Product details
WHO Product ID
WHOAPI-497
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Linezolid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Arene Life Sciences Private Limited
S.R.CHAMBERS, # 3-58
Ramachandrapuram, Sangareddy,
Telangana
502 032
India
APIMF Version Number
ALS/LNZ/RP/01/August-2025
ALS/LNZ/AP/01/August-2025
ALS/LNZ/AP/01/August-2025
Product Grades
API specification number
STP/FP/LNZ/001/04
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary packaging material: Translucent low-density polyethylene (LDPE) bag and tied with a plastic strip seal under nitrogen atmosphere.
Secondary Packaging: Black low-density polyethylene (LDPE) bag and tied with a plastic strip seal under nitrogen atmosphere.
Secondary Packaging: Black low-density polyethylene (LDPE) bag and tied with a plastic strip seal under nitrogen atmosphere.
API Manufacturing Site(s)
Arene Life Sciences Private Limited (Unit-1)
Unit-1, Plot No. 48, 49 & 50, 209, 210 & 211, Phase-II, IDA,, Sangareddy
Pashamylaram,
Telangana
502 307
India