ASPIRIN; HYDROCODONE BITARTRATE: 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
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 29, 2025

ppliers for the Pharmaceutical Drugs: Aspirin and Hydrocodone Bitartrate

Introduction

The pharmaceutical supply chain for essential medications such as Aspirin and Hydrocodone Bitartrate is integral to global health infrastructure. These drugs serve diverse therapeutic purposes: Aspirin is widely used for pain relief, anti-inflammatory effects, and cardiovascular protection, while Hydrocodone Bitartrate is a potent opioid analgesic employed for managing moderate to severe pain. The reliability of suppliers and sourcing integrity directly influence drug availability, affordability, and compliance with regulatory standards. This article examines the key suppliers, manufacturing landscape, and market dynamics underpinning these two critical pharmaceuticals.

Aspirin Suppliers: An Overview

Historical Context and Manufacturing Landscape

Aspirin, chemically known as acetylsalicylic acid, traces its origins to Bayer in the late 19th century. As a generic medication, it boasts a mature manufacturing infrastructure with numerous global suppliers. The product's stability, simple synthesis, and high demand facilitate widespread availability, especially among generic pharmaceutical producers.

Major Suppliers and Manufacturers

Bayer AG: The original patent holder and still a leading supplier of branded Aspirin, Bayer maintains significant production capacity and quality standards. Its global supply chain ensures broad distribution across consumer and pharmaceutical markets.
Teva Pharmaceutical Industries: A dominant player in generics, Teva supplies large volumes of aspirin tablets worldwide, adhering to strict regulatory standards, with manufacturing facilities in Israel, India, and Europe.
Johnson & Johnson: Through its consumer health division, J&J provides aspirin products primarily for over-the-counter use, with manufacturing plants in the United States and Europe.
BASF and Other Chemical Suppliers: Chemical intermediates for aspirin synthesis are sourced from companies like BASF, Lanxess, and Evonik, showcasing a robust supply chain for raw materials.
Regional and Local Manufacturers: Numerous smaller entities in India, China, and other emerging markets produce aspirin, catering to domestic needs and export markets, often under various regulatory compliance standards.

Supply Chain and Regulation

Aspirin manufacturing involves acetylation of salicylic acid, which can be sourced both intrinsically and via intermediates, with a global network ensuring availability at commodity prices. Regulatory bodies such as the FDA, EMA, and WHO monitor manufacturing practices, ensuring safety and quality.

Hydrocodone Bitartrate Suppliers: An In-Depth Analysis

Pharmacological Context and Market Dynamics

Hydrocodone Bitartrate is classified as a Schedule II controlled substance in the United States due to its high potential for abuse and dependence. This status constrains sourcing to licensed manufacturers with stringent oversight, impacting the global supply chain dynamics.

Leading Manufacturers and Suppliers

AbbVie (formerly Abbott Laboratories): Historically a major supplier, AbbVie produces Hydrocodone formulations primarily for North American markets. Its manufacturing facilities comply with FDA standards, with tight regulatory oversight.
Sun Pharmaceutical Industries: As one of India’s largest pharma companies, Sun Pharma has expanded into controlled substances, supplying Hydrocodone products for domestic and export markets with requisite licenses.
Mitsubishi Tanabe Pharma Corporation: Japan-based manufacturer with licensed production capabilities for opioids, including Hydrocodone, primarily for regional markets.
Alvogen: A global pharmaceutical company with operations in Europe and the US, licensed to manufacture and distribute controlled substances, including Hydrocodone formulations.
Contract Manufacturers and API Suppliers: Raw material (API) sourcing involves firms like Hikal Ltd. (India), Piramal Enterprises, and Zhejiang NHU Chemical. They produce Hydrocodone API under strict Good Manufacturing Practices (GMP) for licensed pharmaceutical firms.

Regulatory and Supply Chain Constraints

Hydrocodone’s manufacturing is heavily regulated worldwide, especially in the US under the Drug Enforcement Administration (DEA). These controls limit the number of licensed suppliers, heightening risks of shortages and necessitating vigilant compliance to prevent diversion. Trends indicate increased oversight and initiatives to diversify supply sources without compromising security standards.

