Product Details
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
No 43 Qilidian Road
Guilin,
Guangxi
541004
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
Workshop 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 & Organics Ltd
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