Product details
WHO Product ID
WHOAPI-318a
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
Mangalam Drugs and 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, Version 1.2
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Shelf life
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