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Suppliers and packagers for azilect
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azilect
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3060-56 | 30 TABLET in 1 BOTTLE (0093-3060-56) | 2017-01-03 |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3061-56 | 30 TABLET in 1 BOTTLE (0093-3061-56) | 2017-01-03 |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA | Teva Neuroscience, Inc. | 68546-142-56 | 30 TABLET in 1 BOTTLE (68546-142-56) | 2006-07-10 |
| Teva | AZILECT | rasagiline mesylate | TABLET;ORAL | 021641 | NDA | Teva Neuroscience, Inc. | 68546-229-56 | 30 TABLET in 1 BOTTLE (68546-229-56) | 2006-07-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AZILECT
Introduction
AZILECT (rasagiline) is a prescription medication developed by Teva Pharmaceuticals, primarily utilized in the management of Parkinson’s disease. As a selective monoamine oxidase B (MAO-B) inhibitor, AZILECT plays a crucial role in symptom control when combined with other treatments. Given its significance, understanding the supplier landscape for AZILECT is vital for stakeholders involved in healthcare procurement, distribution, and manufacturing supply chains. This article provides a comprehensive overview of the key suppliers, manufacturing dynamics, and implications for market access.
Manufacturing and Supply Chain Overview
AZILECT is manufactured using complex chemical synthesis processes, necessitating high-quality raw materials—primarily active pharmaceutical ingredients (APIs)—and stringent manufacturing controls. Teva Pharmaceuticals holds the primary patent and manufacturing rights for AZILECT, with their manufacturing facilities adhering to Good Manufacturing Practice (GMP) standards globally. However, the supply chain for AZILECT is not limited solely to Teva; it encompasses a network of raw material suppliers, contract manufacturers, and distribution channels.
Key Suppliers of Raw Materials
The core API, rasagiline mesylate, is synthesized through multi-step chemical processes involving specialized intermediates and raw materials sourced worldwide. The major API suppliers for rasagiline are often located in regions with advanced chemical manufacturing capabilities, including:
- China: A significant hub for bulk pharmaceutical chemicals due to cost-effective manufacturing and large-scale capacity.
- India: Known for robust pharmaceutical ingredient production, with numerous GMP-compliant manufacturers.
- Europe and North America: Some high-purity intermediates and key chemicals are sourced from these regions for quality assurance reasons.
Current market trends indicate that Teva may work with multiple API suppliers to ensure continuity of supply, mitigate geopolitical risks, and optimize costs. While exact supplier identities are often confidential, public procurement records and industry reports suggest the involvement of several ISO-certified chemical manufacturers specializing in MAO-B inhibitor intermediates[1].
Contract Manufacturing Organizations (CMOs)
Teva leverages Contract Manufacturing Organizations (CMOs) globally to produce AZILECT's finished dosage forms. These CMOs handle critical steps such as formulation, tablet compression, and packaging. Key regions involved include:
- India: Hosts multiple CMOs with extensive experience in neuropharmaceuticals.
- Europe: Known for high-quality manufacturing facilities with strict regulatory oversight.
- North America: Focused on distribution and final product assembly in compliance with local regulations.
Engaging multiple CMOs allows Teva to scale production rapidly and respond to fluctuating demand or supply disruptions.
Distribution Networks and Key Stakeholders
Post-manufacturing, AZILECT is distributed through various channels:
- Wholesalers and Distributors: Large pharmaceutical distributors in the U.S., Europe, and Asia facilitate broad accessibility.
- Direct Supply to Healthcare Institutions: Hospitals and clinics often source directly from authorized distributors.
Teva’s global distribution network maintains consistent API and finished product supply, leveraging logistics partners that specialize in temperature-controlled and time-sensitive pharmaceutical transport.
Market Dynamics and Supplier Risks
Supply chain resilience for AZILECT relies on diversification of API sources, geographic dispersion of manufacturing facilities, and robust quality assurance protocols. Disruptions—such as supply chain bottlenecks, geopolitical issues, quality failures, or regulatory changes—can impact availability. The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical supply chains, emphasizing the importance of local manufacturing capacity and strategic stockpiling[2].
Moreover, patent expiration or market competition may influence supplier arrangements. Although AZILECT remains under patent protection, generic entrants targeting rasagiline have begun entering the market, potentially altering procurement strategies and supplier dynamics.
Regulatory and Quality Considerations
Suppliers must adhere to stringent regulatory standards, including FDA, EMA, and other national agencies’ requirements. Good Manufacturing Practice (GMP) compliance ensures product safety and efficacy. Supply chain audits and quality control measures mitigate risks associated with substandard components, which could compromise therapeutic outcomes or lead to regulatory sanctions.
Emerging Trends and Opportunities
Recent developments in API synthesis—such as green chemistry approaches—are gradually transforming supply chains, reducing dependency on hazardous reagents, and lowering production costs. Additionally, manufacturers are increasingly transparent about their supply sources, fostering more resilient supply chains accessible to health authorities and end-users.
Advanced analytics facilitate monitoring supplier performance, forecasting demand, and optimizing inventory levels. These innovations support proactive management of AZILECT supply to meet global demand efficiently.
Conclusion
The supply of AZILECT hinges on a complex, multi-tiered network involving raw material suppliers predominantly based in China, India, and Europe; contract manufacturers across key regions; and an extensive distribution framework. Ensuring continuity requires strategic management, diversification of suppliers, adherence to regulatory standards, and proactive risk mitigation. As market dynamics evolve—particularly with the potential rise of generics—stakeholders must remain vigilant and adaptable to sustain supply chains.
Key Takeaways
- Diverse API Sourcing: Key raw materials are predominantly sourced from China and India, emphasizing the importance of multi-sourcing strategies for supply security.
- Global Manufacturing Flexibility: Teva relies on regional CMOs for formulation and packaging, ensuring adaptability and scalability.
- Regulatory Compliance: Suppliers must maintain GMP standards; quality assurance remains central to supply chain integrity.
- Market and Patent Dynamics: Patent protections and generic competition influence procurement strategies and supplier relationships.
- Supply Chain Resilience: Diversification, transparent sourcing, and technological innovations are vital in mitigating risks associated with disruptions.
FAQs
1. Who are the primary API suppliers for rasagiline (AZILECT)?
Mainly companies based in China and India specialize in the synthesis of rasagiline API, though specific supplier identities are often confidential due to commercial confidentiality. Large-scale chemical manufacturers adhering to GMP standards supply raw materials to ensure quality and consistency.
2. How does Teva ensure the quality of AZILECT’s raw materials?
Teva conducts rigorous supplier qualification processes, including audits, quality assessments, and compliance verification with international standards such as GMP. Continuous monitoring and third-party inspections help maintain high-quality standards.
3. Are there alternative manufacturers for AZILECT?
While Teva currently holds the patent and primary manufacturing rights, potential entrants or competitors may develop generic versions once patent exclusivity expires. This could introduce new manufacturing sources into the supply landscape.
4. What risks threaten the supply chain of AZILECT?
Risks include geopolitical tensions, raw material shortages, regulatory changes, manufacturing disruptions, and global health crises like COVID-19. Diversifying suppliers and maintaining strategic stockpiles mitigate these risks.
5. How might market competition influence AZILECT supply?
Introduction of generic rasagiline by other manufacturers can increase supply options, potentially reducing costs and improving access. However, it also necessitates careful quality assurance and regulatory oversight to ensure consistent therapeutic efficacy.
References
[1] Industry reports on pharmaceutical API supply chains, 2022.
[2] World Health Organization. “The Impact of COVID-19 on Pharmaceutical Supply Chains,” 2021.
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