STALEVO 125 bulk active fine chemical sources

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Last updated: August 3, 2025

Introduction

STALEVO 125 is a pharmaceutical formulation primarily prescribed for Parkinson’s disease management. It combines three active ingredients: levodopa, carbidopa, and entacapone, which collectively enhance dopaminergic activity and inhibit peripheral metabolism of levodopa, thereby improving therapeutic efficacy. Ensuring a reliable supply of high-quality APIs—levodopa, carbidopa, and entacapone—is critical for manufacturing STALEVO 125. This article explores the global sources of these APIs, emphasizing supplier credibility, regulatory compliance, and supply chain stability vital to pharmaceutical companies.

Overview of API Components in STALEVO 125

Levodopa

Levodopa (L-DOPA) is the primary precursor to dopamine, pivotal in Parkinson’s therapy. It is produced via synthesis routes primarily involving chemical processes starting from phenylalanine or tyrosine derivatives. The API demands high purity standards, typically exceeding 98%, with residual monomers and impurities tightly controlled.

Carbidopa

Carbidopa inhibits peripheral aromatic L-amino acid decarboxylase, augmenting levodopa’s central availability. Its synthesis involves complex chemical reactions, and its selectivity and purity are crucial for therapeutic safety.

Entacapone

Entacapone acts as a COMT inhibitor, prolonging levodopa’s effect. It requires advanced organic synthesis techniques and stringent impurity profile controls due to its complex chemical structure.

Global API Manufacturing Hubs

India

India remains the dominant global supplier for pharmaceutical APIs, including levodopa, carbidopa, and entacapone. The country boasts numerous WHO-GMP-approved facilities, with companies like Sun Pharmaceutical Industries, Lupin Limited, Dr. Reddy’s Laboratories, and Natco Pharma leading manufacturing capacity. Indian API manufacturers benefit from robust export infrastructure, cost competitiveness, and a growing reputation for quality compliance.

Key Indian API Suppliers:

Sun Pharmaceutical Industries: One of the largest API producers globally, with extensive experience in complex syntheses, including dopaminergic agents.
Lupin Limited: Known for high-quality APIs, including levodopa and specialty products.
Dr. Reddy’s Laboratories: Offers a broad range of APIs, with approved facilities meeting international standards.

China

China maintains a significant share in the API supply chain, primarily for raw materials and intermediates. Chinese manufacturing bases leverage large-scale operations and competitive pricing. Several API producers in China possess certified facilities for levodopa, carbidopa, and entacapone, though regulatory considerations (e.g., GMP certification, PQP compliance) are paramount.

Notable Chinese API Suppliers:

North China Pharmaceutical Group Corporation (NCPC): Supplies high-quality levodopa intermediates.
Hubei Sanonda: Produces various dopaminergic APIs with GMP certiﬁcation.
Zhejiang Taizhou Huangyan Jerrtop Pharmaceutical: Focused on intermediates and finished APIs.

Europe and North America

While smaller in volume, European and North American API producers cater to premium markets with stringent quality demands. Facilities operated by firms such as Novartis (Switzerland), Pfizer (USA), and Teva (Israel) in the past have supplied APIs, especially for complex or niche applications. However, the majority of production is now outsourced to Indian and Chinese contract manufacturing organizations (CMOs).

Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs)

Outsourcing to CMOs/CDMOs provides flexible, scalable APIs sourcing options with established quality assurance systems. Leading CMOs with proven API production include:

Dr. Reddy’s Laboratories (India): Offers comprehensive API manufacturing, including dopaminergic agents.
Hetero Labs (India): Known for high-volume production of APIs, including levodopa and carbidopa.
Alphapharm (China) and Boehringer Ingelheim (Germany): Provide customized API synthesis services.

These organizations often hold regulatory approvals from major agencies like the US FDA, EMA, and PMDA, ensuring compliance and traceability.

