01 1Cipla
02 1HONOUR LAB LTD
03 1MSN Laboratories
04 1Optimus Pharma
01 4NIRMATRELVIR
01 4India
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37946
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36910
Submission : 2022-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37628
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37393
Submission : 2022-07-29
Status : Active
Type : II
A Paxlovid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paxlovid, including repackagers and relabelers. The FDA regulates Paxlovid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paxlovid 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 Paxlovid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paxlovid supplier is an individual or a company that provides Paxlovid active pharmaceutical ingredient (API) or Paxlovid finished formulations upon request. The Paxlovid suppliers may include Paxlovid API manufacturers, exporters, distributors and traders.
click here to find a list of Paxlovid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paxlovid DMF (Drug Master File) is a document detailing the whole manufacturing process of Paxlovid active pharmaceutical ingredient (API) in detail. Different forms of Paxlovid DMFs exist exist since differing nations have different regulations, such as Paxlovid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paxlovid DMF submitted to regulatory agencies in the US is known as a USDMF. Paxlovid USDMF includes data on Paxlovid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paxlovid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paxlovid suppliers with USDMF on PharmaCompass.
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