01 2Changzhou Pharmaceutical Factory
02 1MSN Laboratories
01 2AGOMELATINE
02 1AGOMELATINE [ROUTE CODE - AG1"]
01 2China
02 1India
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38958
Submission : 2023-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26965
Submission : 2013-03-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27206
Submission : 2013-06-21
Status : Active
Type : II
A Agomelatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Agomelatine, including repackagers and relabelers. The FDA regulates Agomelatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Agomelatine 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 Agomelatine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Agomelatine supplier is an individual or a company that provides Agomelatine active pharmaceutical ingredient (API) or Agomelatine finished formulations upon request. The Agomelatine suppliers may include Agomelatine API manufacturers, exporters, distributors and traders.
click here to find a list of Agomelatine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Agomelatine DMF (Drug Master File) is a document detailing the whole manufacturing process of Agomelatine active pharmaceutical ingredient (API) in detail. Different forms of Agomelatine DMFs exist exist since differing nations have different regulations, such as Agomelatine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Agomelatine DMF submitted to regulatory agencies in the US is known as a USDMF. Agomelatine USDMF includes data on Agomelatine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Agomelatine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Agomelatine suppliers with USDMF on PharmaCompass.
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