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TB385

Product Details
WHO Product ID
TB385
Status
Prequalified
INN, dosage form and strength
Cycloserine Capsules, hard 250mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
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/Alu
Configuration
1x10, 10x10
Shelf life (months)
24
Storage conditions
Do not store above 25°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Solara Active Pharma Sciences Limited
A-1/B, Sipcot Industrial Complex, Kudikadu Village, Tamil Nadu
Cuddalore,
607 005
India
Cycloserine
FPP Manufacturing Site(s)
Lupin Ltd
A-28/1 MIDC Industrial Area, Chikalthana
Aurangabad,
431 210
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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