Product details
WHO Product ID
WHOAPI-153
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Artemether
Confirmation of WHO API prequalification document (version date)
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
APIMF Version Number
MLL/ARM/AP/001/05/September 2022
MLL/ARM/RP/001/05/September 2022
MLL/ARM/RP/001/05/September 2022
Product Grades
API specification number
STP/FPR/ARM/001/05
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
48
Duration type
Retest period
Packaging
Inner white LDPE bag (fastened), placed in an LDPE black polythene bag and heat-sealed.The bag is placed in a Triple laminated aluminum bag and heat- sealed. The bag is transferred into HDPE drums
API Manufacturing Site(s)
Mylan Laboratories Ltd
Unit 1, Survey 10/42, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India