Product Details
WHO Product ID
TB174
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
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
28x24; 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Store tablets in blisters in the provided carton in ord
Packaging Type
Blister, Alu-PVC/PE/PVDC
Configuration
28x24; 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C. Store tablets in the blisters in the provided carton
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
Packaging Type
Blister, Alu/PVC/EVOH/Aclar
Configuration
28x24; 10 x 10
Shelf life (months)
60
Storage conditions
Do not store above 25°C, store in dry condition, 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)
Micro Labs Limited
Unit 3, 92 Sipcot Industrial Complex
Hosur,
Tamil Nadu
635 126
India