Bulk Pharmaceutical API Sources for dolasetron mesylate

Bulk Pharmaceutical API Sources for dolasetron mesylate

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246842
NovoSeek		60653
NovoSeek		3033817
NovoSeek		441346
ISpharm		I06-0341
MolPort		MolPort-005-940-737

Bulk Active Pharmaceutical Ingredient (API) Sources for: DOLASETRON MESYLATE

Last updated: August 8, 2025

Introduction

Dolasetron mesylate, an antiemetic agent predominantly used to prevent nausea and vomiting associated with chemotherapy, is a synthetic serotonin 5-HT3 receptor antagonist. As a critical component in various pharmaceuticals, the sourcing of high-quality bulk APIs such as dolasetron mesylate is fundamental for pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and research entities. This article provides a detailed overview of the primary API suppliers, considerations in sourcing, and emerging trends in the procurement landscape for dolasetron mesylate.

Overview of Dolasetron Mesylate API

Dolasetron mesylate's chemical formula is C19H25N3O4·CH4O3S, with a molecular weight of approximately 429.5 g/mol. Its synthesis involves complex chemical pathways, necessitating suppliers with robust manufacturing processes, stringent quality controls, and regulatory compliance, especially with Good Manufacturing Practice (GMP) standards. The API's stability, purity levels (>99%), and compliance with pharmacopeial standards (USP, EP) are critical for pharmaceutical production and clinical applications.

Global API Suppliers for Dolasetron Mesylate

Several key players dominate the API sourcing landscape for dolasetron mesylate, spanning North America, Europe, and Asia. Each offers varying degrees of manufacturing capacity, quality assurance, and logistical support.

1. North American Suppliers

   • Sandoz (Novartis Division): As a pioneer in generic pharmaceuticals, Sandoz possesses extensive API manufacturing capabilities, including complex molecules like dolasetron mesylate. Their GMP-certified facilities ensure high-purity API production aligned with stringent regulatory standards. Sandoz's global distribution network also facilitates reliable supply chains.

   • Cambrex Corporation: Known for custom manufacturing and high-potency APIs, Cambrex offers APIs with proven quality management systems. Their flexibility in scale and comprehensive analytical support make them a preferred partner for clinical and commercial manufacturing.

2. European Suppliers

   • STS (Sciences Therapeutiques et Synthèses): Specializing in sterile and non-sterile APIs, STS offers advanced synthesis capabilities for serotonergic agents, including dolasetron mesylate. Their adherence to European GMP standards and rigorous quality controls position them as reliable suppliers.

   • Fresenius Kabi: With a focus on sterile APIs and complex molecules, Fresenius Kabi supplies quality APIs to the oncology and supportive care sectors, including agents like dolasetron mesylate.

3. Asian Suppliers

   • Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A leading API manufacturer with a comprehensive portfolio, including serotonergic agents. Their GMP-certified facilities and large-scale production capacity have made them a prominent source for international markets.

   • Hunan Ruidi Pharmaceutical Co., Ltd. (China): Specializes in active pharmaceutical ingredients, offering dolasetron mesylate with a focus on price competitiveness and regulatory compliance for export markets.

   • Valkem Pharma (India): A fast-growing player in the API domain, Valkem delivers high-quality APIs for both domestic and international markets, including dolasetron mesylate, supported by ISO and GMP certifications.

4. Emerging and Contract Manufacturers

   The increasing demand for dolasetron mesylate has motivated several CDMOs (Contract Development and Manufacturing Organizations) to establish or expand capabilities for its synthesis, ensuring supply security and scalability.

Key Considerations in API Sourcing

• Regulatory Compliance: Suppliers must demonstrate compliance with cGMP, FDA, EMA, and other regional standards. Documentation such as Drug Master Files (DMFs) and Certificates of Analysis (CoA) are essential for regulatory submissions.

• Quality and Purity: High-purity (usually >99%) API is critical. Analytical data including HPLC, NMR, and residual solvent analysis confirm API quality.

• Manufacturing Capacity: Lead times depend on production volumes. Suppliers with scalable facilities are preferable to meet fluctuating demand.

• Cost and Pricing: While price remains a crucial factor, it must be balanced against quality, reliability, and regulatory compliance.

• Supply Chain Security: Diversification of sources mitigates risks related to geopolitical issues, natural disasters, or manufacturing disruptions.

Trends and Future Outlook

The API sourcing landscape for dolasetron mesylate is evolving, driven by regulatory pressures, manufacturing innovations, and globalization. Notably:

• Enhanced Quality Standards: Increasingly stringent quality requirements are prompting suppliers to adopt continuous manufacturing and process analytical technology (PAT) for better control.

• Shift Towards Asia: Asian manufacturers, especially Chinese and Indian companies, continue to expand capacity and improve quality to meet international standards, often offering more competitive pricing.

• Supply Chain Resilience: Pharmaceutical companies are increasingly seeking dual sourcing and strategic alliances to safeguard against supply disruptions, especially critical for chemotherapy agents like dolasetron mesylate.

• Regulatory Harmonization: Efforts by global organizations aim to streamline registration and quality assurance processes, reducing compliance barriers for international suppliers.

Conclusion

Secure and compliant sourcing of dolasetron mesylate API is vital for manufacturers and research institutions aiming to deliver safe, effective, and high-quality antiemetic therapies. Leading suppliers in North America, Europe, and Asia provide diverse options catering to different needs regarding capacity, quality, and regulatory adherence. Navigating this landscape requires careful evaluation of supplier reliability, quality assurance, regulatory compliance, and supply chain resilience.

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Key Takeaways

• The global API market for dolasetron mesylate is dominated by North American, European, and Asian manufacturers, each offering distinct advantages in quality and capacity.
• Regulatory compliance, high purity, and supply chain security are critical criteria for selecting API suppliers.
• Asian manufacturers are expanding their share, driven by cost competitiveness and increased focus on quality.
• Future trends point towards enhanced manufacturing technologies, globalization, and efforts toward supply chain robustness.
• Strategic sourcing, including diversification and supplier audits, reduces risk and ensures consistent supply of high-quality dolasetron mesylate API.

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FAQs

1. What are the primary factors to consider when sourcing dolasetron mesylate API?
Key factors include regulatory compliance (cGMP adherence), API purity (>99%), manufacturing capacity, cost-effectiveness, and supply chain reliability.

2. Are there regional differences in API quality standards for dolasetron mesylate?
While regional standards vary, global suppliers often comply with internationally recognized certifications such as FDA, EMA, and ICH Q7 guidelines. Rigorous quality control assures consistency across regions.

3. How do Asian manufacturers compare with Western suppliers in API quality and reliability?
Many Asian manufacturers have made significant quality improvements, matching Western standards. They offer competitive pricing with certified facilities, though due diligence and supplier audits are recommended.

4. Can I obtain GMP-certified dolasetron mesylate API from multiple sources?
Yes, but verifying documentation such as DMFs, CoA, and regulatory approvals is essential. Diversification reduces supply risks.

5. What are emerging trends influencing API sourcing strategies for dolasetron mesylate?
Trends include increased adoption of continuous manufacturing, greater emphasis on supply chain resilience, regional capacity expansions, and efforts toward regulatory harmonization.