01 1Helsinn Advanced Synthesis
02 1MSN Laboratories
03 1Viatris
01 3NETUPITANT
01 1India
02 1Switzerland
03 1U.S.A
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26715
Submission : 2013-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31593
Submission : 2017-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31207
Submission : 2017-01-16
Status : Active
Type : II
A Netupitant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Netupitant, including repackagers and relabelers. The FDA regulates Netupitant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Netupitant 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 Netupitant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Netupitant supplier is an individual or a company that provides Netupitant active pharmaceutical ingredient (API) or Netupitant finished formulations upon request. The Netupitant suppliers may include Netupitant API manufacturers, exporters, distributors and traders.
click here to find a list of Netupitant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Netupitant DMF (Drug Master File) is a document detailing the whole manufacturing process of Netupitant active pharmaceutical ingredient (API) in detail. Different forms of Netupitant DMFs exist exist since differing nations have different regulations, such as Netupitant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Netupitant DMF submitted to regulatory agencies in the US is known as a USDMF. Netupitant USDMF includes data on Netupitant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Netupitant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Netupitant suppliers with USDMF on PharmaCompass.
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