CEFAZOLIN AND DEXTROSE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	CEFAZOLIN AND DEXTROSE	cefazolin sodium	INJECTABLE;INJECTION	050779	NDA	B. Braun Medical Inc.	0264-3103-11	24 CONTAINER in 1 CASE (0264-3103-11) / 50 mL in 1 CONTAINER	2000-07-27
B Braun	CEFAZOLIN AND DEXTROSE	cefazolin sodium	INJECTABLE;INJECTION	050779	NDA	B. Braun Medical Inc.	0264-3105-11	24 CONTAINER in 1 CASE (0264-3105-11) / 50 mL in 1 CONTAINER	2012-01-13
B Braun	CEFAZOLIN AND DEXTROSE	cefazolin sodium	INJECTABLE;INJECTION	050779	NDA	B. Braun Medical Inc.	0264-3107-11	24 CONTAINER in 1 CASE (0264-3107-11) / 50 mL in 1 CONTAINER	2025-03-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 7, 2025

Introduction

In the pharmaceutical landscape, procurement of active pharmaceutical ingredients (APIs) and finished drug formulations hinges upon reliable suppliers that meet stringent quality, regulatory, and supply chain standards. CEFazolin, a first-generation cephalosporin antibiotic, and Dextrose, a common carbohydrate source used in medical and pharmaceutical formulations, are vital components in hospital and clinical settings. Ensuring uninterrupted access to high-quality suppliers for these compounds is crucial for healthcare providers, pharmaceutical companies, and wholesalers aiming to maintain product consistency and patient safety.

Overview of CEFazolin and Dextrose

Cefazolin: A broad-spectrum antibiotic primarily used for prophylaxis against bacterial infections, especially in surgical settings. It is administered via intramuscular or intravenous routes, necessitating a high standard of manufacturing quality. Its global demand is driven by surgical procedures, orthopedic treatments, and healthcare settings requiring reliable infection control.

Dextrose: A form of glucose used extensively in intravenous (IV) solutions, nutritional support, and pharmaceutical excipients. Dextrose solutions are integral for hydration, caloric supplementation, and medication dilutions, making the supply chain critical for hospitals and outpatient clinics.

Global and Regional Suppliers

The supply landscape for both Cefazolin and Dextrose includes a combination of multinational pharmaceutical APIs producers, bulk drug manufacturers, and regional suppliers. The supplier selection is often guided by regulatory compliance (FDA, EMA, MHRA), quality assurance, production capacity, and logistical reliability.

Cefazolin Suppliers

**Leostera SA (France): A leading manufacturer of cephalosporin antibiotics, Leostera supplies Cefazolin to global markets, emphasizing GMP compliance and high purity standards. Their facilities are certified by major regulatory agencies, ensuring adherence to international quality standards.
**Aurobindo Pharma (India): A prominent API producer, Aurobindo manufactures Cefazolin for various markets with certifications from the US FDA, EMA, and WHO. Their scale enables consistent supply and competitive pricing.
**Hikma Pharmaceuticals (UK/Jordan): Engaged in the production of cephalosporins, Hikma offers Cefazolin APIs and finished formulations, serving regulated markets with rigorous quality systems.
**Siegfried AG (Switzerland): Specializes in custom synthesis and API manufacturing, including cephalosporins, with a focus on quality flexibility and innovation.
**Granules India (India): Supplies active cephalosporins, including Cefazolin, with a significant export footprint, supported by robust R&D and manufacturing capabilities.

Dextrose Suppliers

**Tate & Lyle PLC (UK): One of the largest suppliers of pharmaceutical-grade Dextrose, Tate & Lyle provides high-purity glucose products, supporting pharmaceutical, nutritional, and institutional markets globally.
**Cargill, Inc. (USA): A major producer of pharmaceutical-grade Dextrose, Cargill offers a comprehensive product portfolio aligned with GMP and pharmacopeial standards.
**Roquette Frères (France): A key provider of dextrose monohydrate and anhydrous forms, Roquette supplies global pharmaceutical and nutritional sectors.
**Pure Huisen Pharmaceutical (China): A regional supplier with expanding international footprint, offering Dextrose and other glucose derivatives compliant with industry standards.
**Glanbia Nutritionals (Ireland): Provides Dextrose monohydrate used extensively in parenteral nutrition and pharmaceutical formulations.

