Product details
WHO Product ID
WHOAPI-010
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Abacavir (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Tianish Laboratories Private Limited
Plot No. 564/A/22, Road No. 92, Jubilee Hills, Filmnagar, Shaikpet
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/ABC/AP/008/03, February 2021
MLL/ABC/RP/008/03, February 2021
MLL/ABC/AP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/RP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/RP/008/03, February 2021
MLL/ABC/AP/008/03, February 2021/Amend 01- January 2024
MLL/ABC/RP/008/03, February 2021/Amend 01- January 2024
Product Grades
API specification number
STP/FPR/ABC/001/02 (Unit-8) & STP/ABC/FPR/008/00 (Unit-10)
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
White LDPE bag closed and placed in a second PE bag which is black closed and placed in HDPE drums
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Tianish Laboratories Private Limited
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
Jawaharlal Nehru Pharma City,
Andhra Pradesh
531019
India