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CV014

Product Details
WHO Product ID
CV014
Status
Prequalified
INN, dosage form and strength
Molnupiravir Capsules, hard 200mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Applicant organization
Aurobindo Pharma Ltd
Plot No 2, Maitrivihar, Ameerpet
Hyderabad,
Telangana
500 038
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
40x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aurobindo Pharma Limited
Unit-XIV Plot No. 17, Jawaharlal Nehru Pharma City, E-Bonangi Village
Parawada Mandal, Anakapalli District,
Andhra Pradesh
531019
India
Molnupiravir
FPP Manufacturing Site(s)
Aurobindo Pharma Limited (Unit III)
Survey No. 313 & 314 - Block IV Bachupally, Bachupally Mandal, Medchal-Malkajgiri District,
Telangana
500090
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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