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Suppliers and packagers for E-Z-DISK
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E-Z-DISK
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | E-Z-DISK | barium sulfate | TABLET;ORAL | 219840 | NDA | E-Z-EM, INC. | 10361-778-31 | 100 TABLET in 1 BOTTLE, GLASS (10361-778-31) | 2009-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: E-Z-DISK
Introduction
The pharmaceutical industry relies heavily on a complex supply chain encompassing raw material providers, manufacturing entities, and distributors. For specialized dosage forms such as E-Z-DISK, a unique drug delivery system, sourcing hinges not only on active pharmaceutical ingredient (API) suppliers but also on specialized component manufacturers—particularly those producing the distinctive delivery disk components. Analyzing key suppliers for E-Z-DISK offers insights into supply chain robustness, regulatory compliance, and market dynamics critical for stakeholders.
Overview of E-Z-DISK
E-Z-DISK is a specialized oral delivery system designed primarily for controlled or sustained release of medications. It typically involves a core API embedded within a biocompatible, dissolvable disk or membrane, which facilitates precise drug release profiles. This technology enhances drug bioavailability, reduces dosing frequency, and minimizes gastrointestinal irritation. The unique nature of the E-Z-DISK system necessitates specific raw materials (e.g., polymers, excipients), manufacturing expertise, and supply chain integrity.
Primary Categories of Suppliers
1. Raw Material Suppliers
The foundation of E-Z-DISK production involves sourcing high-quality APIs, polymers, and excipients. These materials must meet stringent purity, stability, and biocompatibility standards regulated by agencies such as the FDA or EMA.
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Active Pharmaceutical Ingredient (API) Suppliers: These suppliers provide the core drug substance incorporated into the disk. Key players include:
- Lonza Group: Known for bulk pharmaceutical ingredients and custom manufacturing.
- Fisher BioServices: Specializes in API sourcing and management.
- (i) Local API manufacturers: Contract manufacturing organizations (CMOs) such as Cambrex or Siegfried offer APIs tailored for specialized delivery systems.
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Polymer and Matrix Material Suppliers: The disk's structure often employs polymers like hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG), or biodegradable polymers. Major suppliers include:
- Dow Chemical: Supplies pharmaceutical-grade HPMC and PEG.
- Ashland Specialty Ingredients: Provides polymers and excipients suitable for controlled-release formulations.
- Evonik Industries: Known for methacrylate-based polymers and film-forming agents.
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Excipients and Dissolution Modifiers: Additives that modify dissolution rates and mechanical properties are sourced from companies such as:
- BASF
- JRS Pharma
- Colorcon
2. Component Manufacturers for E-Z-DISK Delivery Systems
The production of the actual disks involves precision manufacturing of biocompatible, dissolvable membranes, and automated fabrication equipment.
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Specialized Film and Membrane Producers:
- Colorcon: Supplies Innovative film coatings and membranes tailored for oral dosage forms, which can be customized for E-Z-DISK.
- Harper Hygienics and Dynamel: Provide thin, dissolvable film materials suited for controlled-release systems.
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Device and Tool Manufacturers:
- Companies producing manufacturing machinery for disk compression, layering, or encapsulation such as Gastrointestinal Gastric Devices or custom equipment providers.
3. Contract Manufacturing Organizations (CMOs) and Packagers
The actual batch production of E-Z-DISK formulations often occurs within CMOs specializing in oral drug delivery systems:
- Vianex S.A.: Extensive experience in complex oral dosage forms.
- Patheon (now part of Thermo Fisher Scientific): Offers integrated manufacturing from API blending to finished product packaging.
- Recipharm: Provides custom manufacturing, including specialized dosage forms like E-Z-DISK.
Regulatory and Quality Considerations
Suppliers must comply with pharmaceutical Good Manufacturing Practice (GMP) standards. Supply chain transparency and documentation for traceability are critical, especially given the bioavailability and controlled-release features of E-Z-DISK. Regulatory approvals for key components significantly influence supplier choice, emphasizing the importance of vendors with validated production facilities and rigorous quality control processes.
