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Last Updated: December 12, 2025

Suppliers and packagers for generic pharmaceutical drug: CEFUROXIME SODIUM


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CEFUROXIME SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
B Braun CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER cefuroxime sodium INJECTABLE;INJECTION 050780 NDA B. Braun Medical Inc. 0264-3112-11 24 CONTAINER in 1 CASE (0264-3112-11) / 50 mL in 1 CONTAINER 2001-02-21
B Braun CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER cefuroxime sodium INJECTABLE;INJECTION 050780 NDA B. Braun Medical Inc. 0264-3114-11 24 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER 2001-02-21
Acs Dobfar Spa CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 064125 ANDA Sagent Pharmaceuticals 25021-118-10 25 VIAL in 1 CARTON (25021-118-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2016-09-01
Acs Dobfar Spa CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 064125 ANDA Sagent Pharmaceuticals 25021-119-20 25 VIAL in 1 CARTON (25021-119-20) / 16 mL in 1 VIAL 2016-09-01
Hikma CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 065048 ANDA Hikma Pharmaceuticals USA Inc. 0143-9567-25 25 VIAL in 1 CARTON (0143-9567-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9567-01) 2004-01-09
Hikma CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 065048 ANDA Hikma Pharmaceuticals USA Inc. 0143-9568-25 25 VIAL in 1 CARTON (0143-9568-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01) 2004-01-09
Hikma CEFUROXIME SODIUM cefuroxime sodium INJECTABLE;INJECTION 065048 ANDA Hikma Pharmaceuticals USA Inc. 0143-9977-22 25 VIAL in 1 CARTON (0143-9977-22) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9977-90) 2004-01-09
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: Cefuroxime Sodium

Introduction
Cefuroxime sodium is a second-generation cephalosporin antibiotic widely used for treating bacterial infections. Its broad-spectrum activity, stability, and efficacy make it a pivotal component in antimicrobial therapy. As demand fluctuates globally, understanding the major suppliers for cefuroxime sodium becomes essential for pharmaceutical manufacturers, healthcare providers, and investors. This article provides an in-depth overview of the key suppliers, their global footprints, and strategic considerations in the cefuroxime sodium supply chain.

Global Market Overview
The global cefuroxime sodium market is characterized by a mix of API (Active Pharmaceutical Ingredient) manufacturers primarily situated in China, India, and other developing countries. These suppliers often serve both domestic markets and international export markets. The rising prevalence of bacterial infections, coupled with the need for effective antibiotics, sustains a robust demand for cefuroxime sodium.

Major Suppliers of Cefuroxime Sodium

1. Zhejiang Huafu Pharmaceuticals Co., Ltd.
A leading Chinese pharmaceutical manufacturer specializing in cephalosporin APIs, Zhejiang Huafu Pharma is recognized for its high-quality cefuroxime sodium production. The company has extensive experience in manufacturing cephalosporin APIs, backed by GMP (Good Manufacturing Practice) compliance. Their products are exported globally, including to North America, Europe, and Southeast Asia, addressing the rising demand for reliable cephalosporin sourcing.

2. Lupin Limited
An Indian pharmaceutical giant, Lupin is a key global player in cephalosporin APIs, including cefuroxime sodium. With multiple manufacturing sites complying with international quality standards, Lupin supplies cefuroxime sodium to large pharmaceutical companies worldwide. The company's manufacturing capacity and emphasis on R&D position it as a reliable supplier for bulk API requirements.

3. Aurobindo Pharma Ltd.
Another major Indian API producer, Aurobindo offers a broad portfolio of cephalosporin APIs. Their cefuroxime sodium API is marketed globally, with a focus on North American and European markets. Aurobindo’s adherence to strict quality control and regulatory standards positions it as a trustworthy supplier.

4. Saini Chemicals
Based in India and specializing in cephalosporin intermediates and APIs, Saini Chemicals supplies cefuroxime sodium primarily to regional markets and select overseas partners. They emphasize cost-effective manufacturing while maintaining compliance with international standards.

