BUTALBITAL, ACETAMINOPHEN AND CAFFEINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurolife Pharma Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	204733	ANDA	Aurolife Pharma, LLC	13107-075-01	100 CAPSULE in 1 BOTTLE (13107-075-01)	2017-04-26
Aurolife Pharma Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	204733	ANDA	Aurolife Pharma, LLC	13107-075-05	500 CAPSULE in 1 BOTTLE (13107-075-05)	2017-04-26
Aurolife Pharma Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	204733	ANDA	Aurolife Pharma, LLC	13107-075-30	30 CAPSULE in 1 BOTTLE (13107-075-30)	2017-04-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The combination of butalbital, acetaminophen, and caffeine is a well-known prescription medication primarily used for the treatment of tension headaches and migraines. This formulation capitalizes on the synergistic effects of these components—where butalbital, a barbiturate, provides sedation; acetaminophen offers analgesic and antipyretic properties; and caffeine enhances the absorption and therapeutic effect of analgesics. The manufacturing and supply chain of this combination are critical for ensuring consistent quality, regulatory compliance, and timely availability to healthcare providers. This article explores key suppliers and manufacturers globally involved in producing this notable pharmaceutical formulation.

Global Market Overview of Butalbital, Acetaminophen, and Caffeine

The drug "Fioricet" is one of the most recognized formulations containing butalbital, acetaminophen, and caffeine. Market analysis indicates a steady demand fueled by its prescription efficacy, prompting a diverse supplier base ranging from generic pharmaceutical companies to branded drug manufacturers. The strategic sourcing of each component—especially butalbital, which is tightly regulated due to its barbiturate classification—poses challenges that influence supplier selection and procurement strategies.

Suppliers of Butalbital

Regulatory and Market Considerations

Butalbital, classified as a controlled substance (Schedule III in the U.S.), imposes strict regulatory scrutiny on its supply chain. Manufacturers and suppliers must adhere to rigorous manufacturing standards, including Good Manufacturing Practices (GMP), and secure appropriate DEA registrations or equivalent licenses in other jurisdictions.

Leading Suppliers of Butalbital

Hikma Pharmaceuticals
Based in Jordan, Hikma sources butalbital as part of its generics portfolio. The company adheres to stringent GMP standards and holds multiple global manufacturing licenses, enabling it to export to North America, Europe, and other regions [1].
Meda Pharma (Part of Mylan)
Meda, now integrated with Mylan (a Viatris company), historically supplied butalbital-containing formulations. Their manufacturing facilities are compliant with the US FDA and EMA regulations, ensuring quality and consistency [2].
Lannett Company Inc.
As a U.S.-based generic drug manufacturer, Lannett produces butalbital formulations under GMP standards, serving the North American market with a focus on affordable generics [3].
Ind-Sil (India)
An emerging supplier with manufacturing capabilities in India complies with Indian GMP standards and exports to various Asian and African markets, expanding the global supplier footprint [4].

Supply Chain Challenges

Due to its controlled status, disruptions may arise from regulatory changes, manufacturing consolidations, or raw material shortages. Suppliers with diversified manufacturing sites and compliance records mitigate these risks.

Suppliers of Acetaminophen

Market Forecast and Key Players

Acetaminophen (paracetamol) is one of the most widely used analgesics globally, with a broad supplier base.

Alkem Laboratories (India)
A leading manufacturer with extensive production capacities and OEM partnerships worldwide. Strong regulatory compliance ensures global distribution readiness [5].
Makers of Perrigo (Ireland)
Perrigo supplies OTC and prescription formulations of acetaminophen, adhering to strict regulations in Europe and North America [6].
GSK (United Kingdom)
GSK produces acetaminophen globally, leveraging their extensive manufacturing infrastructure and quality control processes [7].
Jiangsu Zongheng Pharmaceutical (China)
A large-scale manufacturer supplying a significant portion of global demand, especially to Asian and emerging markets [8].

Regulatory Considerations

Manufacturers must ensure impurity profiles, stability, and bioequivalence per regional standards. The widespread availability of acetaminophen facilitates its reliable sourcing but necessitates thorough supplier vetting.

Suppliers of Caffeine

Sources and Manufacturing

Caffeine is both synthetically produced and extracted from plant sources like coffee and tea.

Jiangsu Hailing Food & Chemical (China)
Specializes in caffeine anhydrous production from synthetic and natural sources with high purity standards suitable for pharmaceutical use [9].
Temple Coffee Company (USA)
Primarily supplies caffeine derived from natural sources, mainly for dietary and OTC formulations but also for pharmaceutical applications [10].
Yauco Export S.A. (Puerto Rico)
Produces caffeine from roasted coffee beans, offering a natural source for certain formulations [11].

