Product details
WHO Product ID
WHOAPI-155
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Lumefantrine
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/LMF/AP/001/04, September 2022
MLL/LMF/RP/001/04, September 2022
MLL/LMF/AP/001/04, September 2022/Amend-01-May 2023
MLL/LMF/RP/001/04, September 2022/Amend-01-May 2023
MLL/LMF/RP/001/04, September 2022
MLL/LMF/AP/001/04, September 2022/Amend-01-May 2023
MLL/LMF/RP/001/04, September 2022/Amend-01-May 2023
Product Grades
API specification number
STP/LMF/FPR/002/07
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Retest period
Packaging
White LDPE bag, secured and tied with plastic fastener. Placed within an HMLDPE bag and heat sealed.The tertiary packaging is a triple laminated aluminium bag and heat-sealed. The bags are then placed in HDPE drums.
API Manufacturing Site(s)
Tianish Laboratories Private Limited
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India