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Suppliers and packagers for DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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DEXTROSE 5% IN SODIUM CHLORIDE 0.9% 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 | DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 016678 | NDA | Baxter Healthcare Company | 0338-0089-03 | 24 BAG in 1 CARTON (0338-0089-03) / 500 mL in 1 BAG | 1970-12-09 |
| Baxter Hlthcare | DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | dextrose; sodium chloride | INJECTABLE;INJECTION | 016678 | NDA | Baxter Healthcare Company | 0338-0089-04 | 14 BAG in 1 CARTON (0338-0089-04) / 1000 mL in 1 BAG | 1970-12-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dextrose 5% in Sodium Chloride 0.9% in Plastic Container
Introduction
Dextrose 5% in Sodium Chloride 0.9% in plastic containers, commonly known as Dextrose Saline or Dextrose 5% in 0.9% Sodium Chloride, is an essential intravenous (IV) fluid solution used extensively in clinical settings for hydration, electrolyte replenishment, and medicinal delivery. Its widespread application across hospitals and clinics places significant demand on reliable suppliers capable of meeting stringent regulatory, quality, and supply chain standards.
This article analyses the primary suppliers of this pharmaceutical formulation, emphasizing global manufacturers, regional distributors, and emerging suppliers. It provides critical insights into their capacities, compliance credentials, and strategic positioning within the IV fluid market.
Key Characteristics of Dextrose 5% in Sodium Chloride 0.9%
Dextrose 5% (D5) provides energy via glucose, while Sodium Chloride 0.9% offers isotonic saline suitable for a range of medical indications. The combination in a plastic container offers ease of administration, stability, and reduced contamination risks, making it a staple in inpatient and outpatient care.
Major Global Suppliers
1. Baxter International Inc.
Overview:
Baxter is a global leader in plasma, renal, and hospital products, with a dominant position in IV fluids (2). Its product portfolio includes Dextrose and Saline solutions manufactured under rigorous quality standards aligned with FDA and EMA regulations.
Supply Capabilities:
Baxter’s manufacturing facilities, notably in the United States, Ireland, and Australia, ensure high-volume production capacities. Their sterile, pre-filled plastic container systems meet global regulatory standards, facilitating consistent supply across markets.
Regulatory Compliance:
Baxter undergoes continuous compliance with the US FDA's cGMP standards and European CE Mark certification, ensuring product safety and efficacy.
2. B. Braun Melsungen AG
Overview:
B. Braun is a German multinational specializing in infusion therapy and clinical nutrition. Their IV fluid range, including Dextrose-Saline solutions, is widely distributed in Europe, North America, and Asia-Pacific (3).
Supply Capabilities:
B. Braun's extensive network of manufacturing plants in Germany, the US, and Singapore ensures reliable global distribution. Their plastic container systems are designed for compatibility with various infusion devices.
Regulatory Compliance:
B. Braun maintains strict adherence to USP, EP, and JP standards and is certified under ISO 13485, emphasizing product quality and safety.
3. Fresenius Kabi AG
Overview:
Fresenius Kabi, headquartered in Germany, is renowned for manufacturing IV solutions, including Dextrose-based solutions in saline for clinical use (4). Their products serve hospitals worldwide, especially in Europe, Asia, and North America.
Supply Capabilities:
Fresenius Kabi operates multiple manufacturing sites with high-capacity production lines. The company's focus on sterile processing ensures supply resilience and product consistency.
Regulatory Compliance:
Their products adhere to stringent international standards, with certifications from FDA, EMA, and other local agencies.
4. Hospira (Pfizer)
Overview:
Now a part of Pfizer, Hospira has historically been a key supplier of sterile IV solutions, including Dextrose and Saline solutions in plastic containers (5). They cater primarily to North America, with a growing presence in emerging markets.
Supply Capabilities:
Hospira's manufacturing facilities are certified under cGMP standards, with capacity expansions aligned with market demand.
Regulatory Compliance:
Their products meet FDA approvals, with ongoing validation processes to ensure compliance.
Regional and Specialized Suppliers
5. Terumo Corporation
Overview:
A prominent Japanese medtech company, Terumo supplies a variety of IV solutions, including Dextrose-Saline formulations, mainly within Asia-Pacific regions (6).
