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HP009

Product Details
WHO Product ID
HP009
Status
Prequalified
INN, dosage form and strength
Sofosbuvir Tablet, Film-coated 400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Strides Pharma Science Limited
Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road
Bangalore,
Karnataka
560 076
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India
Sofosbuvir
FPP Manufacturing Site(s)
Strides Pharma Science Limited
Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk
Bangalore,
Karnataka
562 106
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (includign 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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