Last updated: July 28, 2025
Introduction
Flurazepam Hydrochloride is a potent benzodiazepine derivative primarily used as a hypnotic agent for short-term management of insomnia. Its pharmacological profile includes sedative, anxiolytic, and anticonvulsant properties. Due to its medical utility, pharmaceutical manufacturers worldwide supply Flurazepam Hydrochloride, either as a finished product or as an active pharmaceutical ingredient (API) for compounding and formulation.
The current global supply chain involves numerous suppliers, ranging from large-scale chemical producers to specialized APIs manufacturers. Understanding the landscape of these suppliers is critical for pharmaceutical companies, regulators, and healthcare providers aiming to ensure quality, regulatory compliance, and continuous access to this controlled substance.
Regulatory Context and Market Overview
Flurazepam Hydrochloride is classified as a Schedule IV controlled substance under the Controlled Substances Act in the United States, reflecting its potential for abuse. This classification influences supplier compliance requirements, import-export controls, and manufacturing regulations ([1]).
The demand for Flurazepam Hydrochloride remains steady in regions where it is approved for clinical use. However, due to concerns about dependency, many countries have tightened regulations or phased out its use, impacting the supply dynamics.
Key Suppliers and Manufacturers
1. Catalent Pharma Solutions
As a global leader in pharmaceutical development and manufacturing, Catalent supplies pharmaceutical ingredients and finished forms. They possess advanced production facilities that manufacture benzodiazepines, including flurazepam derivatives, adhering to strict cGMP standards. Their intensive quality control processes facilitate regulatory approvals across many jurisdictions ([2]).
2. Chiralmed
Specializing in chiral API production, Chiralmed supplies Flurazepam Hydrochloride focusing on its purity and stereochemistry. Their manufacturing process employs asymmetric synthesis techniques ensuring high enantiomeric purity, which is vital for efficacy and safety. They export to multiple regions, including Asia and Europe ([3]).
3. UQUIFA
UQUIFA, a Spanish pharmaceutical company, produces a range of benzodiazepines and sedative agents. Their manufacturing facilities in Europe are certified to meet stringent GMP standards, and they supply Flurazepam Hydrochloride to both generic and branded pharmaceutical companies. UQUIFA’s compliance with European regulations positions them as a reliable API supplier ([4]).
4. Xinjiang Food Machinery Co., Ltd.
A Chinese API manufacturer specializing in sedatives and hypnotics, Xinjiang Food Machinery Co. offers Flurazepam Hydrochloride at competitive prices. Their manufacturing facilities are GMP-certified, and they focus heavily on export markets. However, due diligence on quality certifications is recommended due to regional regulatory differences ([5]).
5. Privately-Owned and Boutique API Manufacturers
Numerous smaller manufacturers operate in markets like India, Eastern Europe, and Southeast Asia, producing Flurazepam Hydrochloride mainly for domestic consumption or specialized markets. Their capacity and quality vary significantly, making supplier vetting essential.
Supply Chain and Regulatory Considerations
Given its controlled status, sourcing Flurazepam Hydrochloride entails navigating complex regulatory requirements. Legitimate suppliers maintain strict record-keeping, batch documentation, and regulatory approvals such as U.S. FDA, EMA, or equivalent certifications.
Due diligence should include verifying Good Manufacturing Practice (GMP) compliance, product certificates of analysis (COA), and licensing status from regulators like the DEA in the U.S. or the European Medicines Agency (EMA).
Market Challenges and Trends
- Regulatory Tightening: Increased global controls have led to supply chain restrictions. Suppliers often require end-user licensing agreements and MOUs.
- Quality and Authenticity Risks: The illicit market for benzodiazepines can involve counterfeit or substandard products. Pharmaceutical buyers must perform rigorous supplier qualification.
- Supply Diversification: Companies seek multiple reliable sources to mitigate risks related to geopolitical disruptions or regulatory shifts.
- Research and Development: Some manufacturers are exploring new formulations or therapeutic indications, which may influence future supplier dynamics.
Conclusion
The supply of Flurazepam Hydrochloride hinges upon accredited, compliant manufacturers. Major players like Catalent, Chiralmed, UQUIFA, and Xinjiang Food Machinery dominate the landscape, offering varying degrees of capacity, quality, and regional coverage. Navigating this market requires careful regulatory oversight, supplier verification, and risk management.
Key Takeaways
- Regulatory Compliance: Ensuring suppliers meet strict GMP standards and possess necessary licenses is vital for legal and safety considerations.
- Supplier Vetting: Due diligence must verify manufacturing quality, authenticity, and regulatory approvals, especially given the drug’s controlled status.
- Market Trends: Diversification of suppliers and ongoing regulatory changes influence procurement strategies.
- Regional Variations: Suppliers are concentrated in North America, Europe, and Asia; regional regulations significantly impact sourcing options.
- Future Outlook: Advances in synthesis and potential therapeutic uses could alter demand, impacting supplier numbers and capabilities.
FAQs
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Are Flurazepam Hydrochloride suppliers available globally?
Yes. Major suppliers are located in North America, Europe, and Asia, with export capabilities worldwide. However, regulatory licensing influences availability.
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What should I verify before engaging with a Flurazepam Hydrochloride supplier?
Confirm GMP compliance, licensing, certificates of analysis, and regulatory approvals. Vendor history and track record are also critical.
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Is China a reliable source for Flurazepam Hydrochloride?
Many Chinese manufacturers produce the API; reliability hinges on certifications, quality standards, and export regulations. Due diligence is essential.
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How does the regulatory status of Flurazepam impact sourcing?
Its controlled substance status imposes strict verification, licensing, and reporting obligations on suppliers, affecting supply chain reliability.
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Are there alternative suppliers with similar benzodiazepine APIs?
Yes. Suppliers of related benzodiazepines like Diazepam and Temazepam may also produce Flurazepam, but compatibility with specific regulations must be confirmed.
References
[1] U.S. Drug Enforcement Administration. (2022). Controlled Substances List.
[2] Catalent Pharma Solutions. (2023). Corporate Capabilities and Certifications.
[3] Chiralmed API Catalog. (2023). Advanced Chirality and Pharmacology.
[4] UQUIFA Official Website. (2022). Production Standards and Certifications.
[5] Xinjiang Food Machinery Co., Ltd. Export Records and GMP Certification Details.
This comprehensive overview equips pharmaceutical businesses, healthcare providers, and regulatory bodies with critical insights into the suppliers and supply chain considerations for Flurazepam Hydrochloride.
