HALCION: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	HALCION	triazolam	TABLET;ORAL	017892	NDA	Pharmacia & Upjohn Company LLC	0009-0017-55	100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK	1982-11-15
Pfizer	HALCION	triazolam	TABLET;ORAL	017892	NDA	Pharmacia & Upjohn Company LLC	0009-0017-58	10 TABLET in 1 BOTTLE (0009-0017-58)	1982-11-15
Pfizer	HALCION	triazolam	TABLET;ORAL	017892	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-451-30	30 TABLET in 1 BOTTLE (43353-451-30)	1982-11-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

HALCION, with its active ingredient triazolam, is a benzodiazepine primarily prescribed for short-term treatment of insomnia characterized by difficulty with sleep initiation. As a controlled substance due to its potential for dependence and misuse, the supply chain for HALCION is tightly regulated. This article examines the key suppliers involved in the manufacturing and distribution of HALCION, explores the global landscape of its procurement, and offers insights into the regulatory and logistical intricacies that influence its supply chain.

Overview of HALCION and Its Market

HALCION is marketed under various brand names, including Halcion in the United States and UK markets. Multiple pharmaceutical companies produce triazolam or its equivalents, with Pfizer historically being a significant supplier. The drug's restricted use and controlled substance status limit the number of authorized manufacturers, necessitating a detailed understanding of the suppliers involved globally.

Manufacturers of Triazolam (HALCION Active Ingredient)

The manufacture of HALCION involves the synthesis of triazolam, a potent benzodiazepine. The primary suppliers of triazolam derivatives are located across continents, with manufacturing hubs in North America, Europe, and Asia.

Major Pharmaceutical Companies Producing Triazolam

Pfizer Inc.
Historically, Pfizer has been the principal producer of HALCION, manufacturing both the active pharmaceutical ingredient (API) and finished dosage forms. Pfizer's global manufacturing network ensures availability within regulated markets. Their manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP) and are approved by regulatory agencies such as the FDA and EMA.
Sandoz (Novartis Group)
Sandoz produces generic versions of triazolam, serving markets where patent protections are expired or not enforced. The company operates manufacturing plants in Europe and the United States, capable of supplying both generic APIs and finished products.
Teva Pharmaceuticals
As a leading generic drug manufacturer, Teva has historically supplied triazolam to various markets. Their manufacturing facilities in Israel and Europe produce APIs under GMP standards, often supplying third-party formulations.
Reig Jofre
Reig Jofre, based in Spain, manufactures APIs and finished pharmaceuticals, including benzodiazepines. Their production facilities are compliant with international standards, and they supply both regional and export markets.
Other Regional Manufacturers
Additional regional API producers include South Korean firms such as Hanmi Pharmaceutical, Chinese generic manufacturers like Qilu Pharmaceuticals, and Indian API producers such as Sun Pharma. These regional suppliers primarily serve local markets or export licensed generic products.

Regulatory and Licensing Considerations

As a Schedule IV controlled substance in regions like the US and EU, triazolam's production and distribution are heavily regulated:

United States: The Drug Enforcement Administration (DEA) strictly controls the manufacturing and distribution of triazolam. Manufacturers must obtain Schedule IV registration and comply with annual reporting.
European Union: The European Medicines Agency (EMA) regulates supply with stringent Good Manufacturing Practices (GMP) and marketing authorization requirements.
Asia and Other Regions: Regulations vary; however, globally, API producers must adhere to international standards such as those set by the WHO and ICH. Export permits and licenses are necessary for cross-border movement.

Supply Chain Dynamics and Challenges

Dependence on Few Key Suppliers

The majority of the global market relies on a limited number of manufacturing entities, which amplifies supply risks. Any disruption—such as regulatory action, production outages, or geopolitical issues—can lead to shortages.

Quality and Compliance

Manufacturers must maintain compliance with GMP, necessitating regular audits by regulatory authorities. Non-compliance can lead to product recall or suspension, affecting global supply.

Trade Restrictions and Export Controls

Controlled substances are subject to export licensing, customs checks, and international treaties like the Convention on Psychotropic Substances. These procedures create logistical complexities.

Counterfeit Risks

Due to its controlled status and high demand, counterfeit triazolam products pose a significant risk. Ensuring supply chain security is critical.

Regional Suppliers and Market Considerations

United States and Canada: Pfizer is the primary supplier, with generic options limited due to strict controls.
European Union: Multiple generic manufacturers, including Reig Jofre and Teva, supply APIs and finished drugs.
Asia: Rapidly growing API production, with China and India as significant suppliers, often for export to Western markets under licensing agreements.

Future Trends and Supply Chain Enhancements

Manufacturing Consolidation: Providers are consolidating API production to optimize costs and compliance.
Regulatory Harmonization: International efforts aim to streamline licensing processes, reducing delays.
Supply Chain Digitalization: Blockchain and serialization are increasingly adopted for traceability, reducing counterfeiting risks.
Alternative Synthesis Methods: Research into more efficient synthesis pathways for benzodiazepines could diversify the supplier base.

Conclusion

The supply of HALCION hinges predominantly on a handful of established manufacturers producing high-quality triazolam API. Pfizer historically leads as the primary supplier, supplemented by generic manufacturers like Sandoz, Teva, and regional players in Asia and Europe. Regulatory compliance, quality assurance, and logistic efficiencies are integral to maintaining a stable supply chain for this controlled substance. As global markets evolve and regulations tighten, manufacturers and distributors must adapt to sustain continuous availability.

Key Takeaways

Pfizer remains a central supplier of HALCION's API but faces competition from generic manufacturers.
Regional API producers in Europe, Asia, and India supply both domestic and export markets, often under licensing agreements.
Strict regulatory frameworks protect the supply chain but complicate manufacturing and distribution processes.
Supply chain risks include reliance on limited suppliers, compliance failures, and geopolitical disruptions.
Technological advancements and regulatory harmonization efforts aim to improve supply stability and reduce counterfeit risks.

Frequently Asked Questions

1. Who are the main global suppliers of HALCION's active ingredient?
Pfizer has historically been the primary manufacturer of triazolam for HALCION. Other significant suppliers include Sandoz, Teva, and regional API producers in Europe, Asia, and India.

2. How does regulation impact the supply of HALCION?
As a Schedule IV controlled substance, the production and distribution of HALCION are tightly regulated by agencies such as the DEA in the US and EMA in Europe. These regulations enforce strict compliance, licensing, and import/export controls, which can limit supply flexibility.

3. Are there risks associated with supply chain disruptions for HALCION?
Yes. Dependency on a few key manufacturers, regulatory scrutiny, geopolitical issues, and potential quality compliance failures pose risks that could result in shortages.

4. Can regional manufacturers produce triazolam legally for export?
Yes, provided they hold the necessary licenses and comply with international regulations. Export licensing and registration are essential components of legal distribution across borders.

5. What are the industry trends influencing the future supply of HALCION?
Industry trends include manufacturing consolidation, adoption of digital traceability, regulatory harmonization, and research into newer synthesis methods, all aimed at improving the stability and security of the HALCION supply chain.

References:
[1] U.S. Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products.
[2] European Medicines Agency (EMA). Marketing Authorization Holders.
[3] International Narcotics Control Board (INCB). Pharmacology and Manufacture of Controlled Substances.

Suppliers and packagers for HALCION

HALCION

Suppliers for the Pharmaceutical Drug: HALCION