WHO Product ID
NT020
Status
Prequalified
INN, dosage form and strength
Azithromycin Tablet, Film-coated 500mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Rusan Pharma Ltd.
58-D, Government Industrial Estate, Charkop, Kandivali (West)
Mumbai,
Maharashtra
400067
India
Packaging details and storage conditions
Packaging Type
Blister; Alu/PVC
Configuration
3x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moisture
Packaging Type
Blister; Alu/PVC/PVdC
Configuration
3x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Alembic Pharmaceuticals Limited
API Unit-I, P.O. Tajpura, Near Baska, Taluka-Halol, Panchmahal District, Panelav Village
Gujarat
389350
India
Azithromycin
FPP Manufacturing Site(s)
Rusan Pharma Ltd.
Khasra No. 122 MI, Central Hope Town Selaqui, District
Deharadun,
Uttarakhand
248197
India