Amikacin Inj.Sol 500mg/2ml (EU CTD Available) & 1g/4ml (EU CTD Available: Q3 2021)

Product Description

Amikacin Solution for Injection 
Reference Product: Briklin® / BRISTOL-MYERS SQUIBB
Description: Amikacin sulfate is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella species, Enterobacter species, Serratia species, and Acinetobacter species. 
Dossier Status: EU CTD Available (500mg/2ml) & Q3 2021 (1g/4ml)
Stability Studies: Zone II / Zone IVb
Shelf life: Two (2) years
Batch Size: 18,180 vials (500mg/2ml) & 9,090 vials (1g/4ml)
Pack Size: BT x 1 vial

ANFARM HELLAS S.A.

  • Country/Region:
    Greece
  • On CPHI since:
    2015
Primary activities
Contract Manufacturer
Pharmaceutical Company (generic finished products)
Regulatory Affairs
Supply Chain
Specifications
  • Selling Points
    International Approvals/Standards
  • Supplied from
    Greece

ANFARM HELLAS S.A.

  • Country/Region:
    Greece
  • On CPHI since:
    2015
Primary activities
Contract Manufacturer
Pharmaceutical Company (generic finished products)
Regulatory Affairs
Supply Chain

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