Product details
WHO Product ID
WHOAPI-030
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Amodiaquine (hydrochloride)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
APIMF Version Number
Q5/DMF/AP/04/2021-09-29;
Q5/DMF/RP/04/2021-09-29
Q5/DMF/RP/04/2021-09-29
Product Grades
API specification number
TS/API//Q5/DMF version No. 05
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Double sealed clear Polyethylene bags (LDPE) in fibre/HMHDPE drum
API Manufacturing Site(s)
Ipca Laboratories Ltd
89A-B, 90/91 Industrial Estate, Pologround
Indore,
Madhya Pradesh
452 003
India
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India