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
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-03	30 CAPSULE in 1 BOTTLE (64896-403-03)	2024-04-05

Ongentys (opicapone) API Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for the active pharmaceutical ingredient (API) of Ongentys (opicapone). Key manufacturers and their roles in API production are identified, along with an assessment of potential risks and diversification strategies within the current supply landscape.

Who is the Primary Manufacturer of Ongentys API?

The primary manufacturer of the opicapone API is Chemi S.p.A. Chemi S.p.A. is an Italian pharmaceutical chemical company specializing in the development and commercial manufacturing of APIs for both branded and generic pharmaceuticals. They are a significant player in the API contract manufacturing organization (CMO) space, serving multiple global pharmaceutical companies.

[1]

What is Chemi S.p.A.'s Role in Opicapone Production?

Chemi S.p.A. is responsible for the commercial manufacturing of the opicapone API. This involves the synthesis of the molecule from raw materials through multi-step chemical processes. Their facilities are equipped to handle large-scale production, ensuring a consistent supply for the finished drug product. The company's expertise in complex chemical synthesis and regulatory compliance is critical for meeting the stringent quality standards required for pharmaceutical APIs.

[1]

Are There Other Approved API Manufacturers for Ongentys?

As of the latest publicly available information, Chemi S.p.A. is the sole primary and approved commercial manufacturer listed for the opicapone API. Regulatory approvals for API manufacturing are typically specific to a given manufacturer and their facility. Changes or additions to this approved list would necessitate new regulatory filings and inspections by health authorities.

[1]

What Are the Implications of a Single API Supplier?

A single API supplier presents a concentrated risk profile.

• Supply Disruption: Any interruption at Chemi S.p.A.'s manufacturing site, whether due to unforeseen events like natural disasters, industrial accidents, or geopolitical instability, could lead to a significant shortage of opicapone API. This directly impacts the availability of Ongentys for patients.
• Price Volatility: Dependence on a single supplier can limit negotiation leverage, potentially leading to price increases for the API.
• Quality Control Dependencies: The entire supply chain quality control for the API relies on the established processes and standards of Chemi S.p.A. While regulatory bodies provide oversight, the primary responsibility for consistent quality lies with the single manufacturer.
• Lead Time Sensitivity: Changes in demand or unexpected increases in production requirements might be harder to accommodate quickly if only one manufacturing entity is involved.

[2]

What Are the Regulatory Aspects of Opicapone API Manufacturing?

The manufacturing of opicapone API must adhere to Good Manufacturing Practices (GMP) as mandated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulations cover all aspects of production, including:

• Facility and Equipment: Ensuring appropriate design, maintenance, and cleaning of manufacturing facilities and equipment.
• Raw Material Control: Strict protocols for the sourcing, testing, and approval of all raw materials and intermediates used in the synthesis.
• Process Validation: Rigorous validation of the chemical synthesis process to ensure reproducibility and consistent product quality.
• Quality Control Testing: Comprehensive in-process and final product testing to verify identity, purity, strength, and quality.
• Documentation and Record Keeping: Detailed records of all manufacturing activities, deviations, and investigations.

Chemi S.p.A.'s facilities are subject to periodic inspections by these regulatory bodies to ensure ongoing compliance. The Drug Master File (DMF) submitted to regulatory agencies details the manufacturing process, facilities, and controls for the API.

[3]

What Are the Raw Materials Involved in Opicapone Synthesis?

The synthesis of opicapone is a multi-step process involving several precursor chemicals. While the exact proprietary synthesis route is not fully disclosed, typical starting materials and intermediates in the synthesis of complex organic molecules like opicapone often include:

• Substituted Phenylacetic Acid Derivatives: These form the core aromatic structure.
• Nitrobenzene Derivatives: Used for introducing nitrogen-containing functional groups.
• Halogenated Compounds: Employed in various coupling and substitution reactions.
• Amino Compounds: For building nitrogen-containing heterocycles or functional groups.
• Catalysts and Reagents: Specific catalysts (e.g., palladium catalysts for cross-coupling reactions) and specialized reagents are essential for achieving high yields and purity.
• Solvents: A range of organic solvents, such as toluene, dichloromethane, ethanol, and ethyl acetate, are used throughout the process.

The sourcing of these raw materials is critical, and manufacturers like Chemi S.p.A. typically maintain a network of approved suppliers for their starting materials and key intermediates.

[4]

What is the Geographic Location of Chemi S.p.A.'s Manufacturing?

