acetaminophen; benzhydrocodone hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0145-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0145-1)	2018-02-23
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0167-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0167-1)	2018-02-23
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653	NDA	Zevra Therapeutics, Inc.	70040-0189-1	100 TABLET in 1 BOTTLE, PLASTIC (70040-0189-1)	2018-02-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The global pharmaceutical industry relies on a complex network of suppliers to ensure the consistent availability and quality of active pharmaceutical ingredients (APIs). This is particularly crucial for widely used medications like acetaminophen and benzhydrocodone hydrochloride. As regulatory standards tighten and supply chain complexities increase, understanding the leading suppliers and sourcing strategies for these drugs becomes essential for pharmaceutical companies, healthcare providers, and investors.

Overview of Acetaminophen and Benzhydrocodone Hydrochloride

Acetaminophen, also known as paracetamol, is a non-opioid analgesic and antipyretic agent used worldwide for pain relief and fever reduction. It has a long-standing status as an over-the-counter medication and is produced by numerous manufacturers.

Benzhydrocodone hydrochloride is an opioid analgesic commonly combined with acetaminophen in prescription medications such as Norco, Vicodin, and Lortab. It is a semi-synthetic opioid derived from hydrocodone, used for moderate to severe pain management. The supply of benzhydrocodone hydrochloride is tightly controlled due to its potential for abuse and strict regulatory oversight.

Leading Suppliers of Acetaminophen

Global Manufacturing Leaders

Jiangsu Taknong Pharmaceutical Co., Ltd. (China): One of the largest producers in Asia, supplying a significant share of the global market. The company adheres to Good Manufacturing Practices (GMP) and ISO standards, exporting to North America and Europe.
Mochida Pharmaceutical Co., Ltd. (Japan): A key supplier renowned for high-quality APIs, including acetaminophen, serving predominantly Asian markets with strict compliance to international standards.
CSPC Pharmaceutical Group Ltd. (China): A major Chinese API manufacturer with extensive capacity for acetaminophen production, certified by global regulatory agencies (e.g., FDA, EMA).
Hunan Huakang Pharmaceutical Co., Ltd. (China): Supplies acetaminophen to global markets, emphasizing quality control and regulatory compliance.
Huanghua SeaHop Pharmaceutical Co., Ltd. (China): Known for large-scale synthesis and competitive pricing, with export markets spanning North America, Asia, and Africa.

North American and European Suppliers

BASF SE (Germany): Produces and markets acetaminophen as part of its pharmaceutical ingredients portfolio, focusing on quality and sustainability.
Sinochem Pharmaceuticals (China): A proven supplier with a comprehensive API portfolio, including acetaminophen, servicing North American and European clients.
Qualicaps (Japan): While primarily an encapsulation company, it sources high-grade acetaminophen for formulation purposes, emphasizing quality assurance.

Major Suppliers of Benzhydrocodone Hydrochloride

Regulatory and Industry Constraints

The synthesis of benzhydrocodone hydrochloride is restricted by strict regulatory frameworks, especially in the United States, due to its opioid nature. Only a few API manufacturers are authorized and capable of producing this compound for legitimate medical use.

Key Manufacturers and Suppliers

Mallinckrodt Pharmaceuticals (United States): Historically, a principal producer of hydrocodone and its derivatives, including benzhydrocodone hydrochloride. Mallinckrodt's facilities are compliant with FDA regulations, supplying licensed pharmaceutical companies under strict controls.
Noramco, Inc. (United States): Specializes in controlled substances and intermediates; supplies pharmaceutical-grade benzhydrocodone hydrochloride to licensed manufacturers, with strict oversight.
HIKMA Pharmaceuticals (United Kingdom): A major generic drug manufacturer with the capacity to produce opioid APIs, including benzhydrocodone hydrochloride, under regulatory compliance.
Patheon (Thermo Fisher Scientific) (Global): Offers contracted manufacturing services for controlled substances, including opioid APIs, adhering to U.S. DEA regulations and GMP standards.
Granules India Ltd. (India): While more involved in formulations, some Indian APIs manufacturers produce with licenses the necessary controlled-substance APIs for export pursuant to international treaties.

