Product details
WHO Product ID
WHOAPI-392
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Efavirenz
Confirmation of WHO API prequalification document (version date)
Applicant organization
Arene Lifesciences
Unit-1, Plot No. 48, 49 & 50, 209, 210 & 211, Phase-II, IDA,, Sangareddy
Pashamylaram,
Telangana
502 307
India
APIMF Version Number
ALS/EFZ/AP/01/April-2020
ALS/EFZ/RP/01/April-2020
ALS/EFZ/RP/01/April-2020
Product Grades
API specification number
STP/FP/EFZ/002/03
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Colourless translucent low-density polyethylene (LDPE) bag tied with a plastic fastener in black LDPE bag tied with plastic fastener in high density polyethylene (HDPE) carboy.
API Manufacturing Site(s)
Arene Lifesciences
Unit-1, Plot No. 48, 49 & 50, 209, 210 & 211, Phase-II, IDA,, Sangareddy
Pashamylaram,
Telangana
502 307
India