Bulk Pharmaceutical API Sources for CISATRACURIUM BESYLATE PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for CISATRACURIUM BESYLATE PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou Trylead Chemical Technology		TL8006016
NovoSeek		62886
MolPort		MolPort-003-987-490
ABI Chem		AC1L1XZG
ABI Chem		AC1Q22ND

Bulk Active Pharmaceutical Ingredient (API) Sources for: CISATRACURIUM BESYLATE PRESERVATIVE-FREE

Last updated: July 27, 2025

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Introduction

Cisatracurium besylate, a non-depolarizing neuromuscular blocking agent, is widely utilized in anesthesia to facilitate tracheal intubation and relax skeletal muscles during surgery. The preservative-free formulation of cisatracurium besylate is critical for vulnerable patient populations, including neonates, infants, and individuals with allergies to preservatives. The procurement of high-purity, pharmaceutical-grade cisatracurium besylate API is central to manufacturing these formulations. This guide delineates key sourcing options, emphasizing quality, regulatory compliance, and supply chain robustness.

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Understanding Cisatracurium Besylate and Its Market Dynamics

Cisatracurium besylate, a stereoisomer of atracurium, is synthesized to achieve greater potency and fewer side effects such as histamine release. Its biosynthesis involves complex chemical processes, notably the Hofmann elimination pathway, which affords a predictable duration of action independent of renal or hepatic function. The global demand for preservative-free formulations is rising, driven by safety profiles and pediatric indications.

The market features several experienced API manufacturers specializing in neuromuscular blocking agents, with varying degrees of regulatory approval and manufacturing capacity. Ensuring API purity, potency, and compliance with pharmacopeial standards is fundamental.

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Major API Manufacturers and Suppliers

1. Fresenius Kabi

Fresenius Kabi, a global leader in anesthetics and injectable drugs, manufactures cisatracurium besylate API compliant with international standards such as USP, EP, and JP. Their manufacturing facilities are GMP-certified, ensuring batch-to-batch consistency. The company supplies pharmaceutical-grade APIs directly to drug producers, emphasizing preservative-free formulations for anesthesia.

Key attributes:

• GMP-certified manufacturing sites.
• Strong regulatory compliance.
• Established global distribution network.

2. Organization of Pharmaceutical Products of the Central Military Commission (OPP)

Operational mostly within China, OPP and associated chemical producers offer cisatracurium besylate API at competitive prices. While primarily serving domestic markets, some vendors have obtained GMP certification for export. Buyers should carefully verify regulatory approvals for specific markets.

Key attributes:

• Competitive pricing.
• Increasing GMP compliance.
• Limited international footprint (verify certification status).

3. UQUIFA (Spain)

UQUIFA specializes in anesthetic agents and provides high-purity cisatracurium besylate APIs. Their manufacturing adheres to strict European regulations, with export capabilities worldwide. Their APIs meet EMA standards, making them suitable for prescriptive use in advanced markets.

Key attributes:

• European GMP certification.
• Rigorous quality control.
• Proven track record in anesthetic APIs.

4. Ben Venue Laboratories / Pfizer

Ben Venue Laboratories, historically associated with Pfizer, was a supplier of anesthetic APIs, including cisatracurium. Although their manufacturing has faced disruptions, some legacy supplies and manufacturing licenses remain available.

Note: Verify current operational status directly with Pfizer or former affiliates.

5. Domestic and Regional Manufacturers (India, China, Southeast Asia)

Numerous local manufacturers produce cisatracurium besylate API, often with competitive pricing. Notable Indian producers include:

• Gufic Biosciences
• Raptakos Brett & Co.
• Sun Pharmaceuticals

Similarly, several Chinese API producers have developed manufacturing capabilities, often exporting to international markets.

Key attributes:

• Cost-effective options.
• Varying degrees of GMP compliance.
• Critical to verify certification and regulatory approval before procurement.

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Criteria for Selecting API Sources

• Regulatory Compliance: Ensure the API manufacturer holds cGMP certification and adheres to pharmacopeial standards (USP, EP, JP). Agencies such as the FDA, EMA, or Japanese PMDA accreditation bolster confidence.

