WHO Product ID
TB400
Status
Prequalified
INN, dosage form and strength
Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
6x10, 28x3
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
Packaging Type
Blister, Alu/Alu
Configuration
10x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture, 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
Lupin Ltd.
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India
Rifampicin
Lupin Manufacturing Solutions Ltd.
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India
Pyrazinamide
FPP Manufacturing Site(s)
Lupin Ltd.
A-28/1 MIDC Industrial Area, Chikalthana
Chhatrapati Sambhajinagar,
431 210
India
