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NT012

WHO Product ID
NT012
Status
Prequalified
INN, dosage form and strength
Albendazole Tablets, Chewable 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablets, Chewable
Applicant organization
Medopharm Private Limited
Unit II, No. 50, Kayarambedu Village, Guduvanchery
Tamil Nadu
603 202
India
Packaging details and storage conditions
Packaging Type
LDPE bag in 1800mL HDPE jar
Configuration
1000x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Sequent Scientific Limited
Plot Nos. B-32/G2/G3, MIDC, Raigad District, Mahad
Maharashtra
402309
India
Albendazole
FPP Manufacturing Site(s)
Medopharm Private Limited
Unit II, No. 50, Kayarambedu Village, Guduvanchery
Tamil Nadu
603 202
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 authorized 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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