WHO Product ID
TB403
Status
Prequalified
INN, dosage form and strength
Pretomanid Tablet 200mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
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
Blister, Alu/PVC/PVDC
Configuration
10x10, 10x12, 14x6, 14x12
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
Packaging Type
Bottle, HDPE
Configuration
26x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Lupin Manufacturing Solutions Ltd.
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Pretomanid
FPP Manufacturing Site(s)
Lupin Ltd.
A-28/1 MIDC Industrial Area, Chikalthana
Chhatrapati Sambhajinagar,
431 210
India