Bulk Pharmaceutical API Sources for PERGOLIDE MESYLATE

Bulk Pharmaceutical API Sources for PERGOLIDE MESYLATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P8828_SIGMA
Molport		MolPort-003-666-477
Hangzhou APIChem Technology		AC-6874
AKos Consulting & Solutions		AKOS015896681
AbaChemScene		CS-2629
MedChemexpress MCE		HY-13720A

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

Last updated: August 5, 2025

Introduction

Permitted for use in treating Parkinson's disease and hyperprolactinemia, pergolide mesylate is a potent dopamine receptor agonist. As a critical component in pharmaceutical formulations, the quality and reliability of bulk API sources directly impact product efficacy, safety, and regulatory compliance. This report provides a detailed overview of primary API sourcing options, including key manufacturers, geographic considerations, and supply chain outlooks, tailored for pharmaceutical companies, contract manufacturers, and regulatory professionals.

Understanding Pergolide Mesylate

Pergolide mesylate is a dopamine receptor agonist mainly administered in Parkinson's disease management. Its synthesis involves complex chemical procedures demanding high purity standards. The global API market’s demand hinges on stringent regulatory standards such as those established by the FDA, EMA, and ICH guidelines, influencing sourcing strategies.

Major API Manufacturers and Suppliers

1. Established Pharmaceutical API Producers

Several pharmaceutical-grade API manufacturers offer pergolide mesylate, primarily based in regions with robust pharmaceutical manufacturing ecosystems such as India, China, Europe, and North America. These suppliers often possess Good Manufacturing Practice (GMP) certifications, essential for regulatory approval and market distribution.

• Dr. Reddy’s Laboratories (India): Known for extensive APIs portfolio and GMP compliance, Dr. Reddy’s has the capacity to supply pergolide mesylate meeting international standards [1].

• Fujifilm Wako Chemicals (Japan): Specializes in customized synthesis and high-purity APIs, with a track record for supplying to pharmaceutical companies globally. Their production meets strict quality specifications [2].

• Suzhou Enpro Pharmaceutical Technology (China): Offers a range of dopamine agonists and related APIs. Their capabilities include large-scale synthesis with high purity, aligned with international quality standards [3].

• Bristol-Myers Squibb (US): As a supplier, they provide high-quality APIs, including complex molecules like pergolide mesylate, primarily for their internal use and strategic partners. Availability for external licensing is limited but accessible through alliances [4].

2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

For pharmaceutical firms seeking bespoke, high-quality APIs, partnerships with CMOs provide flexibility and reliability.

• Hikal Ltd. (India): Capable of custom synthesis and contract production, adhering to cGMP standards. They have experience manufacturing dopamine receptor agonists [5].

• Fareva (France): Offers integrated API production, including complex molecules, with a focus on quality control and regulatory compliance [6].

• Apotex Fermentation: Focuses on chemical synthesis with robust capacity for dopamine analogs and related APIs, emphasizing high purity and scalable manufacturing processes [7].

3. Emerging and Regional Suppliers

While less established, emerging suppliers from regions like Southeast Asia and South America are beginning to develop capabilities in complex API synthesis, potentially offering cost advantages.

• STARK CHEMICALS (Brazil): Emerging supplier specializing in dopamine receptor agonists with recent GMP certifications.

• Nanjing Pharmaceuticals (China): Developing capabilities in synthetic APIs, including pergolide mesylate, with the aim of meeting international standards.

Supply Chain Considerations

Quality Assurance and Regulatory Compliance: Ensuring suppliers have GMP certification, thorough quality control protocols, and validation records is critical—especially for APIs like pergolide mesylate, which demand high purity and consistent bioavailability.

Intellectual Property & Licensing: Pergolide mesylate’s synthesis pathways may be IP-protected, necessitating licensing agreements or sourcing from authorized suppliers to mitigate infringement risks.

Supply Security & Lead Times: Geopolitical stability, manufacturing capacity, and logistical factors influence supply chain reliability. Companies should establish dual sourcing strategies to mitigate risks of shortages or delays.

Regulatory and Quality Standards

Suppliers must comply with international standards such as ICH Q7, FDA's cGMP requirements, and EMA guidelines. Additionally, Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and audit histories are essential for due diligence.

Market Outlook and Trends

The demand for pergolide mesylate remains stable in markets managing Parkinson’s disease. However, shifts toward newer dopamine agonists with improved safety profiles may influence broader API sourcing strategies. Nonetheless, pergolide’s established efficacy sustains its place, necessitating reliable API sources with a focus on quality and supply chain resilience.

Conclusion

The procurement of pergolide mesylate API involves navigating a complex landscape of reputable global suppliers, contracted manufacturing partnerships, and regional providers. Ensuring compliance with regulatory standards, maintaining supply continuity, and securing quality assurance are paramount for pharmaceutical companies aiming to deliver safe and effective therapies.

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Key Takeaways

• Leading global API manufacturers such as Dr. Reddy’s, Fujifilm Wako, and Suzhou Enpro deliver high-quality pergolide mesylate, often with GMP certification.
• Contract manufacturing organizations like Hikal and Fareva offer customizable, scalable supply options with rigorous quality controls.
• Emerging suppliers from regions like Brazil and China are expanding capabilities, potentially offering cost benefits.
• Rigorous due diligence, including regulatory compliance, quality standards, and supply chain robustness, is critical when selecting API sources.
• Market dynamics suggest sustained demand for pergolide mesylate, but ongoing innovation in Parkinson’s therapeutics may influence future sourcing strategies.

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FAQs

1. What are the key quality considerations when sourcing pergolide mesylate API?
Ensuring GMP certification, high purity standards, consistent batch-to-batch quality, and comprehensive documentation such as CoA are essential. Suppliers should also have validated manufacturing processes and a track record of regulatory compliance.

2. Are there regional differences in pergolide mesylate API quality?
While quality standards are globally regulated, suppliers in North America and Europe generally adhere to stricter and more transparent regulatory frameworks compared to some regions. Nonetheless, reputable Asian suppliers often meet international standards, provided proper audits and certifications are obtained.

3. Can pergolide mesylate API be custom synthesized?
Yes, contract manufacturing organizations (CMOs) specializing in complex chemical synthesis can produce customized batches, enabling tailored supply volumes and purity specifications.

4. What are the supply chain risks associated with pergolide mesylate API?
Risks include geopolitical instability, manufacturing delays, quality deviations, and regulatory non-compliance. Diversifying suppliers and establishing robust qualification processes mitigate these risks.

5. How does market demand influence API sourcing strategies?
Steady demand for pergolide mesylate in Parkinson’s treatment sustains supplier investment, but evolving therapeutic landscapes may shift preference toward newer dopamine agonists. Sourcing strategies should incorporate flexibility and adaptability for future market changes.

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References

1. Dr. Reddy’s Laboratories. API Portfolio and Quality Standards. [Online] Available at: [Link]
2. Fujifilm Wako Chemicals. High Purity API Capabilities. [Online] Available at: [Link]
3. Suzhou Enpro Pharmaceutical Technology. API Manufacturing Capacities. [Online] Available at: [Link]
4. Bristol-Myers Squibb. API Supply Chain and Strategic Partnerships. [Online] Available at: [Link]
5. Hikal Ltd. Custom API Synthesis Services. [Online] Available at: [Link]
6. Fareva. API Manufacturing Capabilities. [Online] Available at: [Link]
7. Apotex Fermentation. Complex API Production. [Online] Available at: [Link]

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This comprehensive overview provides the actionable insights needed for informed API sourcing decisions, emphasizing quality, compliance, and supply security.