WHO Product ID
TB341
Status
Prequalified
INN, dosage form and strength
Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
MSN Laboratories Private Limited
“MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar,
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
5x3, 7x5, 10x3,10x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
Packaging Type
Bottle, HDPE
Configuration
30x1, 500x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
MSN Pharmachem Pvt Ltd
Plot No: 182 to 186, 192-A, 193-197 & 212/ A, B, C, D, Phase II, I.D.A Pashamylaram Village, Patancheru Mandal
Sangareddy District,
Telangana
502 307
India
Moxifloxacin (hydrochloride)
FPP Manufacturing Site(s)
MSN Laboratories Private Limited
Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District)
Telangana
509228
India
