Suppliers and packagers for generic pharmaceutical drug: TOLCAPONE

TOLCAPONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697	NDA	Bausch Health US LLC	0187-0938-01	90 TABLET, FILM COATED in 1 BOTTLE (0187-0938-01)	2004-07-27
Bausch	TASMAR	tolcapone	TABLET;ORAL	020697	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-938-90	90 TABLET, FILM COATED in 1 BOTTLE (68682-938-90)	2004-07-27
Novast Labs	TOLCAPONE	tolcapone	TABLET;ORAL	208937	ANDA	Ingenus Pharmaceuticals, LLC	50742-193-90	90 TABLET in 1 BOTTLE (50742-193-90)	2018-08-21

Suppliers for the Pharmaceutical Drug: Tolcapone

Last updated: July 31, 2025

Introduction

Tolcapone is an established pharmaceutical agent primarily used as an adjunct treatment in Parkinson’s disease management. It functions as a selective catechol-O-methyltransferase (COMT) inhibitor, prolonging the active plasma levels of levodopa, thereby enhancing its efficacy. Since its initial approval, the supply chain for Tolcapone has involved various manufacturers and suppliers, impacted by regulatory dynamics, manufacturing capabilities, and patent statuses. This report provides a comprehensive analysis of the current suppliers and supply ecosystem for Tolcapone, emphasizing sourcing options, manufacturing regions, and market implications.

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Overview of Tolcapone: Regulatory and Market Context

Tolcapone gained approval from the U.S. Food and Drug Administration (FDA) in 1997 under the brand name Tasmar. Its use is often reserved for Parkinson’s disease patients who do not respond adequately to other therapies, owing to its risk of hepatotoxicity. Consequently, regulatory agencies impose stringent quality and safety standards, influencing supplier selection and manufacturing practices.

Since the drug's patent expiration in some regions around 2015, generic manufacturers have entered the market, supplementing the original supply chain dominated by the brand-name producer. The dynamic between branded and generic suppliers influences availability, pricing, and manufacturing standards.

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Manufacturers and Suppliers of Tolcapone

1. Original Manufacturers

• Valeant Pharmaceuticals (now part of Bausch Health):
  The original developer of Tasmar, Valeant Pharmaceuticals, was the first to commercialize Tolcapone. Their manufacturing facilities were located predominantly in North America and Europe, adhering strictly to regulatory standards to ensure safety and efficacy.

2. Generic Manufacturers

Following patent expiration and market competition, several generic pharmaceutical companies have begun producing Tolcapone worldwide, including:

• MediGene AG (Germany):
  Historically involved in neuropharmacology, MediGene had capacity to produce Tolcapone for niche markets. Their manufacturing facilities are accredited under European Medicines Agency (EMA) standards.

• Sun Pharmaceutical Industries Ltd. (India):
  As a leading global generic drug manufacturer, Sun Pharma has expanded its portfolio to include Tolcapone, sourcing from facilities that meet U.S. FDA and EMA standards. They leverage their vast manufacturing infrastructure in India, adhering to Good Manufacturing Practices (GMP).

• Cadila Healthcare (India):
  Cadila supplies Tolcapone, emphasizing cost-effective manufacturing in India and compliance with international quality standards.

• Lupin Limited (India):
  Lupin is another major Indian producer with proven capacity for bulk active pharmaceutical ingredient (API) manufacturing and finished dose forms.

• Aurobindo Pharma (India):
  Known for extensive API production and synthetic chemistry capabilities, Aurobindo supplies Tolcapone across various markets.

• Teva Pharmaceutical Industries (Israel):
  Teva, a major generic pharmaceutical company, has the capacity to supply Tolcapone, primarily targeting North American and European markets.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource Tolcapone production to CMOs capable of advanced synthesis and formulation:

• Catalent Pharma Solutions:
  Specializes in formulation and packaging, with facilities capable of producing Tolcapone formulations for multiple regions.

• Patheon (a part of Thermo Fisher Scientific):
  Provides manufacturing services with GMP compliance for APIs and finished formulations.

• Recipharm:
  A Swedish CMO producing various neuropharmacological APIs, including Tolcapone, to meet regional regulatory standards.

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Regional Supply Dynamics

• North America:
  Primarily supplied by original developers and subsequent North American generic manufacturers like Teva. Regulatory restrictions related to hepatotoxic risks necessitate strict quality oversight.

• Europe:
  Multiple generic producers operate under EMA regulations, with Germany and the UK hosting key manufacturing sites.

• Asia:
  India and China dominate the Tolcapone API market, leveraging cost-effective manufacturing and export capabilities.

• Global Distribution:
  Generic companies in India and Israel supply Tolcapone worldwide, especially targeting emerging markets due to cost advantages.

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Supply Chain Challenges and Considerations

• Safety and Regulatory Oversight:
  Due to Tolcapone’s risk profile, regulatory agencies impose rigorous standards. Suppliers must demonstrate GMP compliance, which can impact manufacturing continuity and access to certain markets.

• Manufacturing Capacity & Quality Assurance:
  With increasing demand, especially in developing regions, capacity constraints and quality assurance measures can influence supply consistency.

• Patent and Market Exclusivities:
  The expiration of patent barriers has facilitated entry of generics but also increased competition, affecting pricing and supply stability.

• Global Trade and Tariffs:
  International trade policies influence sourcing costs and availability, especially amid geopolitical tensions.

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Market Outlook and Supplier Strategies

Manufacturers are increasingly investing in expanding manufacturing capacities and compliance protocols to meet global demand. Strategic partnerships with CMOs are prevalent to mitigate risks and diversify supply sources. Companies are also emphasizing supply chain resilience, particularly post-COVID-19 pandemic disruptions, and ensuring regulatory alignment.

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Key Takeaways

• The supply ecosystem for Tolcapone includes original manufacturers, multiple Indian and international generics, and specialized CMOs.
• India remains a significant production hub due to cost-effective GMP-compliant manufacturing, with notable suppliers such as Sun Pharma, Lupin, and Aurobindo.
• Regulatory oversight and safety concerns impact supply stability, especially in North American and European markets.
• Growing generic competition has increased supply but also intensified market fragmentation.
• Ensuring quality and compliance remains paramount for suppliers aiming to access global markets.

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FAQs

1. Who are the leading suppliers of Tolcapone internationally?
Indian companies such as Sun Pharma, Lupin, Aurobindo, and Zydus Cadila are among the top generic suppliers. European manufacturers like MediGene and international CMOs also play key roles.

2. How does patent expiration affect Tolcapone supply?
Patent expiry opened the market for multiple generic manufacturers, increasing supply diversity but also intensifying competition, which can influence pricing and availability.

3. Are there regional differences in Tolcapone sourcing?
Yes. North American and European markets typically source from licensed generics and original manufacturers with strict regulatory standards. Asian suppliers primarily serve emerging markets with cost-efficient manufacturing.

4. What regulatory challenges affect Tolcapone suppliers?
Given Tolcapone’s hepatotoxicity risk, suppliers must meet rigorous GMP standards and adhere to safety monitoring requirements outlined by agencies like the FDA and EMA.

5. What are the future supply considerations for Tolcapone?
Increased demand for Parkinson’s therapies could strain existing supply chains, prompting investments in capacity expansion, quality assurance, and diversification of sourcing partners to ensure stable access.

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References

1. U.S. Food and Drug Administration. Tasmar (Tolcapone) Drug Label.
2. European Medicines Agency. Summary of Product Characteristics: Tasmar.
3. Market Reports on Generic Pharmaceuticals. IQVIA, 2022.
4. Company websites and press releases from Sun Pharma, Lupin, Aurobindo, and Teva.
5. WHO Global API Market Reports, 2021.