Product details
WHO Product ID
WHOAPI-354
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
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
India
APIMF Version Number
Dolutegravir Sodium/OP/002/27-September-2021
Dolutegravir Sodium/RP/002/27-Septmber-2021
Dolutegravir Sodium/RP/002/27-Septmber-2021
Product Grades
API specification number
BD1299O0DB Version (Rev. No.) 6.0
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
48
Duration type
Retest period
Packaging
Material is packed in LDPE bag (Inner bag), twisted and tied after flushing Nitrogen. It is the inserted in the HMHDPE/LDPE/LLDPE blend bag (Middle bag) with silica sachet followed by heat sealed. Both these bags are then put into Polyester film/Aluminium foil/Transparent Polyester film/LDPE (Outer bag) and heat sealed. This triple bag is then placed in a fibre drum.
API Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Plot No. Z-15, Industrial Area, Dahej SEZ, Bharuch
Vagra,
Gujarat
392130
India