Market Risks and Supply Chain Security

Due to the opioid crisis, regulation tightening, and geopolitics, suppliers of Hydrocodone face risks such as regulatory changes, supply disruptions, and manufacturing constraints. The reliance on a limited number of API producers amplifies vulnerability, emphasizing the importance of diversified sourcing strategies.

Global Supply Chain Considerations for Aspirin and Hydrocodone Bitartrate

Impact of Geopolitical Factors and Trade Policies

The supply chains for both drugs are sensitive to global trade dynamics. Tariffs, export restrictions, and geopolitical tensions specifically affect depends like API production. For Hydrocodone, compliance requirements heighten the importance of domestic manufacturing and secure licensing frameworks.

Regulatory Harmonization and Quality Standards

Consistent adherence to Good Manufacturing Practices (GMP), WHO guidelines, and country-specific regulatory standards are critical for supply continuity. Disparities across jurisdictions can influence sourcing decisions and availability.

Emerging Markets and Diversification

Emerging markets such as India and China serve as significant sources of raw materials and finished products, offering cost advantages and increased capacity. However, regulatory compliance remains paramount to secure market access.

Conclusion

The supply landscape for Aspirin and Hydrocodone Bitartrate involves a complex interplay of legacy manufacturers, emerging producers, regulatory frameworks, and geopolitical considerations. While Aspirin benefits from a mature and diversified global supply chain, Hydrocodone’s supply is tightly controlled, with limited licensed manufacturers to mitigate abuse risks. Ensuring supply resilience requires strategic risk management, continuous quality assurance, and regulatory compliance across all jurisdictions.

Key Takeaways

Aspirin's widespread generic manufacturing base ensures reliable supply, with major players like Bayer and Teva leading global distribution.
Hydrocodone Bitartrate’s supply chain is highly regulated, with licensed manufacturers such as AbbVie and Sun Pharma dominating North American and regional markets.
API sourcing complexities and regulatory controls significantly impact Hydrocodone availability, emphasizing the importance of diversified and compliant supplier networks.
Global geopolitical and trade factors can disrupt supplies, underscoring the need for robust, compliant, and strategic procurement strategies.
Regulatory compliance and quality assurance are vital across all stages to maintain drug safety, efficacy, and uninterrupted supply.

FAQs

Q1: Who are the leading global suppliers of Aspirin?
A1: Bayer AG, Teva Pharmaceuticals, Johnson & Johnson, BASF, and regional manufacturers in India and China dominate the aspirin supply landscape.

Q2: Why is Hydrocodone Bitartrate production highly regulated?
A2: Due to its high potential for abuse and dependence, Hydrocodone Bitartrate is classified as a Schedule II controlled substance, necessitating strict licensing, manufacturing oversight, and distribution controls.

Q3: How do geopolitical factors influence the supply of these drugs?
A3: Trade restrictions, tariffs, and geopolitical tensions impact raw material sourcing, manufacturing licenses, and distribution channels, increasing risks of shortages and delays.

Q4: What role do raw material suppliers play in the aspirin supply chain?
A4: Chemical intermediates for aspirin, such as salicylic acid, are sourced from chemical giants like BASF and Evonik, forming the backbone of aspirin manufacturing.

Q5: How can pharmaceutical companies mitigate supply risks for Hydrocodone?
A5: By diversifying API sources, maintaining regulatory compliance, engaging multiple licensed manufacturers, and establishing inventory buffers, companies can bolster supply resilience.

References

[1] Bayer AG. Official website and product portfolio.
[2] Teva Pharmaceutical Industries. Annual reports and supply chain data.
[3] FDA Drug Enforcement Administration (DEA). Controlled Substances Act regulations.
[4] World Health Organization (WHO). Good Manufacturing Practices (GMP) guidelines.
[5] Indian Pharmaceutical Association. API manufacturing landscape.

Suppliers and packagers for generic pharmaceutical drug: ASPIRIN; HYDROCODONE BITARTRATE