Chemi S.p.A.'s primary manufacturing site for opicapone API is located in Italy. This location offers several advantages, including access to a skilled workforce, established chemical industry infrastructure, and a regulatory environment familiar to global pharmaceutical standards.

[1]

What are Potential Supply Chain Risks Beyond Manufacturing?

Beyond the primary API manufacturer, other risks exist within the broader supply chain:

• Key Starting Material (KSM) Suppliers: The opicapone synthesis relies on specific KSMs. If any of these KSM suppliers face production issues, it can indirectly impact opicapone API availability. The traceability and quality assurance of these KSMs are paramount.
• Logistics and Transportation: Global shipping disruptions, customs delays, or increased freight costs can affect the timely delivery of both raw materials to the API manufacturer and the API to the drug product manufacturer.
• Geopolitical Factors: Trade disputes, political instability in regions where raw materials are sourced, or changes in international trade policies can create supply chain vulnerabilities.
• Regulatory Changes: Evolving GMP standards or new environmental regulations could necessitate changes in manufacturing processes, potentially leading to temporary disruptions or increased costs.

[2]

What are Strategies for Mitigating Supply Chain Risks?

To mitigate the risks associated with a single API supplier, pharmaceutical companies typically employ several strategies:

• Dual Sourcing: Identifying and qualifying a second API manufacturer, even if not for immediate commercial production, provides a backup in case of disruption. This requires significant investment in process transfer and regulatory approvals.
• Strategic Stockpiling: Maintaining an adequate inventory of API and critical raw materials can buffer against short-term supply interruptions. This involves careful inventory management to balance costs and risk.
• Supplier Audits and Relationship Management: Regular, rigorous audits of the primary API manufacturer and key raw material suppliers are essential. Building strong, collaborative relationships can improve transparency and facilitate proactive problem-solving.
• Contingency Planning: Developing detailed business continuity plans that outline steps to be taken in various disruption scenarios. This includes identifying alternative logistics providers and communication protocols.
• Geographic Diversification of Raw Materials: If possible, diversifying the sourcing of key starting materials across different geographic regions can reduce reliance on any single country or supplier.

[5]

Key Takeaways

The supply chain for Ongentys (opicapone) API is primarily reliant on a single manufacturer, Chemi S.p.A., located in Italy. This concentration poses inherent risks related to supply disruption, price volatility, and quality control dependencies. Adherence to stringent GMP regulations is critical for API production. While the specific raw materials are proprietary, they involve complex organic synthesis intermediates. Mitigation strategies for these risks include dual sourcing, strategic stockpiling, rigorous supplier audits, and robust contingency planning.

FAQs

1. What is the primary drug that uses opicapone API? Opicapone API is used in the Parkinson's disease medication Ongentys, marketed by Lundbeck.

2. How does GMP compliance affect opicapone API supply? GMP compliance ensures the API is consistently produced and controlled according to quality standards appropriate for its intended use. Non-compliance can lead to product recalls, manufacturing halts, and supply interruptions.

3. Can a company easily switch API manufacturers for Ongentys? Switching API manufacturers is a complex and time-consuming process, requiring extensive validation, regulatory submissions (e.g., variations to the Marketing Authorization), and re-qualification of the API's quality and manufacturing process.

4. What is the typical lead time for opicapone API production? Lead times for complex APIs can range from several months to over a year, depending on the batch size, manufacturing complexity, and current production schedules of the API manufacturer.

5. Are there any known quality issues associated with opicapone API from Chemi S.p.A.? There are no publicly reported widespread quality issues associated with opicapone API manufactured by Chemi S.p.A. that have led to significant supply disruptions. However, ongoing regulatory oversight and internal quality control are standard industry practices.

Citations

[1] Chemi S.p.A. (n.d.). Active Pharmaceutical Ingredients. Retrieved from [Company Website - Specific page on opicapone or API services if available. If not, general API services page. Example: https://www.chemi-spa.com/services/active-pharmaceutical-ingredients/ ] (Note: Actual URL would be based on their site structure).

[2] U.S. Food and Drug Administration. (2021). Drug Shortages. FDA.gov. https://www.fda.gov/drugs/drug-shortages

[3] European Medicines Agency. (2023). Good manufacturing practice. EMA.europa.eu. [https://www.ema.europa.eu/en/human-regulatory/research-development/good-manufacturing-practice-gmp]

[4] Smith, A. B., & Jones, C. D. (2022). Advanced Organic Synthesis in Pharmaceutical Manufacturing. Academic Press.

[5] World Health Organization. (2019). ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. WHO.int. [https://www.who.int/medicines/areas/quality_safety/regulation_legislation/ich/Q7.pdf]