Suppliers and packagers for generic pharmaceutical drug: CARBIDOPA

CARBIDOPA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alvogen	CARBIDOPA	carbidopa	TABLET;ORAL	204291	ANDA	Alvogen Inc.	47781-332-01	100 TABLET in 1 BOTTLE (47781-332-01)	2016-01-25
Aurobindo Pharma	CARBIDOPA	carbidopa	TABLET;ORAL	211055	ANDA	NorthStar Rx LLC	16714-067-01	100 TABLET in 1 BOTTLE (16714-067-01)	2019-10-21
Aurobindo Pharma	CARBIDOPA	carbidopa	TABLET;ORAL	211055	ANDA	Aurobindo Pharma Limited	59651-146-01	100 TABLET in 1 BOTTLE (59651-146-01)	2019-10-21
Edenbridge Pharms	CARBIDOPA	carbidopa	TABLET;ORAL	205304	ANDA	Edenbridge Pharmaceuticals LLC.	42799-123-01	100 TABLET in 1 BOTTLE (42799-123-01)	2016-02-19

Suppliers for the Pharmaceutical Drug: CARBIDOPA

Last updated: July 27, 2025

Introduction

Carbidopa is a critical pharmaceutical ingredient used predominantly in combination therapies for Parkinson's disease, notably with levodopa. Its primary function is to inhibit peripheral decarboxylation of levodopa, thereby increasing central nervous system availability and reducing peripheral side effects. The global demand for carbidoapa necessitates a robust supply chain comprising key manufacturers and distributors. This article provides a comprehensive overview of the principal suppliers for carbidoapa, examining their manufacturing capabilities, market positions, and strategic significance within the pharmaceutical industry.

Overview of Carbidoapa and Market Demand

Carbidopa, chemically known as L-3-(3,4-dihydroxyphenyl)alanine, is usually supplied as the salt form, carbidoapa monohydrate, in pharmaceutical grades suitable for formulation. Its therapeutic applications are vast, mainly as a component of fixed-dose combinations like Sinemet (carbidopa/levodopa), which remains the gold standard for Parkinson's disease management. The rising prevalence of Parkinson's worldwide, coupled with the increasing approval of combination therapies, drives sustained demand for high-quality carbidoapa.

Leading Suppliers and Manufacturers of Carbidoapa

1. Daiichi Sankyo (Japan)

Overview: Daiichi Sankyo, a global leader in the pharmaceutical sector, manufactures carbidoapa as part of its neurological therapeutics portfolio. The company's manufacturing units in Japan adhere to stringent quality standards, ensuring supply stability and high purity levels.

Market Position: As an innovator and contract manufacturer, Daiichi Sankyo supplies carbidoapa to major pharmaceutical firms worldwide, leveraging its robust manufacturing infrastructure.

Capabilities: The company produces both active pharmaceutical ingredients (API) and finished dosages, emphasizing compliance with Good Manufacturing Practices (GMP).

2. Sandoz (Novartis) – Switzerland

Overview: Sandoz, a division of Novartis, specializes in generic pharmaceuticals and APIs, including carbidoapa. Its extensive global manufacturing facilities provide significant capacity and supply reliability.

Market Position: Sandoz is recognized for high-quality generics and bulk APIs, maintaining strict quality control aligned with international standards.

Capabilities: Facilities in Europe and North America enable Sandoz to meet global demand efficiently, with dedicated production lines for neurodegenerative therapy APIs.

3. Zhejiang Taichen Pharmaceutical Co., Ltd. (China)

Overview: A prominent Chinese manufacturer, Zhejiang Taichen focuses on producing pharmaceutical intermediates and APIs, including carbidoapa, targeting both domestic and export markets.

Market Position: With competitive pricing and capacity expansion aimed at global markets, Zhejiang Taichen has gained a considerable share in the carbidoapa supply chain.

Capabilities: The company emphasizes quality assurance through rigorous testing, GMP conformity, and technological advancements in synthesis processes.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview: Hengrui, a well-established Chinese pharmaceutical company, manufactures a diverse range of APIs, including carbidoapa, and has expanded its export footprint.

Market Position: Their strategic investment in R&D and manufacturing ensures high-quality API production, making them a notable supplier in Asia and beyond.

Capabilities: The company leverages advanced synthesis pathways and quality management systems to meet international specifications.

5. CordenPharma (Belgium)

Overview: A subsidiary of the International Chemical Investors Group, CordenPharma provides custom synthesis and manufacturing of APIs, including carbidoapa, for the global pharmaceutical industry.

Market Position: Known for high-grade APIs and complex chemical synthesis, CordenPharma caters to multinational clients requiring reliable supply and quality.

Capabilities: Their facilities are GMP-compliant, with flexible manufacturing capacities for bulk production and specialty formulations.

6. Teva Pharmaceutical Industries Ltd. (Israel)

Overview: Teva, one of the world’s largest generic drug manufacturers, produces carbidoapa as part of its broad API portfolio.

Market Position: With extensive global distribution channels, Teva’s supply network ensures steady availability of carbidoapa at competitive pricing.

Capabilities: Teva maintains high GMP standards in manufacturing and has a track record for scalability in API production.

7. WuXi AppTec (China)

Overview: WuXi AppTec supports pharmaceutical R&D and manufacturing, including carbidoapa synthesis, primarily for clients seeking outsourcing solutions.

Market Position: As an integrated platform for pharmaceutical services, WuXi’s capacity for custom API synthesis enhances global supply options.

Capabilities: Their advanced chemical development and scalable GMP manufacturing facilities assure timely delivery.

Factors Influencing Supplier Selection

• Quality Assurance: Suppliers adhering to GMP standards and possessing robust quality management systems are preferred.
• Capacity & Scalability: Large or scalable production facilities ensure supply continuity amid rising demand.
• Regulatory Compliance: Suppliers with proven compliance with international regulations facilitate smoother approvals.
• Pricing & Contracts: Competitive pricing strategies influence purchasing decisions, especially for large-volume needs.
• Geographical Presence: Strategic geographic distribution enables redundancy and minimizes supply chain disruptions.

Emerging Trends and Strategic Considerations

The geographic diversification of suppliers, particularly the increased involvement of Chinese API manufacturers, reflects a broader shift toward cost-effective and scalable production. However, geopolitical factors and regulatory scrutiny influence supplier selection, emphasizing the importance of quality assurance and compliance. Strategic partnerships between pharmaceutical companies and API suppliers foster supply chain resilience, especially amid global disruptions like pandemics or trade restrictions.

Regulatory Landscape and Implications

The production and exportation of carbidoapa are subject to stringent regulatory frameworks. Regulatory agencies such as the FDA (USA), EMA (Europe), and NMPA (China) enforce compliance standards that suppliers must meet. Consistent GMP adherence, robust documentation, and ongoing quality audits are critical for maintaining supplier credibility and ensuring uninterrupted supply.

Future Outlook

The demand for carbidoapa is set to grow in tandem with the global Parkinson's population. Suppliers investing in process optimization, quality improvements, and capacity enhancements will likely secure strategic positions. Innovations in synthesis pathways, such as greener and more efficient methods, might also redefine supplier capabilities.

Key Takeaways

• Leading suppliers of carbidoapa include Daiichi Sankyo, Sandoz, Zhejiang Taichen, Jiangsu Hengrui, CordenPharma, Teva, and WuXi AppTec.
• Quality, regulatory compliance, and capacity are pivotal factors influencing supplier choice.
• China's rapidly expanding API manufacturing sector presents both cost advantages and quality challenges, necessitating diligent supplier evaluation.
• Strategic partnerships and diversified supply chains are essential for ensuring consistent carbidoapa availability amid global uncertainties.
• Ongoing process innovation and regulatory adherence will shape the future landscape of carbidoapa supply.

FAQs

1. What are the key factors to consider when selecting a carbidoapa supplier?
   Quality assurance, manufacturing capacity, regulatory compliance, price competitiveness, and geographic location are critical considerations.

2. Are Chinese manufacturers reliable sources of carbidoapa?
   Many Chinese manufacturers, such as Zhejiang Taichen and Jiangsu Hengrui, meet international GMP standards and supply high-quality APIs. Due diligence and quality audits are essential before engagement.

3. How does regulatory compliance impact carbidoapa suppliers?
   Suppliers must adhere to GMP and other regional regulations to ensure product quality, enabling legal export and safe usage in pharmaceutical formulations.

4. What is the significance of capacity in carbidoapa supply?
   Sufficient capacity ensures that suppliers can meet growing global demand, reducing risks of shortages that could impact Parkinson's disease treatments.

5. What trends are shaping the future of carbidoapa sourcing?
   Increased manufacturing diversification, process innovation, and stricter regulatory standards will shape supplier strategies and global supply chain resilience.

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Sources:

[1] GlobalData Pharma Intelligence Center. "Market Analysis of Parkinson's Disease Drugs." 2022.
[2] U.S. FDA Drug Master Files. "Active Pharmaceutical Ingredient (API) Registration." 2023.
[3] Industry Reports on Chinese API Manufacturers. "Growth and Quality Standards." 2022.
[4] European Medicines Agency. "API Manufacturing Guidelines." 2023.
[5] CordenPharma Corporate Website. "API Capabilities." 2023.