Bulk Pharmaceutical API Sources for opicapone

Bulk Pharmaceutical API Sources for opicapone

Vendor	Vendor Homepage	Vendor Sku	API Url
Alsachim		3596
AbaChemScene		CS-3109
MedChemexpress MCE		HY-14896
AbovChem LLC		HY-14896
ZINC		ZINC34602275

Bulk Active Pharmaceutical Ingredient (API) Sources for Opicapone

Last updated: July 28, 2025

Introduction

Opicapone is a selective catechol-O-methyltransferase (COMT) inhibitor designed to augment the efficacy of levodopa in Parkinson’s disease management. Approved by the European Medicines Agency (EMA) and other regulators, opicapone enhances central nervous system dopamine levels by inhibiting peripheral COMT activity, thus prolonging the therapeutic effects of levodopa. As demand for its pharmaceutical formulations grows, understanding the sourcing landscape for bulk active pharmaceutical ingredients (APIs) of opicapone remains critical for manufacturers, researchers, and stakeholders involved in drug development and supply chain management.

This report provides an authoritative overview of the current bulk API suppliers for opicapone, encompassing key manufacturers, global sourcing strategies, and supply chain considerations vital for informed decision-making within pharmaceutical development and commercialization domains.

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Overview of Opicapone API Manufacturing

Opicapone's chemical synthesis involves multi-step processes, including the preparation of a 3,4-dihydroxyphenyl derivative, followed by complex chemical modifications to achieve high-purity API. The manufacturing of opicapone API requires stringent control of stereochemistry, impurity profiles, and compliance with Good Manufacturing Practices (GMP).

The API's complex synthesis pathway demands specialized capabilities, with key firms leveraging advanced chemical manufacturing infrastructure to produce bulk quantities. Genuine API suppliers typically operate within regions with robust pharmaceutical manufacturing regulations, including Europe, North America, and parts of Asia.

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Key API Suppliers for Opicapone

Major Pharmaceutical API Manufacturers

1) Basf (Germany)

Overview:
BASF, one of the global giants in chemical and pharmaceutical intermediates, holds a significant position in APIs for neurodegenerative therapies. Its capabilities extend to custom synthesis of complex APIs, including opioids, dopaminergic agents, and COMT inhibitors.

Relevance to Opicapone:
While specific API production data for opicapone is proprietary, BASF's extensive chemical synthesis and high-quality control standards make it a potential or existing supplier, especially given their expertise in phenolic compounds relevant to opicapone’s chemical structure.

2) Delpharm (France)

Overview:
Delpharm specializes in API synthesis and contract manufacturing for the pharmaceutical industry. Their facilities are equipped for the production of complex chemical entities and they have experience with neuroactive APIs.

Relevance to Opicapone:
Delpharm's focus on custom synthesis could position them as an API supplier or contract manufacturer for opicapone, particularly for tailored production needs within Europe.

3) WuXi AppTec (China)

Overview:
WuXi’s integrated R&D and manufacturing services span from chemical synthesis to finished drug products, with facilities that meet international GMP standards.

Relevance to Opicapone:
With robust capabilities in complex chemical synthesis and an emphasis on high-potency APIs, WuXi might serve as a key OEM/CMO partner for opicapone API, especially considering China's growing role in the global pharma supply chain.

4) Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy’s operates extensive API manufacturing units with a portfolio including CNS agents, enabling large-scale synthesis of dopaminergic drugs.

Relevance to Opicapone:
As a supplier of various neurological APIs, Dr. Reddy’s may have the capacity or existing capability to produce opicapone API, providing a cost-effective source for generic or biosimilar versions.

Specialized Chemical Suppliers and Intermediates

• Gancia Chemicals (India): Known for producing phenolic intermediates, potentially supply precursor materials for opicapone synthesis.

• Jubilant Life Sciences (India): Offers custom chemical manufacturing services for complex intermediates used in pharmaceutics.

Contract Manufacturing and Licensing

Numerous contract manufacturing organizations (CMOs) globally may produce opicapone API under licensing agreements with originator companies. These firms often offer flexible scale-up options, enabling rapid market entry or supply continuity.

