Bulk Pharmaceutical API Sources for STALEVO 200

Bulk Pharmaceutical API Sources for STALEVO 200

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-5H00538
RR Scientific		R6267804

Bulk Active Pharmaceutical Ingredient (API) Sources for: STALEVO 200

Last updated: July 28, 2025

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Introduction

STALEVO 200, a high-dose formulation of the combination drug containing levodopa, carbidopa, and entacapone, is primarily indicated for managing Parkinson’s disease. As a pharmaceutical product comprising multiple active ingredients, sourcing the bulk APIs — levodopa, carbidopa, and entacapone — is crucial for manufacturing efficacy, quality, and supply chain stability. This report examines the global landscape of API suppliers for STALEVO 200, analyzing market dynamics, leading API manufacturers, regulatory considerations, and competitive strategies.

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API Composition and Manufacturing Significance

STALEVO 200 combines three APIs:

• Levodopa: The primary dopamine precursor, essential for symptomatic relief in Parkinson’s.
• Carbidopa: A peripheral decarboxylase inhibitor that enhances levodopa bioavailability.
• Entacapone: A COMT inhibitor that prolongs the half-life of levodopa.

Manufacturers require reliable, high-quality API sources to produce STALEVO 200 at regulatory approvals and market demand levels. Sourcing APIs from reputable suppliers ensures compliance with Good Manufacturing Practice (GMP), reduces quality-related risks, and aligns with international standards like WHO, FDA, EMA, and PMDA.

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Global API Suppliers for Levodopa

Market Landscape:
Levodopa remains a mature API with a well-established supply chain dominated by a few key players. Asia, particularly India and China, account for over 80% of global production, leveraging cost advantages and large-scale manufacturing capabilities.

Leading Suppliers:

• Sun Pharmaceutical Industries Ltd. (India): Among the largest producers, exporting globally with facilities GMP-certified for Parkinson’s APIs.
• Harrison Organics (India): Specialized in supply and export of APIs including levodopa, holding multiple certifications.
• Jiangsu Hengrui Medicine Co., Ltd. (China): Offers high-quality APIs, compliant with international standards.
• Hikma Pharmaceuticals (UK, with manufacturing in India): Supplies levodopa APIs with focus on quality and regulatory compliance.

Supply Considerations:

• Quality Assurance: Suppliers with GMP certification and documented quality controls are preferred.
• Regulatory Acceptance: Suppliers with proven compliance histories and support documentation ease approval processes globally.

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API Suppliers for Carbidopa

Market Landscape:
Carbidopa production is less widespread than levodopa but is mainly concentrated in India and China. The APIs are similar in sourcing dynamics but entail stringent quality controls, given their peripheral inhibitory role.

Key Suppliers:

• Sun Pharmaceutical Industries Ltd.: Major provider, with significant API output, including carbidopa prepared for global markets.
• Lannett Company (USA): Limited but notable supplier with GMP-certified manufacturing capabilities.
• Targeted Chinese manufacturers: Numerous small to medium-scale producers serve both generic and branded API markets, ensuring supply flexibility.

Supply Considerations:

• Regulatory Verification: Ensuring suppliers meet ICH Q7 guidelines for APIs.
• Documentation & Traceability: Essential for global regulatory submissions and audits.

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API Suppliers for Entacapone

Market Landscape:
Entacapone's synthesis involves complex chemical processes, making high-quality, reliable suppliers vital. The market is smaller but characterized by specialized manufacturers, predominantly based in China and India.

Leading Suppliers:

• Mitsubishi Chemical Corporation (Japan): Known for high-purity entacapone APIs, with extensive regulatory support.
• Hikma Pharmaceuticals: Also supplies entacapone APIs, focusing on the generic Parkinson’s drug market.
• Chinese manufacturers (e.g., Zhejiang Huahai Pharmaceutical): Offer competitively priced APIs with growing regulatory certifications.

Supply Considerations:

• Purity Standards: High API purity (>99%) is necessary to meet oral bioavailability and safety profiles.
• Regulatory Approvals: Suppliers with established dossiers simplify registration processes globally.

