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Suppliers and packagers for FLAGYL I.V. RTU IN PLASTIC CONTAINER
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FLAGYL I.V. RTU 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 |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | FLAGYL I.V. RTU IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018657 | NDA | Baxter Healthcare Corporation | 0338-1055-48 | 24 BAG in 1 CARTON (0338-1055-48) / 100 mL in 1 BAG | 1981-12-24 |
| Baxter Hlthcare | FLAGYL I.V. RTU IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018657 | NDA | Baxter Healthcare Corporation | 0338-9541-24 | 24 BAG in 1 CARTON (0338-9541-24) / 100 mL in 1 BAG | 1981-12-24 |
| Baxter Hlthcare | FLAGYL I.V. RTU IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 018657 | NDA | Civica, Inc. | 72572-540-24 | 24 BAG in 1 CARTON (72572-540-24) / 100 mL in 1 BAG | 1981-12-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FLAGYL I.V. RTU in Plastic Container
Introduction
Flagyl (metronidazole) is an antiprotozoal and antibiotic medication widely used in hospitals and clinics to treat a variety of infections caused by anaerobic bacteria and protozoa. The intravenous (IV) ready-to-use (RTU) formulation in plastic containers offers rapid, sterile administration, essential in emergency and inpatient care settings. Identifying reliable suppliers for Flagyl I.V. RTU in plastic containers is critical for healthcare providers aiming to ensure drug availability, maintain supply chain integrity, and adhere to regulatory standards.
Overview of Flagyl I.V. RTU in Plastic Containers
Flagyl I.V. RTU is marketed as a pre-filled, sterile, single-dose or multi-dose plastic container that facilitates ease of use, reduces contamination risk, and ensures optimal stability. This formulation is especially preferred in acute clinical environments due to its ready-to-administer format, eliminating the need for reconstitution or dilution. The market for this formulation is regulated by health authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulators, which impose strict manufacturing and quality standards.
Major Suppliers and Manufacturers
1. Pfizer Inc.
One of the primary global manufacturers producing commercial batches of Flagyl (metronidazole), including intravenous formulations. Pfizer’s production facilities adhere to stringent cGMP (current Good Manufacturing Practices), ensuring high-quality standards. Pfizer supplies directly to hospitals and through authorized distributors worldwide. Their sterile, plastic container-based Flagyl I.V. RTU is approved in multiple regions, including the U.S. (under FDA approval).
2. Hikma Pharmaceuticals
Hikma is a leading generic pharmaceutical manufacturer with extensive production capabilities for sterile injectables. They produce metronidazole IV formulations, including ready-to-use plastic container options, primarily for markets in Europe, Middle East, and North Africa. Hikma’s manufacturing complies with international quality standards, and their products are distributed via a network of authorized distributors.
3. Sandoz (Novartis)
Sandoz, a division of Novartis, manufactures generic medicines, including antimicrobial IV packages. Their sterile plastic container-based metronidazole formulations are available in selected markets and are supplied through a global network of authorized distributors. Sandoz emphasizes regulatory compliance and supply reliability.
4. Teva Pharmaceuticals
Teva produces a range of injectable antibiotics, including metronidazole IV in plastic containers. Their manufacturing facilities meet international quality standards, making them a key supplier for hospital procurement. Availability varies by geographic region, with distribution through Teva’s extensive network.
5. Local and Regional Manufacturers
In addition to multinational corporations, some regional manufacturers produce Flagyl I.V. RTU formulations consistent with local regulatory standards. These entities often supply hospitals and pharmacies within specific countries. Examples include domestic generics manufacturers in India, China, and Latin America, which cater to local demand and sometimes export.
Distribution Channels and Procurement
- Authorized Distributors and Wholesalers: Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen source Flagyl IV from manufacturers and supply to hospitals, clinics, and pharmacies.
- Government Procurement Entities: In many countries, centralized healthcare procurement agencies or government tenders procure large quantities directly from manufacturers or authorized suppliers, ensuring consistent supply.
