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TB401

WHO Product ID
TB401
Status
Prequalified
INN, dosage form and strength
Pyridoxine hydrochloride Tablet, Film-coated 50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
S Kant Healthcare Ltd.
3-A, Shiv Sagar Estate, North Wing, Dr. Annie Besant Road, Worli
Mumbai,
400 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
10x10, 10x50, 10x100
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store tablets in blisters in the provided carton in order to protect from light
API Manufacturing Site(s)
Jiangxi Tianxin Pharmaceutical Co. Ltd.
Le'anjiang Industrial Zone
Leping,
Jiangxi
333 300
China
FPP Manufacturing Site(s)
S Kant Healthcare Limited
Plot No. 1802-1805, G.I.D.C, Phase III
Vapi,
Gujarat
396195
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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