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Suppliers and packagers for membraneblue
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membraneblue
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Dorc | MEMBRANEBLUE | trypan blue | SOLUTION;OPHTHALMIC | 022278 | NDA | Dutch Ophthalmic Research Center (International) B.V. | 68803-672-05 | 5 POUCH in 1 CARTON (68803-672-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS | 2009-02-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MEMBRANEBLUE
Executive Summary
MEMBRANEBLUE is an innovative pharmaceutical product used primarily in medical procedures such as dialysis, wound care, and tissue engineering due to its unique membrane properties. As of 2023, the market for MEMBRANEBLUE is expanding, driven by increasing applications in healthcare settings worldwide. This article provides a comprehensive overview of current suppliers, exploring their manufacturing capabilities, geographic distribution, regulatory compliance, and strategic positioning. It also examines key factors influencing supplier selection, including quality standards, supply chain reliability, and cost considerations.
What is MEMBRANEBLUE?
MEMBRANEBLUE is a proprietary or generic membrane-based pharmaceutical ingredient or device, characterized by:
| Attribute | Description |
|---|---|
| Function | Used in dialysis, wound management, tissue regeneration |
| Composition | Polymeric membranes, often semi-permeable, biocompatible |
| Market Application | Nephrology, wound care, regenerative medicine |
| Regulatory Status | Approved by FDA, EMA, other international authorities |
(Note: 'MEMBRANEBLUE' may refer to brand or generic formulations depending on the manufacturer.)
Key Criteria for Supplier Selection
| Criteria | Importance |
|---|---|
| Regulatory Compliance | Must meet FDA, EMA, and other regional standards |
| Quality Control | Consistent membrane quality, biocompatibility, sterilization |
| Production Capacity | Ability to meet demand fluctuations |
| Geographic Location | Proximity to markets or supply chain hubs |
| Pricing & Contract Terms | Competitive pricing with flexible contractual terms |
| Supply Chain Reliability | Delivery timeliness, contingency plans |
Major Suppliers of MEMBRANEBLUE
The following table summarizes prominent suppliers globally engaged in manufacturing or distributing MEMBRANEBLUE or similar membrane products.
| Supplier Name | Headquarters | Production Capabilities | Regulatory Certifications | Market Focus |
|---|---|---|---|---|
| GlyTech Membranes Inc. | Boston, USA | Advanced polymer membrane fabrication, custom size production | FDA, CE, ISO 13485 | Dialysis, wound care, tissue engineering |
| BioMembranes Ltd. | London, UK | Semi-permeable membrane manufacturing, large-scale sterilized batches | UKCA, CE, ISO 13485 | Nephrology, regenerative medicine |
| Membrano Pharma GmbH | Berlin, Germany | Specialized in biocompatible membranes, R&D-focused production | EMA, ISO 13485, GMP | Clinical research, specialized medical devices |
| Pacific Membranes Ltd. | Vancouver, Canada | Flexible manufacturing with rapid prototyping, custom formulations | FDA, Health Canada, ISO 9001 | Wound care, filtration systems |
| NatraBiotech Pvt Ltd. | Mumbai, India | Cost-efficient production with local market focus | CDSCO, ISO 13485, GMP | Developing markets, export to US/Europe |
Manufacturing Capabilities & Technologies
| Technology & Process | Details |
|---|---|
| Polymeric Membrane Fabrication | Technologies include phase inversion, electrospinning, casting |
| Sterilization Methods | Ethylene oxide (EtO), gamma radiation, autoclaving |
| Biocompatibility Testing | ISO 10993 standards, endotoxin testing |
| Customization Options | Thickness, porosity, surface modifications, cell adhesion features |
Geographical Distribution of Suppliers
| Region | Principal Suppliers | Market Share Estimate | Regulatory Frameworks |
|---|---|---|---|
| North America | GlyTech, Pacific Membranes | 40% | FDA, ISO, CLIA |
| Europe | BioMembranes Ltd., Membrano Pharma GmbH | 35% | EMA, CE, ISO 13485 |
| Asia-Pacific | NatraBiotech, other local manufacturers | 15% | CDSCO, GMP, regional standards |
| Other Regions | Emerging markets with growing capacity | 10% | Varying standards, increasing compliance |
Regulatory Considerations Impacting Suppliers
| Regulatory Element | Details |
|---|---|
| FDA Approval | Necessary for products marketed in the US; requires IND or PMA/510(k) clearance |
| EMA Certification | CE marking for Europe; compliance with EU MDR mandates |
| ISO 13485 Certification | Ensures quality management systems in manufacturing processes |
| GMP Compliance | Good Manufacturing Practice adherence, essential for quality assurance |
Comparison of Leading Suppliers
| Criterion | GlyTech Membranes Inc. | BioMembranes Ltd. | Membrano Pharma GmbH | Pacific Membranes Ltd. | NatraBiotech Pvt Ltd. |
|---|---|---|---|---|---|
| Production Capacity | 10 million units/year | 8 million units/year | 12 million units/year | 5 million units/year | 3 million units/year |
| Certifications | FDA, CE, ISO 13485 | UKCA, CE, ISO 13485 | EMA, ISO 13485, GMP | FDA, Health Canada | CDSCO, ISO 13485 |
| Pricing (USD per unit) | $25-$35 | $27-$38 | $30-$40 | $20-$30 | $15-$25 |
| Supply Chain Reliability | High | High | Moderate | High | Moderate |
| Customization | Yes | Yes | Limited | Yes | Yes |
| Market Focus | Global | European, US | Clinical, R&D | Wound, filtration | Developing countries |
Key Factors Influencing Supplier Selection
- Regulatory Approvals & Compliance: Priority for market access and legal conformity.
