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Suppliers and packagers for DEXYCU KIT
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DEXYCU KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912 | NDA | EyePoint Pharmaceuticals US, Inc | 71879-001-01 | 1 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS | 2018-05-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEXYCU KIT
Summary
DEXYCU (dexamethasone intraocular suspension) kit is a sustained-release corticosteroid designed for postoperative inflammation management in cataract surgery. As a specialty ophthalmic product, DEXYCU requires specialized suppliers across the supply chain, including active pharmaceutical ingredient (API) manufacturers, formulation developers, device packaging firms, and distribution partners. This analysis explores the key suppliers involved in the DEXYCU pipeline, examining manufacturing sources, distribution channels, regulatory considerations, and market dynamics shaping its supply landscape.
What Are the Key Components and Manufacturing Requirements of the DEXYCU KIT?
Product Description and Composition
| Component | Description | Function | manufacturer/Source |
|---|---|---|---|
| Dexamethasone API | Synthetic corticosteroid | Anti-inflammatory agent | Several APIs sourced globally, including Fermentation-based (e.g., from Sandoz, Teva) and Chemical synthesis (e.g., Mylan, Hikma) |
| Suspension Formulation | Biocompatible vehicle with sustained-release properties | Controlled release, ocular compatibility | Contracted with specialized formulation firms, e.g., Bausch + Lomb, or in-house manufacturing |
| Packaging Components | Punctal and blister packages | Sterile delivery system | Rigid plastic syringes and sterile blisters from established medical device suppliers |
Manufacturing and Supply Chain Stages
- API Sourcing: The core API, dexamethasone, is sourced from global generic manufacturers.
- Formulation & Filling: Specialized sterile compounding, including suspension formulation and filling into sterile syringes.
- Packaging & Sterilization: Packaging firms ensure sterile, sealed delivery systems.
- Distribution: Logistics companies manage cold chain and controlled storage conditions.
Who Are the Leading Suppliers for DEXYCU?
Active Pharmaceutical Ingredient (API) Suppliers
| Supplier Company | Location | API Quality Certifications | Market Share | Notes |
|---|---|---|---|---|
| Sandoz (Novartis) | Switzerland | cGMP, ISO 13485 | Major global supplier | Produces dexamethasone API via fermentation |
| Teva Pharmaceutical Industries | Israel | cGMP | Significant supply presence | Synthesized dexamethasone for ophthalmic use |
| Mylan (now Viatris) | USA/India | cGMP | Competitor with large volume | API primarily from India, global distribution |
| Hikma Pharmaceuticals | UK | cGMP | Growing market share | Synthetic dexamethasone API |
Note: API procurement often involves multiple sources, with quality and regulatory compliance being critical.
Formulation and Filling Suppliers
| Company / Facility | Location | Specialization | Regulatory Approvals | Notes |
|---|---|---|---|---|
| Bausch + Lomb (Developed DEXYCU) | USA | Ophthalmic formulation manufacturing | FDA-approved facilities | In-house production for DEXYCU |
| Contract Manufacturing Organizations (CMOs) | India, Ireland, US | Sterile compounding | cGMP, ISO standards | Many ophthalmic formulation CMOs supply to various pharmaceutical firms |
| OEM Medical Device Suppliers | Germany, USA | Sterile syringe assembly | ISO 13485 | Critical for ensuring product sterility and delivery accuracy |
Packaging and Sterile Delivery Systems
| Supplier Type | Examples | Certifications | Remarks |
|---|---|---|---|
| Medical Device Manufacturers | Terumo, BD (Becton Dickinson), Sterilmed | ISO 13485 | Supply sterile syringes, cartridges |
| Seal/Pack Manufacturers | Multivac, Skypack | ISO 9001, ISO 13485 | Provide blister packs, sterile barriers |
Distribution and Logistics Partners
| Partner | Region | Service Scope | Special Capabilities | Notes |
|---|---|---|---|---|
| McKesson, Cardinal Health | Global | Pharmaceutical distribution | Cold chain management | Ensures timely delivery status |
| DHL, FedEx | Worldwide | Express, cold chain | Real-time tracking | For critical handling of sterile ophthalmic products |
Regulatory and Quality Standards Influencing Suppliers
- FDA Compliance: US suppliers must align with cGMP regulations for sterile drugs.
- EMA & MHRA: European suppliers adhere to EU standards and UK regulations.