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Supply Chain Dynamics and Challenges

Cost and Availability:
Asian API manufacturers generally provide cost-effective, large-scale production. However, supply disruptions—due to regulatory changes, geopolitical tensions, or manufacturing issues—pose risks.

Regulatory Compliance:
Global markets demand GMP certification, stability data, and comprehensive documentation. Regular audits and supplier qualification steps are critical for reliable API procurement.

Technology Transfer and Synthesis Complexity:
Synthesis of entacapone necessitates specialized chemical processes, favoring established suppliers with validated manufacturing routes.

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Regulatory Considerations

APIs for STALEVO 200 must adhere to stringent standards to ensure safety and efficacy. The US FDA, EMA, and other agencies require comprehensive dossiers demonstrating manufacturing quality, process validation, and stability data. Suppliers with approved Drug Master Files (DMFs) streamline registration and batch approval processes.

The availability of APIs with recognized filing support expedites market access and mitigates compliance risks.

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Competitive Strategies in API Sourcing

Vertical Integration:
Pharmaceutical companies increasingly seek to internalize API production or develop exclusive sourcing agreements to secure supply and reduce costs.

Supplier Qualification & Audits:
Rigorous qualification procedures, including on-site audits and quality audits, are vital. Long-term contracts and strategic partnerships foster supply stability.

Diversification:
Relying on multiple suppliers mitigates geopolitical and supply chain risks. Many firms diversify sources for levodopa, carbidopa, and entacapone to prevent production halts.

Innovations & Alternative Sources:
Emerging synthesis methods or biosynthetic approaches may offer future alternative sources, particularly for complex APIs like entacapone.

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Conclusion

The bulk API landscape for STALEVO 200 is primarily centered around well-established suppliers in India, China, and Japan. Ensuring quality, regulatory compliance, and supply chain stability remains paramount for manufacturers. Strategic supplier qualification, diversified sourcing, and adherence to international standards underpin successful API procurement, enabling consistent production of STALEVO 200 to meet global Parkinson’s therapy demands.

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Key Takeaways

• Primary API sources are concentrated in India and China, offering cost-effective manufacturing options with a focus on quality and GMP compliance.
• Levodopa, carbidopa, and entacapone suppliers with established regulatory support and validated manufacturing routes simplify drug registration processes.
• Supply chain resilience hinges on multiple suppliers, rigorous qualification procedures, and strategic partnerships.
• Regulatory adherence remains critical; API suppliers with approved DMFs and high purity standards reduce compliance risks.
• Future trends include exploring biosynthetic routes and pharmaceutical innovations to diversify API sources further.

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Frequently Asked Questions

1. Which countries dominate the bulk API supply for STALEVO 200?
India and China are the primary producers of levodopa, carbidopa, and entacapone APIs, leveraging large-scale manufacturing capabilities and cost advantages.

2. What are the key quality considerations when sourcing APIs for STALEVO 200?
APIs must meet GMP standards, demonstrate high purity (>99%), have detailed regulatory documentation, and be supported by validated manufacturing processes.

3. How does regulatory compliance influence API sourcing strategies?
Suppliers with approved DMFs and certifications facilitate faster registration, reduce approval risks, and ensure global compliance.

4. Can alternative sources replace traditional APIs for Parkinson’s treatment?
Emerging biosynthetic technologies and synthesis methods may offer alternative sources in the future, but current reliance remains on validated chemical synthesis from established suppliers.

5. What risks are associated with API supply chains for STALEVO 200?
Potential risks include supply disruptions, quality issues, regulatory hurdles, and geopolitical factors impacting manufacturing or export capabilities.

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References

[1] Global Pharmaceutical API Market Analysis, MarketWatch, 2022.

[2] WHO GMP Guidelines for APIs, 2020.

[3] FDA Guidelines on API Registration, 2021.

[4] Parkinson’s Disease Treatment Market, IQVIA Reports, 2022.

[5] API Synthesis and Process Development in Pharmaceutical Industry, Journal of Pharmaceutical Sciences, 2021.