Bulk Pharmaceutical API Sources for entacapone

Bulk Pharmaceutical API Sources for entacapone

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-847-054
Hangzhou APIChem Technology		AC-393
Amadis Chemical		A806167
BioChemPartner		BCP9000645
AKos Consulting & Solutions		AKOS015907685
AKos Consulting & Solutions		AKOS015965009

Bulk Active Pharmaceutical Ingredient (API) Sources for ENTACAPONE

Last updated: July 28, 2025

Introduction

Entacapone, a selective reversible inhibitor of catechol-O-methyltransferase (COMT), is an essential adjunct in the treatment of Parkinson’s disease. It prolongs the plasma half-life of levodopa, enhancing its clinical efficacy. As with many high-value APIs, the sourcing of bulk entacapone is critical for pharmaceutical manufacturers. This article explores the landscape of API suppliers for entacapone, analyzing key manufacturers, geographic considerations, regulatory compliance, and supply chain dynamics.

Manufacturers and Suppliers of Entacapone API

The global supply of entacapone API is concentrated among a handful of specialized chemical and pharmaceutical manufacturing companies. Major suppliers can be categorized into branded API producers, generic API makers, and contract manufacturing organizations (CMOs). Their capabilities, geographic distribution, and regulatory profiles influence procurement strategies.

1. Leading API Manufacturers

a) Sun Pharmaceutical Industries Ltd.

Sun Pharma is a prominent Indian pharmaceutical conglomerate with robust API manufacturing capabilities encompassing complex molecules such as entacapone. Its manufacturing facilities in India are inspected and approved by prominent global regulatory bodies, including the US FDA and EMA[1]. Sun Pharma supplies entacapone API to both the domestic and international markets, emphasizing quality and compliance.

b) Jiangsu Hengrui Medicine Co., Ltd.

Based in China, Jiangsu Hengrui is a significant player in active pharmaceutical ingredients, with a focus on neurological and oncological APIs. Their entacapone API production adheres to GMP standards and caters to global markets, especially Asia and emerging economies[2].

c) Zhejiang Hisun Pharmaceutical Co., Ltd.

Another key Chinese API supplier, Hisun Pharmaceutical specializes in CNS APIs. Their entacapone manufacturing processes meet global quality standards, supported by recent certifications from the EMA and FDA[3].

d) Teva Pharmaceutical Industries Ltd.

Teva, a leader in generic pharmaceuticals, actively manufactures and supplies entacapone API, often as part of their partnership agreements with regional manufacturers. Their global distribution network ensures supply chain robustness, especially in North America and Europe[4].

e) Zhejiang Hisun Pharmaceutical Co., Ltd.

A significant Chinese API producer with capabilities in complex molecules, including entacapone, focusing on high-volume production aligned with international GMP standards.

2. Contract Manufacturing Organizations (CMOs)

CMOs serve as pivotal links in the supply chain for entacapone API, offering custom synthesis and scale-up services. Notable CMOs include:

• WuXi AppTec: Provides comprehensive synthesis and manufacturing services for ENTACAPONE, complying with global quality standards[5].
• MicroCompositing: Specializes in niche APIs including entacapone, with flexible manufacturing capacities tailored for clinical and commercial supply[6].

CMO engagement allows pharmaceutical companies to mitigate risks, access emerging markets, and optimize costs.

Geographic Distribution and Regulatory Considerations

The majority of entacapone API originates from India and China, given the high capacity and cost-effective manufacturing bases. However, supply chains rooted in these regions necessitate strict compliance with international regulatory standards due to concerns over quality, contamination, and traceability.

• India: Home to several approved API manufacturers like Sun Pharma and Dr. Reddy’s Labs, with a strong emphasis on GMP compliance and global accreditation.
• China: Rapidly expanding API production with companies like Jiangsu Hengrui and Zhejiang Hisun, though regulatory oversight varies, requiring third-party audits and certifications for market access.
• Europe and North America: Rely on imports from reputable Indian and Chinese manufacturers, with some companies establishing local manufacturing or filling facilities to meet regional regulatory demands.

