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NT016

WHO Product ID
NT016
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
Indoco Remedies Limited
166, C.S.T. Road
Mumbai,
400 098
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
14x4
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
10x6
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
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)
Indoco Remedies Limited
Unit 1, Village Katha, P.O. Baddi, Tehsil: Nalagarh, Dist.: Solan
Himachal Pradesh
173 205
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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