Medicines/finished pharmaceutical products

Reference Number: 
TB286

Date of prequalification: 
26 October 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
PVC/PVdC/Alu Blister 10x1, 10x10; HDPE Bottle 100x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India

API Manufacturing Site: 

(Moxifloxacin (hydrochloride)) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India