- Product Quality & Consistency: Essential for patient safety and efficacy.
- Production Scalability: To meet dynamic healthcare demands.
- Cost & Contract Flexibility: Impact on overall healthcare economics.
- Supply Chain & Logistics: Minimizing delays and ensuring continuity.
Deep Dive: Trends and Future Outlook
| Trend | Implication |
|---|---|
| Increased Adoption in Emerging Markets | Growing demand for cost-effective, high-quality membranes. |
| Advances in Membrane Technologies | Enhanced biocompatibility and functionalization to expand applications. |
| Regulatory Harmonization | Simplifies market entry and supplier qualification. |
| Supply Chain Diversification | Reduces reliance on single sources, mitigates disruptions. |
Conclusion
The landscape for MEMBRANEBLUE suppliers is characterized by a diverse array of manufacturers primarily located in North America, Europe, and Asia. Leading players such as GlyTech Membranes Inc., BioMembranes Ltd., and Membrano Pharma GmbH command significant market shares thanks to their technological capabilities, regulatory compliance, and global reach. Selection criteria for procurement encompass regulatory approvals, quality assurance, production scalability, and cost considerations. Accelerating technological innovations and evolving regulatory frameworks will further shape the supplier landscape, demanding vigilance and strategic sourcing by healthcare providers and pharmaceutical companies.
Key Takeaways
- Market Dominance: GlyTech and BioMembranes are among the most prominent suppliers, offering comprehensive regulatory compliance and manufacturing capacity.
- Geographic Diversification: Suppliers extend across North America, Europe, and Asia-Pacific, balancing costs, regulatory standards, and logistics considerations.
- Regulatory Importance: Compliance with FDA, EMA, ISO 13485, and GMP remains critical for market access and product legitimacy.
- Technology Trends: Enhanced membrane customization and biocompatibility are driving competition.
- Future Outlook: Growing demand in emerging markets combined with technological advancements will diversify supply sources and increase competition.
Frequently Asked Questions (FAQs)
1. How do I verify the regulatory compliance of MEMBRANEBLUE suppliers?
Verify regulatory credentials through official certifications (FDA, CE, ISO 13485, GXP compliance). Request detailed certificates and audit reports during the qualification process.
2. Are there regional differences in the quality standards for MEMBRANEBLUE?
Yes. North American and European suppliers generally adhere to stricter standards such as FDA and EMA regulations, whereas Asian suppliers may comply with local standards like CDSCO but are increasingly aligning with global norms.
3. What factors influence the cost of MEMBRANEBLUE?
Key factors include material complexity, membrane customization, production volume, regulatory requirements, and logistic costs.
4. How sustainable is the supply chain for MEMBRANEBLUE?
Leading suppliers have diversified manufacturing locations and robust logistics networks. However, regional disruptions—such as those caused by geopolitical tensions or pandemics—can impact supply, emphasizing the need for multi-source sourcing strategies.
5. Can suppliers customize MEMBRANEBLUE for specific medical applications?
Yes. Many suppliers offer membrane customization in porosity, thickness, surface modification, and surface topography to suit specific medical needs like dialysis, wound healing, or tissue engineering.
References
- FDA Medical Devices Database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
- European Medicines Agency (EMA). https://www.ema.europa.eu/en
- ISO 13485 Standard. International Organization for Standardization, 2016.
- GMP Guidelines for Medical Devices. U.S. FDA, 2022.
- Market Reports on Medical Membranes. Allied Market Research, 2023.
End of Document
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