Product Details
WHO Product ID
MA113
Status
Prequalified
INN, dosage form and strength
Pyrimethamine/Sulfadoxine Tablet 25mg/500mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Guilin Pharmaceutical Co. Ltd
No 43 Qilidian Road
Guilin,
Guangxi
541004
China
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
100x1; 1000x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container
Packaging Type
Blister, Alu/PVC
Configuration
3x1, 3x10, 3x50, 3x100
Shelf life (months)
36
Storage conditions
Do not store above 30°C
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
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Sulfadoxine
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Sulfadoxine
FPP Manufacturing Site(s)
Guilin Pharmaceutical Co., Ltd.
OSD, No 43 Qilidian Road
Guilin,
Guangxi
541 004
China