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CV021

Product Details
WHO Product ID
CV021
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
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
40x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Honour Lab Limited
Unit III, Plot 4, Hetero Infrastructure Ltd., SEZ, N. Narasapuram Village, Nakkapally, Visakhapatnam
Andhra Pradesh
531081
India
Molnupiravir
FPP Manufacturing Site(s)
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 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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