Product Details
WHO Product ID
HA745
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
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
Packaging Type
Bottle, HDPE
Configuration
100x1, 500x1, 1000x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Trimethoprim
Virchow Laboratories Ltd
Plot No 4 to 10, SV Cooperative Industrial Estate, IDA, Jeedimetla
Hyderabad,
500055
India
Sulfamethoxazole
FPP Manufacturing Site(s)
Ipca Laboratories Ltd
Plot No 255/1, Village Athal
Silvassa,
Dadra and Nagar Haveli
Daman and Diu 396230
India