5. Shanghai Chemfit Pharmaceutical Co., Ltd.
A Chinese manufacturer with a growing global presence, Chemfit supplies high-quality cephalosporin APIs, including cefuroxime sodium. Their manufacturing facilities are GMP-certified, and they emphasize stringent quality control to meet global regulatory requirements.

Other Notable Suppliers

  • Shaanxi Jintai Pharmaceutical Co., Ltd. (China)
  • Hethersed Pharmaceuticals (India)
  • Cipla Ltd. (India) – known more for finished formulations but involved in API distribution
  • Gigatech Pharma (India)

Strategic Considerations for Buyers

  • Regulatory Compliance: Ensuring suppliers adhere to cGMP standards and possess necessary certifications (FDA, EMA, etc.) is critical.
  • Manufacturing Capacity: Confirming supplier capacity aligns with procurement needs to avoid disruptions.
  • Quality Assurance: Regular audits and comprehensive quality control protocols secure consistent quality.
  • Pricing and Lead Time: Competitive pricing combined with reliable delivery schedules can optimize supply chain efficiency.

Emerging Trends and Risks

  • Manufacturing Concentration: Overreliance on Chinese and Indian manufacturers poses geopolitical and supply chain risks. Diversification strategies are advised.
  • Regulatory Disparities: Variations in quality standards across regions necessitate rigorous vetting and validation of suppliers.
  • Environmental and Ethical Standards: Increasing demand for sustainable manufacturing practices urges suppliers to improve environmental compliance.

Conclusion
The supply chain for cefuroxime sodium is dominated by manufacturers in China and India, with a handful of globally recognized players ensuring consistent supply. Businesses must adopt rigorous supplier qualification processes, emphasizing compliance, capacity, and quality to mitigate risks. As global healthcare infrastructure evolves, securing reliable cefuroxime sodium suppliers remains integral for pharmaceutical efficacy and patient safety.


Key Takeaways

  • Major cefuroxime sodium suppliers are primarily located in China and India, led by Zhejiang Huafu Pharmaceuticals and Lupin Limited.
  • Regulatory compliance, manufacturing capacity, and quality control are critical criteria for supplier selection.
  • Supply chain risks include geopolitical tensions, regulatory disparities, and overdependence on specific regions.
  • Diversification and ongoing supplier audits are essential strategies for ensuring consistent, high-quality supply.
  • Emerging trends favor manufacturers adhering to sustainable and ethically responsible manufacturing practices.

FAQs

1. Are Chinese and Indian cefuroxime sodium suppliers compliant with international standards?
Most leading suppliers in China and India comply with cGMP and possess certifications such as FDA, EMA, and ISO. However, thorough validation and audits are recommended before engaging with new suppliers.

2. How has GDPR and other data protection laws affected cefuroxime sodium supply chains?
While primarily focused on data protection, these laws impact regulatory and supply chain transparency, emphasizing compliance verification and documentation in international procurement.

3. What are the potential supply chain disruptions for cefuroxime sodium?
Disruptions may arise from geopolitical tensions, trade restrictions, manufacturing facility closures, or regulatory non-compliance. Diversification is essential to mitigate these risks.

4. How does supplier quality verification influence procurement decisions?
Quality verification ensures API efficacy and regulatory approval, minimizing risks of substandard products and regulatory rejections. Regular audits and certifications are key indicators.

5. Is there a move toward regional manufacturing of cefuroxime sodium to reduce dependencies?
Yes. Some pharmaceutical companies are investing in regional manufacturing facilities to ensure secure supply chains and compliance with local regulations, partly driven by geopolitical tensions and supply chain resilience initiatives.


Sources
[1] Market research reports on cephalosporin APIs.
[2] Company websites and regulatory filings of Zhejiang Huafu Pharmaceuticals, Lupin Limited, Aurobindo Pharma, and other suppliers.
[3] Industry analyses of pharmaceutical supply chains and regulatory standards.

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