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TB375

Product Details
WHO Product ID
TB375
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
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; 28x24
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
FPP Manufacturing Site(s)
Lupin Ltd
EPIP, SIDCO Industrial Complex, Kartholi
Bari Brahmana,
Jammu and Kashmir
181 133
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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