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Suppliers and packagers for MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
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MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| B Braun Medical | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | meropenem | POWDER;INTRAVENOUS | 202106 | NDA | B. Braun Medical Inc. | 0264-3183-11 | 24 CONTAINER in 1 CASE (0264-3183-11) / 50 mL in 1 CONTAINER | 2015-04-30 |
| B Braun Medical | MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER | meropenem | POWDER;INTRAVENOUS | 202106 | NDA | B. Braun Medical Inc. | 0264-3185-11 | 24 CONTAINER in 1 CASE (0264-3185-11) / 50 mL in 1 CONTAINER | 2015-04-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Meropenem and Sodium Chloride in Duplex Container
Introduction
The pharmaceutical industry’s demand for high-quality, reliable suppliers for critical drugs such as Meropenem and Sodium Chloride in specialized packaging formats like duplex containers has surged, driven by the increase in multi-drug resistant infections and the necessity for sterile, stable infusion solutions. This article offers an in-depth analysis of global suppliers capable of providing Meropenem and Sodium Chloride in duplex containers, emphasizing supply chain robustness, regulatory compliance, and market positioning.
Understanding Meropenem and Sodium Chloride in Duplex Containers
Meropenem is a broad-spectrum carbapenem antibiotic, vital in treating severe bacterial infections, particularly those resistant to other antibiotics. Its packaging in duplex containers—dual-compartment systems—enhances stability, reduces contamination risk, and facilitates controlled infusion, which is critical in clinical settings.
Sodium Chloride (0.9% NaCl) solutions are the most common intravenous fluids used in reconstitution and dilution of drugs like Meropenem. Packaging these in duplex containers ensures sterile, self-contained units with extended shelf life and minimized risk of microbial contamination.
Key Attributes for Suppliers
Effective suppliers should demonstrate:
- Regulatory Compliance: Approval from regulatory authorities such as the FDA, EMA, or local health agencies.
- Manufacturing Expertise: Proven capability in sterile filling, aseptic processing, and advanced container technology.
- Quality Assurance: Consistent adherence to cGMP standards.
- Supply Chain Reliability: Ability to meet global demands with flexible logistics.
- Technical Compatibility: Expertise in duplex container design and materials compatible with Meropenem and Sodium Chloride.
Global Suppliers for Meropenem in Duplex Containers
1. Fresenius Kabi
Fresenius Kabi is a leading manufacturer of sterile injectable drugs and infusion solutions. The company offers Meropenem in flexible packaging, including duplex containers tailored for clinical efficacy and safety. Their extensive global manufacturing footprint, including facilities in Germany, the US, and India, ensures reliable supply chains.
Product Highlights:
- Certified cGMP facilities
- Extensive distribution network
- Focus on anti-infectives including carbapenems
2. Sandoz (Novartis)
Sandoz provides generic Meropenem injections, often packaged in advanced container formats. Their manufacturing facilities in Europe and the US support large-scale sterile production, adhering to stringent regulatory standards.
Product Highlights:
- ISO-certified manufacturing units
- Innovative container solutions, including duplex formats
- Proven track record in anti-infective supplies
3. Hikma Pharmaceuticals
Hikma offers generic Meropenem with a focus on stability and sterility, supplied in various container formats, including duplex systems for hospital and outpatient use.
Product Highlights:
- Extensive portfolio of sterile products
- Strong compliance with international quality standards
- Robust global distribution
4. Pfizer
While primarily focused on branded pharmaceuticals, Pfizer's generics division supplies Meropenem in specialized packaging in select markets, leveraging its global manufacturing facilities in Europe and North America.
Product Highlights:
- Regulatory approval across numerous countries
- Advanced aseptic processing technologies
- Strategic partnership with container manufacturers
Suppliers for Sodium Chloride in Duplex Containers
1. Baxter International
Baxter produces a comprehensive portfolio of IV solutions, including Sodium Chloride 0.9% in duplex containers designed for stable, sterile administration. Their global manufacturing facilities and adherence to cGMP standards make them a premier supplier.
Product Highlights:
- Wide distribution network
- Innovation in container technology for stability
- Extensive regulatory approvals
2. B. Braun Melsungen
B. Braun supplies Sodium Chloride solutions in duplex containers, optimized for both clinical and field use. Their containers ensure minimal leaching and compatibility with infusion devices.
