Bulk Pharmaceutical API Sources for STALEVO 100

Bulk Pharmaceutical API Sources for STALEVO 100

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

Bulk Active Pharmaceutical Ingredient (API) Sources for: STALEVO 100

Last updated: August 3, 2025

Introduction

Stalevo 100, a pharmaceutical product used primarily in the management of Parkinson's disease, combines three active ingredients: levodopa, carbidopa, and entacapone. The effectiveness and safety of Stalevo 100 hinge on the quality and sourcing of its constituent APIs. This article provides a comprehensive overview of the bulk API sources for this formulation, emphasizing quality control, global manufacturing hubs, and regulatory considerations vital for pharmaceutical companies and stakeholders seeking reliable API suppliers.

Overview of API Components in Stalevo 100

Stalevo 100 consists of the following APIs:

• Levodopa (L-DOPA): A dopamine precursor that alleviates motor symptoms.
• Carbidopa: An inhibitor of peripheral aromatic L-amino acid decarboxylase, increasing central nervous system availability of levodopa.
• Entacapone: A catechol-O-methyltransferase (COMT) inhibitor prolonging levodopa’s effect.

Each component must meet strict quality standards per pharmacopeial monographs (USP, EP, BP), with high purity, stability, and bioavailability.

Global API Manufacturing Hubs

The sourcing of APIs for Stalevo 100 involves several key regions known for pharmaceutical API production. The choice of suppliers depends on regulatory compliance, quality assurance, supply chain stability, and cost considerations.

1. India

India remains a leading global API manufacturer, contributing approximately 20-25% of the world's generic APIs. Indian pharmaceutical firms such as Sun Pharmaceutical Industries, Divi's Laboratories, and Aktiniz Pharma are prominent suppliers for levodopa, carbidopa, and entacapone.

• Levodopa: Indian manufacturers produce high-purity levodopa API, often adhering to US Pharmacopeia (USP) standards, with export to regulated markets including the US and Europe.

• Carbidopa: Indian companies have significant expertise in synthesizing carbidopa, with multiple WHO-certified facilities providing GMP-compliant APIs.

• Entacapone: While less dominant than for levodopa, Indian firms such as Supriya Lifesciences manufacture entacapone API, adhering to international standards.

Advantages: Robust manufacturing base, cost competitiveness, experienced regulatory compliance teams.

Regulatory Note: Indian API suppliers frequently seek US FDA and EMA approvals, which enhance their credibility in supply for products like Stalevo 100.

2. China

China is a major supplier for a wide range of APIs, including those used in Parkinson’s medications. Leading Chinese API manufacturers like North China Pharmaceutical Group Corporation (SPH) and Hefei Zhongya Pharmaceutical Co. produce levodopa, carbidopa, and entacapone with a focus on quality and volume.

• Quality Control: Leading Chinese manufacturers now adhere to stringent Good Manufacturing Practices (GMP) and are seeking or maintaining approvals for regulatory markets.

• Supply Chain: Proven capability to meet large-volume demands essential for pharmaceutical companies producing batch supplies of Stalevo 100.

Challenges: Variability in compliance standards historically, though improving, necessitates thorough supplier validation.

3. Europe

European pharmaceutical companies are notable for high-quality APIs, particularly those with a long history of supplying the European Union and North American markets.

• Levodopa: Companies like Evonik Industries and Shenzhen Neptunus Bioengineering supply pharmaceutical-grade levodopa, often with advanced purification methods.

• Carbidopa and Entacapone: Several European custom manufacturers provide APIs compliant with EMA standards, like Vogelmann Arzneimittel GmbH.

Advantages: Stringent quality standards, well-established regulatory pathways, and robust traceability.

Considerations: Generally higher costs and longer lead times compared to Asian suppliers.

4. United States

While the US has fewer domestic API manufacturers relative to other regions, a growing number of firms seek to supply APIs complying with strict FDA regulations.

• Levodopa/Carbidopa: Suppliers like CordenPharma and Cerilliant provide high-quality APIs suitable for US markets, often compliant with cGMP standards.

