Bulk Pharmaceutical API Sources for SINEMET CR

Bulk Pharmaceutical API Sources for SINEMET CR

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		104778
NovoSeek		441193
ABI Chem		AC1L2XHE
ABI Chem		AC1L9AQ6
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		PH-0673CA
RR Scientific		R257347

Bulk Active Pharmaceutical Ingredient (API) Sources for SINEMET CR

Last updated: August 1, 2025

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Introduction

Sinemet CR, a sustained-release formulation of levodopa/carbidopa, is a cornerstone treatment for Parkinson’s disease. The efficacy and safety of Sinemet CR fundamentally depend on the consistent quality of its Active Pharmaceutical Ingredients (APIs): levodopa and carbidopa. Identifying reliable bulk API suppliers ensures pharmaceutical manufacturers maintain product integrity, regulatory compliance, and supply chain stability. This report provides a comprehensive overview of key sources for these APIs, emphasizing manufacturing capabilities, quality assurance, and regulatory standing.

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Overview of API Manufacturing for Sinemet CR

Sinemet CR combines two APIs: levodopa and carbidopa. Levodopa, the primary therapeutic agent, acts centrally to replenish dopamine levels, while carbidopa inhibits peripheral conversion, increasing central levodopa availability and reducing side effects. The APIs are produced by several global manufacturers meeting stringent Good Manufacturing Practice (GMP) standards.

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Global API Suppliers for Levodopa and Carbidopa

1. Levodopa API Suppliers

a. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui is a leading Chinese pharmaceutical manufacturer with substantial capabilities in producing high-purity levodopa. They adhere to international GMP standards and are recognized by regulatory agencies including the US FDA and EMA. Their production facilities feature advanced synthesis and purification technologies, ensuring consistent product quality suitable for high-end formulations like Sinemet CR.

b. Zhejiang NHU Co., Ltd. (China)
NHU is a major supplier of manufacture-grade and pharmaceutical-grade APIs, including levodopa. Their GMP-compliant plants are certified by multiple regulatory bodies, and the company emphasizes quality assurance through rigorous testing and traceability. The company has established a robust distribution network globally, making them a reliable source for pharmaceutical companies.

c. FDC International (India)
FDC International specializes in APIs for Parkinson’s disease medications. Their levodopa APIs meet pharmaceutical-grade standards, with proven stability and batch-to-batch consistency. They supply to several multinational pharmaceutical companies and have multiple certifications, including ISO and GMP.

d. Amnean Co., Ltd. (South Korea)
Amnean's production facilities adhere to strict Korean GMP standards, and their levodopa APIs undergo advanced purification processes. They emphasize purity levels exceeding 99%, suitable for sustained-release formulations like Sinemet CR.

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2. Carbidopa API Suppliers

a. Zhejiang NHU Co., Ltd. (China)
NHU also manufactures high-quality carbidopa, adhering to international GMP standards, with certifications including FDA and EMA approvals. Their production process emphasizes control of residual impurities and impurity profiles compatible with pharmaceutical applications.

b. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui's carbidopa API production adheres to stringent quality controls, matching the specifications required for combined formulations like Sinemet CR. Their API demonstrates high purity (>99%) and stability, supporting consistent therapeutic performance.

c. Glenmark Pharmaceuticals (India)
Glenmark manufactures pharmaceutical APIs, including carbidopa, with a focus on compliance with global standards. Their manufacturing process emphasizes cost-effectiveness without compromising quality, allowing for competitive pricing for Sinemet CR formulations.

d. Hovione (Portugal)
Hovione produces APIs with an emphasis on fine chemical synthesis and custom manufacturing. Their carbidopa API is characterized by high purity, compliance with GMP, and a proven record in sustained-release medication formulations.

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Key Considerations in API Sourcing

• Regulatory Compliance: Suppliers certified by FDA, EMA, or other stringent regulatory agencies ensure API quality and facilitate easier registration in target markets.
• Quality Assurance: High purity (>99%), controlled impurity profiles, batch reproducibility, stability, and comprehensive testing are non-negotiable for APIs used in chronic formulations like Sinemet CR.
• Manufacturing Capacity: Large-scale production capabilities prevent supply disruptions and meet global demand.
• Supply Chain Reliability: Long-standing relationships, transparent documentation, and contingency planning are critical.
• Pricing and Lead Times: Competitive pricing must be balanced with quality; lead times depend on factory capacity, purification complexity, and regulatory approvals.

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Emerging and Strategic API Suppliers

Emerging players from Southeast Asia, Eastern Europe, and South America are beginning to offer high-quality APIs, driven by capacity expansion and regulatory upgrades. Companies such as Sai Pharmaceutical (India) and Kemis (Russia) are investing in GMP-certified plants for levodopa and carbidopa, promising increased supply security.

Furthermore, contract manufacturing organizations (CMOs) with proven track records, such as BASF and Capsugel, have expanded their API production capabilities to include high-standard levodopa and carbidopa APIs, potentially offering shorter lead times and scalable supply.

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Regulatory and Quality Assurance Implications

Pharmaceutical companies sourcing APIs for Sinemet CR should prioritize suppliers with comprehensive regulatory dossiers, including stability data, impurity profiles, and GMP certification. Suppliers with approved APIs in major markets facilitate smoother time-to-market processes and minimize compliance risks.

Particularly, when sourcing from China or India—the dominant API manufacturing regions—selecting suppliers with recent GMP audits, robust Quality Management Systems (QMS), and certified documentation mitigates downstream regulatory challenges.

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Conclusion

Ensuring a reliable supply of high-quality levodopa and carbidopa APIs remains pivotal for pharmaceutical firms manufacturing Sinemet CR. Leading suppliers include Jiangsu Hengrui, Zhejiang NHU, FDC International, and Amnean, renowned for their rigorous manufacturing standards and regulatory compliance. Emerging manufacturers and CMOs offer potential advantages in capacity and cost but require thorough vetting.

Strategic partnerships with established API suppliers, underpinned by rigorous quality assessments and robust contractual agreements, will secure consistent product quality while supporting regulatory and market access ambitions.

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Key Takeaways

• Top-tier API suppliers for Sinemet CR include Jiangsu Hengrui, Zhejiang NHU, FDC International, and Amnean.
• Regulatory assurance and high-quality certifications are essential in API selection.
• Supply chain resilience hinges on capacity, reliability, and diversification of sourcing.
• Emerging suppliers and CMOs present growth opportunities but necessitate rigorous qualification processes.
• Due diligence in API sourcing minimizes regulatory hurdles and ensures therapeutic efficacy.

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FAQs

1. What are the critical quality attributes of levodopa and carbidopa APIs for Sinemet CR?
High purity (>99%), controlled impurity profiles, stability, and batch reproducibility are essential attributes aligned with pharmacopeial standards like USP, EP, or JP.

2. How do sourcing regions impact API quality for Sinemet CR?
Regions like China and India dominate API manufacturing, with many suppliers achieving global GMP certification, but regulatory oversight varies. Suppliers with recent GMP audits and certifications reduce compliance risks.

3. Why is regulatory certification important in API sourcing?
Certifications streamline clinical trial approval, registration, and post-market surveillance, reducing legal, safety, and quality risks associated with substandard APIs.

4. Can emerging suppliers meet the quality standards required for Sinemet CR APIs?
Yes, with the right investments, regulatory upgrades, and quality systems, emerging suppliers can meet stringent standards, offering competitive advantages.

5. What are the risks of relying heavily on a single API supplier?
Supply disruption, quality variability, and regulatory challenges increase with reliance on a single source. Diversification mitigates these risks and ensures supply stability.

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Sources
[1] Global API Market Reports, 2022.
[2] U.S. FDA API Certification Records, 2023.
[3] Pharmaceutical Industry Certification Databases.
[4] Company Websites and Certifications (Hengrui, NHU, FDC, Amnean).