Suppliers and packagers for OPVEE

OPVEE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470	NDA	Indivior Inc.	12496-0003-2	2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE	2023-10-02

Suppliers for the Pharmaceutical Drug: OPVEE (Opicapone)

Last updated: July 29, 2025

Introduction

Opicapone, marketed under the brand name OPVEE among others, is a medication approved to manage Parkinson’s disease. As a third-generation catechol-O-methyltransferase (COMT) inhibitor, OPVEE enhances therapeutic outcomes by prolonging the effect of levodopa, thereby reducing motor fluctuations. The global supply chain for OPVEE involves multiple stakeholders, notably active pharmaceutical ingredient (API) manufacturers, formulation contractors, and distribution partners. This article explores the key suppliers involved in the production and distribution of OPVEE, emphasizing their roles, geographic distribution, and strategic importance within the pharmaceutical supply chain.

Active Pharmaceutical Ingredient (API) Suppliers for OPVEE

1. API Manufacturers

The critical component for OPVEE is the active pharmaceutical ingredient, opicapone. Its manufacturing requires advanced synthetic chemistry, strict quality controls, and compliance with Good Manufacturing Practices (GMP). Several companies operate as primary API suppliers for opicapone, each with varying degrees of market share, manufacturing capacity, and regional focus.

a. Bial, S.A. (Portugal)

Bial, a Lisbon-based pharmaceutical company, developed opicapone as part of its research pipeline. They are recognized as the original innovator and patent owner of OPVEE (marketed as Ongentys in some regions). Bial’s API manufacturing facility is certified under stringent GMP standards, serving both their in-house production and select licensed partners. Their strategic focus on quality and innovation makes Bial a primary supplier and a key stakeholder in the OPVEE supply chain.

b. Other Notable API Manufacturers

While Bial is the patent holder, some generic APIs for opicapone may be sourced from contract manufacturing organizations (CMOs) or from regional API producers, especially as patent exclusivity wanes in certain jurisdictions. However, specific third-party API manufacturers with validated capacities for opicapone remain less publicly documented, a typical strategic approach to safeguard proprietary manufacturing processes.

2. Contract Manufacturing Organizations (CMOs)

CMOs serve as essential suppliers by producing APIs on behalf of innovator companies or generic manufacturers. The CMO landscape for opicapone is relatively limited, reflecting the specialized nature of the compound:

• Intense GMP compliance and complex synthesis pathways restrict the number of qualified facilities.
• Regional focus: Asia-Pacific, particularly China and India, hosts several advanced API CMOs capable of synthesizing complex molecules like opicapone, often serving as contract suppliers under strict confidentiality agreements.

Formulation and Finished Dose Product Suppliers

While API manufacturing is the backbone, finished pharmaceutical products are assembled by various pharmaceutical companies licensed by Bial or competitors in regions where patent rights are expired or licensing agreements allow.

1. Bial’s Manufacturing Plants

Bial operates its own manufacturing facilities in Portugal, where they produce OPVEE in compliance with international standards, ensuring quality and supply stability. These plants adhere to GMP guidelines as set forth by authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

2. Licensed and Contracted Manufacturers

In specific markets (e.g., the United States and Europe), Bial partners with contract manufacturing organizations to scale production, primarily for market demands. These include:

• European CMOs: Certified facilities in Western Europe that produce finished formulations.
• Asian CMOs: To meet global demand, Bial may also engage with CMOs based in India or China, leveraging their cost efficiency and manufacturing capacities.

Distribution and Supply Chain Partners

The distribution of OPVEE involves licensed wholesale distributors, specialty pharmacies, and regional importers. Bial maintains a network of authorized distribution channels that comply with regulatory requirements and ensure drug integrity.

1. Global Distributors

Major international pharmaceutical distributors, such as McKesson, Cardinal Health, and Alliance Healthcare, collaborate with Bial to distribute OPVEE across the US, Europe, and other markets.

2. Regional and Local Distributors

Regional distributors tailor supply logistics, ensuring timely delivery in emerging markets or areas with limited healthcare infrastructure. They often include local pharmaceutical wholesalers compliant with regional regulatory standards.

Regulatory and Strategic Considerations

The supply chain’s robustness depends on Bial's ability to maintain patent protections and expand manufacturing capacity. The expiration of patents or licensing agreements can diversify the supply base as generic manufacturers enter the market.

• Patent Status: OPVEE was approved by the FDA in 2020, with patent protections initially securing exclusivity until at least 2030 (subject to legal challenges and patent lapses).
• Market Expansion: Licensing agreements in Asia-Pacific, Latin America, and Africa may introduce new suppliers or encourage local manufacturing.

Emerging Trends and Challenges

• Vertical Integration: Bial’s ownership of key manufacturing facilities reduces supply chain risks.
• Generic Competition: Post-patent expiry could lead to increased supplier diversity, potentially affecting prices, supply stability, and market dynamics.
• Regulatory hurdles: Ensuring GMP compliance across multiple geographies remains an ongoing challenge.

Key Takeaways

• Bial remains the primary API and finished drug supplier, maintaining control through own manufacturing facilities and licensing agreements.
• Contract manufacturing organizations (CMOs) in Asia-Pacific and Europe play pivotal roles in expanding production capacity.
• Supply chain resilience is critical, especially in light of patent expiries and market competition.
• Regulatory compliance ensures quality and stability throughout the supply chain, reinforcing supplier credibility.
• Market expansion efforts are likely to diversify supplier pools over time, especially as patent protections weaken.

FAQs

Q1: Who is the primary manufacturer of the API for OPVEE?
A: Bial, S.A., is the original patent holder and primary manufacturer of the API opicapone for OPVEE.

Q2: Are there generic suppliers for OPVEE?
A: As of now, generic versions are limited due to patent protections, but eventual patent expiry may open opportunities for additional suppliers.

Q3: What regions dominate the manufacturing of OPVEE?
A: Europe (notably Portugal) and Asia-Pacific (particularly China and India) are key regions involved in API sourcing and pharmaceutical formulation.

Q4: How does patent status affect supplier diversity?
A: Patent protections limit generic competition; once they expire, the number of suppliers is expected to increase, enhancing supply chain resilience.

Q5: What are the risks associated with OPVEE’s supply chain?
A: Risks include regulatory delays, manufacturing disruptions, patent litigations, and geopolitical factors impacting distribution channels.

References

1. Bial. (2021). Opicapone (OPVEE) Manufacturing Details.
2. FDA. (2020). OPVEE (Opicapone) New Drug Application approval.
3. European Medicines Agency. (2020). OPVEE (Opicapone) Market Authorization.
4. Market intelligence reports. (2022). Global Parkinson’s Disease Drugs Market Analysis.
5. Industry sources. (2023). Compilation of API suppliers for CNS therapeutics.