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WHOAPI-438: Molnupiravir

Product details
WHO Product ID
WHOAPI-438
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
Optimus Drugs Pvt Ltd
Sy No. 37/A & 37/P, Plot No. 6P, 2nd Floor, Signature Towers, Kothaguda, Kondapur,
Hyderabad,
Telangana
500 084
India
APIMF Version Number
Optimus Drugs/Molnupiravir/RP/00/November-2021
Optimus Drugs/Molnupiravir/OP/00/November-2021;
Optimus Drugs/Molnupiravir/RP/00-01/March-2022
Optimus Drugs/Molnupiravir/OP/00-01/March-2022;
Optimus Drugs/Molnupiravir/OP/00-02/July-2022
Optimus Drugs/Molnupiravir/RP/00-02/July-2022;
Optimus Drugs/Molnupiravir/OP/00-03/November-2022
Optimus Drugs/Molnupiravir/RP/00-03/November-2022;
Optimus Drugs/Molnupiravir/RP/00-04/January-2023
Optimus Drugs/Molnupiravir/OP/00-04/January-2023;
Optimus Drugs/Molnupiravir/OP/00-05/May-2023
Optimus Drugs/Molnupiravir/RP/00-05/May-2023;
Optimus Drugs/Molnupiravir/OP/00-06/June-2023
Optimus Drugs/Molnupiravir/RP/00-06/June-2023
Product Grades
API specification number
FPS/OP-VIT/01-03
Storage condition
Do not store above 30°C
Storage period (months)
24
Duration type
Retest period
Packaging
Primary packing: transparent LDPE bag tied with a strip seal
Secondary Packing: The above bag shall be kept in black LDPE bag, tied with strip seal
Tertiary Packing: The above bag shall be kept in blue color HDPE container with closed lid

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