Product Details
WHO Product ID
TB360
Status
Prequalified
INN, dosage form and strength
Isoniazid/Rifampicin Tablet, Dispersible 50mg/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
6x14, 10x1, 28x3
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
Packaging Type
Blister, Alu/Alu
Configuration
5x1, 28x3
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
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
FPP Manufacturing Site(s)
Lupin Ltd
A-28/1 MIDC Industrial Area, Chikalthana
Aurangabad,
431 210
India