01 1CHEMO IBERICA SA
01 1TIANEPTINE SODIUM
01 1Spain
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22308
Submission : 2008-12-12
Status : Active
Type : II
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A Tatinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tatinol, including repackagers and relabelers. The FDA regulates Tatinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tatinol 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 Tatinol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tatinol supplier is an individual or a company that provides Tatinol active pharmaceutical ingredient (API) or Tatinol finished formulations upon request. The Tatinol suppliers may include Tatinol API manufacturers, exporters, distributors and traders.
click here to find a list of Tatinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tatinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tatinol active pharmaceutical ingredient (API) in detail. Different forms of Tatinol DMFs exist exist since differing nations have different regulations, such as Tatinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tatinol DMF submitted to regulatory agencies in the US is known as a USDMF. Tatinol USDMF includes data on Tatinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tatinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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