Product Details
WHO Product ID
HA639
Status
Prequalified
INN, dosage form and strength
Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim Tablet 300mg/25mg/800mg/160mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Container, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Inventaa Chemicals Ltd
Survey No 137, Keesara Village, Krishna District
Kanchikacherla Mandalam,
Andhra Pradesh
521180
India
Trimethoprim
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
Virchow Laboratories Ltd
Plot No 4 to 10, SV Cooperative Industrial Estate, IDA, Jeedimetla
Hyderabad,
500055
India
Sulfamethoxazole
FPP Manufacturing Site(s)
Cipla Quality Chemical Industries Ltd
PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park
Kampala,
Uganda
Cipla
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India