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Suppliers and packagers for RELENZA
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RELENZA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036 | NDA | GlaxoSmithKline LLC | 0173-0681-01 | 5 PACKAGE in 1 CARTON (0173-0681-01) / 4 POWDER in 1 PACKAGE | 1999-09-22 |
| Glaxosmithkline | RELENZA | zanamivir | POWDER;INHALATION | 021036 | NDA | GlaxoSmithKline LLC | 0173-0681-22 | 5 PACKAGE in 1 CARTON (0173-0681-22) / 4 POWDER in 1 PACKAGE | 1999-09-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RELEZNA
Introduction
Relenza (zanamivir) is an antiviral medication used primarily for the treatment and prevention of influenza. As a neuraminidase inhibitor, it impedes viral replication, offering a vital option in influenza management, especially during seasonal epidemics. Securing a reliable supply chain for Relenza is essential for pharmaceutical companies, healthcare providers, and governments to address influenza outbreaks effectively. This article provides a comprehensive overview of the key suppliers involved in the manufacturing and distribution of Relenza, analyzing their roles, manufacturing capacities, and strategic significance in the global pharmaceutical landscape.
Manufacturing Overview of Relenza
Relenza was developed by GlaxoSmithKline (GSK), which is responsible for its original manufacturing and commercialization. The production process involves the synthesis of zanamivir, a complex molecule that requires specialized facilities adhering to Good Manufacturing Practices (GMP). The drug is supplied via inhalation, necessitating specific device components that are often provided by third-party suppliers.
Since the patent expiration or geographic licensing agreements, several generic manufacturers have entered the market, especially in regions like India and China, diversifying the supply chain and increasing global availability.
Primary Original Supplier: GlaxoSmithKline
GSK remains the predominant supplier of Relenza, controlling the drug's manufacturing rights and distribution channels. The company operates multiple production sites across Europe and North America, equipped with advanced facilities capable of large-scale zanamivir synthesis. These facilities ensure compliant, high-quality production aligned with global standards.
Key points:
- Manufacturing Sites: Multiple GSK facilities across Europe and the U.S.
- Capacity: Capable of producing millions of treatment courses annually.
- Distribution: Global, with a focus on North America, Europe, and select Asian markets.
GSK’s strategic partnerships sometimes involve licensing agreements with regional manufacturers to extend product reach, particularly in emerging markets.
Generic Manufacturers of Zanamivir
Post-patent, several generic pharmaceutical companies have secured approval to produce zanamivir, enhancing supply security. These manufacturers often operate under strict quality controls, adhering to international standards such as GMP, ISO, and WHO prequalification.
Key Generic Suppliers
1. Cipla (India)
Cipla is one of the leading manufacturers of zanamivir, with extensive experience in respiratory and antiviral therapeutics. The company’s manufacturing suite includes high-capacity facilities approved by the Drugs Controller General of India (DCGI) and international regulators. Cipla supplies zanamivir both domestically and internationally, including to markets with generic substitution policies.
2. Dr. Reddy’s Laboratories (India)
Another major player, Dr. Reddy’s, produces zanamivir for multiple regions, especially Asia and Latin America. Their facilities meet US FDA, EMA, and WHO standards, ensuring product quality.
3. Sandoz (Novartis)
Sandoz, a Novartis division, has manufacturing capabilities in Europe and the U.S., providing zanamivir for both the generic market and regional supply partnerships. Their facilities maintain high compliance standards.
4. Zhejiang Hisun Pharmaceutical (China)
As a significant generic producer in China, Hisun has expanded its portfolio to include antiviral agents, including zanamivir, catering to domestic and export markets.
5. Others
Additional regional players include Hetero Labs (India), Gilead Sciences (for competing antivirals), and local manufacturers in Brazil and Russia, each contributing to supply diversification.
Device and Inhaler Components Suppliers
Relenza's inhalation delivery system necessitates specialized device components, including inhalers and nebulizers. These are often supplied by third-party device manufacturers:
- Viatris (formerly Mylan): Supplies compatible inhalation devices for generic zanamivir.
