Suppliers and packagers for generic pharmaceutical drug: remimazolam besylate

remimazolam besylate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295	NDA	Acacia Pharma, Ltd.	71390-011-11	10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00)	2020-10-06

Suppliers for the Pharmaceutical Drug: REMIMAZOLAM BESYLATE

Last updated: July 29, 2025

Introduction

Remimazolam besylate is an ultra-short-acting benzodiazepine designed for procedural sedation, anesthesia induction, and intensive care applications. It offers rapid onset and recovery, making it an attractive alternative to traditional agents like midazolam and propofol. As demand for remimazolam continues to grow, identifying key suppliers across the supply chain has become vital for pharmaceutical companies, healthcare providers, and investors. This report analyzes current and potential suppliers for remimazolam besylate, including active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution channels.

Overview of Remimazolam Besylate Production

Remimazolam besylate is a proprietary compound primarily developed and marketed by pharmaceutical innovators like Fuji Pharma and PAION. Its synthesis involves complex chemical processes requiring specialized intermediates and APIs. The supply chain typically includes firms capable of manufacturing high-purity APIs, excipients, and finished dosage forms, often within stringent regulatory environments such as the EU, US, and Japan.

Existing API Suppliers

1. Fuji Pharma Co., Ltd.

• Position: Pioneering manufacturer and exclusive marketer of remimazolam in Japan.
• Capabilities: Full in-house synthesis of remimazolam besylate API aligned with Japanese Good Manufacturing Practices (GMP).
• Market role: Since its development, Fuji Pharma has been the primary supplier and sole authorized producer of remimazolam API for Japan, leveraging proprietary synthesis pathways.

2. PAION AG

• Position: Co-developer and licensee of remimazolam, with manufacturing agreements.
• Facilities: Collaborates with contract manufacturing organizations (CMOs) to supply the API for clinical and commercial purposes.
• Implication: PAION’s strategic partnerships suggest potential access to multiple API sources, including CMOs in Europe and Asia.

3. Contract Manufacturing Organizations (CMOs)

Given the specialized nature of remimazolam besylate synthesis, several CMOs across Asia and Europe have emerged as potential API suppliers:

• WuXi AppTec (China): A leading CMO with capacity for complex API synthesis, adhering to global regulatory standards.
• CordenPharma (Europe/Asia): Offers custom synthesis services and has been involved in producing benzodiazepine-related APIs.
• Hikal Ltd. (India): Provides high-quality drug substances for specialty APIs, with potential for scale-up.

Future and Emerging API Suppliers

As patent protections evolve and generic opportunities surface, other manufacturers could enter the market:

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Known for producing tranquilizer APIs, potentially capable of synthesizing benzodiazepine derivatives.
• Mitsubishi Tanabe Pharma Corporation (Japan): An R&D-focused firm with capabilities for API development in sedatives.

Formulation and Finished Dosage Form Suppliers

While API manufacturing is critical, suppliers capable of formulation, encapsulation, and final packaging are equally essential:

• Fresenius Kabi: Expertise in injectable formulations, including sedatives like remimazolam.
• Baxter International: Collaborates globally on anesthetic agents and infusion solutions.
• Local Contract Manufacturers: Regional firms, especially in China and India, are increasingly involved in filling, finishing, and distributing remimazolam products.

Regulatory Considerations

Suppliers must comply with strict regulatory standards—FDA, EMA, PMDA, and others—regarding GMP, stability, and purity. Cross-border manufacturing agreements often stipulate adherence to these standards, impacting supplier selection.

Market Dynamics and Strategic Sourcing

The concentrated nature of remimazolam besylate manufacturing underlines reliance on a limited number of high-quality suppliers. As patent protections diminish, generic manufacturers are likely to enter, increasing the supplier pool and driving competitive pricing.

Pharmaceutical companies seeking supply security should evaluate supplier capacity, compliance history, and geographic diversification. Strategic partnerships with CMOs and capacity expansion are key to mitigating supply chain risks.

Conclusion

The supply landscape for remimazolam besylate revolves primarily around Fuji Pharma, with emerging potential from established CMOs specializing in complex API synthesis. Transitioning into broader markets will depend on expanding supplier bases, ensuring regulatory compliance, and developing robust formulation capabilities.

Key Takeaways

• Fuji Pharma is the dominant supplier of remimazolam besylate API, primarily serving Japan.
• Strategic partnerships with CMOs in China, India, and Europe will shape future API supply options.
• Regulatory standards are paramount; suppliers must demonstrate GMP compliance.
• The market is poised for increased competition, especially as patent exclusivity wanes.
• Securing diversified suppliers will mitigate risks and ensure consistent supply for global markets.

FAQs

1. Who are the leading API manufacturers for remimazolam besylate?
Currently, Fuji Pharma is the primary API manufacturer, with collaborations involving CMOs such as WuXi AppTec and CordenPharma. Emerging manufacturers in China, India, and Japan may enter the market as patents expire.

2. Can generic pharmaceutical companies produce remimazolam besylate?
Yes. As patent protections diminish, generic manufacturers with robust synthesis capabilities and regulatory approval experience will likely enter the market, expanding the supplier base.

3. What factors influence supplier selection for remimazolam besylate?
Key factors include GMP compliance, manufacturing capacity, quality control, regulatory track record, geographical reliability, and the ability to scale production.

4. Are there regional differences in remimazolam API sourcing?
Yes. Japanese companies primarily produce for domestic use, while global supply chains are increasingly relying on Asian CMOs, notably in China and India, which offer cost-effective and scalable solutions.

5. What are the risks associated with remimazolam besylate supply chain?
Risks include regulatory delays, manufacturing bottlenecks, source concentration, geopolitical issues, and quality discrepancies. Diversification and rigorous quality assessment are essential mitigation strategies.

References

[1] Fuji Pharma Co., Ltd. Official Website. “Remimazolam.”
[2] PAION AG. Corporate Reports. “Remimazolam Development and Supply.”
[3] WuXi AppTec. Capabilities Overview.
[4] CordenPharma. Contract Manufacturing Capabilities.
[5] Market Analysis Reports. “Global Sedative APIs Market Outlook.”