Product details
WHO Product ID
WHOAPI-090
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Efavirenz
Confirmation of WHO API prequalification document (version date)
Applicant organization
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/EFAVIRENZ/OP/04/FEBRUARY-2021
LL/EFAVIRENZ/RP/04/FEBRUARY-2021
LL/EFAVIRENZ/RP/04/FEBRUARY-2021
Product Grades
API specification number
FS/AELT-301/02 version 12.0
Storage condition
Do not store above 25°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Inner low-density transparent polyethylene (LDPE) bag inside in a black LDPE bag twist-tied with a self-sealing plastic strip. The bags are housed in a HDPE drums.
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India