Ceftriaxone Injection

Injections · Powder for Injection (Lyophilized) · 500mg / 1gm

Trade Information

Minimum Order Qty	10,000 vials
Capacity	50 Million Vials per month
Strength	500mg / 1gm
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Single vial pack with WFI
Single vial pack with Lidocaine
Tray pack (10 vials)
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African, Asian, and CIS markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Ceftriaxone Sodium
Dosage Form	Powder for Injection (Lyophilized)
Pack Size	Vial + WFI ampoule / Vial + Lidocaine ampoule / Custom packing available
Storage	Store below 25°C in a dry place, protected from light
Shelf Life	24 months from date of manufacture

Description

Ceftriaxone is a third-generation cephalosporin antibiotic administered by injection for the treatment of serious bacterial infections. It is one of the most widely used injectable antibiotics in hospitals worldwide and is listed on the WHO Model List of Essential Medicines.

Ceftriaxone offers broad-spectrum activity against gram-positive and gram-negative bacteria, excellent tissue penetration, and the convenience of once-daily dosing. It is a first-line treatment in hospitals across Africa, Asia, and Latin America for severe infections including meningitis, sepsis, and pneumonia.

BioGalen manufactures Ceftriaxone Injection in 500mg and 1gm strengths as a sterile lyophilized powder, as well as Ceftriaxone + Sulbactam combination. Our injectable products are manufactured in dedicated sterile facilities under strict aseptic conditions.

Mechanism of Action

Ceftriaxone is a third-generation cephalosporin that kills bacteria by inhibiting cell wall synthesis. It binds with high affinity to penicillin-binding proteins (PBPs), particularly PBP-1a, PBP-1b, and PBP-3, blocking the transpeptidation reaction essential for cross-linking peptidoglycan chains in the bacterial cell wall. The weakened cell wall cannot withstand osmotic pressure, leading to bacterial lysis. Ceftriaxone has exceptional stability against most beta-lactamase enzymes and achieves high concentrations in cerebrospinal fluid (CSF), making it a first-line treatment for bacterial meningitis. Its unusually long half-life of 6–9 hours — the longest of any cephalosporin — allows once-daily dosing, which is a significant advantage in hospital settings where nursing resources are limited.

Indications

Bacterial meningitis
Septicaemia and bacteraemia
Community-acquired and hospital-acquired pneumonia
Urinary tract infections (complicated)
Intra-abdominal infections and peritonitis
Bone and joint infections (osteomyelitis)
Skin and soft tissue infections
Gonorrhoea (single-dose treatment)
Surgical prophylaxis
Typhoid fever

Available Variants

Ceftriaxone Injection 500mg
Ceftriaxone Injection 1gm
Ceftriaxone Injection 1gm + Sulbactam 0.5gm

Frequently Asked Questions

Why is Ceftriaxone supplied as a lyophilized powder rather than a ready-to-use solution?

Ceftriaxone has limited stability in solution and must be reconstituted immediately before administration. The lyophilized (freeze-dried) powder form ensures a 24-month shelf life and maintains potency throughout the supply chain, including in tropical climates. Each vial is supplied with a matching ampoule of Water for Injection (WFI) or Lidocaine for reconstitution.

What is the difference between Ceftriaxone and Ceftriaxone + Sulbactam?

Ceftriaxone alone covers a broad spectrum of bacteria. The addition of Sulbactam (a beta-lactamase inhibitor) extends coverage to beta-lactamase-producing organisms that would otherwise be resistant. The combination product (1gm + 0.5gm) is increasingly specified in hospital formularies across Asia and Africa for empirical treatment of serious infections where resistance patterns are uncertain.

What are the cold chain and storage requirements for export?

BioGalen Ceftriaxone Injection should be stored below 25°C, protected from light. It does not require cold chain transport but should be protected from extreme heat during transit. Our packaging is designed for tropical logistics with Zone IVa/IVb stability data available. We can advise on shipping conditions for specific routes.

What is the manufacturing capacity for injectable products?

BioGalen's dedicated sterile injectable facility has a capacity of 50 million vials per month. All injectable products are manufactured under strict aseptic conditions in classified cleanrooms. Our facility is WHO-GMP certified and undergoes regular audits by national and international regulatory authorities.

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