01 1Servier
01 1AZEPAN
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27980
Submission : 2014-03-14
Status : Active
Type : II
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A AZEPAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AZEPAN, including repackagers and relabelers. The FDA regulates AZEPAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AZEPAN API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A AZEPAN supplier is an individual or a company that provides AZEPAN active pharmaceutical ingredient (API) or AZEPAN finished formulations upon request. The AZEPAN suppliers may include AZEPAN API manufacturers, exporters, distributors and traders.
click here to find a list of AZEPAN suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AZEPAN DMF (Drug Master File) is a document detailing the whole manufacturing process of AZEPAN active pharmaceutical ingredient (API) in detail. Different forms of AZEPAN DMFs exist exist since differing nations have different regulations, such as AZEPAN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AZEPAN DMF submitted to regulatory agencies in the US is known as a USDMF. AZEPAN USDMF includes data on AZEPAN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AZEPAN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AZEPAN suppliers with USDMF on PharmaCompass.
