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Suppliers and packagers for FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
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FLUCONAZOLE IN DEXTROSE 5% 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hikma Farmaceutica | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078764 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9666-06 | 6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) | 2012-01-30 |
| Hikma Farmaceutica | FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | fluconazole | INJECTABLE;INJECTION | 078764 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9667-06 | 6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) | 2012-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fluconazole in Dextrose 5% in Plastic Container
Overview of Fluconazole in Dextrose 5%
Fluconazole, a triazole antifungal agent, is used extensively in hospitals to treat and prevent fungal infections such as candidiasis, cryptococcal meningitis, and systemic candidiasis. This medication, when formulated with Dextrose 5% in a plastic container (often PVC or polypropylene), offers compatibility for intravenous administration, ensuring rapid absorption and effective treatment.
This specific formulation—fluconazole in dextrose 5%—is critical in intravenous therapy, especially for immunocompromised patients. The formulation in plastic containers is preferred over glass for ease of handling, decreased risk of breakage, and compatibility with modern infusion systems.
Global and Regional Supplier Landscape
The pharmaceutical supply chain for injectable antifungals like fluconazole is consolidated among multinational pharmaceutical corporations, regional generics manufacturers, and contract manufacturing organizations (CMOs). The landscape varies significantly across regions, influenced by regulatory frameworks, manufacturing capacities, and global supply chain disruptions.
Major Global Suppliers
1. Pfizer Inc.
- Product Portfolio: Pfizer markets a broad range of antifungal medications, including fluconazole in injectable forms.
- Supply Capacity: Pfizer’s global production facilities in the United States, Belgium, and other regions ensure high-volume production of fluconazole IV formulations (including dextrose-based solutions).
- Regulatory Status: Products are typically FDA- and EMA-approved, complying with international Good Manufacturing Practices (GMP).
2. Cipla Ltd.
- Overview: An Indian multinational, Cipla supplies generic fluconazole formulations in various delivery formats, including IV solutions.
- Availability: Cipla’s manufacturing facilities comply with WHO-GMP standards, making their products accessible in many developing markets.
- Plastic Container Formulation: They produce fluconazole in Dextrose 5% in plastic containers suitable for hospital use.
3. Mylan N.V. (now part of Viatris)
- Product Range: Mylan supplies generic fluconazole injections, including formulations with Dextrose 5%.
- Manufacturing: Their facilities in Europe, the U.S., and emerging markets cater to broad distribution networks.
- Market Presence: Their products are well-established in North America, Europe, and Asia.
4. Hospira (Now part of Pfizer)
- Specialization: Hospira specializes in sterile injectables, providing fluconazole in plastic containers.
- Note: Being acquired by Pfizer, their manufacturing capacities are integrated into Pfizer’s global supply chain.
Regional and Local Suppliers
1. Torrent Pharmaceuticals
- An Indian pharmaceutical firm manufacturing fluconazole IV formulations in Dextrose 5%, suitable for regional markets.
- Emphasizing affordable generics, Torrent’s manufacturing ensures adherence to international quality standards.
2. Fresenius Kabi
- A global leader in hospital-based infusion solutions.
- Supplies fluoreszole in IV-compatible plastic containers, including Dextrose 5%, primarily aimed at European and Asian markets.
- Known for high-quality manufacturing standards and wide distribution networks.
3. Sandoz (Novartis division)
- Produces numerous generic injectable medicines, including fluconazole.
- Supplies include plastic container formulations intended for hospital use.
4. Local Generics Manufacturers
In regions such as Africa, Southeast Asia, and Latin America, local pharmaceutical firms often produce fluconazole under local licenses or through partnerships with international companies, complying with regional GMP standards.
Sources and Manufacturing Considerations
GMP Compliance:
Suppliers must adhere to Good Manufacturing Practices, verified through national regulators (FDA, EMA, MHRA, etc.) and certifications like WHO-GMP.
Formulation Stability and Compatibility:
Formulations with Dextrose 5% in plastic containers require stability data that ensure no leaching or degradation over shelf life. Manufacturers conducting rigorous stability testing ensure safety and efficacy.
Supply Chain Management:
Global supply chains experienced disruptions, especially during the COVID-19 pandemic, underscoring the importance of diversified sourcing strategies.
Key Suppliers by Region
| Region | Major Suppliers | Notes |
|---|---|---|
| North America | Pfizer, Mylan, Hospira | High production volume, regulatory rigor |
| Europe | Fresenius Kabi, Sandoz, Pfizer | Emphasis on GMP compliance and supply reliability |
| Asia-Pacific | Cipla, Torrent, Dr. Reddy's Laboratories | Cost-effective manufacturing, expanding export capacity |
| Latin America & Africa | Local generic manufacturers, partnerships with global firms | Focused on affordability and regional distribution |
Market Dynamics and Opportunities
- Supply Stability: Due to high global demand, ensuring supply stability involves engaging with multiple suppliers and maintaining inventory buffers.
- Regulatory Acceptance: Importers should verify that suppliers hold necessary certifications, such as WHO-GMP or equivalent, to ensure product compliance.
- Price Competition: Generics often dominate procurement, with regional suppliers providing competitively priced options.
- Innovation and Formulation Improvements: Manufacturers investing in advanced packaging, such as pre-filled plastic containers with stability-enhancing coatings, could increase market share.
Conclusion
Securing reliable suppliers for fluconazole in Dextrose 5% in plastic containers requires credible partnerships with established pharmaceutical companies that meet rigorous quality standards. Global giants like Pfizer, Mylan, and Fresenius Kabi dominate supply, supplemented by regional manufacturers such as Cipla, Torrent, and Sandoz. Ensuring compliance with regulatory standards, product stability, and supply chain robustness remains paramount for healthcare providers and procurement agencies.
Key Takeaways
- Identify reputable, GMP-compliant suppliers capable of meeting regional demand for fluconazole in Dextrose 5% in plastic containers.
- Diversify procurement channels to mitigate supply risks amid global disruptions.
- Prioritize suppliers with extensive distribution networks and a proven track record of quality assurance.
- Regularly verify certifications and stability data to ensure product efficacy and safety.
- Engage with regional manufacturers to optimize cost-effectiveness without compromising quality.
FAQs
1. What are the leading global manufacturers of fluconazole in Dextrose 5%?
Pfizer, Mylan (Viatris), Hospira, and Fresenius Kabi are among the top global suppliers, offering high-quality formulations approved by regulatory authorities.
2. How can healthcare providers ensure the quality of fluconazole supplied by regional manufacturers?
Verify certifications such as WHO-GMP, review stability data, and conduct audits or supplier assessments to ensure compliance with international standards.
3. Are there any emerging suppliers in the market?
Yes. Several regional manufacturers in Asia, Latin America, and Africa are expanding capacities, often through licensing agreements with global firms, to meet increasing demand.
4. What packaging considerations are critical for fluconazole in plastic containers?
Materials must ensure chemical inertness, shelf stability, and compatibility with infusion systems, with quality controls to prevent leaching or degradation.
5. How has the COVID-19 pandemic affected the supply chain for antifungal drugs?
Disruptions in logistics, raw material shortages, and increased global demand have underscored the importance of diversified sourcing and inventory management strategies for reliable medicine availability.
Sources:
- [1] Pfizer Inc. Product documentation and supply chain information.
- [2] Cipla Ltd. Official product catalog.
- [3] Viatris (formerly Mylan) product disclosures.
- [4] Fresenius Kabi product offerings and regional distribution info.
- [5] WHO Global Surveillance of the Supply Chain for Essential Medicines.
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