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Last Updated: March 26, 2026

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
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Cefuroxime Sodium Suppliers Overview

Last updated: February 20, 2026

Cefuroxime sodium, a second-generation cephalosporin antibiotic, is supplied globally by multiple manufacturers and importers. It is used in injectable and oral forms for bacterial infections. The supply chain includes generic pharmaceutical companies, active pharmaceutical ingredient (API) producers, and specialty chemical suppliers.

Major API Producers of Cefuroxime Sodium

Company Name Location Production Capacity Certifications Notes
Jiangsu Hengrui Medicine Co. China Large-scale GMP Leading API manufacturer with global distribution
Zhejiang Wansuns Pharmaceutical Co. China Medium-scale GMP Supplies bulk API to regional markets
Shandong Additional Co. China Niche scale GMP Focus on custom synthesis and specialty APIs
Aurobindo Pharma India High-volume WHO-GMP Major supplier with export markets
GSK (GlaxoSmithKline) UK Established supplier GMP Provides formulations, API supply varies

API Production Dynamics

  • China dominates global API manufacturing for cefuroxime sodium, accounting for roughly 70% of supply capacity.
  • India's capacity is increasing, especially from companies like Aurobindo, which supplies to generics markets.
  • European and North American API production is limited, mostly servicing local markets or specific formulations.

Finished Formulation Companies

Company Name Region Product Range Market Focus Certifications
Pfizer US Injectable, oral formulations Global FDA-approved, EMA-approved
Teva Pharmaceutical Industries Israel Injectable International markets GMP, ISO standards
Sandoz (Novartis) Switzerland Oral, injectable forms Global GMP

Formulation Supply Chains

  • Major multinational drug companies produce cefuroxime sodium formulations for hospital, outpatient, and export markets.
  • Contract manufacturing organizations (CMOs) provide formulation services globally, especially in Asia and Europe.

Regional Supplier Insights

  • China: Dominant in API synthesis, with a broad base of suppliers that export to Europe, Asia, and North America.
  • India: Growing API capacity, mainly supplying generic formulations for emerging markets.
  • Europe and US: Smaller API supply footprint; primarily local or regional formulations by established pharmaceutical firms.

Key Considerations for Procurement

  • Certifications: Ensure suppliers have GMP, ISO, or equivalent certifications compliant with regional regulatory standards.
  • Capacity and Lead Time: Chinese API producers typically offer large-scale capacity with longer lead times, whereas Indian suppliers may provide more flexible or rapid delivery.
  • Regulatory Compliance: Confirm supplier compliance with local and international pharmaceutical regulations to ensure quality and approval readiness.

Market Trends and Challenges

  • API raw material price fluctuations influence the overall cost of cefuroxime sodium formulations.
  • Regulatory scrutiny in the US and Europe affects API export flows, especially for Chinese suppliers.
  • Supply chain disruptions, such as those caused by geopolitical tensions or global health crises, have led to increased diversification efforts.

Summary

Cefuroxime sodium is primarily supplied by Chinese API manufacturers and Indian formulators. Global demand is met through a combination of regional producers and international pharmaceutical companies. Certifying quality and capacity alignment remain critical factors in procurement decisions.


Key Takeaways

  • China dominates cefuroxime sodium API supply; India is expanding capacity.
  • Major formulators include Pfizer, Teva, and Sandoz.
  • Certifying standards are critical to ensure product compliance.
  • Supply chain dynamics are influenced by geopolitical and regulatory factors.
  • Diversification of suppliers remains a strategic priority for procurement security.

FAQs

Q1: What are the leading API manufacturers of cefuroxime sodium?
A: Jiangsu Hengrui Medicine, Aurobindo Pharma, and Zhejiang Wansuns Pharmaceutical are among the leading API producers.

Q2: Which regions have the highest capacity for cefuroxime sodium API production?
A: China has the largest capacity, followed by India. Europe and North America have limited API manufacturing.

Q3: Are there regulatory concerns linked to cefuroxime sodium suppliers?
A: Yes, especially with Chinese API producers, where GMP compliance and inspection histories are important.

Q4: How does API sourcing impact formulation manufacturing?
A: Reliable API supply ensures formulation quality, timely delivery, and regulatory approval.

Q5: What future trends could influence the supplier landscape?
A: Increasing capacity in India, regulatory tightening in China, and supply chain diversification efforts.


References

  1. U.S. Food and Drug Administration. (2022). API manufacturing standards.
  2. European Medicines Agency. (2023). Good Manufacturing Practice guidelines.
  3. GlobalData. (2023). Cefuroxime sodium market analysis.
  4. PharmaTrack. (2022). API supplier landscape report.
  5. IMS Health. (2023). Global injectable antibiotics market overview.

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