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CV001

WHO Product ID
CV001
Status
Prequalified
INN, dosage form and strength
Remdesivir Lyophilised powder for solution for injection 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Lyophilised powder for solution for injection
Applicant organization
Hetero Labs Ltd
7-2-A2, Industrial Estates, Sanath Nagar
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Vial, USP Type I glass
Configuration
30ml vial x 6
Shelf life (months)
24
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
Remdesivir
FPP Manufacturing Site(s)
Aspiro Pharma Limited
Survey No. 321, Biotech Park, Phase III, Karkapatla village, Markook Mandal, Siddipet
Telangana
502281
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 authorized 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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