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Suppliers and packagers for DEXTROSE 25%
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DEXTROSE 25%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | DEXTROSE 25% | dextrose | INJECTABLE;INJECTION | 019445 | NDA | Henry Schein, Inc. | 0404-9844-10 | 1 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE | 2022-01-10 |
| Hospira | DEXTROSE 25% | dextrose | INJECTABLE;INJECTION | 019445 | NDA | Henry Schein, Inc. | 0404-9845-50 | 1 SYRINGE in 1 BAG (0404-9845-50) / 50 mL in 1 SYRINGE | 2022-01-10 |
| Hospira | DEXTROSE 25% | dextrose | INJECTABLE;INJECTION | 019445 | NDA | Henry Schein, Inc. | 0404-9847-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9847-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-01-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dextrose 25%
Introduction
Dextrose 25%, a concentrated glucose solution, plays a vital role in clinical nutrition, fluid resuscitation, and parenteral nutrition therapies. As a critical pharmaceutical ingredient, ensuring a reliable supply chain is essential for healthcare providers, manufacturers, and regulators. This report analyzes key suppliers of Dextrose 25%, examining their market positioning, manufacturing capacities, quality standards, and geographic reach to guide stakeholders in procurement and strategic planning.
Market Overview of Dextrose 25%
Dextrose (d-glucose) solutions are sterile, aqueous preparations used extensively in intravenous therapy. The 25% concentration offers a hypertonic solution suitable for replenishing glucose levels rapidly. The global demand for this product correlates with the expansion of hospital-based nutrition services and emergency medical interventions.
The primary manufacturers and suppliers span regions including North America, Europe, and Asia, each adhering to stringent regulatory standards such as the US FDA, European EMA, and WHO Good Manufacturing Practices (GMP). Several key players possess the capacity and regulatory approval to supply pharmaceutical-grade Dextrose 25%.
Leading Suppliers and Manufacturers
1. Baxter International Inc.
Baxter is a leading global provider of sterile infusion solutions, including Dextrose 25%. Their manufacturing facilities adhere to FDA and EMA standards, ensuring high-quality, consistent product delivery. Baxter supplies hospitals and pharmaceutical companies worldwide, supported by extensive distribution channels and robust quality assurance protocols.
2. Fresenius Kabi
Fresenius Kabi specializes in infusion therapies and parenteral nutrition components. Their Dextrose 25% solutions are produced in compliant facilities across Europe, North America, and Asia. They emphasize manufacturing excellence, certifying their products under GMP standards, making them a preferred vendor for many healthcare providers.
3. B. Braun Melsungen AG
B. Braun offers a broad portfolio of sterile solutions, including Dextrose 25%. Their global manufacturing footprint ensures supply stability. B. Braun emphasizes safety, quality, and compliance, with products certified by multiple regulatory agencies ensuring suitability for pharmaceutical applications.
4. Pfizer Inc.
Pfizer supplies pharmaceutical-grade glucose solutions, including Dextrose 25%. Their manufacturing aligns with stringent quality standards, catering primarily to institutional and hospital markets. Their extensive global infrastructure allows for reliable, scalable supply.
5. Hospira (A Pfizer Company)
Hospira specializes in sterile injectables and infusion solutions, including Dextrose 25%. Their focus on quality and compliance ensures products meet or exceed pharmacopeial standards, offering trusted supply chains across multiple geographies.
6. Conrad & Schering's (Part of the local German suppliers)
While smaller in scale, some regional manufacturers such as Conrad & Schering's provide high-purity Dextrose solutions, especially for European markets. These suppliers often operate under strict GMP guidelines, serving niche or specialty applications.
Regional Suppliers and their Capabilities
The geographic diversity among suppliers ensures supply chain resilience. North American companies like Baxter and Hospira dominate the market with advanced manufacturing facilities, meeting FDA regulations. European firms like Fresenius Kabi and B. Braun benefit from EMAs' rigorous standards, providing high-quality products across Europe and beyond.
