Product Details
WHO Product ID
HA762
Status
Prequalified
INN, dosage form and strength
Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet, Film-coated 300mg/25mg/800mg/160mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
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
Bottle, HDPE
Configuration
30x1 (without desiccant)
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in the original container
Packaging Type
Blister, Alu/Alu/OPA/PVC
Configuration
10x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in the original container
API Manufacturing Site(s)
By Organization
By Active Ingredient
Jiangxi Tianxin Pharmaceutical Co. Ltd.
Le'anjiang Industrial Zone
Leping,
Jiangxi
333 300
China
Pyridoxine hydrochloride
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China
Isoniazid
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