Suppliers and packagers for tasmar

tasmar

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

Suppliers for the Pharmaceutical Drug: TASMAR

Last updated: August 2, 2025

Introduction
TASMAR (tolcapone) is a prescription medication used primarily as an adjunct in treating Parkinson’s disease, functioning as a centrally acting catechol-O-methyltransferase (COMT) inhibitor. Approved by the FDA in 1998, TASMAR's unique mechanism extends the efficacy of levodopa therapy by inhibiting peripheral and central degradation of dopamine. As with many specialty drugs, the supply chain landscape is shaped by patent status, manufacturing capabilities, regulatory compliance, and market demand. This report delineates the key suppliers for TASMAR, examining their roles, market presence, and implications for stakeholders.

Manufacturers and Licensed Suppliers

1. Novartis Pharmaceuticals
Novartis holds the original patent and manufacturing rights for TASMAR. The company's facility for tolcapone production complies with stringent Good Manufacturing Practices (GMP) standards, ensuring product quality and supply stability. Since gaining FDA approval, Novartis has been the primary and, until recent patent expirations, the exclusive supplier of TASMAR in key markets, including the United States and Europe.

2. Contract Manufacturing Organizations (CMOs)
Post-patent expiry or in scenarios involving regulatory or supply disruptions, other pharmaceutical entities may source tolcapone via contract manufacturing arrangements, especially for generic versions. CMOs with expertise in complex chemical synthesis and regulatory approval for CNS-active drugs serve as alternative suppliers or intermediaries. Examples include global CMOs such as Lonza, Fujifilm Diosynth Biotechnologies, and Thermo Fisher Scientific—although their involvement is project-specific and often limited to intermediates or finished APIs for generic manufacturers.

3. Generic Manufacturers
Following patent expiry, numerous generic pharmaceutical firms have shown interest in producing tolcapone. Notable companies include:

• Mylan (now part of Viatris)
• Sandoz (Novartis generics division)
• Sun Pharmaceutical Industries
  These firms typically manufacture the active pharmaceutical ingredient (API) and distribute it to generic product manufacturers or compounding pharmacies.

4. Regional and Local Suppliers
In emerging markets and regions with less stringent patent enforcement, local suppliers may produce and distribute tolcapone. These suppliers often operate under licensed agreements or through regulatory exemptions, sometimes posing quality assurance challenges.

Regulatory and Supply Dynamics

Patent and Market Exclusivity:
Novartis secured relatively broad patent protection for TASMAR, but key patents have expired in many jurisdictions, leading to an increase in generic availability [1]. The expiration catalyzed a shift towards multiple suppliers and increased market competition.

Supply Chain Dependencies:
The complex synthesis of tolcapone requires sophisticated chemical processing, limiting the number of capable manufacturers. Disruptions—such as quality control issues, regulatory non-compliance, or manufacturing capacity constraints—can impact global supply levels. Recent supply shortages have reportedly stemmed from manufacturing challenges and regulatory actions by authorities such as the FDA [2].

Quality Control and Regulatory Compliance
Manufacturers supplying for commercial distribution must adhere to GMP standards, with regulatory bodies conducting regular inspections. Only suppliers meeting these standards can legally supply API for prescription drug manufacturing. Suppliers outside major markets may face barriers to entry, impacting supply reliability.

Market Outlook and Alternative Sources
Although TASMAR remains on the market mainly through Novartis, growing interest in generic formulations suggests an expanding supplier base. This diversification could mitigate supply risks but also introduces concerns about API quality consistency and regulatory oversight. Stakeholders should monitor approvals, manufacturing authorizations, and regulatory advisories from authorities like FDA and EMA to stay informed about credible suppliers.

Key Supply Considerations for Stakeholders

• Pharmaceutical Companies: Need to verify supplier GMP compliance, batch-to-batch consistency, and regulatory approval status. Diversifying supplier sources post-patent expiry can ensure stable supply and competitive pricing.

• Healthcare Providers: Should confirm that acquired TASMAR products originate from licensed suppliers to maintain patient safety and regulatory compliance.

• Regulators: Must oversee manufacturing quality, monitor supply disruptions, and enforce import/export controls to protect patient safety.

• Investors and Market Analysts: Should monitor patent status changes, market entry of generics, and manufacturing capacity developments impacting supply dynamics.

Conclusion
The supply landscape for TASMAR has evolved markedly since its initial market approval. Novartis remains a key player, but patent expirations and rising generic competition have diversified the supplier base, especially in regions with less stringent patent protections. Ensuring supply security hinges on strict regulatory compliance, manufacturing capacity, and quality assurance. Market participants must actively monitor regulatory developments and supply chain movements to mitigate risks associated with drug availability.

Key Takeaways

• Primary manufacturer: Novartis continues as the main supplier; however, patent expirations have facilitated entry of generics.
• Emerging suppliers: Generic manufacturers and CMOs now contribute to the global TASMAR supply chain, increasing competition.
• Supply stability: Disruptions often stem from manufacturing or regulatory issues; diversified sourcing can mitigate risks.
• Quality and compliance: Regulatory oversight remains crucial to ensure API safety, efficacy, and manufacturer credibility.
• Future outlook: Continued patent expiries and market growth of generics may further diversify and stabilize supply in the coming years.

FAQs

1. Who are the main suppliers of TASMAR currently?
Novartis remains the primary supplier. However, post-patent expiration, several generic firms and CMOs have entered the market, expanding the supplier base globally.

2. What challenges exist in sourcing TASMAR APIs?
Manufacturing complexity, regulatory compliance, and quality assurance are significant challenges. Supply shortages can occur due to production issues or regulatory bans stemming from safety concerns.

3. Are generic versions of TASMAR available globally?
In many regions, yes. Post-patent expiry, multiple generics and APIs from local suppliers are available, though their quality and regulatory approval may vary.

4. How can buyers verify the quality of TASMAR supplied by different manufacturers?
By reviewing GMP certifications, regulatory approvals, batch testing reports, and supplier audits. Engaging with reputable and certified suppliers is essential.

5. What future trends could impact TASMAR supply?
Patent expiries, regulatory actions, and the emergence of biosimilars or alternative therapies could influence the supply landscape, requiring continuous monitoring from stakeholders.

References
[1] U.S. Patent and Trademark Office. Patent Details for TASMAR.
[2] FDA Drug Shortage Database. Reports on API manufacturing disruptions.