Product Details
WHO Product ID
HA686
Status
Prequalified
INN, dosage form and strength
Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Mylan Laboratories Limited
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
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
100x1, 1000x1
Shelf life (months)
24
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
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