WHO Product ID
MA117
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet, Dispersible + Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg + 153mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible + Tablet, Dispersible
Applicant organization
Guilin Pharmaceutical Co Ltd
OSD, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
(1+3) x 50
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Guilin Pharmaceutical Co Ltd
API-I No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
Pyrimethamine, Sulfadoxine
Ipca Laboratories Ltd
89A-B, 90/91 Industrial Estate, Pologround
Indore,
Madhya Pradesh
452 003
India
Amodiaquine (hydrochloride)
Mangalam Drugs and Organics Limited
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Sulfadoxine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Amodiaquine (hydrochloride), Sulfadoxine
FPP Manufacturing Site(s)
Guilin Pharmaceutical Co Ltd
OSD, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China
