Medicines/finished pharmaceutical products

Reference Number: 
TB253

Date of prequalification: 
04 November 2013
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, protect from moisture, protect from light
Shelf life (months): 
60
Packaging: 
Blister Alu/PVC/PVdC: 5x1,10x1,10x10
Applicant: 
Sun Pharmaceutical Industries Limited, Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, 400063, India
FPP Manufacturing Site: 

MSN Laboratories Pvt Ltd, Formulation Division, Plot No 42, Anrich Industrial Estate, Bollaram, Medak District, Andhra Pradesh, 502 325, India

API Manufacturing Site: 

(Moxifloxacin (hydrochloride)) MSN Pharmachem Pvt Ltd, Plot No 212, A, B, C, D, IDA Phase II, Pashamylaram, Patancheru (M), Medak District, 502 307, India

API WHO Public Inspection Reports: