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IN001

Product Details
WHO Product ID
IN001
Status
Prequalified
INN, dosage form and strength
Oseltamivir (phosphate) Capsules, hard 75mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Influenza
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 25°C
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
10x1
Shelf life (months)
24
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Oseltamivir (phosphate)
Cipla Ltd
Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Oseltamivir (phosphate)
FPP Manufacturing Site(s)
Cipla Ltd
Unit 3, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla Ltd
Unit 4, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla Ltd
Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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