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TB386

Product Details
WHO Product ID
TB386
Status
Prequalified
INN, dosage form and strength
Pretomanid Tablet 200mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
United States Food and Drug Administration
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
26x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/PVC
Configuration
14x1
Shelf life (months)
18
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
182x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Pretomanid
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 5 , Part 7

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