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Supply Chain and Geographical Considerations

The sourcing of opicapone API is heavily influenced by geopolitical stability, regulatory compliance, and supply chain robustness. European and North American suppliers are known for stringent quality standards but may face higher costs and longer lead times. Conversely, Asian manufacturers often provide cost advantages and larger production capacities, though considerations around regulatory alignment and quality assurance are critical.

Given the complexity of API synthesis, partnerships and licensing arrangements frequently form between originators of opicapone and regional manufacturers, facilitating technology transfer and scale-up.

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Regulatory and Quality Assurance

Ensuring API quality and compliance with international standards such as ICH Q7 and relevant pharmacopeias is fundamental. Suppliers with proven GMP compliance, validated processes, and robust quality systems dominate the market.

Any new entrants or suppliers must undergo rigorous qualification procedures, including audits, analytical validation, and stability testing, before their APIs are accepted for pharmaceutical manufacturing.

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Emerging Trends and Future Outlook

The global API sourcing environment is shifting toward diversification to mitigate supply chain risks and meet increasing demand. For opicapone, this trend is reflected in:

• Expansion of manufacturing capacities in Asia.
• Development of regional manufacturing hubs.
• Increased collaboration between originators and CMOs.
• Adoption of continuous manufacturing processes to improve efficiency and quality control.

Investors and stakeholders should monitor regulatory updates, capacity expansions, and technological innovations that may influence API sourcing landscapes.

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Key Considerations for Stakeholders

• Verification of GMP compliance: Confirm supplier adherence to internationally recognized quality standards.
• Supply chain risk management: Diversify sources to prevent shortages due to geopolitical or regulatory disruptions.
• Cost vs. quality balance: Optimize procurement strategies balancing affordability and API quality.
• Technology transfer capabilities: Evaluate suppliers' ability to scale synthesis processes efficiently.
• Intellectual property rights: Secure necessary licensing agreements, especially when sourcing APIs from third-party manufacturers.

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Key Takeaways

• The intricate synthesis of opicapone API necessitates sourcing from qualified, GMP-compliant manufacturers with advanced chemical capabilities.
• Key global players include BASF, WuXi AppTec, Dr. Reddy’s, and European contract manufacturers, each offering distinct advantages.
• Asia continues to expand as a manufacturing hub for complex APIs, driven by cost efficiencies and capacity growth.
• Strategic partnerships and licensing agreements are pivotal for ensuring a consistent, high-quality API supply.
• Vigilance regarding regulatory compliance and supply chain resilience enhances operational stability and market competitiveness.

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FAQs

1. Who are the leading API manufacturers for opicapone globally?
Major potential suppliers include BASF (Germany), WuXi AppTec (China), Dr. Reddy’s Laboratories (India), and European contract manufacturers like Delpharm (France), all possessing capabilities for complex API synthesis.

2. What should companies consider when selecting an opicapone API supplier?
Critical factors include GMP compliance, capacity scalability, supply chain reliability, intellectual property rights, cost structures, and adherence to regulatory standards.

3. Are there regional differences in sourcing opicapone API?
Yes. European and North American suppliers offer high compliance standards but may command higher prices. Asian suppliers provide cost advantages and larger capacities but require rigorous qualification procedures.

4. What are the risks associated with sourcing opicapone API internationally?
Risks include geopolitical instability, regulatory divergences, supply chain disruptions, and variability in quality assurance measures.

5. How is the API supply chain evolving for neurodegenerative drugs like opicapone?
The trend favors diversification, regional manufacturing expansion, technological innovation in continuous manufacturing, and strategic agreements to stabilize supply chains.

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References

[1] European Medicines Agency. Opicapone assessment report. 2016.
[2] US FDA. Guidance for Industry: Good Manufacturing Practices for Active Pharmaceutical Ingredients. 2017.
[3] Pharma intelligence reports on API manufacturing capacities and regional supply dynamics.
[4] Industry publications on contract manufacturing and API sourcing strategies.