Product details
WHO Product ID
WHOAPI-332
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Linezolid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Symed Labs Ltd
8-2-293/174/3, Beside BN Reddy Colony, Road No. 14, Banjara Hills, Telangana
Hyderabad,
500 034
India
APIMF Version Number
Symed Labs Limited/Linezolid (Form-III)/OP/2LIN-001-01/October-2018
Symed Labs Limited/Linezolid (Form-III)/RP/2LIN-001-01/October-2018
Symed Labs Limited/Linezolid (Form-III)/OP/
2LIN-001-01/October-2018/ Amend-01/August-2021
Symed Labs Limited/Linezolid (Form-III)/RP/
2LIN-001-01/October-2018/ Amend-01/August-2021
Symed Labs Limited/Linezolid (Form-III)/RP/2LIN-001-01/October-2018
Symed Labs Limited/Linezolid (Form-III)/OP/
2LIN-001-01/October-2018/ Amend-01/August-2021
Symed Labs Limited/Linezolid (Form-III)/RP/
2LIN-001-01/October-2018/ Amend-01/August-2021
Product Grades
API specification number
FP-LIN-013-00
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Shelf life
Packaging
Primary packaging: white polythene bag. Secondary packaging: black polythene bag placed in an aluminium bag and in a HDPE drum
API Manufacturing Site(s)
Symed Labs Limited (Unit-I)
Survey No 353, Domadugu (Village), Gummadidala (Mandal), Sanga Reddy (Dist)
Telangana
502 313
India
Symed Labs Limited
Plot-25/B, Phase-III, I.D.A. Jeedimetla, Quthbullapur Medchal- Malkajgiri Dist
500055
India