CLORAZEPATE DIPOTASSIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	071858	ANDA	Aurolife Pharma LLC	13107-282-01	100 TABLET in 1 BOTTLE (13107-282-01)	2023-09-23
Aurobindo Pharma	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	071858	ANDA	Aurolife Pharma LLC	13107-282-05	500 TABLET in 1 BOTTLE, PLASTIC (13107-282-05)	2023-09-23
Aurobindo Pharma	CLORAZEPATE DIPOTASSIUM	clorazepate dipotassium	TABLET;ORAL	071858	ANDA	Aurolife Pharma LLC	13107-283-01	100 TABLET in 1 BOTTLE, PLASTIC (13107-283-01)	2023-09-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Clorazepate dipotassium is a benzodiazepine primarily used for managing anxiety, seizures, and alcohol withdrawal symptoms. Since its initial approval in the late 20th century, it has become a staple in multiple therapeutic domains. With rising global demand for anxiolytics and anticonvulsants, identifying reliable suppliers of clorazepate dipotassium is crucial for pharmaceutical companies, healthcare providers, and generic manufacturers.

This comprehensive analysis explores the key suppliers of clorazepate dipot potassium, examining manufacturing origins, geographic distribution, regulatory compliance, and market trends. It aims to provide stakeholders with detailed insights into the supply landscape for strategic sourcing and risk management.

Manufacturers and Suppliers Overview

Major Pharmaceutical Companies Producing Clorazepate Dipotassium

1. Cephalon (Teva Pharmaceuticals)

Teva Pharmaceuticals, a leading generic drug manufacturer, acquired rights for several benzodiazepines, including clorazepate dipotassium. Their manufacturing facilities in Europe and North America produce high-volume batches compliant with international standards.

2. Novartis

Novartis historically produced clorazepate dipotassium through licensed agreements. Although their production focus has shifted, some formulations might still be sourced via licensed partners.

3. Mylan (now part of Viatris)

Mylan, a dominant player in generics, historically supplied clorazepate dipotassium, often through collaborations with Asian manufacturing units. They adhere to strict quality certifications, including Good Manufacturing Practices (GMP).

4. Hexal (part of Novartis)

Hexal supplies generic benzodiazepines, including clorazepate dipotassium, with manufacturing units in Germany ensuring high-quality standards.

Contract Manufacturing Organizations (CMOs)

In addition to branded manufacturers, numerous CMOs globally specialize in producing pharmaceutical salts like clorazepate dipotassium, often for third-party clients:

Siegfried AG (Switzerland): Known for complex chemical synthesis and API manufacturing.
Aenova Group (Germany): Offers contract manufacturing services with capabilities for API synthesis.
FAM (Formosa Advanced Manufacturing, Taiwan): Provides large-scale API production, including benzodiazepines.

Geographic Distribution of Suppliers

North America

The US and Canada host several key players, including Teva and Mylan, with manufacturing facilities regulated by the FDA and Health Canada, ensuring high compliance standards.

Europe

Germany and Switzerland are prominent centers, with Hexal and Siegfried AG providing robust supply chains. European suppliers benefit from strict EU regulations for pharmaceuticals.

Asia

India and China are significant sources of generics and APIs, populated with numerous manufacturers leveraging cost-effective production. Companies like Cadila Healthcare and Zhejiang Huiyuan are involved in benzodiazepine synthesis.

Regulatory and Quality Considerations

Suppliers must adhere to strict regulatory standards, especially those regulated by USFDA, EMA, or comparable agencies. Importantly, API suppliers should demonstrate compliance with GMP, stability data, and rigorous quality control protocols.

Qualified suppliers typically hold certifications such as:

FDA registration for US importation
EMA approval for European supply
ISO certifications (e.g., ISO 9001, ISO 13485)

Procurement decisions depend heavily on such certifications to mitigate risks associated with subpar drug quality and regulatory non-compliance.

