Product Details
WHO Product ID
CV012
Status
Prequalified
INN, dosage form and strength
Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150 mg + 100 mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Film-coated
Applicant organization
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Blister: Alu/Alu
Configuration
5x(4-Nirmatrelvir Tablets + 2-Ritonavir Tablets)
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Drugs Limited
Unit IX, Plot No.1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Ritonavir
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Ritonavir
Honour Lab Limited
Unit III, Plot 4, Hetero Infrastructure Ltd., SEZ, N. Narasapuram Village, Nakkapally, Visakhapatnam
Andhra Pradesh
531081
India
Nirmatrelvir
FPP Manufacturing Site(s)
Hetero Drugs Limited
Unit IX, Plot No.1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India