WHO Product ID
TB339
Status
Prequalified
INN, dosage form and strength
Levofloxacin Tablet, Film-coated 500mg
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
Configuration
10x1, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
Packaging Type
Bottle, HDPE
Configuration
50x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
MSN Life Sciences Private Limited
Unit II, Sy.No. Parts of 454, 455, 457, 458 & 459 Chandampet (Village), Shankarampet-R (Mandal), Medak District
Telangana
502 255
India
Levofloxacin
Neuland Laboratories Limited
Unit-I, Sy No: 291, 346P, 347, 348P, 473, 474, 490/2 Veerabhadraswamy Temple Road Domadugu Village, Bonthapally Village Gummadidala Mandel Sangareddy District
Telangana
502 313
India
Levofloxacin
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