Criteria for Selecting Suppliers

For procurement professionals, supplier evaluation should encompass:

Regulatory Certification: Suppliers must hold GMP, ISO 9001, and relevant pharmacopeial certifications (USP, EP, BP).
Quality Assurance & Control: Consistent batch-to-batch quality, validated manufacturing processes, and rigorous testing.
Capacity & Reliability: Ability to meet supply demand, especially during market surges or pandemics.
Pricing & Contract Terms: Competitive pricing aligned with quality standards.
Supply Chain Transparency: Traceability and compliance with Good Distribution Practices (GDP).
Regional Presence & Logistics: Proximity to markets, reliable shipping, and customs clearance capabilities.

Emerging Trends and Challenges

Supply Chain Disruptions: Global crises, geopolitical tensions, and pandemic-related shutdowns impact API and excipient availability. Companies are exploring diversified supplier bases and regional manufacturing hubs to mitigate risks.

Regulatory Compliance: Increasing scrutiny from regulatory authorities emphasizes the importance of supplier audits, validation documentation, and ongoing compliance verification.

Sustainability and Ethical Sourcing: Suppliers demonstrating environmentally sustainable practices and ethical sourcing are gaining preference, aligning with corporate responsibility standards.

Technological Innovation: Suppliers adopting continuous manufacturing, AI-driven quality control, and digital transparency tools streamline supply chain reliability.

Conclusion

Securing reliable suppliers for Cefazolin and Dextrose is essential for pharmaceutical companies and healthcare providers committed to uninterrupted patient care. Leading global players such as Leostera, Aurobindo, and Cargill stand out for their regulatory compliance and manufacturing excellence. The selection process must prioritize quality, capacity, and logistical robustness, with strategic diversification to buffer against disruptions. As regulatory pressures intensify and supply chain complexities escalate, proactive supplier management becomes a strategic imperative.

Key Takeaways

Regulatory compliance and quality assurance are non-negotiable criteria for selecting Cefazolin and Dextrose suppliers.
Global and regional suppliers offer various options, but diversified sourcing minimizes risk.
Emerging supply chain challenges necessitate establishing relationships with multiple suppliers and regionally distributed manufacturing.
Technological innovations are improving supplier transparency, quality control, and supply chain agility.
Sustainable sourcing is increasingly influential in supplier selection and stakeholder trust.

FAQs

1. What are the primary factors in choosing suppliers for Cefazolin?
Regulatory compliance (GMP, FDA, EMA), consistent quality, manufacturing capacity, and supply chain reliability are key determinants.

2. Are there regional differences in suppliers for Dextrose?
Yes; North American and European suppliers like Cargill and Roquette dominate, but Asian suppliers like Pure Huisen are growing due to regional demand and manufacturing expansion.

3. How do regulatory standards impact supplier selection?
Suppliers must meet pharmaceutical regulatory standards, undergo audits, and provide validation documentation to ensure product quality and compliance.

4. What risks exist in the Cefazolin and Dextrose supply chains?
Disruptions due to geopolitical issues, pandemics, raw material shortages, and regulatory changes can impact supply continuity.

5. How can pharmaceutical companies mitigate supply chain risks for these commodities?
By diversifying supplier bases, establishing regional manufacturing partnerships, maintaining safety stock, and engaging in long-term contracts.

Sources:

[1] Pharmascroll, "Top Cefazolin API Manufacturers," 2022.
[2] PharmaCompass, "Global Dextrose Suppliers," 2022.
[3] FDA Drug Label Database, "Cefazolin."
[4] WHO Prequalification of Medicines Programme, "API Suppliers Standards," 2023.
[5] Industry reports on pharmaceutical supply chains, 2022.

Note: All information is current as of 2023 and subject to change with market dynamics.

Suppliers and packagers for CEFAZOLIN AND DEXTROSE