import permits.

Acetaminophen API Suppliers

Acetaminophen is a widely produced API with a more diverse supplier base compared to oxycodone.

Global Manufacturing Hubs: Production is concentrated in countries with significant chemical manufacturing infrastructure, including China and India. However, U.S.-based production also exists.
Key Global Players:
- Granules India Ltd.: A major global manufacturer of acetaminophen API.
- Aceto Corporation: A supplier of pharmaceutical intermediates and APIs, including acetaminophen.
- Anqiu Fengyuan Pharmaceutical Co., Ltd. (China): A significant producer of acetaminophen API in China.
- Hebei Jiheng Pharmaceutical Co., Ltd. (China): Another prominent Chinese acetaminophen API manufacturer.
- Nanjing Union Chemical Company Ltd. (China): Supplies various pharmaceutical raw materials, including acetaminophen.
- Mallinckrodt Pharmaceuticals: Also a producer of acetaminophen API.
- Lanxess AG: A specialty chemicals company with a division producing acetaminophen for pharmaceutical applications.
Quality and Compliance: Suppliers must adhere to FDA cGMP standards. Regular inspections by the FDA and other regulatory bodies ensure product quality and manufacturing integrity. Price competitiveness is a significant factor in the acetaminophen API market due to its broad generic availability.

Who are the primary manufacturers of finished oxycodone and acetaminophen drug products?

Finished dosage form manufacturers are responsible for formulating the APIs into final drug products (e.g., tablets, capsules) and packaging them for distribution. This segment also includes companies specializing in both branded and generic versions.

Branded Product Manufacturers

Purdue Pharma L.P.: The originator of the branded drug OxyContin (oxycodone hydrochloride extended-release), and historically involved in combination products. However, its market position and manufacturing have been significantly altered by bankruptcy proceedings and legal settlements.
Janssen Pharmaceuticals (part of Johnson & Johnson): Holds rights to or manufactures certain opioid-containing products.

Generic Product Manufacturers

The market for generic oxycodone and acetaminophen combination products is highly competitive, with numerous companies holding Abbreviated New Drug Applications (ANDAs) approved by the FDA.

Teva Pharmaceutical Industries Ltd.: A major supplier of generic pharmaceuticals, including oxycodone and acetaminophen tablets.
Endo International plc: Produces and markets generic opioid analgesics.
Amneal Pharmaceuticals LLC: Offers a portfolio of generic controlled substances.
Actavis Generics (part of Teva): Operates as a significant provider of generic medications.
Sun Pharmaceutical Industries Ltd.: A global pharmaceutical company with a strong generic presence in the U.S.
Viatris Inc.: Formed from the merger of Mylan and Upjohn, Viatris is a substantial player in the generic drug market.
Hikma Pharmaceuticals PLC: Manufactures and markets a range of generic injectable and oral medications, including controlled substances.
ANI Pharmaceuticals, Inc.: Focuses on developing, manufacturing, and marketing generic and branded prescription pharmaceuticals.

Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies, particularly smaller generic manufacturers, utilize CMOs to produce their finished drug products. These CMOs must have specialized facilities for handling controlled substances.

Key CMOs with Controlled Substance Capabilities:
- Therapharm Inc.: Provides contract manufacturing services for controlled substances.
- Recordati Rare Diseases (formerly Orphan Pacific): Operates manufacturing facilities capable of handling controlled substances.
- Pii (formerly Patient Infusions Inc.): A CDMO offering sterile and non-sterile drug product manufacturing, including controlled substances.

What are the regulatory considerations for suppliers in the oxycodone and acetaminophen supply chain?

Regulatory compliance is paramount due to the controlled substance nature of oxycodone and the general pharmaceutical quality requirements for acetaminophen and finished drug products.

Controlled Substance Regulations (Oxycodone)

Drug Enforcement Administration (DEA):
- Registration: All entities handling Schedule II controlled substances (including oxycodone API and finished products) must be registered with the DEA.
- Quotas: The DEA sets aggregate production quotas annually for Schedule II controlled substances to limit the total amount manufactured or imported into the U.S. Companies must apply for individual manufacturing or import quotas.
- Security: Stringent physical security measures are mandated for facilities storing and handling controlled substances to prevent diversion and theft. This includes safes, vaults, alarm systems, and access controls.
- Record-Keeping and Reporting: Detailed records of all transactions, inventory, and disposal of controlled substances are required. Regular reports must be submitted to the DEA (e.g., ARCOS reporting for sales and acquisitions).
- Import/Export Permits: Specific permits are required for the importation and exportation of controlled substances.
Food and Drug Administration (FDA):
- cGMP Compliance: All manufacturers, including API producers and finished drug product manufacturers, must adhere to current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211. This ensures product quality, safety, and efficacy.
- Facility Inspections: FDA conducts regular inspections of manufacturing facilities to verify cGMP compliance.
- ANDAs: Companies seeking to market generic versions of oxycodone and acetaminophen products must submit and obtain approval for an Abbreviated New Drug Application (ANDA) from the FDA.

General Pharmaceutical Regulations (Acetaminophen and Finished Products)

FDA:
- cGMP Compliance: As with oxycodone, acetaminophen API manufacturers and finished product manufacturers must comply with cGMP.
- Drug Master Files (DMFs): API manufacturers often file DMFs with the FDA, which contain confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Drug product manufacturers can reference these DMFs in their applications.
- Labeling and Advertising: All drug products must comply with FDA regulations regarding labeling, including prescribing information, warnings, and indications. Advertising is also regulated.
- Post-Market Surveillance: Manufacturers are responsible for monitoring and reporting adverse events associated with their products.

