Suppliers and packagers for generic pharmaceutical drug: TRIAZOLAM

TRIAZOLAM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drug: Triazolam

Last updated: July 28, 2025

Introduction

Triazolam, a potent short-acting benzodiazepine, is primarily prescribed for the management of insomnia. Recognized for its rapid onset and short duration of action, triazolam is classified as a Schedule IV controlled substance in many jurisdictions due to its potential for dependency and misuse. As demand persists for both branded and generic formulations, understanding the landscape of suppliers that produce and distribute triazolam becomes crucial for pharmaceutical companies, regulators, and healthcare providers.

This report offers an in-depth analysis of the key suppliers involved in the manufacturing and distribution of triazolam, emphasizing regulatory frameworks, manufacturing capacities, geographic presence, and market dynamics. Stakeholders can leverage this information to navigate the complex supply chain, ensure compliance, and assess supply security.

Regulatory Framework and Legal Status

Before delving into supplier specifics, it is essential to note that triazolam's distribution is tightly regulated by authorities such as the U.S. Drug Enforcement Administration (DEA), European Medicines Agency (EMA), and respective national agencies. Its classification as a controlled substance imposes stringent manufacturing, registration, and distribution standards to prevent diversion and misuse.

Manufacturers of Triazolam

1. Major Generic Manufacturers

Most of the triazolam supply stems from generic pharmaceutical producers, which hold various approvals across markets:

• Teva Pharmaceuticals
  Israel-based Teva is one of the world's largest generic drug manufacturers, offering triazolam under its regulatory approvals. Their extensive manufacturing footprint and rigorous quality protocols position them as a primary supplier globally, especially in North America and Europe.

• Sandoz (Novartis)
  Sandoz, a Novartis division, produces a broad spectrum of benzodiazepines, including triazolam, primarily for wholesale distribution in Europe and North America. Their facilities adhere to Good Manufacturing Practices (GMP) and possess extensive distribution networks.

• MannKind Corporation
  While primarily recognized for inhaled therapies, MannKind's interest in formulations involving benzodiazepines has led to partnerships and capacities that include triazolam, especially through licensing agreements. However, their principal focus remains on novel delivery systems.

• Hospira (Pfizer)
  Acquired by Pfizer, Hospira historically produced injectable formulations of controlled substances, including benzodiazepines. Their involvement in triazolam is limited but remains relevant in specific formulations and markets.

2. Specialty and Contract Manufacturers

The manufacturing of triazolam often relies on Contract Manufacturing Organizations (CMOs) with specialized capabilities:

• Fujifilm Diosynth Biotechnologies
  Known for contract production, especially in complex molecules, their involvement in small-molecule benzodiazepines, including triazolam, aids in capacity expansion for generic producers.

• Patheon (Thermo Fisher Scientific)
  Provides contract manufacturing services for controlled substances, including formulation development and commercial-scale production for batch needs.

3. Brand Name Manufacturers

While triazolam’s market is largely dominated by generics, some branded versions may exist or have existed historically:

• Halcion (by Upjohn, now Pfizer)
  Halcion was the original branded formulation of triazolam. Although its production has decreased in some regions due to regulatory issues and market dynamics, it remains a reference for branded supply in certain markets.

Global Geographic Distribution of Suppliers

North America

The U.S. market primarily sources triazolam from major generic manufacturers such as Teva, Sandoz, and Pfizer’s former portfolio. Regulatory requirements mandate stringent compliance, making these players dominant in the supply chain.

Europe

In the European Union, suppliers include Sandoz, Teva, and local generics companies regulated by the EMA. European suppliers often produce both for domestic use and export, adhering to EMA GMP standards.

Asia and Emerging Markets

Manufacturers in India and China have increased their roles in supplying generic benzodiazepines, including triazolam. Companies like Aurobindo Pharma, Dr. Reddy’s Laboratories, and Zydus Cadila are prominent players. Due to regulatory variations, some supplies might be for regional markets under different compliance standards.

Other Markets

Other regions, such as Latin America and the Middle East, rely on both local generics and imports from major international suppliers, often bridging gaps due to regional manufacturing limitations or regulatory approvals.

