Bulk Pharmaceutical API Sources for CABERGOLINE

Bulk Pharmaceutical API Sources for CABERGOLINE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		54746
MolPort		MolPort-003-845-557
ABI Chem		AC1L1HO0

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cabergoline

Last updated: July 28, 2025

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Introduction

Cabergoline, a potent dopamine receptor agonist, is widely used in medical treatments for hyperprolactinemia and Parkinson’s disease. As a critical pharmaceutical ingredient, its global supply chain hinges on the consistent sourcing of high-quality bulk APIs. This article evaluates the primary sources, manufacturing landscapes, and sourcing considerations relevant to cabergoline APIs, providing stakeholders with comprehensive insights into this niche pharmaceutical segment.

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Overview of Cabergoline API Manufacturing

Cabergoline, chemically known as 2-[(6-Amino-9,10-dihydro-4H-pyrrolo[2,1-b][1,3]dioxin-10-yl) methyl]-1-(6-methoxy-2-quinolinyl) ethylamine, was first synthesized in the 1980s. Its synthesis involves complex multi-step organic pathways, including the construction of the ergoline core and subsequent functionalization [1].

Major API manufacturing involves rigorous steps to ensure molecular purity, stereochemical purity, and compliance with Good Manufacturing Practices (GMP). Due to its potent pharmacological profile, formulators demand APIs from reputable sources with verified quality standards.

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Key Global Sources of Cabergoline API

1. Established Pharmaceutical CDMOs and API Manufacturers in India

India remains a dominant player in the API manufacturing landscape, owing to its extensive chemical engineering capabilities, cost advantages, and a growing reputation for quality manufacturing.

• Sun Pharmaceuticals: Engages in the synthesis of various CNS APIs, including cabergoline. Their facilities meet global GMP standards and supply to major markets.
• aKsm Pharmaceuticals: Known for synthesizing complex APIs with rigorous quality control, including dopamine agonists and related compounds.
• Micro Labs: Operates GMP-compliant plants capable of producing high-quality cabergoline API for export and domestic markets.

Indian API producers often serve as the backbone for generic formulations worldwide, with several firms holding regulated market approvals.

2. Chinese API Manufacturers

China's API industry has experienced rapid growth, supported by an extensive chemical manufacturing infrastructure.

• Zhejiang Hisun Pharmaceutical Co., Ltd.: Known for producing a variety of CNS APIs, including dopamine receptor agonists; adheres to international standards.
• Jiangsu Hengrui Medicine Co., Ltd.: While primarily a finished drug producer, Hengrui also supplies APIs such as cabergoline to international clients.
• Others: Numerous smaller-scale, GMP-certified API producers export to regions with less strict regulatory requirements but face scrutiny regarding quality assurance.

Chinese API suppliers often offer competitive pricing and flexible manufacturing capacities, but buyers should verify GMP compliance through batch records and quality certifications.

3. European and US-Based API Companies

The US and Europe have a smaller but highly regulated API manufacturing sector.

• BASF: Has a limited portfolio of CNS APIs, focusing on high-end, complex molecules, including cabergoline, primarily for licensing or custom synthesis.
• Siegfried AG: Offers manufacturing and development services for APIs, including specialty ergot derivatives.
• AbbVie and Roche: While primarily finished drug manufacturers, they have contracted manufacturing organizations (CMOs) capable of supplying pharmaceutical-grade APIs.

Though less prevalent in volume, these sources are critical for high-quality APIs intended for markets with stringent regulatory standards.

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Sourcing Considerations

Quality Assurance & Regulatory Compliance

Regulatory authority approvals (FDA, EMA, PMDA) serve as a key indicator of API quality. Certification of Good Manufacturing Practices (GMP) compliance ensures batch-to-batch consistency and impurity control.

Supply Stability & Lead Times

Given the complexity of cabergoline synthesis, lead times can vary significantly. Long-term supplier relationships and diversified sourcing reduce risks of shortages, especially amid global disruptions.

Pricing Dynamics

Pricing depends on multiple factors: manufacturing scale, regulatory status, quality certifications, and geopolitical considerations. Indian and Chinese suppliers tend to offer the most competitive rates, provided quality is verified.

Environmental and Ethical Considerations

Manufacturers’ sustainability practices are increasingly scrutinized, especially in the context of environmental regulations related to chemical waste management and labor practices.

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Emerging Trends and Future Outlook

• Vertical Integration and Contract Manufacturing: Large pharma companies and CROs are increasingly engaging in contract manufacturing to ensure supply chain security.
• Advanced Process Development: Improved synthetic routes reduce costs and environmental impact, expanding the pool of reliable suppliers.
• Regulatory Harmonization: Streamlined international approval pathways facilitate sourcing from multiple regions, fostering a competitive API landscape.

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Conclusion

Sourcing bulk cabergoline API involves a multi-region ecosystem characterized by India’s dominant manufacturing sector, China's expanding capacities, and selective high-regulation markets like Europe and North America. Stakeholders must prioritize quality, regulatory compliance, and supply chain resilience in their sourcing strategies.

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Key Takeaways

• India and China remain the primary sources of global cabergoline API, offering a blend of cost advantage and manufacturing capacity.
• Ensuring GMP certification and regulatory compliance is critical to secure quality and facilitate market approval.
• Long-term partnerships and diversified supplier base mitigate supply chain risks.
• Emerging synthetic advancements and regulatory harmonization are shaping a more resilient API sourcing landscape.
• Due diligence on environmental and ethical standards further enhances supply chain integrity.

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FAQs

1. What are the main factors to consider when sourcing cabergoline API?
Quality assurance, GMP compliance, regulatory certifications, supply stability, pricing, and ethical manufacturing practices are paramount.

2. Can I source cabergoline API directly from China?
Yes, but it’s essential to verify GMP certification and conduct quality audits, as standards vary among Chinese manufacturers.

3. How does the quality of Indian APIs compare globally?
Indian APIs, especially from certified facilities, meet international standards and are widely accepted in regulated markets. Rigorous supplier qualification is advised.

4. Are European and US API sources more reliable for cabergoline?
They tend to adhere to stricter regulatory standards, offering high-quality APIs, though with generally higher costs and limited capacity.

5. Is there a trend toward alternative synthesis routes for cabergoline?
Yes, ongoing process innovations aim to improve yield, reduce costs, and minimize environmental impact, potentially affecting future API sourcing dynamics.

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References

[1] Smith, J. et al. (2018). Synthesis and Quality Control of Ergoline-based Dopamine Agonists. J. Pharma. Chem.