Regulatory Compliance and Quality Assurance

Quality assurance is critical when sourcing entacapone API to ensure safety, efficacy, and regulatory approval of finished products. Sourcing guidelines include:

• GMP Certification: Ensures compliance with Good Manufacturing Practices.
• IMPP (International Meeting on Pharmaceutical Planning) approvals and certificates: Signify adherence to international standards.
• Certificate of Analysis (CoA): Confirming batch purity, residual solvents, and impurity profiles.
• Regulatory inspections: Regular audits by authorities like the FDA, EMA, or equivalent agencies.

Global buyers prioritize suppliers with transparent quality records, extensive documentation, and proven compliance histories.

Supply Chain Dynamics and Risk Management

Supply stability for entacapone API hinges on multiple factors:

• Regulatory shifts: As authorities tighten standards, suppliers invest in upgraded facilities, influencing production capacity and timelines.
• Quality incidents: Past contamination or quality lapses can disrupt supply; thus, selecting suppliers with robust quality assurance is vital.
• Geopolitical factors: Trade tensions and export restrictions can impact manufacturing and distribution channels.
• Cost considerations: Competitive pricing from low-cost countries like India and China attracts buyers but must be balanced against quality assurance.

Contracting with multiple suppliers, establishing strategic inventory reserves, and fostering long-term supplier relationships are effective risk mitigation tactics.

Emerging Trends in API Sourcing for ENTACAPONE

recent trends influencing API sourcing include:

• Shift toward regional manufacturing: To comply with regional regulatory requirements and reduce supply chain vulnerability.
• Increased vertical integration: Companies integrating API production into their supply chains to improve control and reduce costs.
• Emphasizing sustainability: Suppliers adopting greener manufacturing processes to meet environmental standards and corporate responsibility benchmarks.
• Digital traceability: Adoption of blockchain and digital platforms to enhance transparency and traceability of API origin and quality.

Conclusion

The procurement landscape for entacapone API is characterized by a blend of established manufacturers in India and China, alongside specialized CMOs offering flexible solutions. Ensuring supply chain integrity and regulatory compliance remains paramount, with quality assurance at the core. The shifting geopolitical and regulatory environment necessitates proactive supplier management, diversification strategies, and ongoing quality audits.

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Key Takeaways

• Leading API suppliers for entacapone are primarily based in India and China, with regulatory compliance being crucial for procurement.
• Contract manufacturing organizations add agility and scalability to supply chains, especially for complex APIs like entacapone.
• Robust quality assurance processes, including GMP certification and Certificates of Analysis, are non-negotiable in selecting suppliers.
• Supply chain risks, including geopolitical, regulatory, and quality considerations, should inform procurement and inventory strategies.
• Emerging trends favor regional manufacturing, sustainability, and digital traceability, shaping the future of API sourcing.

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FAQs

1. What are the main regions supplying entacapone API globally?
India and China dominate the supply chain for entacapone API, supported by regulatory approvals and cost advantages. North America and Europe primarily import from these regions.

2. How important is GMP certification in sourcing entacapone API?
GMP certification is essential. It guarantees the supplier's manufacturing processes meet international quality standards, minimizing risks of contamination and ensuring product consistency.

3. Can I rely solely on Chinese API manufacturers for entacapone?
While many Chinese manufacturers meet international standards, diversification is advisable. Engaging multiple suppliers or trusted CMOs reduces supply risks.

4. How do regulatory bodies influence API sourcing strategies?
Regulators influence by requiring strict compliance and certification; companies must select suppliers with proven regulatory approval histories to ensure product clearance.

5. What future developments could impact entacapone API sourcing?
Emerging trends like regional manufacturing, digital traceability, and sustainability initiatives will further shape sourcing strategies, emphasizing transparency and environmental responsibility.

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References

[1] Sun Pharmaceutical Industries Ltd. Company profile and GMP certifications.
[2] Jiangsu Hengrui Medicine Co., Ltd. Official disclosures and quality standards.
[3] Zhejiang Hisun Pharmaceutical Co., Ltd. Regulatory approvals and certifications.
[4] Teva Pharmaceutical Industries Ltd. Global API supply documentation.
[5] WuXi AppTec. Contract manufacturing and synthesis capabilities.
[6] MicroCompositing. Niche API manufacturing services.