Bulk Pharmaceutical API Sources for COMTAN

Bulk Pharmaceutical API Sources for COMTAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-847-054
Hangzhou APIChem Technology		AC-393
Amadis Chemical		A806167
BioChemPartner		BCP9000645

Bulk Active Pharmaceutical Ingredient (API) Sources for COMTAN

Last updated: July 29, 2025

Introduction

COMTAN (entacapone) is a selective catechol-O-methyltransferase (COMT) inhibitor used adjunctively with levodopa and carbidopa in the management of Parkinson’s disease. Its efficacy hinges on high-quality active pharmaceutical ingredients (APIs), with purity standards essential for drug safety and regulatory compliance. This report examines global sources for bulk entacapone APIs, analyzing suppliers, manufacturing quality, regulatory status, and market dynamics critical for pharmaceutical companies seeking reliable API procurement.

Market Overview of Entacapone API

The API market for entacapone remains relatively niche but vital within Parkinson’s disease therapeutics. Increasing prevalence of Parkinson’s and the importance of combination therapies sustain demand. The API supply chain is concentrated among a few key manufacturers, primarily from China and India, which dominate the global production landscape due to cost advantages and manufacturing capacity.

Major API Manufacturers and Suppliers

1. Chinese API Manufacturers

China’s API manufacturing sector leads globally, with several companies authorized to produce entacapone API. These suppliers benefit from large-scale production facilities, cost efficiencies, and extensive export networks.

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  As a prominent Chinese pharmaceutical manufacturer, Hisun Pharmaceutical produces APIs including entacapone under stringent quality control conditions aligning with Good Manufacturing Practices (GMP). Their APIs are exported worldwide, emphasizing compliance with European and US standards.

• Shenzhen Salubris Pharmaceuticals Co., Ltd.
  Known for synthesizing bulk APIs for neurological and cardiovascular indications, Salubris offers entacapone APIs with purity levels exceeding 98%, validated via HPLC testing according to ICH guidelines.

• Jiangsu Hengrui Medicine Co., Ltd.
  Hengrui strategically manufactures and supplies entacapone APIs, supporting both domestic and international markets. Hengrui emphasizes scalable production processes and strict quality assurance measures.

2. Indian API Manufacturers

India’s pharma sector comprises several bulk API producers with the capacity to supply entacapone, often with competitive pricing and robust quality standards.

• Sun Pharmaceutical Industries Ltd.
  As one of India’s leading pharma conglomerates, Sun Pharma maintains GMP-certified API manufacturing facilities, supplying high-purity entacapone APIs suitable for global markets.

• Alkem Laboratories
  Alkem offers APIs with verified purity levels, quality controls aligned with USFDA, and EUGMP standards, making their entacapone APIs a popular choice among generic pharmaceutical companies.

• Lupin Limited
  Lupin’s dedicated API division produces entacapone, adhering to international regulatory compliance, including WHO and ISO certifications.

3. European & US API Suppliers

Limited compared to Chinese and Indian sources, a few specialized suppliers in Europe and North America supply APIs with enhanced compliance or for niche applications.

• EuroAPI (France)
  EuroAPI provides high-quality APIs for Parkinson’s disease treatment, including entacapone. Their manufacturing processes comply with European Pharmacopoeia standards.

• Novartis (US/Switzerland)
  Though primarily a finished drug manufacturer, Novartis maintains in-house API production and sometimes supplies APIs for external use, emphasizing high purity and regulatory adherence.

Regulatory and Quality Considerations

Suppliers for entacapone API must meet rigorous regulatory standards such as FDA, EMA, and ICH guidelines. Many Chinese and Indian manufacturers have achieved WHO-GMP, USFDA, or EMA approval, facilitating export to stringent markets. Quality assurance includes identity, potency, residual solvent analysis, heavy metals testing, microbial limits, and stability data.

High purity (>99%) is critical to avoid adverse effects and ensure predictable pharmacokinetics. Batch-to-batch consistency, traceability, comprehensive documentation, and validated manufacturing processes are non-negotiable.

Market Dynamics and Sourcing Strategies

The API sourcing landscape for COMTAN is shaped by cost, quality, regulatory status, and supply chain stability. While Chinese and Indian manufacturers dominate due to cost efficiency, Western suppliers offer advantages in regulatory assurances and often serve niche markets or specialty formulations.

Pharmaceutical firms often adopt a dual-sourcing approach—diversifying suppliers to mitigate risks related to supply disruptions, quality variability, or geopolitical tensions. Strategic partnerships with licensed manufacturers and thorough vendor audits are standard practices.

Emerging Trends and Future Outlook

• Quality Enhancement: Demand for APIs with higher purity and lower residual solvents promotes investments in advanced synthesis and purification technologies.
• Regulatory Stringency: Increasing regulatory scrutiny may favor established suppliers with proven compliance records.
• Supply Chain Diversification: Emerging API producers from Taiwan, South Korea, and Southeast Asia could offer additional sourcing options, driven by technological advancements and regulatory improvements.

Conclusion

The procurement of bulk entacapone API hinges on selecting suppliers that balance cost, quality, regulatory compliance, and supply chain reliability. Chinese and Indian manufacturers dominate the landscape with proven extensive capacity and compliance programs. European suppliers are preferred where regulatory assurance is paramount. Strategic sourcing, thorough vendor validation, and monitoring regulatory developments remain essential to secure a dependable API supply for COMTAN production.

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Key Takeaways

• Major sources for entacapone API are predominantly from Chinese and Indian manufacturers, offering cost-effective and high-quality options.
• Regulatory compliance (GMP, WHO, USFDA, EMA) is critical, with reputable suppliers maintaining strict quality controls.
• Supply security recommends dual sourcing and thorough vendor audits, especially amid geopolitical and logistical uncertainties.
• Quality standards are paramount; suppliers must verify high purity (>99%) and consistency across batches.
• Emerging markets and technologies could diversify supply options, potentially reducing reliance on traditional regions.

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FAQs

1. What are the key quality attributes to consider when sourcing entacapone API?
High purity (>99%), consistent batch-to-batch quality, compliance with GMP, WHO, or FDA standards, and comprehensive documentation.

2. How do Chinese and Indian API manufacturers differ in their offerings for entacapone?
Chinese companies typically advantage in volume capacity and cost, with many holding international certifications, whereas Indian suppliers often emphasize regulatory compliance and quality assurance for global markets.

3. What are the risks associated with sourcing APIs from emerging suppliers?
Potential risks include variable quality standards, regulatory uncertainties, supply chain instability, and limited transparency in manufacturing processes.

4. How does regulatory approval impact API sourcing decisions?
Regulatory approval (e.g., GMP, FDA, EMA) ensures adherence to strict manufacturing standards, simplifying approval processes for finished drug products and reducing compliance risks.

5. What trends could influence the future API sourcing landscape for COMTAN?
Advances in manufacturing technology, stricter regulatory requirements, geopolitical shifts, and increased focus on supply chain resilience will shape future sourcing strategies.

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Sources

[1] U.S. Food and Drug Administration (FDA), "API Registration & Compliance," FDA.gov.
[2] World Health Organization (WHO), "Prequalification of Pharmaceuticals," WHO.int.
[3] Chinese Pharmacopoeia and Manufacturer websites, Zhejiang Hisun Pharmaceutical, Shenzhen Salubris Pharmaceuticals.
[4] Indian Pharmaceutical Association, "Indian API Manufacturers," IPA.in.
[5] Market Research Reports, "Global API Market for Parkinson's Drugs," PharmaMarketAnalytics, 2022.