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TB304

Product Details
WHO Product ID
TB304
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
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
100x1
Shelf life (months)
24
Storage conditions
Do not store above 25°C
Packaging Type
Blister, Alu/Alu
Configuration
10x1; 10x10
Shelf life (months)
24
Storage conditions
Do not store above 25°C
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)
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Aurangabad,
Maharashtra
431 136
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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