Product Highlights:
- Quality-controlled manufacturing
- Emphasis on material safety and compatibility
- Strong compliance with global standards
3. Hospira (a Pfizer company)
Hospira offers Sodium Chloride in duplex containers, with a focus on stability and sterility for critical care environments. Their manufacturing plants in the US and Europe support high-volume, reliable supply.
Product Highlights:
- Alignment with global regulatory standards
- Reliable logistics infrastructure
- Compatibility with various infusion systems
4. Otsuka Pharmaceutical
Otsuka’s sterile infusion solutions include Sodium Chloride in duplex containers, emphasizing compatibility with advanced sterilization techniques and container materials.
Product Highlights:
- Innovative container designs
- Proven excellence in sterile production
- Regulatory approval in multiple jurisdictions
Market Dynamics and Future Trends
Global Supply Chain Challenges: The COVID-19 pandemic underscored vulnerabilities in the supply chain for sterile injectable drugs, prompting industry shifts toward diversification of suppliers and regional manufacturing.
Regulatory Stringency: The increased rigor of cGMP standards and regional compliance requirements necessitate thorough supplier due diligence, especially for complex container types like duplex systems.
Technological Innovation: Advances in container technology—such as barrier properties, compatibility with potent drugs like Meropenem, and enhanced stability—favor suppliers investing in R&D aligned with regulatory standards.
Emerging Suppliers: Countries such as India and China are increasingly becoming key players, driven by cost advantages and expanding manufacturing capabilities, provided they comply with international standards.
Conclusion
The procurement of Meropenem and Sodium Chloride in duplex containers involves meticulous supplier evaluation focused on quality, compliance, capacity, and technological innovation. Major global suppliers such as Fresenius Kabi, Sandoz, Baxter, and B. Braun possess established capabilities to provide high-quality sterile drugs in duplex containers, ensuring supply chain resilience in an evolving regulatory landscape.
Key Takeaways
- Identifying reliable suppliers with cGMP certification and global reach is critical for sourcing Meropenem and Sodium Chloride in duplex containers.
- Leading companies like Fresenius Kabi, Baxter, Sandoz, and B. Braun have demonstrated expertise in sterile injectables and advanced container systems.
- Regulatory compliance, supply chain flexibility, and technological compatibility should influence procurement strategies.
- Emerging markets and technological innovations are reshaping the supply landscape, offering new sourcing opportunities.
- Proactive due diligence and supplier qualification are essential for maintaining uninterrupted supply and ensuring patient safety.
FAQs
1. What are duplex containers, and why are they preferred for Meropenem and Sodium Chloride?
Duplex containers are dual-chamber systems that separate incompatible components or stabilize sensitive drugs. They reduce contamination risk, extend shelf life, and facilitate administration, crucial for drugs like Meropenem and solutions like Sodium Chloride.
2. Are there regional differences in suppliers for these drugs?
Yes. North American and European markets predominantly feature suppliers like Baxter and B. Braun, while India and China are emerging as cost-effective sources with reputable manufacturing capabilities that meet international standards.
3. What regulatory considerations should be taken into account when sourcing these drugs?
Suppliers must demonstrate compliance with cGMP standards, and products should have approvals from bodies like the FDA, EMA, or respective local agencies, ensuring safety and efficacy.
4. How does technological innovation impact the supply of these drugs?
Advanced container designs improve stability and compatibility, enhancing drug shelf life and reducing contamination risks. Suppliers investing in R&D are better positioned to meet evolving clinical needs.
5. Can secondary suppliers provide equivalent quality in duplex containers?
While secondary suppliers may offer competitive pricing, rigorous qualification processes, including regulatory validation and quality audits, are crucial to ensure product integrity and compliance.
Sources:
[1] U.S. Food and Drug Administration, “Approved Drug Products with Therapeutic Equivalence Evaluations,” 2022.
[2] European Medicines Agency, “Guidelines on Good Manufacturing Practice,” 2023.
[3] Company websites and product catalogs from Fresenius Kabi, Sandoz, Baxter, and B. Braun.
[4] Industry reports on sterile injectable markets, 2022.
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