Market Trends and Supply Dynamics

Global Supply Chain Challenges

Recent years have seen disruptions in chemical supply chains, notably during the COVID-19 pandemic, impacting raw material availability for API manufacturing. Businesses increasingly favor diversified supplier bases to mitigate risks.

Biosimilar and Generic Competition

As patent expirations and patent litigations unfold, multiple manufacturers are entering the market, expanding the supplier landscape. Generic manufacturers secure supply contracts with originators or establish independent production lines for clorazepate dipotassium.

Regulatory Changes

Enhanced scrutiny over benzodiazepine manufacturing standards due to abuse potential influences supplier operation and compliance processes. Suppliers with rigorous quality assurance are favored.

Supply Chain Risks and Mitigation

Regulatory non-compliance: suppliers must maintain current certifications and adhere to evolving standards.
Raw material shortages: diversification with multiple suppliers reduces dependence on single sources.
Geopolitical tensions: sourcing from politically stable regions minimizes risks.
Quality variability: rigorous audits and quality assurance programs ensure consistency.

Emerging Suppliers and Technological Advances

Innovations in chemical synthesis and biotechnological methods can expand supplier options in the future. Custom synthesis providers in China and India invest heavily in compliant manufacturing, ensuring the evolving demands for high-purity APIs are met.

Strategic Sourcing Recommendations

Establish relationships with multiple, qualified suppliers across different geographies.
Conduct thorough audits to ensure compliance with regulatory and quality standards.
Monitor geopolitical and supply chain trends to anticipate disruptions.
Engage with suppliers committed to sustainable and ethical manufacturing practices.

Conclusion

The supply landscape for clorazepate dipotassium is characterized by established pharmaceutical firms in North America and Europe, augmented by a growing network of credible Asian manufacturers and CMOs. Ensuring a stable, high-quality supply requires ongoing supplier qualification, diversified sourcing strategies, and vigilant regulatory oversight.

Key Takeaways

The primary global suppliers of clorazepate dipotassium are Teva, Mylan, Hexal, and various specialized CMOs.
Geographic diversification—particularly between North America, Europe, and Asia—reduces supply chain risks.
Regulatory compliance (GMP, FDA, EMA) is critical; suppliers must demonstrate high standards.
Market shifts, including increased generic competition and evolving regulations, influence supplier choices.
Proactive supply chain management, including multiple sourcing and regulatory monitoring, optimizes reliability and cost-efficiency.

FAQs

1. Who are the main global suppliers of clorazepate dipotassium?
Main suppliers include Teva Pharmaceuticals, Mylan (Viatris), Hexal (Novartis), and several Asian contract manufacturers like FAM and Zhejiang Huiyuan.

2. How do regulatory standards impact supplier selection?
Suppliers must adhere to GMP and hold certifications like FDA registration or EMA approval, ensuring product quality and legal compliance in target markets.

3. Are there risks associated with sourcing from Asian suppliers?
Potential risks include regulatory discrepancy, quality variability, and geopolitical factors. Mitigation includes thorough qualification, audits, and diversification.

4. What trends are influencing the supply chain of clorazepate dipotassium?
Increased generic competition, supply chain disruptions due to COVID-19, and stricter regulatory scrutiny shape the supply landscape.

5. How can companies secure a reliable supply of clorazepate dipot potassium?
By establishing relationships with multiple qualified suppliers across different regions, conducting regular quality audits, and staying updated on regulatory changes.

References

[1] U.S. Food and Drug Administration (FDA). Approved Drug Products: Clorazepate Dipotassium.
[2] European Medicines Agency (EMA). Pharmacovigilance of Benzodiazepines.
[3] Teva Pharmaceuticals Annual Report 2022.
[4] Mylan (Viatris) Global API Supply Chain Overview, 2021.
[5] Contract Manufacturing Organizations' Capabilities and Certifications, 2022.

Suppliers and packagers for CLORAZEPATE DIPOTASSIUM