- Direct Manufacturer Contracts: Large hospital networks sometimes establish direct agreements with manufacturers or regional suppliers to secure preferential pricing and guaranteed delivery.
Regulatory and Quality Considerations
Suppliers must comply with local regulatory standards, including approval of both product presentation and manufacturing practices. Manufacturers typically hold approvals from agencies such as the FDA (U.S.), EMA (Europe), PMDA (Japan), or local authorities certifying GMP compliance. These ensure the drug’s sterility, stability, efficacy, and safety.
Healthcare institutions should verify supplier certifications, batch release documents, and expiry dates before procurement. Cross-border trade may require import licenses and adherence to customs regulations, especially for sealed, pre-filled plastic containers.
Supply Challenges and Contingencies
Current global supply chains face disruptions due to manufacturing delays, logistical bottlenecks, and increased demand. To mitigate risks:
- Establish relationships with multiple authorized suppliers.
- Monitor market alerts and recall notices.
- Engage in long-term procurement contracts where feasible.
- Maintain buffer stocks aligned with consumption rates.
Emerging Trends and Innovations
- Biodegradable Containers: Shift towards eco-friendly plastics for IV containers, aligning with sustainability initiatives.
- Extended Stability: Development of formulations with extended shelf life in plastic containers, simplifying storage logistics.
- Digital Traceability: Incorporation of serialization and anti-counterfeit measures to ensure product authenticity.
Summary Table of Key Suppliers
| Supplier | Region Focus | Key Features | Certifications |
|---|---|---|---|
| Pfizer Inc. | Global (US, Europe, etc.) | FDA-approved, broad availability | cGMP, ISO certification |
| Hikma Pharmaceuticals | MENA, Europe | Generic, reliable supply, regional focus | EMA, local approvals |
| Sandoz (Novartis) | Europe, North America | Generic injectable antimicrobial formulations | GMP, ISO |
| Teva Pharmaceuticals | Global | Cost-effective, extensive distribution | cGMP, international standards |
| Regional Manufacturers | Local markets | Tailored to regional requirements, cost-efficient | Local approvals |
Key Takeaways
- Multiple suppliers, including Pfizer, Hikma, Sandoz, and Teva, manufacture Flagyl I.V. RTU in plastic containers, with regional variations in availability.
- Ensuring supplier compliance with international quality standards and obtaining proper certifications is essential for procurement and patient safety.
- Diversification of suppliers reduces supply chain risks amidst global disruptions.
- Establishing long-term relationships with authorized distributors enhances supply reliability and compliance.
- Monitoring regulatory updates and technological innovations can lead to improved procurement strategies and product quality.
FAQs
1. What are the primary considerations when sourcing Flagyl I.V. RTU in plastic containers?
Procurement professionals should verify supplier certifications, ensure product compliance with local regulatory standards, confirm product shelf life, and establish reliable distribution channels within authorized networks.
2. Are there regional differences in suppliers for Flagyl I.V. RTU?
Yes. While global pharmaceutical giants supply major markets, regional manufacturers may cater to local needs, affecting availability and lead times.
3. How can healthcare providers ensure the authenticity of Flagyl I.V. products?
Verification through serialization, anti-counterfeit features, batch documentation, supplier accreditation, and strict adherence to regulatory standards are critical.
4. What challenges exist in the global supply of Flagyl IV in plastic containers?
Supply chain disruptions, raw material shortages, manufacturing delays, and regulatory changes can impact availability, requiring proactive procurement planning.
5. Is there a move towards more sustainable IV container packaging?
Yes. Industry trends include the development of biodegradable plastics and environmentally friendly packaging options to reduce ecological impact.
References
[1] U.S. Food and Drug Administration (FDA). Approved Drugs Database.
[2] European Medicines Agency (EMA). Summary of Product Characteristics.
[3] pharmaceutical market reports, last accessed 2023.
[4] Company websites: Pfizer, Hikma, Sandoz, Teva.
[5] International Society for Pharmaceutical Engineering (ISPE). Good Manufacturing Practices (GMP) Standards.
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