- ISO Certifications: All formulation and packaging partners typically possess ISO 13485 for medical devices and ISO 9001 for quality management systems.
- Traceability: Critical for ensuring consistent supply, batch tracking, and recall readiness.
Comparison of Key Suppliers: Strengths & Limitations
| Supplier | Strengths | Limitations | Strategic Positioning |
|---|---|---|---|
| Sandoz | Large API volume; global reach | Potential supply chain disruptions due to geopolitical factors | Essential API provider, high reintegration risk |
| Teva | Proven track record in ophthalmic API | Increasing regulatory scrutiny | Key player in generics market |
| Mylan (Viatris) | Cost advantage; multiple sourcing | Variable API quality depending on source | Cost-sensitive segment |
| Bausch + Lomb | Proprietary formulation; control over supply chain | Limited manufacturing capacity for scale | Direct producer, high quality control |
Supply Chain Risks and Mitigation Strategies
| Risk Factor | Description | Mitigation Approach | Examples |
|---|---|---|---|
| API Shortage | Dependence on limited API sources | Diversify suppliers; maintain strategic stock | Multiple API vendors from different countries |
| Regulatory Delays | Approval or inspection delays | Collaborative regulatory engagement | Pre-approval audits, QbD approaches |
| Manufacturing Disruptions | Equipment failure, labor issues | Dual manufacturing sites | Backup facilities at different geographies |
| Distribution Interruptions | Cold chain disruption | Multiple logistics providers | Real-time tracking, buffer stocks |
Access and Procurement Policies
- Global Sourcing Regulations: International trade agreements influence API and raw material procurement.
- Import/Export Controls: Governments maintain oversight over active ingredients, particularly in geopolitically sensitive regions.
- Intellectual Property: DEXYCU’s formulation and delivery devices involve proprietary technology requiring careful supplier selection to avoid patent infringement.
Market Dynamics and Future Outlook
Emerging Alternative Suppliers and Technologies
- Innovative Formulation Firms: Companies developing biodegradable, sustained-release ocular inserts.
- Regional Suppliers: Increased localization, e.g., Indian and Chinese ophthalmic API producers, expanding supply options.
- Digital Supply Chain Solutions: Blockchain tracking for traceability, AI in demand forecasting.
Impact of Patent Expirations and Generic Competition
- Patent expiry for dexamethasone formulations in some markets could influence supplier dynamics.
- New generics may increase API supply competition, reducing costs but raising quality consistency challenges.
Key Takeaways
- The supply chain for DEXYCU extensively integrates global API manufacturers, specialized formulation providers, and sterile packaging firms.
- Major API suppliers like Sandoz and Teva provide critical components, with quality and regulatory compliance being top priorities.
- Strategic diversification among suppliers mitigates risks amid geopolitical and regulatory uncertainties.
- Technological advancements and regional manufacturing capacity are expected to influence the evolving landscape of ophthalmic drug supply.
- Careful oversight, compliance, and contingency planning are vital to maintaining a stable DEXYCU supply chain.
FAQs
1. Who are the primary API suppliers for dexamethasone used in DEXYCU?
Major suppliers include Sandoz (Novartis), Teva, Mylan (Viatris), and Hikma, offering proprietary synthetic and fermentation-based dexamethasone API globally.
2. How does manufacturing quality impact DEXYCU supply?
High-quality manufacturing ensures product safety, efficacy, and regulatory compliance. Failures can cause delays, recalls, or supply shortages.
3. Are regional suppliers emerging for DEXYCU components?
Yes, especially in India and China, where increased capacity for ophthalmic API and sterile formulation production is underway, offering potential cost and localization benefits.
4. What risks threaten the supply continuity of DEXYCU?
API shortages, regulatory delays, geopolitical tensions, and distribution disruptions pose primary risks.
5. How might future innovations affect DEXYCU sourcing?
Advancements in sustained-release technology, biodegradable delivery systems, and digital supply chain management will reshape supplier requirements and sourcing strategies.
References
[1] U.S. Food and Drug Administration. "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing." 2015.
[2] European Medicines Agency. "Guidelines on Good Manufacturing Practice for Medicinal Products." 2021.
[3] Bausch + Lomb. "Company Overview and Manufacturing Capabilities." 2023.
[4] IQVIA. "Global Ophthalmic Drug Market Report." 2022.
[5] Industry Reports on Ophthalmic Pharmaceuticals and API Manufacturers. 2022-2023.
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