Product details
WHO Product ID
WHOAPI-286
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
Optimus Drugs Pvt Ltd
Sy No. 37/A & 37/P, Plot No. 6P, 2nd Floor, Signature Towers, Kothaguda, Kondapur,
Hyderabad,
Telangana
500 084
India
APIMF Version Number
Optimus Drugs/Linezolid/OP/05/April-2022
Optimus Drugs/Linezolid/RP/05/April-2022
Optimus Drugs/Linezolid/RP/05/April-2022
Product Grades
API specification number
FPS/OP-LEZ/01-02
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Shelf life
Packaging
The API is contained in transparent LDPE bag with tag seal. Further the LDPE bag is placed in black LDPE bag with tag seal. Finally the bag is placed in HDPE drum.
API Manufacturing Site(s)
Optimus Drugs Pvt Ltd
Unit I, Survey No 239 and 240, Dothigudem, Pochampally (M), Yadadri-Bhuvanagiri (D)
Telangana
508 284
India