Product details
WHO Product ID
WHOAPI-120a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artemether
Confirmation of WHO API prequalification document (version date)
Applicant organization
Calyx Chemicals & Pharmaceuticals Ltd
A-37, 38 Kalyan Shill Road, MIDC Phase-I, Golvali, Thane District
Dombivli,
Maharashtra
421 203
India
APIMF Version Number
Calyx/Artemether/OP/04/Nov-2021
Calyx/Artemether/RP/04/Nov-2021
Calyx/Artemether/OP/04/Nov-2021/Amend 01 - Jan-2023
Calyx/Artemether/RP/04/Nov-2021/Amend 01 - Jan-2023
Calyx/Artemether/RP/04/Nov-2021
Calyx/Artemether/OP/04/Nov-2021/Amend 01 - Jan-2023
Calyx/Artemether/RP/04/Nov-2021/Amend 01 - Jan-2023
Product Grades
API specification number
SP/FP/71, Revision: 10
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Twin HMHDPE/LDPE bags placed in HDPE drums; Inner transparent LDPE food grade bag and outer food grade black coloured LDPE bag placed in 25/50kg HDPE Drums
API Manufacturing Site(s)
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India