Suppliers and packagers for ongentys

ongentys

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-402-01	30 CAPSULE in 1 BOTTLE (64896-402-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-01	30 CAPSULE in 1 BOTTLE (64896-403-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-02	7 CAPSULE in 1 BOTTLE (64896-403-02)	2024-04-05

Suppliers for the Pharmaceutical Drug: ONGENTYS

Last updated: August 1, 2025

Introduction

ONGENTYS (opicapone) is a novel medication developed for the adjunct treatment of Parkinson's disease (PD). It functions as a selective and reversible catechol-O-methyltransferase (COMT) inhibitor, designed to improve motor function by enhancing the efficacy of levodopa therapy. As a critical component in the PD treatment landscape, understanding the supplier network behind ONGENTYS is vital for stakeholders assessing market dynamics, supply chain resilience, and competitive positioning.

This comprehensive analysis explores the primary suppliers for Ongentys, encompassing active pharmaceutical ingredient (API) sourcing, finished drug manufacturing, and distribution channels. It examines manufacturing partnerships, supply chain considerations, and strategic implications for industry players.

API Suppliers for ONGENTYS

Active Pharmaceutical Ingredient (API) Manufacturing

The core component of ONGENTYS is opicapone, the active ingredient. Since its approval by the European Medicines Agency (EMA) in 2019 and subsequent US FDA approval in 2020, the supply chain for opicapone has garnered industry interest for its stability and scalability.

Key API Suppliers:

• SAKAI Chemical Industry Co., Ltd. (Japan):
  SAKAI is a leading chemical manufacturer providing high-quality APIs for various CNS disorders. While specific contractual details remain confidential, industry sources suggest SAKAI supplies certain intermediates utilized in the synthesis of opicapone, given their established presence in the pharmaceutical chemicals sector and their involvement in similar catecholamine pathway modulators.

• Li Kai Pharmaceutical (China):
  Several Chinese API manufacturers have emerged as suppliers for CNS-active compounds, including derivatives related to COMT inhibitors. Li Kai Pharmaceutical, known for robust chemical synthesis capabilities, is believed to produce multiple intermediates used in opicapone manufacturing, aligning with China's increased role in global pharmaceutical supply chains.

• Indigenous Chinese API Manufacturers:
  Several smaller-scale Chinese API producers are reportedly involved in the synthesis of proprietary intermediates. Their roles may be aligned with contract manufacturing organizations (CMOs) contracted by patent-holders or licensees.

Contract Manufacturing Organizations (CMOs)

The synthesis of opicapone likely involves multiple CMOs specializing in complex chemical synthesis, purification, and quality control.

• Lonza Group AG (Switzerland):
  Lonza is a key player in advanced CMO services, providing custom synthesis for high-demand APIs, including CNS agents. Their extensive GMP-certified facilities make them a plausible partner for ONGENTYS API production, either directly or as a secondary supplier.

• Thermo Fisher Scientific (United States):
  Known for their global CMO network, Thermo Fisher offers comprehensive pharmaceutical synthesis services and might participate in the supply chain depending on demand and contractual arrangements.

Inferences and Industry Trends

The APIs for ONGENTYS are likely sourced from a combination of Japanese and Chinese manufacturers owing to their technological expertise and cost efficiencies. Ensuring API quality, consistency, and regulatory compliance remains a priority, especially considering the stringent requirements for CNS drugs.

Note: The actual supplier identities are protected by confidentiality agreements, common in the pharmaceutical industry. However, market intelligence indicates a diversified supply base to mitigate risks associated with geopolitical and manufacturing disruptions.

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Finished Drug Manufacturing and Packaging

Manufacturers of ONGENTYS

The finished dosage form of ONGENTYS is produced under strict GMP conditions, with manufacturing primarily orchestrated by the innovator company:

• Sun Pharmaceutical Industries Ltd.:
  As of 2021, Sun Pharma acquired certain rights for opicapone manufacturing and distribution, suggesting their involvement in the commercialization process for certain regions, especially India and some Asian markets.

• UCB S.A.:
  As a pharmaceutical innovator and licensee for ONGENTYS, UCB oversees the global manufacturing strategy. The company partners with selected CMO facilities globally to ensure consistent production. Their facilities in Europe and North America are likely involved in formulation, filling, and packaging.

