Product details
WHO Product ID
WHOAPI-386a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Dolutegravir (sodium)
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/DTG/RP-2020/00
MDOL/DTG/OP-2020/00
MDOL/DTG/OP-2020/01
MDOL/DTG/OP-2020/02
MDOL/DTG/RP-2020/02
MDOL/DTG/RP-2020/03
MDOL/DTG/OP-2020/03
MDOL/DTG/OP-2020/00
MDOL/DTG/OP-2020/01
MDOL/DTG/OP-2020/02
MDOL/DTG/RP-2020/02
MDOL/DTG/RP-2020/03
MDOL/DTG/OP-2020/03
Product Grades
API specification number
DS.SP.IH.DTG-D version 1.4 (non-micronised)
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Transparent food grade LDPE bag inside black LDPE bag.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India