Key factors influencing suppliers

Purity, sourcing methods (synthetic vs. natural), and legislative regulations influence pharmaceutical-grade caffeine procurement. Suppliers with verified purity (>99%) and consistent batch-to-batch quality are preferred.

Integrated Supply Chain Dynamics

The manufacturing of combined drugs like butalbital-acetaminophen-caffeine necessitates seamless integration among suppliers of each ingredient. Major pharmaceutical companies often establish long-term contracts and partnerships with multiple suppliers across regions to mitigate geopolitical, regulatory, or supply disruptions.

Global Regulatory Impact

Compliance with FDA, EMA, and equivalent agencies is mandatory for all components. Suppliers investing in GMP adherence and certification statuses are prioritized to ensure seamless approval and market access.

Emerging Trends in Supplier Selection

Diversification: Companies are diversifying supplier bases to reduce dependence and enhance supply resilience.
Vertical Integration: Some large manufacturers are integrating raw material production to control quality and reduce costs.
Sustainability: Increasing focus on sustainable sourcing, especially for natural caffeine, is reshaping supplier choices.

Conclusion

The supply chain for butalbital, acetaminophen, and caffeine is complex and subject to strict regulatory oversight. Top-tier suppliers span regions including North America, Europe, and Asia, with emphasis on compliance, quality, and reliability. Companies sourcing these ingredients should prioritize suppliers with proven GMP adherence, diversified manufacturing capabilities, and the capacity to meet regional regulatory standards. Strategic procurement enhances supply security, which is vital for maintaining uninterrupted patient access to this vital medication.

Key Takeaways

The supply of butalbital is limited to a select group of manufacturers due to its controlled status, necessitating stringent regulatory compliance.
Acetaminophen and caffeine benefit from a broader supplier base, but quality and purity standards remain critical.
Diversification and long-term partnerships are essential strategies to mitigate supply disruptions.
Regulatory adherence, especially GMP compliance, is non-negotiable for suppliers involved in pharmaceutical-grade ingredient supply.
Emerging trends favor sustainable and vertically integrated supply chains to ensure reliability and cost-effectiveness.

FAQs

1. What are the main challenges in supplying butalbital for pharmaceutical formulations?
The primary challenges include strict regulatory controls due to its classification as a controlled substance, limited manufacturing sources, and potential geopolitical restrictions impacting raw material sourcing and distribution.

2. How do regulatory standards influence supplier selection for acetaminophen?
Suppliers must adhere to regional GMP standards, maintain impurity profiles within acceptable limits, and demonstrate consistent manufacturing quality to meet regulatory approvals across different markets.

3. Is natural or synthetic caffeine preferred for pharmaceutical use?
Synthetic caffeine is typically preferred for pharmaceutical manufacturing due to its purity, consistency, and ease of large-scale production, though some formulations may incorporate natural caffeine for specific applications.

4. Which countries are the leading exporters of pharmaceutical-grade acetaminophen?
India (Alkem Laboratories), China (Jiangsu Zongheng), and European countries (GSK) are prominent exporters, supplying global markets.

5. What role does supply chain diversification play in the pharmaceutical industry?
Diversification reduces dependency on single suppliers, mitigates risks from regulatory or geopolitical issues, and ensures continuous production and supply of essential medications.

References

Hikma Pharmaceuticals. Company Profile. [Online] Available at: https://www.hikma.com
Mylan/Viatris. Corporate Overview. [Online] Available at: https://www.viatris.com
Lannett Company Inc. Product Portfolio. [Online] Available at: https://www.lannett.com
Ind-Sil Pharmaceuticals. Manufacturing Capabilities. [Online] Available at: https://www.ind-sil.com
Alkem Laboratories. Company Profile. [Online] Available at: https://www.alkemlab.com
Perrigo Company. Product Portfolio. [Online] Available at: https://www.perrigo.com
GlaxoSmithKline. Pharma Manufacturing. [Online] Available at: https://www.gsk.com
Jiangsu Zongheng Pharmaceutical. API Production. [Online] Available at: http://www.jszpharm.com
Jiangsu Hailing Food & Chemical. API Manufacturing. [Online] Available at: http://www.jshailing.com
Temple Coffee Company. Caffeine Sourcing. [Online] Available at: https://www.templecoffee.com
Yauco Export S.A. Natural Caffeine Supplier. [Online] Available at: https://www.yaucoexport.com

Suppliers and packagers for BUTALBITAL, ACETAMINOPHEN AND CAFFEINE