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

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lgm Pharma	HYDROCODONE BITARTRATE AND ASPIRIN	aspirin; hydrocodone bitartrate	TABLET;ORAL	205479	ANDA	LGM PHARMA SOLUTIONS, LLC	79739-7182-1	100 TABLET in 1 BOTTLE (79739-7182-1)	2021-05-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The combination of hydrocodone bitartrate and aspirin is a widely prescribed analgesic used to manage moderate to severe pain. Its formulation combines an opioid analgesic with an anti-inflammatory agent, providing effective pain relief. Due to the drug’s clinical importance and potential for misuse, understanding its supply chain, including key suppliers, is crucial for stakeholders involved in manufacturing, distribution, and regulation.

Regulatory Landscape and Market Overview

Hydrocodone bitartrate and aspirin compound formulations are classified as controlled substances under regulations such as the U.S. Drug Enforcement Administration (DEA) Schedule II status. These stringent controls impact the supply chain, necessitating compliance with multi-layered licensing and manufacturing standards.

The global market for hydrocodone and similar combination products is dominated by a handful of licensed manufacturers, mostly within North America, Europe, and select Asian countries. The demand is driven by both prescription volumes and considerations surrounding opioid-based therapies amidst the ongoing opioid epidemic.

Primary Suppliers of Hydrocodone Bitartrate

1. Major Manufacturers of Hydrocodone

Hydrocodone is synthesized predominantly in specialized pharmaceutical settings under strict regulatory oversight. Some of the leading suppliers include:

Mallinckrodt Pharmaceuticals: Based in the U.S., Mallinckrodt is one of the largest producers of controlled substances in the world, including hydrocodone, required for formulations like Hydrocodone Bitartrate and Aspirin.
Purdue Pharma: Historically, Purdue has been a significant supplier of opioid products, although its involvement has decreased following legal and regulatory actions. Nonetheless, its legacy formulations and manufacturing capabilities remain relevant.
Zydus Cadila (India): A prominent Indian pharmaceutical company with licensed production of hydrocodone for export and domestic use, adhering to global compliance standards.
Alkaloids Limited (India): Known for manufacturing opioid raw materials and intermediates, including hydrocodone, primarily for US and European markets.
Sun Pharmaceutical Industries: Engaged in the production of opioid raw materials, including hydrocodone, often as intermediates for further formulation.

2. Synthetic Chemical Suppliers and Contract Manufacturers

Companies specializing in active pharmaceutical ingredient (API) synthesis and contract manufacturing play vital roles:

Nitto Denko (Japan): Produces raw materials and intermediates used in hydrocodone synthesis.
Cerilliant Corporation: Supplies analytical standards and raw materials relevant for manufacturing processes.
Contract manufacturing organizations (CMOs) globally, including Hikma Pharmaceuticals and Nippon Pharma, often produce hydrocodone under licensing arrangements.

Aspirin Suppliers

Aspirin (acetylsalicylic acid) is among the most widely produced APIs globally, with multiple manufacturers providing high-quality raw materials to the market:

BASF SE: The largest producer of aspirin worldwide, offering pharmaceutical-grade acetylsalicylic acid for formulations.
Teva Pharmaceutical Industries: Supplies generic aspirin, including APIs and finished products.
Zhejiang Hisun Pharmaceutical: A leading Chinese manufacturer known for producing aspirin and related APIs.
Micro Labs Limited (India): Offers aspirin API conforming to international standards.
MeadWestvaco (USA): Historically involved in chemical manufacturing, including aspirin API.

Formulation and Final Product Manufacturers

Once the APIs are procured, they are supplied to pharmaceutical firms for final drug formulation:

Johnson & Johnson: Provides branded versions of hydrocodone and aspirin combination drugs.
Mylan (now part of Viatris): Manufactures generic formulations ensuring supply under various brand names.
Sandoz: Offers generic opioid-NSAID combination drugs for pain management.
Amneal Pharmaceuticals: Active in producing formulations for distribution in North America.

