WHO Product ID
HA687
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
Mylan Laboratories Ltd.
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x1
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
100x1, 500x1, 1000x1
Shelf life (months)
24
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
Trimethoprim
Virchow Laboratories Ltd
Plot No 4 to 10, SV Cooperative Industrial Estate, IDA, Jeedimetla
Hyderabad,
500055
India
Sulfamethoxazole
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India
