Medicines/finished pharmaceutical products

Reference Number: 
TB285

Date of prequalification: 
26 September 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet 300mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 30x1, 1000x1 (with desiccant); 30x1, 1000x1 (without desiccant)
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 H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Isoniazid) Second Pharma Co Ltd, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, 312 369, China (People's Republic of)

API WHO Public Inspection Reports: