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Suppliers and packagers for METRO I.V. IN PLASTIC CONTAINER
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METRO I.V. IN PLASTIC 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 | METRO I.V. IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018900 | NDA | B. Braun Medical Inc. | 0264-5535-32 | 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER | 1983-09-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: METRO I.V. in Plastic Container
Introduction
The pharmaceutical market for intravenous (IV) solutions such as METRO I.V. continues to expand driven by increased demand for safely and efficiently administered medications. METRO I.V., distinguished by its sterile packaging in plastic containers, is critical in hospital settings, outpatient care, and emergency medicine. Identifying reliable suppliers for this product requires understanding the manufacturing landscape, quality standards, and distribution networks.
This article provides an in-depth overview of key suppliers manufacturing or distributing METRO I.V. in plastic containers, emphasizing their market presence, compliance standards, and strategic advantages for healthcare providers and distributors.
Understanding METRO I.V. in Plastic Containers
METRO I.V. solutions typically refer to sterile, drug-specific or diluent IV fluids packaged primarily in plastic containers. Compared to traditional glass bottles, plastic containers offer benefits including reduced breakage risk, weight savings, and enhanced patient safety. Manufacturers produce these solutions under strict GMP (Good Manufacturing Practice) conditions, complying with agencies such as the FDA in the USA, EMA in Europe, or other relevant regulatory bodies.
Major Manufacturers and Suppliers of METRO I.V. in Plastic Containers
1. Baxter International Inc.
Overview: Baxter is a global leader in sterile IV solutions, offering a broad portfolio that includes various forms of METRO I.V. solutions in plastic containers such as flexible IV bags and bottles.
Product Range & Packaging: Baxter’s products are available in multi-dose plastic containers designed for compatibility, sterility, and durability. Their portfolio includes common formulations like saline, dextrose, and electrolyte solutions.
Market Presence: Baxter’s extensive distribution network, rigorous quality certifications (ISO 13485, FDA approval), and commitment to innovation make them a preferred supplier for hospitals worldwide.
Supply Chain & Compliance: Baxter emphasizes traceability, sterilization validation, and compliance with USP standards, ensuring their plastic containers meet the highest safety standards ([1]).
2. B. Braun Melsungen AG
Overview: A leading manufacturer of infusion therapy and clinical nutrition products, B. Braun supplies various IV solutions in plastic containers, including METRO I.V.
Product Line: The company offers a wide range of sterile solutions in plastics, including pre-filled syringes, bottles, and flexible bags, tailored for specific therapeutic needs.
Certifications & Standards: B. Braun products undergo stringent testing aligned with the European Medicines Agency (EMA) and the FDA, emphasizing safety, stability, and compatibility.
Distribution Network: Regional manufacturing sites across Europe, North America, and Asia facilitate supply chain robustness ([2]).
3. Hospira (Pfizer)
Overview: Acquired by Pfizer, Hospira was historically recognized for its injectable drug portfolio, including METRO I.V. solutions in plastic containers.
Product Specifications: Hospira’s IV solutions are supplied in polypropylene or PET plastic bottles, designed to meet hospital standards for sterility and stability.
Quality & Regulation: Their manufacturing process adheres to cGMP and ISO standards, ensuring high-quality, safe, and reliable products.
Distribution Reach: Extensive global distribution capabilities enable rapid delivery of IV solutions in plastic containers to healthcare providers ([3]).
4. Winthrop Pharmaceuticals (Part of Sun Pharma)
Overview: Winthrop produces generic IV solutions, including METRO I.V., packaged in plastic containers that comply with international standards.
Packaging Options: They offer solutions in glass bottles and plastic containers with tamper-evident features for patient safety.
Market Focus: Emphasizing affordability without compromising quality, they serve markets in Asia, Africa, and emerging regions.
Standards & Certification: Their manufacturing facilities are certified by regulatory authorities such as the US FDA and the Indian CDSCO ([4]).
5. Local and Regional Manufacturers
Numerous regional pharmaceutical companies manufacture and supply METRO I.V. solutions in plastic containers tailored to local regulatory standards and supply demands.
Examples:
- HoseTech Ltd. (India) – supplies generic IV solutions with a focus on cost-effective packaging.
