Product Details
WHO Product ID
HA599
Status
Prequalified
INN, dosage form and strength
Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x10, 10x50, 10x100
Shelf life (months)
60
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
100x1, 500x1, 1000x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shouguang Fukang Pharmaceuticals Co Ltd
North-East of Dongwaihuan Road, Dongcheng Industrial Area
Shouguang City, Shandong Province,
262 700
China
Sulfamethoxazole, Trimethoprim
Virchow Laboratories Ltd
Plot No 4 to 10, SV Cooperative Industrial Estate, IDA, Jeedimetla
Hyderabad,
500055
India
Sulfamethoxazole
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India
Micro Labs Limited
ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area
Bangalore,
560 074
India