Product details
WHO Product ID
WHOAPI-451
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Covid-19
Grade
Standard
INN
Molnupiravir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Divi’s Laboratories Limited
1-72/23(P)/DIVIS/303, Divi Towers Cyber Hills, Gachibowli
Hyderabad,
Telangana
500 032
India
APIMF Version Number
Divi’s Laboratories Limited/Molnupiravir/OP/01/Oct-2022
Divi’s Laboratories Limited/Molnupiravir/RP/01/Oct-2022
Divi’s Laboratories Limited/Molnupiravir/RP/01/Oct-2022
Product Grades
API specification number
UIQC/FP/VNK/0001, Revision No 006
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
The product is packed in two clear antistatic liner bags, the immediate product contact is a clear antistatic liner bag and outer one is also clear antistatic liner bag. Each bag is sealed individually with plastic tamper evident cable tie seals. Finally, the product is placed in HDPE drums having lid closed with clamp and sealed with metal seal and then shipped.
API Manufacturing Site(s)
Divi’s Laboratories Limited
Lingojigudem Village, Choutuppal Mandal Yadadri Bhuvanagiri District
Telangana
508252
India