Last updated: February 20, 2026
Who are the primary suppliers for flurazepam hydrochloride?
Flurazepam hydrochloride is a benzodiazepine used as a sleep aid. It is classified as a controlled substance under regulatory authorities, constraining its production and distribution. The supply chain involves a limited group of global manufacturers, primarily located in countries with established pharmaceutical manufacturing capabilities.
Major Manufacturers and Suppliers
| Company Name |
Country |
Production Status |
Notes |
| Shandong Xinhua Pharmaceutical |
China |
Commercial production |
Has licensed production agreements; exports globally |
| Hubei Wuchang Pharmaceutical |
China |
Produces active pharmaceutical ingredients (APIs) |
Supplies to European and Asian markets |
| Aurobindo Pharma |
India |
API manufacturing and finished formulations |
Supplies to North America and Europe |
| Mylan (now part of Viatris) |
International (India & US-based) |
Produces APIs and formulations |
Limited by tight control under regulations |
Note: Exact production volumes are proprietary; detailed data on capacity remains undisclosed publicly.
Regulatory and Supply Constraints
- Controlled Substance Classification: Under the Controlled Substances Act in the US, flurazepam is scheduled as a Schedule IV drug. This classification restricts manufacturing, procurement, and distribution.
- Manufacturing Licenses: Only companies with Drug Enforcement Administration (DEA) registration in the US or equivalent authorities elsewhere can produce or import flurazepam hydrochloride.
- Export Controls: Export permits are mandatory; global trade is affected by international drug control treaties.
Supply Chain Dynamics
- Manufacturing mostly occurs in countries with robust pharmaceutical sectors, such as China and India.
- Several companies supply APIs, but branded finished products are limited and often produced under strict licensing agreements.
- Imports in regulated markets are subject to oversight by food and drug administrations (FDAs), country-specific regulations, and import permits.
Market Entry and Barriers
- Regulatory approval: Patents on formulations may have expired, but manufacturing licenses and regulatory approvals remain hurdles.
- Pricing and sourcing: API prices vary based on demand, regulatory costs, and manufacturing capacity, affecting supplier choice.
Key Trends and Risks
- Increased regulation on controlled substances limits new market entrants.
- Supply chain disruptions, such as factory shutdowns or export restrictions, affect availability.
- Growing demand for sleep aids temporarily increases API demand, influencing supplier stock levels.
Geographical Focus
| Region |
Leading Suppliers |
Notes |
| United States |
Few domestic suppliers due to strict DEA licensing |
Reliance on imports; limited domestic production |
| China |
Multiple API producers, including Shandong Xinhua |
Major global exporter; manufacturing capacity expanding |
| India |
Several API manufacturers, including Aurobindo, Mylan |
Cost-competitive; exports to Europe, US, and Asia |
Summary
Flurazepam hydrochloride's supply relies on a restricted pool of licensed API manufacturers, mainly in China and India. Production is tightly regulated due to its controlled substance status. Companies with DEA or equivalent licenses in their jurisdictions are the primary suppliers. Global supply chains face regulatory, logistical, and geopolitical challenges that influence availability and pricing.
Key Takeaways
- Supply mainly from China and India due to manufacturing capacity.
- Limited number of licensed API manufacturers globally.
- Regulatory controls restrict entry, production, and distribution.
- Supply chain disruptions significantly impact availability.
- Market primarily served through licensed imports under regulatory oversight.
FAQs
1. Are there generic suppliers for flurazepam hydrochloride?
Yes. Several generic API producers in China and India supply flurazepam hydrochloride, primarily through licensing agreements.
2. What regulations impact the sourcing of flurazepam hydrochloride?
It is classified as a Schedule IV controlled substance under the US DEA, requiring strict licensing and import/export controls in most jurisdictions.
3. Are there notable differences between suppliers’ API quality?
Quality standards adhere to Good Manufacturing Practices (GMP). Differences are controlled through regulatory approvals; verified suppliers meet international quality standards.
4. Is domestic production common?
No. Due to regulatory restrictions, actual domestic production within countries like the US is minimal; most procurement occurs via imports.
5. How do supply chain disruptions affect drug availability?
Shifts in manufacturing capacity, export restrictions, or logistical disruptions can impair supply, leading to shortages in certain markets.
References
[1] U.S. Drug Enforcement Administration. (2022). Controlled Substance Schedules. DEA.gov.
[2] European Medicines Agency. (2021). Regulatory status of benzodiazepines. EMA.europa.eu.
[3] GlobalData. (2022). API Manufacturing Market Reports.
[4] World Health Organization. (2018). List of controlled substances. WHO.int.
[5] IQVIA. (2022). Pharmaceutical Market Reports: Sleeping aids. IQVIA.com.
