Bulk Pharmaceutical API Sources for flurazepam hydrochloride

Bulk Pharmaceutical API Sources for flurazepam hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F103_SIGMA
NovoSeek		14434
ABI Chem		AC1L23TS

Bulk Active Pharmaceutical Ingredient (API) Sources for: Flurazepam Hydrochloride

Last updated: August 1, 2025

---

Introduction

Flurazepam hydrochloride is a benzodiazepine derivative primarily prescribed as a hypnotic agent for the short-term treatment of insomnia. As a controlled substance due to its sedative properties, the manufacturing, sourcing, and distribution of flurazepam hydrochloride APIs are highly regulated. Reliable API sourcing is critical for pharmaceutical companies seeking quality, regulatory compliance, and cost efficiency.

This article explores the central players and regional markets supplying flurazepam hydrochloride API, with an emphasis on their manufacturing capabilities, regulatory landscape, and supply chain dynamics.

---

Global API Manufacturing Landscape for Flurazepam Hydrochloride

1. Major API Manufacturers

The production of flurazepam hydrochloride API is predominantly confined to a select group of pharmaceutical manufacturers with advanced chemical synthesis capabilities and strict quality controls.

• Asian Suppliers (India and China):
  India and China dominate the manufacturing of generic APIs, exploiting cost advantages and extensive chemical manufacturing infrastructure. Notably, Indian firms such as IPCA Laboratories and Macleods Pharmaceuticals have established APIs' synthesis processes for benzodiazepines, with some facilities registered under strict cGMP protocols. Chinese manufacturers like North China Pharmaceutical Group and North China Pharmaceutical have historically supplied APIs to Western markets, although regulatory scrutiny has increased over quality concerns.

• European Manufacturers:
  Companies like Evonik Industries and Siegfried AG operate state-of-the-art facilities in Europe producing APIs, focusing on compliance with stringent EU regulations (EMA standards). Their APIs often serve the premium pharmaceutical segment, emphasizing quality and regulatory adherence.

• North American Sources:
  North American API manufacturing of benzodiazepines is limited due to regulatory hurdles and market size. Most of their APIs are imported or produced through outsourcing.

2. Regulatory Considerations

All API suppliers must comply with regulations from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and local authorities. The controlled status of flurazepam hydrochloride means that manufacturing facilities require Schedule IV licensing in the U.S. under the Controlled Substances Act, which entails rigorous security and compliance measures.

Manufacturers with approvals or registrations from multiple authorities have a competitive advantage, providing pharmaceutical entities with confidence in sourcing.

---

Key Regions and Their API Supply Capabilities

A. India

India remains a prominent API supplier for benzodiazepines, including flurazepam hydrochloride, owing to its extensive chemical manufacturing base, competitive pricing, and growing regulatory framework.

• Example Suppliers:

  • Capsugel India (part of Lonza) — known for high-quality APIs; however, specific benzodiazepine capabilities are limited but expanding.
  • Hetero Labs — with a diversified portfolio, including controlled substances, under strict regulatory oversight.

• Regulatory Compliance:
  India’s Central Drugs Standard Control Organization (CDSCO) enforces compliance, with many manufacturers achieving WHO-GMP certification, critical for exports.

B. China

Chinese API manufacturers offer competitive pricing and production volume for benzodiazepines, including flurazepam hydrochloride.

• Key Players:

  • North China Pharmaceutical Group
  • North China Pharmaceutical
  • Shandong Xinhua Pharmaceutical

• Supply Chain Considerations:
  The Chinese market faces some regulatory and quality assurance challenges, but recent reforms and quality controls have improved API standards.

• Export Volume:
  Many Chinese APIs are exported globally, but regulatory barriers necessitate thorough vetting and qualification.

C. Europe

Europe offers high-quality APIs with rigorous compliance standards, including GMP certification and thorough inspection by the EMA.

• Leading Companies:

  • Evonik Industries
  • Siegfried AG

• Market Focus:
  On manufacturing high-purity APIs for premium markets, often with a focus on regulatory compliance.

D. North America

The U.S. and Canada have limited domestic API production for benzodiazepines; instead, they rely heavily on imports.

• Regulatory Context:
  Due to strict controlled substance regulations, domestic production is complex, but several specialized suppliers exist, including legacy manufacturers with FBI and DEA registration.

---

Supply Chain Challenges and Considerations

• Regulatory Hurdles:
  The Schedule IV status of flurazepam hydrochloride necessitates strict controls, complicating procurement. Suppliers must hold appropriate licenses, and import/export must comply with DEA or equivalent authorities.