Key Considerations for Supply Sources

Regulatory Approval: Only companies holding appropriate licenses from authorities like the DEA (U.S. Drug Enforcement Administration), EMA, or respective national agencies are authorized to produce and supply benzhydrocodone hydrochloride.
Supply Chain Security: Due to the high potential for diversion, APIs for opioids undergo rigorous tracking and security measures.
Quality Certifications: Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP) and possess certifications such as ISO, cGMP, and regulatory approvals from relevant authorities.

Supply Chain Dynamics and Challenges

The supply of acetaminophen is relatively stable, supported by numerous manufacturers capable of scaling production globally. Conversely, the supply of benzhydrocodone hydrochloride remains highly concentrated due to regulatory hurdles, with most manufacturing localized within strict licensing regimes. Disruptions in manufacturing plants—due to regulatory issues, geopolitical conflicts, or the COVID-19 pandemic—can significantly impact availability.

Transportation and security are additional challenges for opioid API suppliers, necessitating high levels of oversight, security protocols, and compliance with international drug control treaties such as the Single Convention on Narcotic Drugs (1961).

Emerging Trends & Strategic Considerations

Diversification of Suppliers: Pharmaceutical companies are increasingly diversifying sourcing to mitigate risks associated with supply disruptions, especially for opioids.
Alternate Synthesis Routes: Research into synthetic pathways aims to reduce dependency on limited API producers and potentially bypass regulatory bottlenecks.
Regional Manufacturing Expansion: Countries like India and China are expanding capacity, but regulatory compliance remains paramount.
Supply Chain Transparency: Enhanced traceability and blockchain solutions are emerging to improve security, authenticity, and regulatory compliance.

Conclusion

The supply landscape for acetaminophen benefits from a broad and mature manufacturing base across Asia, Europe, and North America, ensuring stability and competitiveness. In contrast, benzhydrocodone hydrochloride's supply is more constrained, dominated by a handful of licensed manufacturers within highly regulated jurisdictions.

For stakeholders, understanding the nuances of API sourcing—particularly regulatory compliance, security measures, and manufacturing quality—is vital to maintaining uninterrupted supply chains and ensuring regulatory adherence, especially for controlled substances like benzhydrocodone hydrochloride.

Key Takeaways

Diverse Sources for Acetaminophen: Multiple global manufacturers secure stable supply; key players include Jiangsu Taknong, Mochida, and CSPC.
Limited, Regulated Supply of Benzhydrocodone Hydrochloride: Production is restricted to licensed, compliance-driven manufacturers such as Mallinckrodt and HIKMA.
Regulatory Compliance Is Critical: Only suppliers with proper licensing and GMP certifications can legally produce and distribute these APIs.
Supply Chain Security Matters: Increased focus on traceability and security protocols for opioid APIs mitigates diversion risks.
Emerging Supply Chain Strategies: Diversification, regional manufacturing, and technological innovations are shaping the future of API sourcing.

FAQs

Who are the top global suppliers of acetaminophen?
Major suppliers include Jiangsu Taknong Pharmaceutical (China), Mochida Pharmaceutical (Japan), CSPC Pharmaceutical Group (China), and BASF (Germany), among others.
What regulations govern the production of benzhydrocodone hydrochloride?
Production is strictly regulated under national and international laws for controlled substances, such as the US DEA, EMA, and comparable agencies worldwide, requiring licensing, GMP compliance, and security measures.
Are there alternative sources for opioid APIs like benzhydrocodone hydrochloride?
While alternative synthesis routes are under research, current legal production is limited to licensed manufacturers within jurisdictions with strict controls, mainly the US, UK, and some European nations.
What risks exist in the supply chain for these drugs?
Regulatory disruptions, geopolitical issues, manufacturing capacity constraints, and security risks—especially for opioids—pose significant threats to supply continuity.
How is the industry addressing supply chain vulnerabilities?
Through supplier diversification, technological innovations like blockchain for traceability, capacity expansion in emerging markets, and strengthened regulatory oversight.

Sources:
[1] U.S. Food & Drug Administration (FDA), "Drug Establishments and Manufacturing," 2022.
[2] International Narcotics Control Board (INCB), "Annual Reports," 2022.
[3] Pharma Intelligence, "Global API Market Report," 2023.
[4] Euromonitor International, "Pharmaceuticals Industry Data," 2022.
[5] Regulatory filings and certifications from manufacturers cited.

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