Medicines/finished pharmaceutical products

Reference Number: 
TB340

Date of prequalification: 
15 May 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Levofloxacin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 750mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
36
Packaging: 
Blister,Alu/PVC 1x1, 10x1; Bottle,HDPE 20x1
Applicant: 
MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

MSN Laboratories Private Limited, Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District), Telangana, 509228, India

API Manufacturing Site: 

(Levofloxacin) Neuland Laboratories Limited, Unit - 1, Veerabhadraswamy Temple Road, No: 347, 473, 474, 490/2, Bonthapally (Village), Hyderabad, Gummadidala (M), Sangareddy District, Telangana, 502 313, India