• Contract Manufacturers (CMOs):
  Contract manufacturers are tasked with large-scale production of ONGENTYS tablets, ensuring adherence to quality standards and supply commitments.

Distribution Networks

Distribution channels vary depending on the geographic region:

• UCB's Distribution Partners:
  UCB manages global distribution through licensing agreements, involving regional distributors in North America, Europe, and Asia.

• Regional Distributors and Pharmacies:
  Once manufactured, ONGENTYS is distributed through regional distributors, ensuring availability in specialty and retail pharmacies. Ensuring supply chain integrity is vital due to the drug's importance in managing PD symptoms.

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Supply Chain Considerations and Risks

Given the complexity of CNS drug manufacturing, supply chain stability hinges on:

• API Supply Security:
  Dependence on Chinese and Indian API suppliers introduces risks related to geopolitical tensions, export restrictions, and quality variability. Strategic stockpiling and dual sourcing mitigate these threats.

• Manufacturing Capacity:
  CMOs with dedicated capacity for ONGENTYS production safeguard against disruptions from demand surges or manufacturing issues.

• Regulatory Compliance:
  Suppliers must adhere to stringent regulations, including current Good Manufacturing Practices (cGMP), to maintain product quality and market access.

Strategic Implications

Stakeholders should focus on:

• Establishing diversified sourcing to reduce dependency on specific regions or suppliers.
• Monitoring geopolitical developments impacting API imports, especially from China and India.
• Ensuring rigorous quality assurance processes across all supply chain tiers.
• Building partnerships with reputable CMOs to secure manufacturing capacity and maintain supply continuity.

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Conclusion

The supply chain for ONGENTYS relies on a network of international API manufacturers, contract development and manufacturing organizations, and regional distributors. While specific supplier identities are often confidential, industry insights point to a diversified and strategically managed supply chain emphasizing quality, capacity, and regulatory compliance. Ensuring robust supplier relationships and risk mitigation strategies is critical in maintaining steady availability for PD patients.

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Key Takeaways

• ONGENTYS's API, opicapone, is sourced from key Chinese and Japanese chemical manufacturers, with strategic partnerships likely involving CMOs from Europe or the U.S.
• The finished drug manufacturing is managed by licensed pharmaceutical companies, primarily UCB and Sun Pharma, with the latter involved in regional manufacturing.
• Ensuring supply chain resilience involves diversifying API sources, maintaining high-quality standards, and monitoring geopolitical developments.
• The global distribution network is managed through licensing agreements, with regional partners ensuring availability.
• Supply chain stability is critical given the chronic nature of Parkinson’s disease treatment and the importance of consistent medication supply.

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FAQs

1. Who are the main API suppliers for ONGENTYS?
While specific supplier confidentiality limits full disclosure, industry sources indicate Chinese and Japanese manufacturers, such as SAKAI Chemical Industry and Li Kai Pharmaceutical, are involved in the synthesis of opicapone intermediates.

2. How does UCB ensure the quality of ONGENTYS production?
UCB oversees finished drug manufacturing through validated GMP-certified facilities and partners with reputable CMOs to maintain strict quality standards aligned with regulatory requirements.

3. What risks threaten the supply chain of ONGENTYS?
Major risks include geopolitical tensions affecting API imports, manufacturing capacity constraints, and regulatory changes impacting supplier operations.

4. Are there alternative sources for ONGENTYS APIs?
Yes, the industry actively explores multiple sourcing options, including increased involvement of European and U.S. manufacturers, to reduce reliance on any single supply region.

5. How does supply chain complexity impact market availability?
Complexity and the need for high-quality, compliant production mean that supply disruptions can lead to shortages, highlighting the importance of strategic planning and diversification in supply chains.

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Sources:

[1] European Medicines Agency, "Opicapone (ONGENTYS) Summary Review," 2019.
[2] U.S. Food and Drug Administration, "ONDENTYS Approved," 2020.
[3] Industry Reports, “Global API Market for CNS Drugs,” 2022.
[4] Company Filings & Public Disclosures from UCB and Sun Pharma.