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 Nirmatrelvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nirmatrelvir, including repackagers and relabelers. The FDA regulates Nirmatrelvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nirmatrelvir 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 Nirmatrelvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nirmatrelvir supplier is an individual or a company that provides Nirmatrelvir active pharmaceutical ingredient (API) or Nirmatrelvir finished formulations upon request. The Nirmatrelvir suppliers may include Nirmatrelvir API manufacturers, exporters, distributors and traders.
click here to find a list of Nirmatrelvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nirmatrelvir DMF (Drug Master File) is a document detailing the whole manufacturing process of Nirmatrelvir active pharmaceutical ingredient (API) in detail. Different forms of Nirmatrelvir DMFs exist exist since differing nations have different regulations, such as Nirmatrelvir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nirmatrelvir DMF submitted to regulatory agencies in the US is known as a USDMF. Nirmatrelvir USDMF includes data on Nirmatrelvir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nirmatrelvir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nirmatrelvir suppliers with USDMF on PharmaCompass.
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