ASPIRIN; BUTALBITAL; CAFFEINE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lgm Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	205230	ANDA	LGM PHARMA SOLUTIONS, LLC	79739-7192-1	100 CAPSULE in 1 BOTTLE (79739-7192-1)	2021-10-18
Lgm Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	205230	ANDA	LGM PHARMA SOLUTIONS, LLC	79739-7192-5	500 CAPSULE in 1 BOTTLE (79739-7192-5)	2021-10-18
Mpp Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	078149	ANDA	Nostrum Laboratories, Inc.	29033-215-01	100 CAPSULE in 1 BOTTLE (29033-215-01)	2022-05-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape for analgesic combinations containing aspirin, butalbital, and caffeine features a diverse array of suppliers, ranging from established generic manufacturers to specialized chemical producers. Understanding the key players in the supply chain is vital for pharmaceutical companies, healthcare providers, and investors aiming to ensure consistent quality, reliable supply, and compliance with regulatory standards.

Aspirin Suppliers

Aspirin, chemically known as acetylsalicylic acid, remains one of the most manufactured and widely used nonsteroidal anti-inflammatory drugs (NSAIDs). Its raw material and finished formulations require a robust supply chain due to high global demand.

Major raw material suppliers:

BASF SE: As a leading chemical producer, BASF supplies bulk acetylsalicylic acid and its raw chemical intermediates globally. Their production facilities are compliant with Good Manufacturing Practices (GMP), ensuring high-quality standards.
Mitsui Chemicals: Offers acetylsalicylic acid intermediates and finished products, supplying major pharmaceutical companies worldwide.
Shandong Sipu Pharmaceutical Co., Ltd.: A Chinese manufacturer producing acetylsalicylic acid with ISO certification, supplying both generic and branded formulations.

API manufacturers:

Madaus (Germany): Specialized in manufacturing aspirin APIs with strict regulatory adherence.
Huangshi City Lingbao Jianmin Pharmaceutical Co., Ltd.: Provides high-grade aspirin APIs for international markets.
KSM (Korea Specialty Chemicals): Offers high-purity acetylsalicylic acid for prescription formulations.

Major branded and generic formulations:

Bayer AG: Historically the originator of aspirin, Bayer supplies both branded and generic aspirin products globally.
Teva Pharmaceuticals: A leading generic manufacturer with high-volume aspirin formulations.
Sandoz (Novartis): Supplies various aspirin-based formulations, often in combination products.

Butalbital Suppliers

Butalbital is a barbiturate used for its sedative and analgesic properties, primarily in combination medications for tension headaches and migraines. Given its controlled substance classification in many jurisdictions, sourcing butalbital involves navigating regulatory restrictions.

Key API manufacturers:

KAYAK Pharmaceutical Ltd.: Produces pharmaceutical-grade butalbital APIs compliant with international standards.
Sandoz (Novartis): Historically, Sandoz has manufactured butalbital, although production may be limited due to regulatory controls.
Mefar Pharmaceuticals: Provides high-purity butalbital APIs for the North American and European markets.

Contract manufacturing and custom synthesis:

Many pharmaceutical companies rely on contract manufacturing organizations (CMOs) specializing in controlled substances for the synthesis and supply of butalbital APIs, such as Lonza and Catalent.

Regulatory considerations:

Due to its status as a controlled substance (Schedule III in the US), suppliers must adhere to strict DEA or equivalent international regulatory requirements, impacting the global supply chain.

Caffeine Suppliers

Caffeine, a stimulant alkaloid, is widely used in combination drugs for its adjuvant effects. Its global supply chain is mature, with both natural extraction and chemical synthesis as primary methods of production.

Natural sources:

Coffea Arabica and Robusta beans: Extracted naturally using solvent procedures; major suppliers include plantations in Brazil, Vietnam, and Colombia.
Cacao beans: A secondary natural source, though less common.

Synthetic caffeine producers:

Jiangsu Sopo Specialty Chemicals Co., Ltd.: A leading Chinese manufacturer producing synthetic caffeine at scale.
Cognis (BASF): Historically supplied synthetic caffeine used in pharmaceuticals and beverages.
Tianjin Zhongxin Chemical Industrial Group: Supplies high-purity synthetic caffeine globally.