Regulatory Considerations and Quality Standards

Ensuring the APIs meet pharmacopeial standards—USP, EP, or BP—is critical. Suppliers must demonstrate compliance with current Good Manufacturing Practice (cGMP) standards, have appropriate regulatory approvals, and conduct rigorous analytical validation.

Key factors include:

GMP Compliance: Verified by inspections from regulatory authorities such as FDA, EMA, or local agencies.
Certificate of Suitability (CEP): From EDQM for European markets.
DMF (Drug Master File) Submissions: Facilitating regulatory approval processes.
Impurity Profiles and Residual Solvents: Strict adherence to quality limits to minimize adverse effects.

Supply Chain Challenges and Risk Mitigation

Global supply chains face disruptions from geopolitical issues, regulatory shifts, and pandemic-related bottlenecks. Dependence on single-source suppliers or regions increases vulnerability.

Strategies include:

Diversification: Sourcing APIs from multiple qualified suppliers across different geographies.
Strategic Inventory Management: Maintaining safety stocks to buffer supply interruptions.
Supplier Qualification Audits: Ensuring continuous compliance and capacity assurance.

Regular engagement with suppliers and reviews of their regulatory standing are essential for uninterrupted API supplies.

Emerging Trends and Future Outlook

Technological innovations in API synthesis, such as green chemistry techniques, continuous manufacturing, and bioengineered pathways, promise to enhance quality and reduce costs. Companies increasingly seek suppliers capable of scaling up innovative processes, particularly in the context of personalized medicine and complex formulations like STALEVO 125.

The geopolitical landscape is likely to influence sourcing policies, favoring established, compliant, and diversified supply chains.

Conclusion

Sourcing high-quality APIs for STALEVO 125 involves navigating a complex landscape of global suppliers, regulatory frameworks, and supply chain considerations. Indian and Chinese manufacturers dominate the bulk API production space, backed by extensive GMP-certified facilities and cost advantages, with European and North American players focusing on niche or high-value components. Establishing multi-sourcing strategies, rigorous supplier qualification, and strict adherence to quality standards are vital for pharmaceutical companies seeking reliable API supplies for safe and efficacious Parkinson’s therapies.

Key Takeaways

Indian manufacturers are primary sources for levodopa, carbidopa, and entacapone, offering cost-effective and regulated supplies.
Chinese suppliers provide intermediates and bulk APIs; due diligence on GMP certification is essential.
European and North American APIs are available but mainly target premium markets, with fewer large-scale producers.
Maintaining regulatory compliance, including GMP certification and appropriate filings, is critical in API sourcing.
Diversification, strategic inventory, and ongoing supplier audits mitigate supply chain risks, ensuring continuous production of STALEVO 125.

FAQs

1. What are the primary global regions supplying APIs for STALEVO 125?
India and China dominate API production, with Europe and North America providing specialized or high-purity APIs.

2. How can pharmaceutical companies ensure the quality of sourced APIs?
Through supplier qualification, verifying GMP certification, reviewing Certificates of Suitability, and conducting incoming quality inspections.

3. Are there regulatory challenges associated with sourcing APIs from China and India?
Yes, regulatory agencies require compliance verification, documentation, and audits, due to historical concerns about manufacturing practices, although standards are improving.

4. What measures can companies take to mitigate API supply risks?
Implement diversified sourcing, maintain safety stock levels, and establish long-term relationships with multiple qualified suppliers.

5. How are emerging trends impacting API sourcing for Parkinson's drugs like STALEVO 125?
Advancements in green synthesis and continuous manufacturing may shift procurement strategies toward more innovative, efficient, and sustainable API production methods.

Sources:

U.S. Pharmacopeia (USP). API Quality Requirements.
European Directorate for the Quality of Medicines & HealthCare (EDQM). Certificate of Suitability (CEP).
Indian Drug Manufacturers Association (IDMA). API manufacturing landscape.
Chinese Pharmacopoeia, API supply reports.
Market research reports on global API industry trends.

Bulk Pharmaceutical API Sources for STALEVO 125