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TB070

Product Details
WHO Product ID
TB070
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
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
6x15, 14x24
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Al/PVC/PVdC
Configuration
6x15, 28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture, protect from light
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture, protect from light
Packaging Type
Blister Alu/PVC/PE/PVdC
Configuration
28x24
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India
Isoniazid
Lupin Ltd
Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate
Ankleshwar,
Gujarat
393 002
India
Ethambutol hydrochloride
Lupin Ltd
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India
Pyrazinamide, Rifampicin
Lupin Manufacturing Solutions Ltd
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India
Pyrazinamide
Olon Active Pharmaceutical Ingredients India Private Limited
Plot No: L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Raigad District
Mahad,
Maharashtra
402 301
India
Rifampicin
FPP Manufacturing Site(s)
Lupin Ltd
EPIP, SIDCO Industrial Complex, Kartholi
Bari Brahmana,
Jammu and Kashmir
181 133
India
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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