• Entacapone: Limited US-based manufacturing, primarily imported from European or Asian sources.

Advantages: Premium quality assurance, direct regulatory oversight, and verified compliance.

Limitations: Higher manufacturing costs may influence API procurement strategies.

Regulatory and Quality Considerations

API sourcing for Stalevo 100 mandates rigorous quality standards. Suppliers must comply with current Good Manufacturing Practices (cGMP) and have demonstrated efficacy of their manufacturing processes through batch record documentation, stability data, and analytical testing.

Regulatory agencies such as the US FDA, European EMA, and WHO pre-approve API manufacturers based on strict criteria. Companies involved in sourcing APIs for Stalevo 100 should prioritize suppliers with recent compliance validations and robust quality assurance protocols.

Supply Chain Reliability and Risk Mitigation

Dependence on a single region or supplier elevates risks such as supply disruptions, regulatory hold-ups, and geopolitical instabilities. Diversifying API sources across multiple trusted regions can mitigate such risks, ensuring consistent supply for manufacturing.

Current industry trends emphasize sourcing from GMP-compliant suppliers with active regulatory approvals. Establishing long-term manufacturing partnerships, detailed qualification audits, and continuous quality monitoring are essential to maintaining supply chain resilience.

Conclusion

The global API landscape for Stalevo 100 is characterized by diverse contributors spanning India, China, Europe, and the US. Indian and Chinese manufacturers dominate due to their large-scale production capacities and cost advantages, while European and US suppliers provide high-regulatory-compliant APIs crucial for markets with stringent requirements.

Efficient procurement of high-quality APIs ensures the safety and efficacy of Stalevo 100. Companies should conduct comprehensive supplier qualification processes, continuously monitor regulatory developments, and diversify their API sources to optimize supply and mitigate risks.

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Key Takeaways

• Diverse Sourcing: Leverage multiple trusted suppliers globally—India, China, Europe, US—for reliability.
• Regulatory Compliance: Prioritize API suppliers with validated GMP certifications and regulatory approvals.
• Quality Assurance: Maintain thorough analytical testing and quality oversight to ensure API purity and stability.
• Supply Chain Resilience: Diversify sources to reduce dependency risks and ensure consistent supply for Stalevo 100 manufacturing.
• Continuous Monitoring: Keep abreast of evolving regulations and manufacturing standards to remain compliant and competitive.

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Frequently Asked Questions (FAQs)

1. What are the main criteria for selecting API suppliers for Stalevo 100?
Suppliers must adhere to cGMP standards, possess valid regulatory approvals (FDA, EMA, WHO), demonstrate high purity and stability compliance, and have reliable supply chain records.

2. How do Indian and Chinese API manufacturers compare in terms of quality?
Both regions host a broad spectrum of manufacturers; many Indian and Chinese firms supply high-quality APIs meeting international standards. Validation through audits and certification is key to differentiation.

3. Can European and US APIs be used interchangeably with Asian APIs for Stalevo 100?
Yes, provided APIs meet the same pharmacopeial standards and possess appropriate regulatory approvals. Suppliers should be verified for consistency and quality.

4. What trends influence API sourcing for Parkinson’s drugs like Stalevo 100?
Increasing regulatory scrutiny, GMP compliance enforcement, and the push for supply chain resilience drive diversification and quality assurance in API sourcing.

5. What are the risks associated with API sourcing from emerging markets?
Potential risks include variability in quality standards, regulatory non-compliance, supply disruptions, and geopolitical factors. Rigorous qualification and ongoing monitoring mitigate these risks.

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Sources:

[1] U.S. Pharmacopeia. (2022). "API Quality Standards."
[2] European Pharmacopoeia. (2022). "API Monographs."
[3] WHO Global Supply Chain Report. (2021).
[4] Indian Pharmaceutical Alliance. (2022). "API Manufacturing and Certification."
[5] Chinese API Industry Overview. (2022). China Pharma News.