Suppliers and packagers for SINEMET

SINEMET

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555	NDA	Organon LLC	78206-166-01	100 TABLET in 1 BOTTLE (78206-166-01)	2021-06-01
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555	NDA	Organon LLC	78206-167-01	100 TABLET in 1 BOTTLE (78206-167-01)	2021-06-01
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555	NDA	Organon LLC	78206-168-01	100 TABLET in 1 BOTTLE (78206-168-01)	2021-06-01
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555	NDA	Organon LLC	78206-190-01	100 TABLET in 1 BOTTLE (78206-190-01)	2025-02-28

Suppliers for the Pharmaceutical Drug: SINEMET

Last updated: July 28, 2025

Introduction

SINEMET, a widely prescribed combination medication for Parkinson’s disease, contains levodopa and carbidopa. Its efficacy relies on consistent quality and reliable supply chains, making supplier selection critical for pharmaceutical companies, healthcare providers, and distributors. This article critically examines the key suppliers of SINEMET, analyzing manufacturing sources, global supply networks, regulatory considerations, and market dynamics shaping its availability.

Overview of SINEMET and Its Market Significance

SINEMET, developed by various pharmaceutical manufacturers, primarily combines levodopa—an amino acid precursor to dopamine—with carbidopa, a peripheral decarboxylase inhibitor. The drug aims to elevate dopamine levels in the brain and reduce side effects associated with peripheral conversion of levodopa. Marketed under multiple brand names, including Sinemet (AbbVie) and generic formulations from various manufacturers, its global market demand remains substantial due to the rising prevalence of Parkinson’s disease.

Major Suppliers of Active Pharmaceutical Ingredients (APIs)

Levodopa API Suppliers

Levodopa remains the cornerstone API for SINEMET production. The primary sources for high-quality levodopa include:

• Japan’s Evonik Industries: Historically a leader in amino acid synthesis, Evonik supplies pharmaceutical-grade levodopa globally, leveraging advanced fermentation and chemical synthesis processes to ensure purity and consistent quality [1].

• China’s Zhejiang Jingxin Pharmaceutical Co. Ltd.: A notable supplier, Jingxin manufactures levodopa with GMP certification, offering cost-effective options for generics manufacturers. However, regulatory inspections and quality control are vital considerations when integrating Chinese APIs into regulated markets [2].

• India’s Sun Pharma and Hetero Drugs: Both companies produce levodopa as part of their neurological API portfolio, meeting stringent regulatory standards for US and European markets. Their capacities support large-scale production and supply continuity [3].

Carbidopa API Suppliers

Carbidopa is less widely sourced commercially but produced by established pharmaceutical intermediates manufacturers:

• AbbVie (original patent holder): Produces high-quality carbidopa for its branded SINEMET and licensed generics, with manufacturing facilities complying with international quality standards [4].

• Indian pharmaceutical firms: Companies like Natco and Strides Pharma produce carbidopa APIs for licensed and generic SINEMET formulations, often sourcing from local and international suppliers to meet global demand [5].

Finished Product Manufacturers and Regional Supply Dynamics

Global manufacturing of SINEMET is distributed among several major players, with production sites in North America, Europe, and Asia to meet localized regulatory requirements and market demands.

• AbbVie (United States and Europe): As the original innovator, AbbVie manufactures proprietary SINEMET formulations, ensuring strict quality control, and supplies worldwide through both direct and licensed distribution channels.

• Generic Manufacturers: Numerous generic pharmaceutical companies produce SINEMET, including:

  • Mylan (now part of Viatris): Offers generic SINEMET formulations globally, sourcing APIs from trusted suppliers and complying with international Good Manufacturing Practices (GMP).

  • Sun Pharma, Hetero, and Strides Pharma: These Indian companies produce both APIs and finished formulations. Their manufacturing plants are inspected regularly by the US FDA, EMA, and other regulatory authorities.

  • Chinese Generics Firms: Companies such as Zhejiang Huazhong Pharmaceutical Co. and Guangzhou Baiyunshan Pharmaceutical Holdings produce both APIs and finished drugs, often serving Asian and emerging markets.

