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