Medicines/finished pharmaceutical products

Reference Number: 
HA639

Date of prequalification: 
21 December 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 300mg/25mg/800mg/160mg
Shelf life (months): 
36
Packaging: 
HDPE container 30 30x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 1, Plot A-33, A-37 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Sulfamethoxazole) Virchow Laboratories Ltd, Plot No 4 to 10, SV Coopearive Industrial Estate, IDA, Jeedimetla, Hyderabad, 500055, India
(Trimethoprim) Inventaa Chemicals Ltd, Survey No 137, Keesara Village, Kanchikacherla Mandalam, Krishna District, Andhra Pradesh, 521180, India
(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)
(Pyridoxine hydrochloride) Zhejiang Tianxin Pharmaceutical Co Ltd, 215 Fengze Road, Tiantai, Zhejiang, 317200, China (People's Republic of)
Jiangxi Tianxin Pharmaceutical Co. Ltd., Le'anjiang Industrial Zone, Leping, Jiangxi Province, 333 300, China (People's Republic of)