Regulatory Considerations and Quality Assurance

Suppliers must meet the regulatory standards of target markets, notably cGMP compliance for APIs and finished products, as stipulated by agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Companies like Evonik and Sun Pharma have established robust regulatory dossiers, enabling smooth approval processes.

Ensuring consistent API quality, batch-to-batch uniformity, and supply stability is paramount. Recent trends emphasize digital traceability and decentralized manufacturing verification to mitigate risks of contamination, counterfeiting, and regulatory non-compliance.

Supply Chain Challenges and Market Trends

The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains, especially for APIs sourced from Asia. Disruptions led to increased procurement costs and prompted companies to consider diversifying suppliers.

Furthermore, geopolitical considerations, such as U.S.-China trade relations, influence supplier strategies. Some companies are shifting towards nearshoring or increasing inventory buffers to ensure steady SINEMET supplies.

The growing prevalence of Parkinson’s disease worldwide boosts the demand for both branded and generic SINEMET, intensifying competition among suppliers and exerting upward pressure on API prices. Market entrants with GMP-certified APIs and reliable logistics networks are positioned for sustained growth.

Emerging Suppliers and Future Outlook

Interest in biosynthetic and sustainable API production methods is rising. Innovations include microbial fermentation techniques to produce levodopa, reducing reliance on chemical synthesis and minimizing environmental impact. Companies investing in such technologies could reshape future supply landscapes.

Additionally, collaborations between multinational corporations and regional suppliers aim to improve supply resilience, quality assurance, and cost-efficiency, all vital to maintaining global SINEMET availability.

Conclusion

The supply chain for SINEMET encompasses a broad network of API producers, finished formulation manufacturers, and regional distributors. Key suppliers include Japanese, Chinese, Indian, and Western pharmaceutical companies, each operating under rigorous regulatory standards. As demand escalates amidst geopolitical and market uncertainties, diversification, quality assurance, and technological advancements remain critical to ensuring uninterrupted, high-quality SINEMET supplies globally.

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Key Takeaways

• Diverse API sourcing: International suppliers, especially from Japan, India, and China, form the backbone of SINEMET’s API supply chain, with strict quality controls necessary for regulatory compliance.

• Market dynamics: Growing global demand and geopolitical factors are prompting supply chain diversification and innovation in API manufacturing.

• Regulatory compliance: Suppliers must adhere to cGMP standards and regional regulations, ensuring safety and efficacy in all markets.

• Supply chain resilience: Pandemic-driven disruptions highlight the importance of supply chain agility, including strategic stockpiling and supplier diversification.

• Technological innovation: Emerging biosynthetic methods present opportunities to enhance API sustainability, quality, and supply security.

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FAQs

1. Who are the leading API suppliers for levodopa used in SINEMET production?
Japanese firms like Evonik Industries, Chinese manufacturers such as Zhejiang Jingxin Pharmaceutical, and Indian companies like Sun Pharma are major API suppliers for levodopa, all maintaining compliance with international manufacturing standards.

2. How do regulatory standards impact API supplier selection for SINEMET?
APIs must be produced under cGMP conditions and approved by authorities like the FDA or EMA. Regulatory compliance ensures product quality, safety, and facilitates market approvals.

3. Are there regional differences in SINEMET manufacturing and supply?
Yes. While North American and European companies primarily manufacture proprietary formulations, generic producers in India and China supply APIs and finished drugs tailored for regional markets, often under local regulatory oversight.

4. What are the risks associated with the current global API supply chain for SINEMET?
Risks include geopolitical tensions, pandemics, regulatory scrutiny, and manufacturing disruptions, which can impact availability and pricing.

5. What innovations could reshape future SINEMET supply chains?
Advances in biosynthetic API production, digital supply chain management, and regional manufacturing hubs aim to improve resilience, reduce costs, and ensure high-quality supplies of SINEMET worldwide.

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References

[1] Evonik Industries. Levodopa manufacturing profile.
[2] Zhejiang Jingxin Pharmaceutical Co. Ltd. API quality standards.
[3] Sun Pharma and Hetero Drugs. API production capabilities.
[4] AbbVie. Carbidopa manufacturing and quality assurance.
[5] Indian pharmaceutical companies’ API portfolios.