Prequalified Medicinal Products

Reference Number: 
CV012

Date of prequalification: 
25 December 2022
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Nirmatrelvir + Ritonavir
Therapeutic area: 
COVID-19
Dosage form & strength: 
Tablet, Film-coated 150mg + 100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
18
Packaging: 
Blister: Alu-Alu 5x(4-Nirmatrelvir Tablets + 2-Ritonavir Tablets)
Applicant: 
Hetero Labs Ltd, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
Hetero Drugs Limited, Unit IX, Plot No. 1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

FPP WHO Public Inspection Reports: 

Hetero Labs Limited - Unit 3 (Jeedimetla) - Desk Assessment - (21 September - 02 October 2020), Hyderabad, India

API Manufacturing Site: 

(Nirmatrelvir) Honour Lab Limited, Unit III, Plot No. 4, Hetero Infrastructure Ltd., SEZ, N. Narasapuram Village, Nakkapalli Mandal, Visakhapatnam, Andhra Pradesh, 531081, India
(Ritonavir) Hetero Drugs Limited, Unit IX, Plot No. 1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Ritonavir) Hetero Labs Limited, Unit IX, Plot No. 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapally Mandal, Anakapalli District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: 

Honour Lab Limited – Desk Assessment - (21 - 30 August 2020), Visakhapatnam, India