Bulk Pharmaceutical API Sources for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5281042
NovoSeek		5281080
ABI Chem		AC1NQXXZ
ABI Chem		AC1NQXZZ
ChemMol		49402056
ChemMol		49421596
Chembase.cn		1095

Bulk Active Pharmaceutical Ingredient (API) Sources for MIVACRON (Rocuronium Bromide) in Dextrose 5% in Plastic Container

Last updated: August 10, 2025

Introduction

The pharmaceutical industry's reliance on high-quality APIs governs the safety, efficacy, and regulatory compliance of injectable drugs such as MIVACRON (rocuronium bromide). As a neuromuscular-blocking agent used predominantly in anesthesia, MIVACRON's API sourcing is critical for pharmaceutical manufacturers aiming to maintain product integrity, meet stringent regulatory standards, and optimize supply chain resilience. This analysis explores the primary global suppliers of rocuronium bromide API suitable for formulation into Dextrose 5% injections in plastic containers.

Global API Manufacturing Landscape for Rocuronium Bromide

Rocuronium bromide is a complex, synthetic steroidal neuromuscular blocker that requires sophisticated manufacturing techniques involving multiple chemical synthesis steps, stringent purity standards, and comprehensive quality controls. Its global manufacturing is concentrated primarily within North America, Europe, and parts of Asia, with a mix of branded and generic API producers.

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Key API Suppliers for Rocuronium Bromide

1. Fosun Pharmaceutical (China)

Fosun Pharma is one of the leading Chinese pharmaceutical companies offering high-quality rocuronium bromide API. Their manufacturing facilities are GMP-compliant, and they have extensive experience in producing anesthetic and neuromuscular blocking agents. Fosun's API production is aligned with international quality standards, making it a preferred choice for global markets. The company actively exports to North America and Europe via certified supply channels.

2. Sun Pharmaceutical Industries Ltd. (India)

Sun Pharma has expanded its portfolio to include neuromuscular blocking agents, including rocuronium bromide API. Their manufacturing facilities in India adhere to WHO-GMP standards and have established a reputation for producing reliable APIs with high purity levels. Their strategic location allows cost-effective production and global distribution capabilities.

3. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui is a major Chinese pharmaceutical manufacturer that supplies various injectables and APIs. Their manufacturing processes incorporate advanced synthetic chemistry techniques that meet international regulatory requirements, offering consistent API quality suitable for critical care medications like MIVACRON.

4. Sagent Pharmaceuticals (USA)

Sagent specializes in sterile injectable APIs and finished pharmaceuticals. Their API manufacturing facilities are FDA-inspected, with robust quality assurance systems. They have a niche focus on neuromuscular blocking agents, making them a trusted source for rocuronium API intended for high-end, clinical-grade formulations.

5. TAIHO Pharmaceutical Co., Ltd. (Japan)

TAIHO produces high-quality pharmaceutical APIs, including neuromuscular blockers. Their products are distributed globally, with a focus on compliance with Japanese and international standards. Their API manufacturing facilities are rated highly for quality assurance and regulatory compliance, making them a viable source for premium pharmaceutical companies.

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Criteria for Selecting API Suppliers for MIVACRON

When sourcing rocuronium bromide API for Dextrose 5% injectable formulations, pharmaceutical companies must evaluate:

• Regulatory Compliance: Suppliers must provide documentation demonstrating compliance with cGMP, FDA, EMA, or PHARMACOPEIAL standards.
• API Purity and Quality: Typical specifications include ≥99.0% purity, low levels of residual solvents, endotoxins, and heavy metals.
• Consistency and Batch-to-Batch Reproducibility: Critical for maintaining product efficacy and safety.
• Supply Chain Security: Reliable manufacturing capacity and logistics to ensure timely delivery.
• Cost-effectiveness: Competitive pricing aligned with quality standards.
• Environmental and Ethical Standards: Compliance with sustainability and ethical sourcing policies.

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Supply Chain Considerations for API Integration

Integrating a new API source into the manufacturing process requires rigorous validation, including stability testing, compatibility assessments with Dextrose 5%, and sterility assurance for final products. Furthermore, supply agreements should incorporate clauses for regulatory audits, ongoing quality monitoring, and contingency planning to mitigate supply disruptions.

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Regulatory and Certification Aspects

Suppliers must furnish comprehensive regulatory dossiers, including Certificates of Analysis (CoA), Certificates of Suitability (CEP), and Drug Master Files (DMF). In addition, APIs intended for injectable formulations must comply with Pharmacopeial standards such as those outlined in the USP, EP, or JP monographs, depending on the market.

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Concluding Perspectives

The global landscape for rocuronium bromide API supplies is characterized by a mix of established manufacturers in China, India, Japan, and the USA. Pharmaceutical companies seeking high-quality API sources for MIVACRON in Dextrose 5% in plastic containers should prioritize suppliers demonstrating consistent quality, regulatory compliance, and reliable logistics.

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Key Takeaways

• Diverse Global Suppliers: Established manufacturers in China, India, Japan, and the USA offer high-quality rocuro­nium bromide APIs suitable for injectable formulations.
• Regulatory Compliance Is Paramount: Ensure suppliers hold necessary certifications and provide comprehensive documentation for regulatory submissions.
• Quality, Consistency, Cost Balance: Critical to select API sources that balance high purity standards with cost efficiencies.
• Supply Chain Reliability: Long-term partnerships require assured supply capacity and contingency planning.
• Validation and Compatibility: Confirm that the API integrates seamlessly with formulation processes, including stability in Dextrose 5%, and complies with relevant pharmacopeial standards.

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FAQs

1. What are the primary quality standards for rocuronium bromide API intended for injectable formulations?
   The API must meet buyer-specific specifications aligned with USP, EP, or JP monographs, including high purity (≥99.0%), low residual solvents, endotoxins, and heavy metals, and compliance with cGMP guidelines.

2. Are Chinese and Indian API manufacturers reliable for pharmaceutical quality?
   Yes. Major Chinese and Indian manufacturers like Fosun Pharma, Hengrui, and Sun Pharma have established GMP-compliant facilities and have been approved or inspected by regulatory authorities such as the US FDA, EMA, or WHO, ensuring reliable quality.

3. How does API supply impact the manufacturing of MIVACRON in Dextrose 5%?
   The API's purity, stability, and consistency directly influence the product's safety, efficacy, and shelf life. A reliable API supply ensures uninterrupted production and regulatory compliance.

4. What are critical factors in validating a new API source for injectable neuromuscular blockers?
   Validation involves confirming API quality, stability in Dextrose 5%, sterility, compatibility with excipients, and batch-to-batch reproducibility, alongside regulatory dossier submission.

5. How can pharmaceutical companies mitigate risks associated with API supply chain disruptions?
   Establish dual sourcing, maintain strategic safety stock, develop strong supplier relationships, conduct periodic audits, and implement contingency plans with backup suppliers.

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References

[1] U.S. Pharmacopeia (USP). "Rocuronium Bromide Monograph." 2022.
[2] European Pharmacopoeia (EP). "Rocuronium Bromide Specification." 2022.
[3] WHO Guidelines on Good Manufacturing Practices. 2021.
[4] GlobalData. "Rocuronium Bromide API Market Report." 2022.
[5] Industry Reports and Supplier Websites (Fosun Pharma, Sun Pharma, Jiangsu Hengrui, Sagent, TAIHO).