01 1Waitaki Biosciences
01 1FETUIN (PEDERSEN)
01 1New Zealand
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9435
Submission : 1991-11-14
Status : Inactive
Type : II
A Pederin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pederin, including repackagers and relabelers. The FDA regulates Pederin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pederin 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 Pederin supplier is an individual or a company that provides Pederin active pharmaceutical ingredient (API) or Pederin finished formulations upon request. The Pederin suppliers may include Pederin API manufacturers, exporters, distributors and traders.
click here to find a list of Pederin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pederin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pederin active pharmaceutical ingredient (API) in detail. Different forms of Pederin DMFs exist exist since differing nations have different regulations, such as Pederin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pederin DMF submitted to regulatory agencies in the US is known as a USDMF. Pederin USDMF includes data on Pederin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pederin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pederin suppliers with USDMF on PharmaCompass.
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