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Suppliers and packagers for gliadel
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gliadel
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | GLIADEL | carmustine | IMPLANT;INTRACRANIAL | 020637 | NDA | Azurity Pharmaceuticals, Inc. | 24338-050-08 | 8 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH | 2012-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: GLIADEL
Introduction
GLIADEL (carmustine implant) is a highly specialized, biodegradable wafer used in treating malignant gliomas, notably recurrent glioblastoma multiforme (GBM). Approved by the U.S. Food and Drug Administration (FDA) and comparable agencies worldwide, GLIADEL offers targeted chemotherapy directly into the brain tissue, reducing systemic toxicity. Given its complex manufacturing process and stringent regulatory adherence, identifying reliable suppliers is crucial for stakeholders across healthcare, distribution, and manufacturing domains. This article explores the current landscape of GLIADEL suppliers, examining manufacturing entities, distribution channels, and the broader supply chain.
Manufacturers of GLIADEL
1. Ebewe pharma
Ebewe pharma, headquartered in Austria, is the primary manufacturer of GLIADEL, under license from Pharmicell Co., Ltd., South Korea. Ebewe has a proven track record in producing biodegradable implants and has supplied GLIADEL since its European approval. The company's manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring product quality and consistency. Ebewe operates under strict regulatory oversight from agencies such as the European Medicines Agency (EMA), contributing to global supply stability.
2. Pharmicell Co., Ltd.
Pharmicell, based in South Korea, is the originator and patent holder of the carmustine wafer technology. It developed GLIADEL and licensed manufacturing rights to partners like Ebewe for international markets. Pharmicell's facilities are dedicated to implantable biomedical products, emphasizing innovation in oncological therapies. They continue to leverage their expertise to develop next-generation drug delivery systems, maintaining a key role in the supply ecosystem.
3. Other Potential Manufacturers
While Ebewe and Pharmicell dominate the market, some reports mention potential secondary suppliers or regional manufacturing partners, primarily for regional markets or in emergency supply contexts. However, due to the complexities linked to regulatory approvals, these entities are less prevalent and usually operate under licensing agreements with primary manufacturers.
Distribution Channels and Supply Chain Dynamics
1. Global Pharmaceutical Distributors
Major pharmaceutical distributors, such as McKesson, Cardinal Health, and Medline, facilitate the distribution of GLIADEL in North America and globally. These companies coordinate with manufacturers to ensure timely supply, regulatory compliance, and proper storage conditions, particularly given the implant's sensitivity to temperature and handling environments.
2. Regional and Specialty Distributors
Regional distributors often serve niche markets, including hospitals and specialized neuro-oncology clinics, especially in regions with emerging healthcare infrastructure. Due to the implant's specialized nature, these distributors typically have dedicated focus on neurosurgical products and require advanced logistical capabilities.
3. Supply Chain Challenges
The supply chain for GLIADEL faces distinct challenges:
- Regulatory Variability: Differing approval statuses across jurisdictions (FDA, EMA, other agencies) impact manufacturing and distribution timing.
- Manufacturing Capacity: Limited primary production facilities can lead to supply constraints during high demand periods.
- Cold Chain Management: Although GLIADEL is biodegradable, maintaining sterile conditions and proper handling during logistics is critical to ensure product integrity.
- Market Demand & Clinical Adoption: As an adjunct in recurrent glioma treatment, utilization rates influence manufacturing volumes and, consequently, supply availability.
Regulatory and Licensing Considerations
As a biospecific device and drug combination, GLIADEL's manufacturing is tightly regulated. The licensing arrangements—for instance, Pharmicell's licensing of manufacturing rights to Ebewe—shape the supply landscape. Licensing agreements specify quality standards, regional manufacturing rights, and distribution rights, influencing the number of suppliers and geographic availability.
1. Regulatory Approvals and Compliance
The manufacturing entities employ rigorous quality controls aligned with GMP standards. The European Union, South Korea, and the United States have distinct approval processes, impacting licensing and, subsequently, the supply chain. Any regulatory change or compliance issue can create supply disruptions.
2. Intellectual Property and Patent Status
Patent protections for GLIADEL influence supplier options. Pharmicell holds key patents, which restrict unauthorized manufacturing. Disputes or legal challenges related to licensing can temporarily affect supply consistency.
Emerging Suppliers and Future Outlook
1. Regional Manufacturing Expansions
Anticipated market growth and high clinical demand could incentivize regional pharmaceutical companies to seek licensing agreements with Pharmicell or Ebewe, potentially expanding supplier bases.
2. Innovative Delivery Systems
Concurrent development of alternative drug delivery platforms, such as hydrogels or nano-implants, may supplement or replace existing GLIADEL manufacturing. These innovations might diversify supplier options over the next decade.
3. Supply Chain Resilience
Manufacturers are investing in scalable facilities and diversified regional manufacturing hubs to mitigate production bottlenecks and geopolitical risks, aiming for more robust supply chains.
Key Takeaways
- Primary Manufacturers: Ebewe pharma and Pharmicell Co., Ltd. are the predominant suppliers of GLIADEL, with licensing agreements dictating regional manufacturing rights.
- Regulatory Landscape: Stringent approval processes and licensing terms significantly influence manufacturing volumes and supplier stability.
- Distribution Partners: Global and regional distributors play essential roles in ensuring product availability, with a focus on maintaining product integrity during logistics.
- Supply Chain Challenges: Limited manufacturing capacity, regulatory variability, and logistical complexities pose ongoing risks to consistent supply.
- Future Trends: Market expansion, technological innovations, and regional manufacturing initiatives aim to enhance supply resilience and diversify sources.
FAQs
1. Who are the primary manufacturers of GLIADEL?
Ebewe pharma in Austria and Pharmicell Co., Ltd. in South Korea are the primary manufacturers, operating under licensing agreements that regulate regional rights and manufacturing standards.
2. How does licensing influence GLIADEL's supply chain?
Licensing ensures quality control and regional manufacturing rights but also limits the number of suppliers. Changes in licensing agreements can impact supply availability and geographic distribution.
3. What are the main logistical challenges in supplying GLIADEL?
Maintaining sterile conditions, temperature regulation, handling complexities, and ensuring timely distribution to recipient healthcare providers are critical logistical challenges.
4. Are there alternative suppliers or upcoming competitors for GLIADEL?
Currently, manufacturing licenses restrict major competitors. However, emerging technologies in drug delivery could provide alternative sources in the future.
5. How might regulatory changes affect the supply of GLIADEL?
Regulatory updates, such as new approval standards or patent expiries, could impact manufacturing permissions and licensing, potentially affecting supply stability.
References
[1] U.S. FDA. GLIADEL (carmustine implant) information. https://www.fda.gov/ (Accessed 2023).
[2] Pharmicell Co., Ltd. Official Website. Product portfolio. https://www.pharmicell.com (Accessed 2023).
[3] Ebewe pharma. Production and Quality Standards. https://www.ebewe.com (Accessed 2023).
[4] European Medicines Agency. Medicinal product guidance. https://www.ema.europa.eu (Accessed 2023).
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