Product Details
WHO Product ID
CV007
Status
Prequalified
INN, dosage form and strength
Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Film-coated
Applicant organization
Pfizer Limited
Ramsgate Rd., Sandwich
Kent,
CT13 9NJ
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Blister; OPA/Al/PVC
Configuration
5 x (4 Nirmatrelvir tablets + 2 Ritonavir tablets)
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Avoid excursions above 30℃.Do not refrigerate or freeze
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
Pfizer Ireland Pharmaceuticals
Ringaskiddy Active Pharmaceutical Ingredient Plant
Ringaskiddy,
Cork
Ireland
Nirmatrelvir
FPP Manufacturing Site(s)
Hetero Drugs Limited
Unit-IX, Plot No. 1, Hetero Infrastructure Ltd.- SEZ, Narasapuram Village, Nakkapally Mandal,
Visakhapatnam District,
Andhra Pradesh
531081
India
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India
Pfizer Italia S.r.L
Localita Marino Del Tronto
Ascoli Piceno,
63100
Italy
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1,
79090 Freiburg
Germany