Amikacin Injection

Injections · Solution for Injection · 250mg / 500mg

Trade Information

Minimum Order Qty	500,000 vials
Capacity	50 Million Vials per month
Strength	250mg / 500mg
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

Vial
Ampoule
Tray pack
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African and Asian 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	Amikacin Sulphate
Dosage Form	Solution for Injection
Pack Size	Vial / Ampoule / Custom packing available
Storage	Store below 25°C, protected from light
Shelf Life	24 months from date of manufacture

Description

Amikacin is an aminoglycoside antibiotic used for serious Gram-negative bacterial infections, often in combination with other antibiotics. It is listed on the WHO Model List of Essential Medicines.

BioGalen manufactures Amikacin injection in 250mg and 500mg presentations, supplied through hospital and tender channels for severe infections, and it also has a role in the treatment of certain drug-resistant infections.

Mechanism of Action

Amikacin is an aminoglycoside antibiotic that binds the 30S bacterial ribosomal subunit, causing misreading of the genetic code and inhibiting protein synthesis, which is bactericidal. It has potent activity against serious Gram-negative organisms, including many that are resistant to other aminoglycosides, because it resists several common aminoglycoside-inactivating enzymes. It is frequently combined with beta-lactam antibiotics for synergistic coverage of severe infections.

Indications

Serious Gram-negative bacterial infections
Sepsis and bloodstream infections
Complicated urinary tract infections
Complicated intra-abdominal infections
Combination therapy for severe infections

Available Variants

Amikacin Injection 250mg
Amikacin Injection 500mg
Amikacin Injection 100mg (paediatric)

Frequently Asked Questions

What is Amikacin used for?

Amikacin is an aminoglycoside antibiotic used for serious Gram-negative infections including sepsis and complicated urinary and intra-abdominal infections, often in combination with beta-lactam antibiotics, and has a role in certain drug-resistant infections.

How is Amikacin different from beta-lactam antibiotics?

Amikacin is an aminoglycoside, a different antibiotic class from beta-lactams such as penicillins and cephalosporins, with a distinct mechanism and strong Gram-negative activity. It is frequently combined with beta-lactams for broader coverage in serious infections.

Does BioGalen supply Amikacin for hospitals and tenders?

Yes. BioGalen supplies WHO-GMP Amikacin injection in 250 mg and 500 mg presentations to hospitals, tender suppliers, and national procurement programmes, with flexible packaging.

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