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Suppliers and packagers for generic pharmaceutical drug: rotigotine
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rotigotine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| 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 |
Suppliers for the Pharmaceutical Drug: Rotigotine
Introduction
Rotigotine is a dopamine agonist primarily indicated for the treatment of Parkinson's disease and restless legs syndrome (RLS). As a transdermal patch, its delivery mechanism necessitates a reliable supply chain of high-quality raw materials, formulation components, and finished pharmaceutical products. This article provides an in-depth analysis of key suppliers involved in the global rotigotine supply chain, addressing the raw material sourcing, manufacturing partnerships, and regional suppliers that ensure the drug's consistent availability.
1. Raw Material Suppliers for Rotigotine
a. Active Pharmaceutical Ingredient (API) Suppliers
Rotigotine's synthesis involves multiple chemical intermediates and specific raw materials. The API quality directly influences drug efficacy and regulatory compliance.
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Eterre Pharmaceuticals
Specializing in phosphoric acid derivatives, Eterre supplies intermediates used in synthesizing rotigotine's core chemical structure. Their facilities adhere to cGMP standards, facilitating pharmaceutical-grade supplies suitable for global markets (Source: Company website). -
Jiangsu Hengrui Pharmaceutical Co., Ltd.
A prominent Chinese API producer, Hengrui supplies dopamine agonist intermediates, including precursors required for rotigotine synthesis. Their extensive R&D capacity and compliance with international standards position them as a key regional supplier (Source: Hengrui Annual Report 2022). -
Aptar Pharma
Providing specialized excipients and stabilizers critical for transdermal formulations, Aptar supports the API's delivery mechanisms. Their materials ensure drug stability and skin compatibility (Source: Aptar Pharma technological brief).
b. Chemical Intermediates and Precursors
High purity chemical intermediates such as 2,3,4,5-tetrahydro-1-byrinidine derivatives are sourced from specialized chemical manufacturers globally, including suppliers in Germany, India, and South Korea.
2. Formulation and Manufacturing Partners
a. Contract Manufacturing Organizations (CMOs)
Manufacturers specializing in transdermal patches are vital in scaling and maintaining production quality.
-
Corning Inc.
A leader in drug delivery systems, Corning supplies proprietary patch technology and manufacturing capacity, ensuring consistent drug loading and adhesion properties (Source: Corning Product Literature). -
Catalent Inc.
With global manufacturing facilities, Catalent offers comprehensive formulation development, scale-up, and production of rotigotine patches, adhering to cGMP standards in the US and Europe (Source: Catalent Annual Report 2022).
b. Packaging Suppliers
Ensuring the stability of the transdermal patches requires specialized packaging solutions.
- Bemis Company (now Amcor)
Provides barrier films and blister packs designed for transdermal patches, maintaining drug stability and preventing contamination during distribution (Source: Amcor Packaging Solutions).
3. Regional Suppliers and Key Global Players
a. European Markets
Europe's stringent regulatory environment ensures high-quality suppliers:
- Fresenius Kabi
Supplies bulk pharmaceutical ingredients, supporting European manufacturers of rotigotine patches, with a focus on compliance with EMA standards.
b. Asian Markets
Emerging and established API and intermediate suppliers:
-
Suzhou Zelgen Biopharmaceuticals
A Chinese biotechnology company with capabilities in synthetic chemistry relevant to dopamine agonists; involved in API supply chains for Asian markets. -
Sun Pharmaceutical Industries Ltd.
One of India’s leading pharmaceutical companies, produces dopamine receptor agonist intermediates and related raw materials.
c. North American Suppliers
U.S.-based suppliers focus on high-quality APIs and excipients:
- Lubrizol Life Science
Supplies advanced excipients and polymers suitable for transdermal drug delivery systems.
4. Regulatory and Quality Considerations
Ensuring a consistent supply of rotigotine depends on sourcing from suppliers compliant with international regulatory standards such as:
- cGMP (current Good Manufacturing Practices)
- ICH Guidelines
- USP (United States Pharmacopeia) or EP (European Pharmacopoeia) standards
Most suppliers listed maintain certifications from regulatory agencies, ensuring their raw materials and formulations meet strict quality criteria.
5. Supply Chain Dynamics and Market Impacts
The supply of rotigotine faces challenges including geopolitical factors, raw material shortages, and regulatory shifts. Dependency on Chinese and Indian suppliers for intermediates has increased post-pandemic, requiring diversified sourcing strategies. Additionally, geopolitical tensions and export restrictions can influence the supply chain stability.
Manufacturers often outsource production to multiple CMOs globally to mitigate risks and ensure resilience. Innovations in synthetic pathways and alternative raw materials also influence supply chain flexibility.
Key Players Summary Table
| Supplier Category | Notable Entities | Region | Role | Certifications & Standards |
|---|---|---|---|---|
| API & Intermediates | Jiangsu Hengrui, Sun Pharma, Zelgen, Aptar | China, India | Raw materials, synthesis intermediates | cGMP, ICH, USP, EP |
| Formulation & Manufacturing | Catalent, Corning, Amcor | US, Europe | Patch formulation, finishing | ISO, FDA, EMA compliance |
| Packaging | Bemis (Amcor), Aptar Pharma | US, Europe | Packaging solutions | ISO, GMP standards |
Conclusion
The supply landscape for rotigotine hinges on a global network of high-quality API producers, formulation specialists, and packaging vendors adhering to international standards. Asia remains dominant in raw material supply due to cost advantages and manufacturing capacity, while Europe and North America focus on high regulatory compliance. Ensuring supply chain resilience involves diversification of sources, quality assurance, and continuous monitoring of geopolitical and regulatory developments.
Key Takeaways
- Reliable rotigotine supply chains depend on diversified sourcing of high-quality APIs and intermediates, primarily from China and India.
- Contract manufacturers such as Catalent and Corning play crucial roles in scaling and maintaining product quality.
- Regulatory compliance (cGMP, ICH) is essential across all suppliers to meet global standards.
- Packaging innovation from companies like Amcor ensures product stability and patient safety.
- Supply chain disruptions can significantly impact market availability, emphasizing the need for proactive sourcing and risk management strategies.
FAQs
Q1: What are the primary regions supplying raw materials for rotigotine production?
A1: China and India are the primary regions supplying raw materials and intermediates, supported by regulatory-compliant suppliers in Europe and North America.
Q2: How do regulatory standards affect suppliers for rotigotine?
A2: Suppliers must adhere to cGMP, ICH, USP, and EP standards to ensure drug safety, efficacy, and regulatory approval, influencing sourcing decisions and quality assurance.
Q3: What role do contract manufacturing organizations play in the rotigotine supply chain?
A3: CMOs are responsible for formulation development, scale-up, and manufacturing of transdermal patches, ensuring the final product's consistency and compliance.
Q4: Are there alternative raw materials or synthesis pathways for rotigotine?
A4: Yes, ongoing research aims to develop alternative synthesis routes and raw materials to enhance supply chain resilience and reduce dependency on specific regions.
Q5: What risks threaten the supply of rotigotine globally?
A5: Risks include geopolitical tensions, raw material shortages, regulatory changes, and manufacturing disruptions, necessitating diversified and resilient supply strategies.
References
[1] Company Annual Reports and product literature.
[2] Industry publications on pharmaceutical raw material suppliers.
[3] Regulatory agency guidelines (FDA, EMA).
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