- Philips Respironics and Pari: Provide nebulizer systems used in hospital settings.
- Custom device manufacturers vary by region, with some jurisdictions developing locally produced inhalers to mitigate supply disruptions.
Device manufacturing involves rigorous testing and calibration to ensure accurate drug delivery, and supplies are synchronized with active pharmaceutical ingredient (API) production.
Supply Chain Dynamics and Geographic Diversification
The supply of Relena is affected by various factors, including manufacturing capacities, regulatory approvals, regional licensing, and geopolitical stability. The mid-2020s have witnessed increased diversification efforts, with manufacturers shifting towards local production in Africa, Asia, and Latin America to ensure buffer stocks against global disruptions.
Impacts of Supply Chain Contingencies
- Regulatory Approvals: Eased pathways for generic approvals in developing regions bolster supply.
- Pandemic Effects: COVID-19 highlighted vulnerabilities in global supply chains, prompting manufacturers to diversify sources.
- Market Demand Fluctuations: Anticipated seasonal surges influence inventory planning among suppliers.
Strategic Considerations for Stakeholders
- Verification of Regulatory Compliance: Ensuring suppliers maintain GMP standards and possess proper licensing to prevent counterfeit or substandard products.
- Supply Agreement Stability: Long-term contracts reduce shortages, particularly with regional manufacturers.
- Diversification: Relying on multiple suppliers mitigates risks linked to geopolitical issues or manufacturing disruptions.
- Monitoring Capacity Expansion: Tracking capacity increases in emerging markets provides insights into future supply stability.
Conclusion
The supply landscape for Relenza revolves around a mix of original manufacturing by GSK and a broad base of generic producers across Asia and other regions, complemented by specialized device component suppliers. Strengthening supply security involves diligent oversight of manufacturing quality, regulatory compliance, and regional licensing agreements. Given the global reliance on this antiviral during influenza seasons and health emergencies, supply chain resilience remains a priority for manufacturers, regulators, and healthcare systems.
Key Takeaways
- GSK leads in the manufacturing and distribution of Relenza, with extensive global infrastructure.
- Multiple Indian and Chinese generic manufacturers—such as Cipla, Dr. Reddy’s, and Zhejiang Hisun—have become vital suppliers, increasing global availability.
- Device component suppliers are integral to ensuring effective drug delivery; partnerships with device manufacturers are critical.
- Diversification of supply sources and regional manufacturing expansion mitigate risks of shortages.
- Rigorous regulatory oversight and long-term agreements ensure consistent product quality and supply stability.
FAQs
Q1. Who are the main producers of zanamivir for Relenza?
The primary original producer is GlaxoSmithKline, while notable generic manufacturers include Cipla, Dr. Reddy’s Laboratories, and Sandoz.
Q2. Are there regional differences in Relenza supply?
Yes. While GSK supplies globally from its manufacturing sites, regional generic manufacturers enhance availability in Asia, Latin America, and Africa, often under licensing agreements.
Q3. What role do device component suppliers play in Relenza’s supply?
They provide inhaler and nebulizer components essential for drug delivery, often sourced from specialized medical device manufacturers to meet regulatory standards.
Q4. How does patent expiration influence the supply chain?
Patent expiration opens markets for generic manufacturers, increasing the number of suppliers and enhancing supply security, provided quality standards are maintained.
Q5. What challenges could disrupt Relenza’s supply chain?
Regulatory changes, manufacturing disruptions, geopolitical conflicts, and global health crises—like pandemics—pose risks to consistent supply.
References
- GSK official product information.
- Indian Ministry of Health & Family Welfare, DCGI approvals.
- WHO Prequalification database.
- Industry reports on antiviral manufacturing capacities[1].
- Market analyses on generic drug supplies in Asia[2].
This comprehensive overview provides key insights necessary for pharmaceutical stakeholders aiming to secure and optimize the supply chain for Relenza in a competitive and evolving global environment.
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