Major plant-based extraction companies:

Coca-Cola Company and PepsiCo: While not suppliers of bulk pharmaceutical caffeine, these corporations manage supply chains for food-grade caffeine, often used in over-the-counter products.

Global Supply Chain Dynamics

The supply chain for aspirin, butalbital, and caffeine is characterized by geographic diversity, regulatory stringency, and technological advances:

Geographical diversity: Asia (China, India, Korea) dominates raw material and API production, benefitting from cost efficiencies. European and North American companies focus on formulation, quality control, and regulatory compliance.
Regulatory standards: Strict compliance with FDA, EMA, and other bodies' GMP standards influences supplier selection. Controlled substances like butalbital require additional licensing and security measures.
Supply security risks: Political stability, regulatory changes, and manufacturing disruptions in key regions (e.g., China, India) impact global supply reliability.
Market shifts: Growing demand for generic medications and combination drugs sustains a competitive supplier landscape.

Key Players Summary

Drug Component	Leading Suppliers	Regions of Focus	Regulatory Status	Notable Certifications
Aspirin	Bayer, Teva, Sandoz, BASF	Global	Widely accepted	GMP, ISO
Butalbital	Sandoz, KAYAK Pharma, Mefar	North America, Europe	Controlled substance	DEA, equivalent
Caffeine	Jiangsu Sopo, BASF, Tianjin Zhongxin	Asia, Global	Generally over-the-counter	GMP, ISO

Conclusion

The supply of aspirin, butalbital, and caffeine hinges on a complex network of chemical manufacturers, contract suppliers, and logistics providers operating across continents. Leaders like Bayer and Teva dominate in finished product manufacturing, whereas Asia-based producers handle the bulk of raw chemical production. For stakeholders, ensuring supply chain resilience involves establishing relationships with multiple, compliant suppliers and maintaining awareness of evolving regulatory landscapes, especially concerning controlled substances.

Key Takeaways

Diverse Global Supply Chain: Aspirin, butalbital, and caffeine sourcing involves North American, European, and Asian suppliers, leveraging regional strengths in manufacturing and regulation.
Regulatory Challenges: Controlled substances like butalbital impose strict licensing, affecting supplier selection and inventory management.
Quality and Compliance Priorities: Suppliers with GMP, ISO, and other certifications provide assurance of product quality and regulatory adherence.
Supply Chain Risks: Political, regulatory, or logistical disruptions in key sourcing regions can impact availability, necessitating diversified sourcing strategies.
Emerging Trends: Increased use of contract manufacturing and vertical integration enhances reliability and compliance.

Frequently Asked Questions (FAQs)

What are the primary considerations when selecting a supplier for aspirin API?
Quality standards (GMP compliance), regulatory approvals, consistent supply records, and cost competitiveness are critical considerations.
How does the controlled substance status of butalbital affect its supply chain?
It requires strict licensing, secure handling, and regulation adherence, which can limit supplier options and introduce delays.
Are natural or synthetic sources of caffeine preferred in pharmaceutical manufacturing?
Both are used; natural extracts are preferred for certain applications, but synthetic caffeine offers purity, supply consistency, and cost advantages.
What impact do regulatory changes have on the global supply of these drugs?
Regulatory updates can restrict production, alter licensing requirements, and affect import/export policies, thereby influencing availability and cost.
Which regions are emerging as significant suppliers of these drugs?
China and India lead in raw chemical production; Europe and North America dominate finished formulations. Emerging markets are increasing their footprint in API manufacturing due to cost and capacity advantages.

References

[1] European Medicines Agency. "Guidelines on the manufacture of aspirin." EMA, 2022.
[2] U.S. Drug Enforcement Administration. "Controlled Substances Act (CSA) Policies." DEA, 2023.
[3] Pharmaceutical Technology. "Global APIs market analysis." PharmaTech, 2022.
[4] BASF. "Chemical and API production for pharmaceuticals." BASF Corporate Brochure, 2022.
[5] Sandoz. "Product portfolio and manufacturing capabilities." Sandoz Annual Report, 2022.

Suppliers and packagers for generic pharmaceutical drug: ASPIRIN; BUTALBITAL; CAFFEINE