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TB362

Product Details
WHO Product ID
TB362
Status
Prequalified
INN, dosage form and strength
Clofazimine Tablet, Film-coated 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC/PVdC
Configuration
28x10; 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
Packaging Type
Strip, Alu/Alu
Configuration
6x8; 10x10
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
Packaging Type
Bottle, HDPE
Configuration
100x1
Shelf life (months)
36
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
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Clofazimine
FPP Manufacturing Site(s)
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
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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