Product details
WHO Product ID
WHOAPI-318b
Status
Prequalified
Date of prequalification
Therapeutic area
HIV/AIDS
Grade
micronized
INN
Efavirenz
Confirmation of WHO API prequalification document (version date)
Applicant organization
Mangalam Drugs & Organics Ltd
Rupam Building, 3rd Floor, 239 P.D'mello Rd, near GPO
Mumbai,
Maharashtra
400 001
India
APIMF Version Number
MDOL/EFD/OP-2020/00
MDOL/EFD/RP-2020/00
MDOL/EFD/OP-2020/01
MDOL/EFD/RP-2020/01
MDOL/EFD/OP-2020/02
MDOL/EFD/RP-2020/02
MDOL/EFD/RP-2020/00
MDOL/EFD/OP-2020/01
MDOL/EFD/RP-2020/01
MDOL/EFD/OP-2020/02
MDOL/EFD/RP-2020/02
Product Grades
API specification number
DS.SP.IH.EFD-D-M, Version 1.3
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
The primary packaging material is colorless virgin / food grade single polyethylene bag (LDPE). The colourless bag is inserted in a black coloured single polyethylene bag (LDPE) and placed in HDPE drum.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India