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
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
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/Amend-01, June 2024
MLL/ARM/AP/001/05, September 2022/Amend-01, June 2024
MLL/ARM/RP/001/05, September 2022/Amend-02, September 2025
MLL/ARM/AP/001/05, September 2022/Amend-02, September 2025
MLL/ARM/RP/001/05/September 2022
MLL/ARM/RP/001/05, September 2022/Amend-01, June 2024
MLL/ARM/AP/001/05, September 2022/Amend-01, June 2024
MLL/ARM/RP/001/05, September 2022/Amend-02, September 2025
MLL/ARM/AP/001/05, September 2022/Amend-02, September 2025
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)
Matrix Pharmacorp Private Limited
Unit 1, Survey 10, Kazipally Industrial Area Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India