International Supplier Requirements

FDA Foreign Inspections: The FDA inspects foreign manufacturing facilities to ensure compliance with U.S. cGMP standards.
Import Alerts: Products from facilities that do not meet U.S. standards may be subject to import alerts, preventing their entry into the U.S.
Pharmaceutical Export Certificates: Many countries require export certificates to attest that a drug is approved for sale in its country of origin or meets specific quality standards.

What are the market dynamics and trends affecting suppliers of oxycodone and acetaminophen?

The market for these drugs is shaped by a complex interplay of regulatory pressures, public health concerns, and generic competition.

Impact of the Opioid Crisis

Increased Scrutiny and Litigation: Manufacturers of oxycodone APIs and finished products have faced intense scrutiny and numerous lawsuits related to their alleged role in fueling the opioid epidemic. This has led to significant financial settlements, changes in business practices, and a focus on responsible manufacturing and distribution.
DEA Quota Adjustments: The DEA has historically adjusted production quotas for oxycodone based on both legitimate medical needs and efforts to combat diversion. This can impact the availability and pricing of the API.
Shift Towards Abuse-Deterrent Formulations (ADFs): While less common for immediate-release combination products, there has been a trend towards developing and utilizing ADFs for extended-release opioid formulations to reduce abuse potential. This impacts the innovation landscape for opioid products.

Generic Competition and Pricing Pressures

Oxycodone and Acetaminophen Tablets: The market for immediate-release oxycodone and acetaminophen tablets is dominated by generics. This leads to intense price competition among manufacturers and can squeeze profit margins.
API Sourcing: Generic manufacturers often seek the lowest-cost API suppliers, creating competition among acetaminophen producers globally. For oxycodone API, the limited supplier base due to regulatory hurdles means price is influenced by quota availability and producer costs.

Supply Chain Resilience

Geopolitical Factors: Dependence on international suppliers for APIs, particularly acetaminophen from Asia, introduces risks related to trade disputes, shipping disruptions, and public health crises (e.g., pandemics).
Diversification: Companies are increasingly focused on diversifying their supply chains to mitigate risks, which can involve dual-sourcing APIs or establishing manufacturing in multiple geographic regions.

Evolving Treatment Guidelines

Reduced Opioid Prescribing: Public health initiatives and evolving pain management guidelines encourage reduced reliance on opioid medications where effective alternatives exist. This can temper overall market demand for oxycodone-containing products.
Focus on Non-Opioid Analgesics: Increased research and development into non-opioid pain management alternatives can impact the long-term market share of opioid-based analgesics.

Key Takeaways

The supply chain for oxycodone is highly concentrated and tightly regulated due to its Schedule II controlled substance status, with a limited number of DEA-licensed API manufacturers.
Acetaminophen API production is more globally distributed, with significant manufacturing capacity in Asia, subject to FDA cGMP standards.
Finished oxycodone and acetaminophen drug products are primarily manufactured by generic pharmaceutical companies, with a competitive landscape influenced by pricing and ANDA approvals.
Contract Manufacturing Organizations (CMOs) play a crucial role, particularly for companies requiring specialized facilities for controlled substance handling.
Regulatory compliance, especially DEA quotas and security for oxycodone, alongside FDA cGMP for all components, is critical for all suppliers.
The market is significantly shaped by the ongoing impact of the opioid crisis, leading to increased regulatory oversight, litigation, and efforts to control diversion.
Generic competition drives pricing pressures, while supply chain resilience is becoming a strategic imperative due to geopolitical and health-related risks.

Frequently Asked Questions

What is the typical lead time for securing oxycodone API from a licensed manufacturer? Lead times can vary significantly, often ranging from 3 to 9 months. This is influenced by DEA quota allocations, existing supplier contracts, and the manufacturer's production schedules. Companies must plan well in advance for API procurement.
Are there significant differences in the quality standards for acetaminophen API sourced from China versus India versus the U.S.? Quality standards are primarily dictated by FDA's cGMP regulations, which apply regardless of the country of origin. Reputable suppliers in all regions adhere to these standards. However, the rigor of regulatory enforcement and supply chain transparency can differ, necessitating thorough supplier qualification and auditing.
How does DEA quota availability impact the price of oxycodone API? Limited DEA quotas can create supply constraints. When demand for legitimate medical use exceeds the allocated supply, it can lead to increased pricing due to scarcity and competition among quota holders.
What are the primary risks associated with relying on a single supplier for either oxycodone or acetaminophen API? The primary risks include supply chain disruption (due to manufacturing issues, regulatory action, or geopolitical events), price volatility, and a lack of negotiation leverage. Diversification across multiple qualified suppliers mitigates these risks.
Can a pharmaceutical company manufacture its own oxycodone API if it has the necessary chemical synthesis capabilities, or must it always source from a DEA-registered third-party supplier? A company can manufacture its own oxycodone API if it obtains the appropriate DEA registration for manufacturing controlled substances, secures its own production quotas, and adheres to all DEA and FDA regulations for security, record-keeping, and cGMP. This is a complex and capital-intensive undertaking, often less practical than sourcing from specialized API manufacturers.

Citations

[1] Drug Enforcement Administration. (n.d.). Controlled Substances Act. U.S. Department of Justice. Retrieved from https://www.deadiversion.usdoj.gov/21cfr_text/ [2] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) Regulations. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp [3] U.S. Food & Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas [4] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/forms-and-fees/drug-master-files-dmfs [5] U.S. Food & Drug Administration. (n.d.). Import Alerts. Retrieved from https://www.fda.gov/trade-program/import-program/import-alerts

Suppliers and packagers for OXYCODONE AND ACETAMINOPHEN