Product Details
WHO Product ID
TB276
Status
Prequalified
INN, dosage form and strength
Isoniazid Tablet 300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Cadila Pharmaceuticals Ltd
OSD non-beta + Rifa, 1389 Trasad Road, Dholka
Ahmedabad,
Gujarat
387 810
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
500x1, 1000x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x10, 28x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India
Isoniazid
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Isoniazid
FPP Manufacturing Site(s)
Cadila Pharmaceuticals Ltd
OSD non-beta + Rifa, 1389 Trasad Road, Dholka
Ahmedabad,
Gujarat
387 810
India