Medicines/finished pharmaceutical products

Reference Number: 
HA686

Date of prequalification: 
05 April 2019
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): 
24
Packaging: 
Bottle, HDPE 100x1, 1000x1; Blister, Alu/PVC/PVdC 10x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India

API Manufacturing Site: 

(Sulfamethoxazole) Virchow Laboratories Ltd, Plot No 4 to 10, SV Coopearive Industrial Estate, IDA, Jeedimetla, Hyderabad, 500055, India
(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: