Product details
WHO Product ID
WHOAPI-134
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
Mangalam Drugs and Organics Ltd
Rupam Building, 3rd Floor, 239 P.D'mello Rd, near GPO
Mumbai,
Maharashtra
400 001
India
APIMF Version Number
MDOL/AMQ/OP-2021/00
MDOL/AMQ/RP-2021/00
MDOL/AMQ/RP-2021/00
Product Grades
API specification number
DS.SP.IH.AMQ-D, Version 1.1
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Shelf life
Packaging
Colourless LDPE bag inserted in a black colored LDPE bag, placed in HDPE drum.
API Manufacturing Site(s)
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India