- China State Pharmaceutical Corporation (Sinopharm) – offers a range of IV fluids in plastic containers for Asian and international markets.
Market Dynamics: These suppliers often offer competitive pricing and rapid delivery but require due diligence regarding regulatory compliance and quality standards.
Supply Chain and Regulatory Considerations
Procurement of METRO I.V. solutions in plastic containers necessitates adherence to stringent regulatory standards. Suppliers must:
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Ensure GMP compliance: Manufacturing processes aligned with regulatory agencies like the FDA (21 CFR Part 211) and EMA guidelines.
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Maintain sterile manufacturing environments: To prevent contamination.
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Obtain necessary certifications: ISO 13485, BSI, or equivalent for medical device manufacturing.
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Manage packaging integrity: Plastic containers should be tamper-evident, sterile, and compatible with IV administration systems.
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Establish reliable logistical channels: Ensuring timely delivery, especially for critical care situations.
Emerging Trends and Innovations
1. Prefilled Plastic Containers
Advanced designs featuring prefilled syringes and bottles improve safety profiles and ease of use, reducing infection risk and medication errors.
2. Eco-Friendly Packaging
Sustainability initiatives increasingly influence plastic container manufacturing, focusing on recyclable materials and reduced plastic use.
3. Smart Packaging Solutions
Integration of RFID and barcode scanning to track and monitor the distribution and storage of IV solutions.
4. Customization & Formulation Flexibility
Suppliers offering tailored formulations and packaging sizes to meet diverse clinical needs.
Conclusion
The supply of METRO I.V. in plastic containers involves a robust network of global manufacturers equipped with advanced manufacturing capabilities and regulatory compliance. Leading suppliers such as Baxter, B. Braun, Pfizer (Hospira), and regional producers underpin the global procurement landscape, each emphasizing safety, quality, and supply chain resilience.
Healthcare providers and distributors must prioritize partnerships with suppliers demonstrating certified quality standards, transparent supply chains, and innovative packaging solutions to ensure patient safety and operational efficiency.
Key Takeaways
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Market Leaders: Baxter and B. Braun dominate as primary suppliers of METRO I.V. solutions in plastic containers, backed by extensive global networks.
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Regulatory Compliance: Only engage suppliers with requisite GMP, ISO, and regional certifications to ensure product safety and efficacy.
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Packaging Advancements: Pre-filled and eco-friendly plastic containers are emerging trends worth considering for future procurement strategies.
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Regional Suppliers: Local manufacturers can offer cost advantages but must be rigorously vetted for quality standards.
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Supply Chain Resilience: Diversify sourcing and establish reliable logistics channels to mitigate disruptions, especially in critical care contexts.
FAQs
1. Are all plastic containers used for METRO I.V. solutions compatible with all IV administration systems?
Most plastic containers, particularly those made of medical-grade polypropylene or PET, are compatible with standard IV administration equipment. However, compatibility should be confirmed based on specific formulation and container design.
2. What regulatory standards should suppliers of METRO I.V. solutions meet?
Suppliers must comply with cGMP, ISO 13485, and regional standards such as the FDA’s 21 CFR, EMA guidelines, or equivalent, ensuring sterility, safety, and quality.
3. How do I verify the quality of plastic containers used in IV solutions?
Verify certifications, inspect documentation regarding sterilization and material safety, and confirm compliance with relevant standards such as USP, EP, or ISO.
4. What are the advantages of plastic over traditional glass containers for METRO I.V.?
Plastic containers reduce breakage risk, are lighter, facilitate prefilled and tamper-evident packaging, and can be designed for easier medical handling.
5. Can regional or local suppliers reliably meet global standards for METRO I.V. solutions?
Yes, provided they adhere to international regulatory standards, maintain rigorous quality controls, and undergo regular audits and certifications, regional suppliers can reliably supply compliant products.
References
- Baxter International. (2022). Product Portfolio and Quality Certifications.
- B. Braun. (2023). Infusion Solutions Packaging Standards.
- Pfizer. (2022). Hospira IV Solutions Manufacturing and Distribution.
- Sun Pharma. (2023). Winthrop Collection of IV Solutions.
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