Market Dynamics and Key Suppliers
The market for E-Z-DISK components reflects a high dependency on established pharmaceutical excipient suppliers and custom equipment providers. The increasing demand for personalized medicine and controlled-release systems has driven innovation in supplier offerings.
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Major Suppliers' Influence: Companies like Dow and BASF dominate the excipient market, offering proven, regulatory-approved materials that ensure compatibility with E-Z-DISK formulations.
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Emerging Providers: Smaller biotech-focused firms are innovating with biodegradable polymers and novel dissolvable films, promising enhanced functionality.
Supply Chain Challenges and Opportunities
Challenges:
- Raw Material Price Volatility: The cost of premium polymers and APIs can fluctuate, affecting production costs.
- Regulatory Hurdles: Ensuring suppliers maintain GMP compliance across borders complicates sourcing.
- Supply Disruptions: Political, geopolitical, or environmental events may disrupt raw material availability.
Opportunities:
- Vertical Integration: Collaborating with key suppliers for customized API or polymer development ensures supply stability.
- Strategic Partnerships: Establishing long-term agreements with trusted vendors enhances supply chain resilience.
- Innovation Collaboration: Working with suppliers on novel dissolvable polymers can differentiate E-Z-DISK products.
Conclusion
The supply chain for E-Z-DISK involves a nuanced network of API providers, polymer manufacturers, component fabricators, and CMOs adhering to strict quality and regulatory standards. The key suppliers include global industry leaders such as Dow, BASF, Ashland, and Colorcon, complemented by specialized manufacturers capable of producing dissolvable membranes and disks. Ensuring supply chain integrity requires strategic sourcing, rigorous quality assurance, and adaptable logistics to mitigate risks and capitalize on market opportunities.
Key Takeaways
- Diverse Supplier Base: E-Z-DISK production depends on reputable API sources, polymer suppliers, and specialized component manufacturers, predominantly from established global firms.
- Regulatory Compliance: Suppliers must meet GMP standards to ensure product safety, efficacy, and regulatory approval.
- Supply Chain Resilience: Diversification and long-term partnerships mitigate risks associated with raw material shortages or regulatory changes.
- Innovation Drive: Emerging suppliers focus on biodegradable and high-performance polymers, enabling next-generation E-Z-DISK systems.
- Strategic Sourcing: Collaboration with key suppliers enhances product quality, reduces costs, and accelerates regulatory approval processes.
FAQs
1. Who are the primary API suppliers for E-Z-DISK formulations?
Major suppliers include contract manufacturers like Cambrex and Siegfried, as well as global API providers such as Lonza and specialized regional CMOs.
2. What polymers are commonly used in E-Z-DISK manufacturing?
Hydroxypropyl methylcellulose (HPMC), polyethylene glycol (PEG), and biodegradable polymers like polylactic acid (PLA) are typical materials.
3. How does supplier quality impact E-Z-DISK product development?
High-quality, GMP-compliant suppliers ensure the safety, efficacy, and regulatory approval of E-Z-DISK, minimizing risks of recalls or delays.
4. Are there emerging suppliers or technologies shaping the E-Z-DISK supply chain?
Yes, firms developing novel biodegradable and film-forming polymers are expanding options, potentially improving delivery profiles and environmental profiles.
5. What challenges exist in sourcing components for E-Z-DISK?
Volatile raw material costs, regulatory hurdles, and supply disruptions pose significant risks; proactive supplier management is essential.
References
[1] Pharmaceutical Technology. "The Role of Excipients in Controlled-Release Formulations." 2022.
[2] FDA Guidelines. Good Manufacturing Practice for Active Pharmaceutical Ingredients. 2021.
[3] Market Research Reports. "Global Oral Delivery Systems Market." 2022.
[4] Industry Journals. "Innovations in Dissolvable Film Technologies." 2021.
[5] Company Websites and Public Filings for Dow, BASF, Ashland, Colorcon, and other key suppliers.
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