• Quality Assurance: Batch records, analytical methods, impurity profiles, and stability data must meet regulatory specifications. Certificates of Analysis (CoA) should be verified for each batch.

• Supply Chain Reliability: Assess the manufacturer’s capacity, delivery timelines, and proven track record of consistent supply.

• Pricing and Payment Terms: While competitive pricing is vital, it cannot compromise quality. Long-term agreements often secure better terms.

• Environmental and Ethical Standards: Compliance with environmental regulations and ethical standards further assures product integrity.

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Regulatory Considerations for Preservative-Free APIs

Preservative-free cisatracurium besylate APIs are subject to rigorous quality controls given their application in vulnerable populations. The API must conform to stringent purity profiles, minimized endotoxins, and appropriate residual solvent levels. Regulatory agencies may request detailed validation data, including stability studies for preservative-free formulations.

Manufacturers with prior approval for preservative-free synthesis or who undergo added validation steps are preferred to mitigate regulatory hurdles.

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Emerging Trends and Supply Chain Optimization

The increased focus on preservative-free formulations has prompted API manufacturers to refine synthesis pathways for higher purity and fewer impurities. Advancements include:

• Improved stereoselective synthesis techniques.
• Enhanced purification processes.
• Validation of stability and compatibility in preservative-free matrices.

Supply chain diversification, such as sourcing from multiple certified manufacturers, mitigates risks related to disruptions, as evident during the COVID-19 pandemic. Strategic partnerships with reputable API producers ensure continuity and compliance.

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Summary

Sourcing high-quality, preservative-free cisatracurium besylate API involves evaluating manufacturers across regulatory, quality, and operational criteria. Established global players like Fresenius Kabi and UQUIFA offer reliable procurement options, supported by stringent GMP adherence and certification. Regional manufacturers can provide cost-effective alternatives but require thorough vetting to ensure compliance with applicable standards.

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Key Takeaways

• Prioritize GMP-certified and regulated manufacturers to ensure API potency, purity, and safety for preservative-free formulations.
• Verify detailed analytical and stability data to meet pharmacopeial standards, especially given the sensitivity of preservative-free products.
• Diversify supply sources to mitigate risks of disruption and secure a consistent supply chain.
• Engage in transparent communication with suppliers, including quality specifications, batch documentation, and compliance certification.
• Monitor evolving regulations and industry standards to stay compliant with regional and international pharmacopoeial requirements, especially concerning preservative-free APIs.

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FAQs

Q1: What distinguishes preservative-free cisatracurium besylate API from standard formulations?
A: Preservative-free APIs are manufactured and processed to eliminate or minimize preservatives, reducing hypersensitivity risks, particularly vital for pediatric and sensitive populations.

Q2: Which certifications should I verify when sourcing cisatracurium besylate API?
A: Confirm GMP certification, and compliance with pharmacopeial standards like USP, EP, or JP. Additionally, regulatory approvals such as FDA or EMA registration enhance confidence.

Q3: Are regional API manufacturers reliable for pharmaceutical production?
A: Many regional manufacturers, especially from India and China, meet international quality standards and are reliable when they possess proper certifications and documentation. Due diligence is essential.

Q4: How does the manufacturing process impact the quality of preservative-free cisatracurium API?
A: The process influences purity, stereoisomeric content, impurities, and contaminant levels, all critical factors for safety and efficacy in preservative-free formulations.

Q5: What are the main challenges in sourcing preservative-free cisatracurium besylate API?
A: Challenges include ensuring consistent quality, meeting stringent regulatory requirements, maintaining supply chain stability, and verifying supplier compliance with evolving standards.

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References

[1] U.S. Pharmacopeia. USP Monographs for Cisatracurium Besylate. 2022.
[2] European Pharmacopoeia. Cisatracurium Besylate Specification. 2022.
[3] Anesthesia & Analgesia. "Advances in Neuromuscular Blocking Agents," 2021.
[4] Transparency Market Research. "Global Market for Neuromuscular Blocking Agents," 2022.
[5] Company websites and GMP certification documents.

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This comprehensive sourcing guide supports pharmaceutical manufacturers and procurement professionals in securing high-quality cisatracurium besylate API for preservative-free therapeutic formulations.