Product details
WHO Product ID
WHOAPI-120b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard (<25°C)
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/166, Revision 01
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
Food grade twin HMHDPE/LDPE bags inner transparent/translucent or black bag and outer black bag and outer black bag placed in 25/50kg HDPE Drums.