Asian suppliers, including CPF (China Pharmaceutical Federation) members and Indian pharmaceutical companies, are increasingly expanding their production capacities, often offering competitive pricing and meeting international standards. However, procurement from Asian suppliers necessitates diligent validation of regulatory compliance and quality assurance.
Quality and Regulatory Compliance
Suppliers of Dextrose 25% must comply with pharmacopeial standards—USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). ISO certification, GMP adherence, and rigorous sterility testing are prerequisites for pharmaceutical-grade supplies. Due diligence includes auditing manufacturing facilities, reviewing batch records, and verifying stability data.
Supply Chain Considerations
- Regulatory Approvals: Ensuring suppliers possess necessary approvals from relevant authorities such as the FDA, EMA, or local regulators.
- Certification and Documentation: Certificates of analysis (CoA), batch-specific testing, and stability data are vital for compliance.
- Manufacturing Capacity: Reliable suppliers maintain enough inventory and scalable capacities to meet fluctuating demand.
- Logistics and Distribution: Effective cold chain and logistics infrastructure guarantee product integrity during transit.
Emerging Trends and Challenges
- Globalization: Increased intercontinental manufacturing aids in diversification but requires stringent verification.
- Supply Chain Disruptions: COVID-19 highlighted vulnerabilities, prompting suppliers to bolster inventories and local manufacturing.
- Regulatory Changes: Shift toward stricter standards necessitate ongoing supplier validation and quality management.
- Price Competition: Asian suppliers often offer competitive pricing, influencing procurement strategies.
Conclusion
The landscape for Dextrose 25% suppliers encompasses well-established global players like Baxter, Fresenius Kabi, B. Braun, and Pfizer, complemented by regional manufacturers in Europe and Asia. Ensuring product quality, regulatory compliance, and supply stability remains paramount for healthcare providers and pharmaceutical companies. Strategic partnerships with certified, scalable suppliers facilitate uninterrupted patient care and adherence to regulatory standards.
Key Takeaways
- Leading global suppliers such as Baxter, Fresenius Kabi, and B. Braun provide high-quality Dextrose 25% solutions, maintaining compliance with international standards.
- Regional manufacturers in Europe and Asia contribute to supply diversity, often with cost advantages but requiring meticulous compliance checks.
- Ensuring regulatory approvals and GMP certification is critical in selecting reliable suppliers for pharmaceutical-grade Dextrose 25%.
- Logistical robustness and supply chain resilience, especially post-pandemic, influence procurement decisions.
- Continuous supplier audits and validation safeguard product quality, compliance, and uninterrupted availability.
FAQs
1. What are the main regulatory standards suppliers of Dextrose 25% must meet?
Suppliers should comply with pharmacopeial standards such as the USP, EP, or JP, along with GMP certification, and possess approvals from relevant authorities like the FDA or EMA.
2. How can healthcare providers verify supplier quality?
Providers should request Certificates of Analysis (CoA), audit manufacturing facilities when possible, and review regulatory compliance documentation.
3. Are Asian suppliers of Dextrose 25% suitable for pharmaceutical use?
Yes, many Asian suppliers meet international GMP standards; however, due diligence is essential to verify quality certifications and regulatory compliance.
4. What factors influence the choice of a Dextrose 25% supplier?
Key factors include product quality, regulatory compliance, manufacturing capacity, delivery reliability, price, and supply chain resilience.
5. How is supply chain disruption mitigated for critical ingredients like Dextrose 25%?
Through diversification of suppliers, maintaining safety stock, establishing regional manufacturing partnerships, and ongoing supplier audits.
Sources:
[1] Baxter International. Corporate Website. (2023).
[2] Fresenius Kabi. Product Portfolio & Quality Assurance. (2023).
[3] B. Braun Melsungen AG. Corporate Standards and Product Certifications. (2023).
[4] Pfizer Inc. Parenteral Solutions Documentation. (2023).
[5] European Pharmacopoeia. Sterile Solutions Guidelines. (2022).
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