Medicines/finished pharmaceutical products

Reference Number: 
TB321

Date of prequalification: 
07 December 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Linezolid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 20x1; Blister,Alu/PVC 10x2
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit IV, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Pithampur, Dhar District, Madhya Pradesh, 454 775, India

API Manufacturing Site: 

(Linezolid) Symed Labs Ltd, Survey No 353, Domadugu (Village), Jinnaram (Mandal), Medak (Dist), Telangana, 502 313, India