01 1Aurore Life Sciences
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1HONOUR LAB LTD
04 1MSN Laboratories
05 1Optimus Pharma
06 1SMS Pharmaceuticals
07 1Shandong Luxi Pharmaceutical Co.,Ltd.
01 7MOLNUPIRAVIR
01 2China
02 5India
01 7Active
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36329
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37435
Submission : 2022-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36282
Submission : 2021-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35960
Submission : 2021-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2021-06-28
DMF Number : 36078
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37087
Submission : 2022-05-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36770
Submission : 2022-07-15
Status : Active
Type : II
A Molnupiravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Molnupiravir, including repackagers and relabelers. The FDA regulates Molnupiravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Molnupiravir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Molnupiravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Molnupiravir supplier is an individual or a company that provides Molnupiravir active pharmaceutical ingredient (API) or Molnupiravir finished formulations upon request. The Molnupiravir suppliers may include Molnupiravir API manufacturers, exporters, distributors and traders.
click here to find a list of Molnupiravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Molnupiravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Molnupiravir active pharmaceutical ingredient (API) in detail. Different forms of Molnupiravir DMFs exist exist since differing nations have different regulations, such as Molnupiravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Molnupiravir DMF submitted to regulatory agencies in the US is known as a USDMF. Molnupiravir USDMF includes data on Molnupiravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Molnupiravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Molnupiravir suppliers with USDMF on PharmaCompass.
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