• Quality Assurance:
  Buyers should verify GMP certification, batch consistency, and recent manufacturing audits. Given past concerns on quality variance, due diligence is essential.

• Price Volatility:
  API prices are affected by raw material costs, regulatory changes, and geopolitical factors. Asian suppliers often offer lower prices but may face variability in quality assurance.

• Intellectual Property and Patents:
  As a generic benzodiazepine, patent protections on flurazepam hydrochloride API have generally expired, allowing multiple manufacturers. However, regulatory exclusivities and proprietary synthesis processes can influence sourcing options.

---

Implications for Pharmaceutical Companies and Importers

• Due Diligence:
  Firms should prioritize suppliers with recognized GMP and cGMP certifications, positive regulatory inspection history, and transparent quality documentation.

• Risk Mitigation:
  Diversify supplier base across regions, particularly including European or North American sources for higher assurance levels, especially for high-volume or sensitive applications.

• Regulatory Compliance:
  Ensure all suppliers maintain proper controlled substance licenses and adhere to international standards for import/export.

• Supply Chain Security:
  Establish quality agreements, perform qualification audits, and monitor ongoing supplier compliance to mitigate supply disruptions and quality issues.

---

Conclusion

The global sourcing of flurazepam hydrochloride API is characterized by a limited number of specialized manufacturers, primarily in India, China, and Europe. While Asian suppliers offer competitive pricing, stringent quality assurance and regulatory compliance are paramount—especially given the controlled status of the substance. European and North American suppliers deliver high-grade products, though often at higher costs and with limited capacity.

Strategic procurement involves balancing price, quality, regulatory adherence, and supply chain resilience. As regulatory scrutiny intensifies, especially across Asian markets, enterprises sourcing flurazepam hydrochloride API must conduct diligent vetting and maintain diversified supplier relationships.

---

Key Takeaways

• Limited but Diversified Supply: Few global suppliers produce flurazepam hydrochloride API, mainly in India, China, and Europe, with vendors varying in quality assurances.
• Regulatory Robustness: Suppliers must operate under strict GMP standards and possess proper controlled substance licenses; due diligence is essential.
• Cost vs. Quality Trade-off: Indian and Chinese APIs typically offer lower costs but require rigorous quality validation, whereas European sources provide higher reliability.
• Supply Chain Resilience: Diversifying suppliers and regions mitigates risks associated with geopolitical and regulatory disruptions.
• Regulatory Compliance: Ongoing monitoring of legal and regulatory changes is vital for continuity and compliance, especially regarding controlled substance regulations.

---

FAQs

1. Are there domestic U.S. manufacturers for flurazepam hydrochloride API?
Limited domestic production exists primarily due to regulations governing controlled substances. Most U.S. supply is imported or sourced through licensed international suppliers compliant with DEA and FDA standards.

2. What are the primary concerns when sourcing APIs for controlled substances like flurazepam hydrochloride?
Regulatory compliance, licensing, quality assurance, security protocols, and consistent supply are paramount concerns. Suppliers must adhere to strict controls mandated by agencies like DEA, EMA, and relevant authorities.

3. How do quality standards differ between Asian and European suppliers?
European suppliers typically follow more rigorous regulatory standards, including EMA and EU-GMP compliance, possibly resulting in higher quality assurance. Asian suppliers can meet GMP standards but require careful verification due to variable compliance levels.

4. What trends are influencing future API sourcing strategies for benzodiazepines?
Growing regulatory scrutiny, quality assurance enhancements, geopolitical tensions, and supply chain resilience initiatives are shaping sourcing strategies, emphasizing supplier diversification and enhanced validation processes.

5. What are the key factors affecting the pricing of flurazepam hydrochloride API?
Raw material costs, manufacturing scale, regulatory compliance costs, geopolitical factors, and currency fluctuations significantly impact pricing. Asian suppliers typically offer lower prices but may involve higher logistical or regulatory compliance costs.

---

Sources

[1] U.S. Drug Enforcement Administration, "Controlled Substances Schedules," DEA, 2023.
[2] Indian Pharmacopoeia Commission, "Guidelines for API Manufacturing," 2022.
[3] European Medicines Agency, "Good Manufacturing Practice (GMP) Guidelines," EMA, 2023.
[4] Industry reports on API manufacturing, Market Research Reports, 2022.