neupro: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829	NDA	UCB, Inc.	50474-801-03	30 POUCH in 1 CARTON (50474-801-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH	2012-04-02
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829	NDA	UCB, Inc.	50474-801-17	7 POUCH in 1 CARTON (50474-801-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH	2012-04-02
Ucb Inc	NEUPRO	rotigotine	FILM, EXTENDED RELEASE;TRANSDERMAL	021829	NDA	UCB, Inc.	50474-802-03	30 POUCH in 1 CARTON (50474-802-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH	2012-04-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Neupro, a transdermal patch formulation of the dopaminergic agent rotigotine, stands as a vital therapeutic product for Parkinson's disease and restless legs syndrome (RLS). As a specialty medication, Neupro's supply chain is critical to meeting clinical demand, especially given the global incidence of Parkinson's and related disorders. Understanding its suppliers—from active pharmaceutical ingredient (API) providers to patch manufacturing companies—is essential for stakeholders aiming to secure reliable access, assess supply chain risks, or analyze market dynamics.

Manufacturing and Supply Chain Overview

Neupro’s complex formulation involves multiple stages: API manufacturing, formulation development, patch production, and distribution. Each stage depends on specialized suppliers, primarily located across North America, Europe, and Asia. The supply chain intricacies include sourcing high-purity rotigotine API, manufacturing adhesive layers, and ensuring stringent quality control to meet regulatory standards set by agencies such as the FDA and EMA.

Active Pharmaceutical Ingredient (API) Suppliers

Rotigotine API manufacturers are pivotal to Neupro’s supply chain. Several companies produce rotigotine under strict quality protocols, often serving multiple pharmaceutical firms. Key API suppliers include:

Sun Pharmaceutical Industries Ltd.: A major player with manufacturing facilities in India and the United States, Sun Pharma supplies rotigotine API to various formulations, including patch delivery systems. Its capacity and compliance with international standards make it a significant supplier in this space [1].
MEP Metrics/NIH: Some research institutions have supplied research-grade rotigotine, but commercial production predominantly resides within pharmaceutical companies.
CMOs (Contract Manufacturing Organizations): Several CMOs in India, China, and Europe engage in custom synthesis of rotigotine API, often under confidentiality agreements, for clients seeking to produce Neupro or similar formulations.

Given the criticality of API purity and stability, the original developer of rotigotine, UCB S.A., historically managed or contracted specific API manufacturing lines to ensure supply quality and consistency.

Formulation and Patch Manufacturing Suppliers

Leading pharmaceutical companies and specialized contract manufacturers oversee Neupro’s patch production:

UCB S.A.: The original developer and patent holder of Neupro, UCB remains a principal manufacturer, controlling the formulation process and ensuring the product's consistent quality. Their manufacturing facilities in Belgium and South Korea are equipped for large-scale production.
Merck KGaA (Darmstadt): Historically involved in contract manufacturing of pharmaceutical forms, Merck's related divisions may participate in active components or formulation phases, although specific involvement with Neupro remains proprietary.
CMOs and Contract Manufacturers: Several contract manufacturing organizations (CMOs) are engaged globally to produce components such as adhesive layers and patches, often under licensing agreements with patent holders like UCB.

The involvement of CMOs enables scalability and diversification of supply sources, particularly in response to market demands and geopolitical considerations.

Distribution and Market Access

Distribution channels for Neupro involve:

Generic Manufacturers: After patent expiration, multiple generic companies have entered the market, sourcing APIs from various suppliers and manufacturing patches in their facilities.
Regional Suppliers: In certain markets, local pharmaceutical firms produce authorized generics or authorized copies, often sourcing APIs from regional suppliers meeting local regulatory standards.

Given regulatory constraints and patent protections, original manufacturers like UCB control much of the initial supply chain, with third-party suppliers and generic companies filling market gaps subsequently.

Regulatory and Quality Considerations

Suppliers for Neupro must adhere to Good Manufacturing Practice (GMP) standards as mandated by authorities such as the FDA and EMA. The complexity of transdermal systems also demands rigorous quality assurance for adhesive stability, drug release profiles, and patch durability.

Regulatory approval processes often specify approved suppliers, especially for API components. Companies seeking to supply rotigotine API or reinforce supply chains must demonstrate compliance with these standards. Any disruption—such as supplier shortages, regulatory hurdles, or geopolitical issues—can impact Neupro’s market availability.

Market Dynamics and Supplier Risks

The supply landscape for Neupro is subject to various factors:

Patent expirations have prompted the entry of generic manufacturers, diversifying supply sources and potentially lowering costs but also complicating supplier credentials.
Supply disruptions: The concentration of API manufacturing in specific geographies, notably India and China, exposes the supply chain to geopolitical, logistical, and quality risks.
Manufacturing capacity constraints: High demand for Parkinson's medications can stress manufacturing lines, emphasizing the importance of diverse suppliers.
Regulatory changes: Updates in approval standards can restrict or expand supplier options, influencing availability.

Conclusion

The supply of Neupro hinges on a network of high-quality API manufacturers, formulation specialists, and contract manufacturers. Original developer UCB retains a significant role, but the landscape has increasingly diversified, especially following patent expirations and market entry of generics. Ensuring the stability of supply requires ongoing monitoring of supplier compliance, geopolitical factors, and manufacturing capacity—all vital considerations for healthcare providers, distributors, and policymakers.

Key Takeaways

Primary API suppliers include Sun Pharma and various CMOs in India and Europe, with UCB maintaining a critical manufacturing role.
Formulation and patch manufacturing involve both original developers and specialized CMOs, enabling scalability and supply diversification.
Regulatory standards and quality controls are crucial at every stage, affecting both supplier selection and market access.
Market dynamics shift with patent expirations, generics proliferation, and geopolitical risks, impacting supply stability.
Supply chain resilience necessitates diversified sourcing strategies, close regulatory oversight, and contingency planning.

FAQs

1. Who are the primary suppliers of rotigotine API for Neupro?
Sun Pharmaceutical Industries Ltd. is among the leading API suppliers, along with various CMOs in India and Europe engaged in custom synthesis, under strict compliance with GMP standards [1].

2. Does UCB still manufacture Neupro components?
Yes. UCB remains a principal manufacturer for Neupro, especially for formulation and patch assembly, leveraging their specialized facilities in Belgium and South Korea.

3. Have generics impacted the supply chain of Neupro?
Absolutely. Patent expirations have led to multiple generic entrants, sourcing APIs from diverse suppliers, which broadens supply options but also introduces variability and potential quality considerations.

4. What risks threaten the supply stability of Neupro?
Risks include API supply disruptions from geopolitical issues, manufacturing capacity constraints, regulatory changes, and quality non-compliance among suppliers.

5. How do regulatory standards influence supplier options?
Regulatory approvals require suppliers to meet strict GMP standards, and only approved suppliers are permitted for high-quality production, which can limit or expand sourcing depending on regulatory updates.

References

[1] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[2] European Medicines Agency (EMA). Neupro (rotigotine) Summary of Product Characteristics.
[3] UCB S.A. Corporate Website and Product Portfolio.
[4] FDA Drug Approvals and Regulatory Guidance Documents.

Suppliers and packagers for neupro

neupro

Suppliers for the Pharmaceutical Drug: Neupro