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IN019

Product Details
WHO Product ID
IN019
Status
Prequalified
INN, dosage form and strength
Oseltamivir (phosphate) Capsules, hard 45mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Influenza
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Applicant organization
MSN Laboratories Private Limited
“MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Telangana
Hyderabad,
500 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC/PE/PVDC
Configuration
10x1, 10x3, 10x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
MSN Pharmachem Pvt Ltd
Plot No 212, A, B, C, D, Phase II, I.D.A Pashamylaram Village, Sangareddy District
Patancheru Mandal,
Telangana
502 307
India
Oseltamivir (phosphate)
FPP Manufacturing Site(s)
MSN Laboratories Private Limited
Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District)
Telangana
509228
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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