Product details
WHO Product ID
WHOAPI-050
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Lopinavir
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/LPV/AP/006/05, August 2020
MLL/LPV/AP/006/05, August 2020
MLL/LPV/AP/006/05, August 2020/Amend 01, Dec 2020
MLL/LPV/RP/006/05, August 2020/Amend 01, Dec 2020
MLL/LPV/AP/006/05, August 2020/Amend 02,Nov 2022
MLL/LPV/RP/006/05, August 2020/Amend 02, Nov 2022
MLL/LPV/AP/006/05, August 2020 / Amend 03- Jun 2023
MLL/LPV/RP/006/05, August 2020 / Amend 03- Jun 2023
MLL/LPV/AP/006/05, August 2020/ Amend 04- October 2023
MLL/LPV/RP/006/05, August 2020/ Amend 04- October 2023
MLL/LPV/AP/006/05, August 2020
MLL/LPV/AP/006/05, August 2020/Amend 01, Dec 2020
MLL/LPV/RP/006/05, August 2020/Amend 01, Dec 2020
MLL/LPV/AP/006/05, August 2020/Amend 02,Nov 2022
MLL/LPV/RP/006/05, August 2020/Amend 02, Nov 2022
MLL/LPV/AP/006/05, August 2020 / Amend 03- Jun 2023
MLL/LPV/RP/006/05, August 2020 / Amend 03- Jun 2023
MLL/LPV/AP/006/05, August 2020/ Amend 04- October 2023
MLL/LPV/RP/006/05, August 2020/ Amend 04- October 2023
Product Grades
API specification number
STP/FPR/LPV/007/00
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Retest period
Packaging
The material shall be packed in LDPE bag, twisted and tied with plastic fastener under nitrogen atmosphere. It is then inserted in I-IMLDPE bag with two silica gel sachet and one molecular sieve sachet, heat sealed. Both these bags are then put into the outer triple laminated bag with one molecular sieve sachet, heat sealed. Such bags are further packed in FIDPE drums, closed with plastic lids having rubber gasket followed by locking ring with metal seal and labelled.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India