Distribution Channels and Regulatory Compliance

Supply chains for hydrocodone bitartrate and aspirin involve strict regulatory oversight. Distribution channels include authorized wholesalers, pharmacies, and hospitals. Importantly, the sourcing of hydrocodone involves adherence to DEA regulations in the U.S. and equivalent authorities in other jurisdictions, limiting the number of authorized suppliers.

Certifications such as Good Manufacturing Practice (GMP) and compliance with the International Conference on Harmonisation (ICH) guidelines are mandatory for manufacturers. These practices ensure product quality, safety, and consistency across the supply chain.

Challenges in the Supply Chain

Regulatory Constraints: Stringent controls on opioids limit the number of authorized suppliers, often leading to bottlenecks in supply.
Production Limitations: Synthesis of hydrocodone is complex, requiring specialized facilities, which reduces the number of capable suppliers.
Illicit Diversion Risks: The high potential for misuse necessitates tight monitoring, impacting logistics and sourcing strategies.
Global Supply Chain Disruptions: Political, economic, or health crises (like the COVID-19 pandemic) disrupt raw material sourcing and manufacturing schedules.

Emerging Trends and Strategic Considerations

Alternative Sourcing: Companies are diversifying suppliers, including negotiations with Asian manufacturers, to mitigate supply risks.
Synthetic Refinements: Advances in synthetic chemistry aim to optimize yields, reduce costs, and minimize diversion potential.
Regulatory Harmonization: International cooperation strives for unified standards, easing cross-border procurement of APIs.
Generics and Biosimilars: Increasing production of generic hydrocodone/aspirin formulations offers competitive pricing but amplifies supply chain complexity.

Key Takeaways

Major suppliers of hydrocodone bitartrate include Mallinckrodt, Zydus Cadila, and Alkaloids Limited, with tight regulation limiting market entry.
Aspirin, as an extensively produced API, has a broad supplier base, with BASF leading globally.
The supply chain is heavily regulated to prevent diversion, necessitating strict licensing and compliance measures.
Global manufacturing and geopolitical factors influence the stability of supply sources.
Strategic diversification and technological advancements are critical to ensuring consistent and compliant drug supply.

FAQs

1. Who are the leading global suppliers of hydrocodone for pharmaceutical manufacturing?
Mallinckrodt Pharmaceuticals and Zydus Cadila are among the top licensed providers of hydrocodone API, with operations regulated under strict compliance standards to produce raw materials for formulations like hydrocodone bitartrate and aspirin combinations.

2. How does regulatory control affect the supply of hydrocodone APIs?
Regulations designate hydrocodone as a Schedule II controlled substance, imposing licensing requirements, strict inventory tracking, and distribution controls, which limit supplier numbers and enhance supply chain security.

3. Can smaller pharmaceutical companies access hydrocodone APIs?
Access is limited due to licensing, manufacturing capacity, and regulatory compliance hurdles. Typically, only authorized and established entities with proper licenses can procure and manufacture hydrocodone APIs.

4. What role do Asian pharmaceutical firms play in the supply of hydrocodone and aspirin?
Companies like Zydus Cadila and Alkaloids Limited supply hydrocodone and aspirin APIs to global markets, often providing cost-effective options while adhering to international quality standards; however, regulatory approval is necessary for specific markets.

5. Are there any risks associated with sourcing these APIs globally?
Yes. Risks include supply disruptions due to geopolitical issues, regulatory changes, quality compliance failures, and transportation logistics, which can impact continual drug availability.

References

U.S. DEA. (2022). Controlled Substances Schedules.
BASF. (2023). Aspirin API Production Overview.
Mallinckrodt Pharmaceuticals. (2023). Product Portfolio and Supply Capabilities.
Zydus Cadila. (2022). API Manufacturing and Export Data.
World Health Organization. (2021). Guidelines on the Production and Handling of Controlled Substances.

Suppliers and packagers for HYDROCODONE BITARTRATE AND ASPIRIN