01 1Nifty Labs
02 1Synthelabo Tanabe Chimie
01 1DIBENZO [B,F] [1,4] THIAZEPIN-11 (10H)-ONE
02 1THIAZEPIN
01 1France
02 1India
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29059
Submission : 2015-01-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9544
Submission : 1992-02-18
Status : Inactive
Type : II
A Tianeptine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tianeptine, including repackagers and relabelers. The FDA regulates Tianeptine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tianeptine 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 Tianeptine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tianeptine supplier is an individual or a company that provides Tianeptine active pharmaceutical ingredient (API) or Tianeptine finished formulations upon request. The Tianeptine suppliers may include Tianeptine API manufacturers, exporters, distributors and traders.
click here to find a list of Tianeptine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tianeptine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tianeptine active pharmaceutical ingredient (API) in detail. Different forms of Tianeptine DMFs exist exist since differing nations have different regulations, such as Tianeptine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tianeptine DMF submitted to regulatory agencies in the US is known as a USDMF. Tianeptine USDMF includes data on Tianeptine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tianeptine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tianeptine suppliers with USDMF on PharmaCompass.
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