Supply Capabilities:
Their regional manufacturing centers facilitate quick distribution, with a focus on maintaining high standards of sterility and stability.
Regulatory Compliance:
Compliance with Japanese Pharmacopeia standards and international certifications enables their integration into global supply chains.
6. Local and Contract Manufacturing Organizations (CMOs)
Besides multinational firms, regional CMOs often produce Dextrose in Saline solutions under licensing agreements. These entities play a significant role, especially in emerging markets, by providing cost-effective, compliant manufacturing solutions.
Supply Chain Considerations
Regulatory Certification:
Suppliers must comply with local and international standards such as FDA cGMP, EMA directives, and ISO 13485. The procurement decision should prioritize suppliers with recent certifications and proven track records.
Production Capacity and Lead Time:
Capacity constraints can impact supply, especially during global health crises, such as the COVID-19 pandemic. Established suppliers like Baxter, B. Braun, and Fresenius typically have scalable operations to meet surges in demand.
Quality Control and Traceability:
Rigorous quality assurance processes, including batch tracking and sterilization validation, are critical for ensuring patient safety and regulatory compliance.
Distribution Network:
Proximity to end-user regions, logistical infrastructure, and inventory management influence supply reliability.
Market Trends and Future Outlook
The global IV fluids market is projected to grow at a CAGR of approximately 6% over the next five years (7). Key drivers include increased hospital admissions, aging populations, and rising chronic disease prevalence. Suppliers investing in advanced manufacturing technologies, such as sealed pre-filled containers, non-PVC plastics, and antimicrobial packaging, will maintain competitive advantages.
Emerging markets are witnessing increased local manufacturing and partnerships to reduce dependence on imports, indicating a shift towards regionalized supply chains. Innovations in stability, shelf life, and ease of administration will influence future supplier development.
Key Takeaways
- Dominant Suppliers: Baxter, B. Braun, Fresenius Kabi, and Pfizer/Hospira remain the primary global providers, offering extensive manufacturing capacity and compliance standards.
- Quality and Compliance: Ensuring certification adherence (FDA, EMA, ISO) is non-negotiable for procurement.
- Supply Chain Resilience: Capacity expansion and diversification of suppliers mitigate risks of shortages.
- Regional Suppliers: Local CMOs and Asian manufacturers are increasingly relevant, offering cost-effective solutions aligned with regional regulations.
- Innovation and Future Readiness: Suppliers investing in packaging technology, stability improvements, and sustainable materials will better serve evolving market demands.
FAQs
Q1: What are the leading international manufacturers of Dextrose 5% in saline in plastic containers?
A1: Baxter, B. Braun, Fresenius Kabi, and Pfizer/Hospira are the leading global manufacturers supplying this formulation.
Q2: What regulatory standards should I verify when sourcing Dextrose saline solutions?
A2: Verify compliance with FDA cGMP standards, EMA directives, ISO 13485 certification, and local pharmacopeia requirements like USP, EP, or JP.
Q3: How can supply chain disruptions be mitigated in sourcing IV fluids?
A3: Establish relationships with multiple certified suppliers, diversify geographical sourcing, and maintain safety stock to buffer potential disruptions.
Q4: Are there regional suppliers that meet international quality standards?
A4: Yes, regional manufacturers in Europe, Asia, and North America often meet international standards and can provide reliable local supply.
Q5: What future developments should procurement professionals monitor?
A5: Innovations in container technology, stability enhancements, sustainable packaging, and regional manufacturing expansions are key areas to watch.
References
[1] Baxter International. (2023). Product Portfolio. Retrieved from https://www.baxter.com
[2] B. Braun Melsungen AG. (2023). Corporate Overview. Retrieved from https://www.bbraun.com
[3] Fresenius Kabi. (2023). Infusion Solutions. Retrieved from https://www.fresenius-kabi.com
[4] Pfizer. (2023). Pediatric and Hospital Products. Retrieved from https://www.pfizer.com
[5] Terumo Corporation. (2023). Medical Solutions. Retrieved from https://www.terumo.com
[6] MarketWatch. (2023). IV Fluid Market Trends. Retrieved from https://www.marketwatch.com
[7] GlobeNewswire. (2022). IV Fluids Market Growth Forecast. Retrieved from https://www.globenewswire.com
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