Product details
WHO Product ID
WHOAPI-466
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
M/s. Apitoria Pharma Private Limited
Floors 22-24, Plot No. 1, Survey No. 83/1, Galaxy Tower, Hyderabad Knowledge City, Raidurg Panmaktha
Hyde,
Telangana
500032
India
APIMF Version Number
Dolutegravir Sodium/OP-00/June-2022
Dolutegravir Sodium/RP-00/June-2022
Dolutegravir Sodium/OP-00/June-2022 Update/03-2024
Dolutegravir Sodium/RP-00/June-2022 Update/03-2024
Dolutegravir Sodium/OP-00/June-2022 Update/01-2025
Dolutegravir Sodium/RP-00/June-2022 Update/01-2025
Dolutegravir Sodium/OP-00/June-2022 Update/11-2025
Dolutegravir Sodium/RP-00/June-2022 Update/11-2025
Dolutegravir Sodium/RP-00/June-2022
Dolutegravir Sodium/OP-00/June-2022 Update/03-2024
Dolutegravir Sodium/RP-00/June-2022 Update/03-2024
Dolutegravir Sodium/OP-00/June-2022 Update/01-2025
Dolutegravir Sodium/RP-00/June-2022 Update/01-2025
Dolutegravir Sodium/OP-00/June-2022 Update/11-2025
Dolutegravir Sodium/RP-00/June-2022 Update/11-2025
Product Grades
API specification number
SPC140216102, Revision Number 01 (micronised)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Low-density polyethylene (LDPE) bag inserted in a second LDPE bag heat sealed and placed in a triple-laminated bags.
API Manufacturing Site(s)
Apitoria Pharma Private Ltd
Unit IV, Survey No 1/22, 2/1 to 5, 6 to 61 - 69, Pydibhimavaram, Mandal Ranasthalam, District Srikakulam
Andhra Pradesh
532409
India