Amikacin Inj.Sol 500mg/2ml (EU CTD Available) & 1g/4ml (EU CTD Available: Q3 2021)
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
|Categories||Generic APIsGeneric Antibiotics; Finished Dosage FormsInjectables; Finished Dosage FormsOut-licensing|
|Sales markets||Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South East Asia (e.g. Thailand, Philippines, Singapore)|
|Selling Points||International Approvals/Standards|
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