Medicines/finished pharmaceutical products

Reference Number: 
HA598

Date of prequalification: 
23 May 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Sulfamethoxazole/Trimethoprim
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 400mg/80mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
60
Packaging: 
HDPE Bottle 100x1, 500x 1, 1000x1; Alu/PVC/PVdC Blister 10x10, 10x50, 10x100
Applicant: 
Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area, Bangalore, 560 074, India

API Manufacturing Site: 

(Sulfamethoxazole) Virchow Laboratories Ltd, Plot No 4 to 10, SV Coopearive Industrial Estate, IDA, Jeedimetla, Hyderabad, 500055, India
(Sulfamethoxazole) Shouguang Fukang Pharmaceuticals Co Ltd, 168 Beihai Road, North-East of Dongwaihuan Road,, Dongcheng Industrial Area, Shouguang City, Shandong, 262 700, China (People's Republic of)
(Trimethoprim) Shouguang Fukang Pharmaceuticals Co Ltd, 168 Beihai Road, North-East of Dongwaihuan Road,, Dongcheng Industrial Area, Shouguang City, Shandong, 262 700, China (People's Republic of)

API WHO Public Inspection Reports: