01 1Siegfried AG
02 1Blank
01 2CANDICIDIN
01 1Switzerland
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 324
Submission : 1959-01-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13584
Submission : 1998-09-01
Status : Inactive
Type : II
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A Candeptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Candeptin, including repackagers and relabelers. The FDA regulates Candeptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Candeptin 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 Candeptin supplier is an individual or a company that provides Candeptin active pharmaceutical ingredient (API) or Candeptin finished formulations upon request. The Candeptin suppliers may include Candeptin API manufacturers, exporters, distributors and traders.
click here to find a list of Candeptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Candeptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Candeptin active pharmaceutical ingredient (API) in detail. Different forms of Candeptin DMFs exist exist since differing nations have different regulations, such as Candeptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Candeptin DMF submitted to regulatory agencies in the US is known as a USDMF. Candeptin USDMF includes data on Candeptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Candeptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Candeptin suppliers with USDMF on PharmaCompass.
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