Product details
WHO Product ID
WHOAPI-436
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
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/001/05-December-2023
Dolutegravir Sodium/RP/001/05-December-2023
Dolutegravir Sodium/RP/001/05-December-2023
Product Grades
API specification number
No. 2025646, Rev. No. 9
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Material is packed in LDPE bag (Inner bag), twisted and tied after flushing with nitrogen. It is inserted in HMHDPE/LDPE/LLDPE blend bag (Middle bag) with silica sachet and then heat sealed. Both these bags are then put into Polyester film/Aluminium foil/Transparent Polyester Film/LDPE bag (Outer bag) and heat sealed. This triple bag is then placed in a fibre drum.