Product Details
WHO Product ID
TB299
Status
Prequalified
INN, dosage form and strength
Linezolid Tablet, Film-coated 600mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
20x1, 100x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
10x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Symed Labs Limited (Unit-I)
Survey No 353, Domadugu (Village), Gummadidala (Mandal), Sanga Reddy (Dist)
Telangana
502 313
India
Linezolid
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District
Telangana
509 301
India