Supply Chain and Market Dynamics

The supply of triazolam is affected by several factors:

• Regulatory Scrutiny: Ongoing restrictions on benzodiazepines influence manufacturing volumes and distribution channels, especially in markets concerned about misuse.

• Manufacturing Capacity: Limited facilities with appropriate DEA or equivalent licenses impact global supply, leading to potential shortages or reliance on a few key suppliers.

• Patent and Exclusivity Status: As a generic molecule, triazolam’s manufacturing is widespread once patent protections lapse, resulting in a fragmented supplier landscape.

• Global Demand Fluctuations: The rising prevalence of sleep disorders and pharmaceutical regulations influence demand and supply stability.

• Quality and Compliance: Suppliers must meet local and international standards, including GMP compliance, quality control, and proper licensing, reducing the number of eligible manufacturers.

Challenges and Opportunities in the Supply Chain

Challenges

• Regulatory Barriers: Stringent control measures, such as DEA scheduling, complicate licensing and batch release procedures. This limits the number of reliable suppliers and increases manufacturing costs.

• Supply Disruptions: Political, logistical, or manufacturing issues at key facilities can cause shortages, impacting healthcare providers and patients.

• Illicit Diversion: The potential for misuse necessitates tight security and monitoring, which increases operational costs for suppliers.

Opportunities

• Expansion of Contract Manufacturing: CMOs with specialized capabilities can meet growing global demand, especially in emerging markets.

• Development of Novel Delivery Systems: Suppliers innovating in formulations (e.g., transdermal, sublingual) can expand the market and mitigate regulatory limitations.

• Supply Chain Diversification: Engaging multiple approved manufacturers enhances resilience against disruptions.

Conclusion

The supply landscape for triazolam is characterized by a limited yet strategic group of international manufacturers, predominantly in North America, Europe, and Asia. Major players like Teva, Sandoz, and Pfizer (via its legacy brands) continue to dominate the global supply chain, supported by a network of CMOs and regional producers. Regulatory compliance remains a fundamental consideration, controlling access and distribution channels.

As demand persists and regulatory environments evolve, suppliers must adapt through capacity expansion, quality assurance, and innovation. Stakeholders should monitor geopolitical and regulatory developments to mitigate risks of shortages and ensure a stable supply of this critical sleep aid.

---

Key Takeaways

• The global supply of triazolam is concentrated among a handful of established generics manufacturers, with Teva and Sandoz leading in terms of capacity and distribution.

• Regulatory frameworks and controlled substance schedules impose strict manufacturing and distribution requirements, influencing supplier eligibility and supply chain stability.

• Contract manufacturing organizations are vital partners, expanding production capacity, especially in regions with burgeoning markets.

• Geographical diversification in supply sources is essential to mitigate risks from regional disruptions or regulatory shifts.

• Innovation in drug delivery and formulation offers avenues for suppliers to expand or differentiate their offerings amid regulatory constraints.

---

FAQs

1. Who are the primary global suppliers of triazolam?
Teva Pharmaceuticals and Sandoz are the leading global generic manufacturers, with additional inputs from regional CMOs and specialized contract manufacturers.

2. Can I source triazolam outside of the United States?
Yes, but supply depends on regional regulatory approvals. In Europe, Sandoz and local generics dominate; in Asia, companies like Aurobindo and Dr. Reddy’s contribute regional supplies.

3. How does regulatory status affect triazolam’s supply chain?
As a Schedule IV controlled substance, manufacturing and distribution require strict licensing and adherence to regulatory standards, limiting the number of eligible suppliers and potentially affecting supply continuity.

4. Are there opportunities for new entrants in the triazolam market?
Opportunities exist primarily through partnerships with CMOs and potential development of novel formulations that address regulatory concerns or enhance patient compliance.

5. What risks threaten the supply stability of triazolam?
Regulatory restrictions, manufacturing disruptions, security concerns over diversion, and geopolitical issues can all impact supply stability, requiring ongoing risk management strategies.

---

Sources

1. U.S. Drug Enforcement Administration. (2023). Controlled Substances Scheduling.
2. European Medicines Agency. (2022). List of Approved Medicines.
3. Teva Pharmaceuticals. (2023). Product Portfolio.
4. Sandoz International GmbH. (2023). General Product Information.
5. Regulatory filings and manufacturer disclosures.