01 1Nippon Kayaku
01 1AUREOBASIDIN A
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9875
Submission : 1992-09-24
Status : Inactive
Type : II
A Aureobasidin E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aureobasidin E, including repackagers and relabelers. The FDA regulates Aureobasidin E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aureobasidin E 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 Aureobasidin E supplier is an individual or a company that provides Aureobasidin E active pharmaceutical ingredient (API) or Aureobasidin E finished formulations upon request. The Aureobasidin E suppliers may include Aureobasidin E API manufacturers, exporters, distributors and traders.
click here to find a list of Aureobasidin E suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aureobasidin E DMF (Drug Master File) is a document detailing the whole manufacturing process of Aureobasidin E active pharmaceutical ingredient (API) in detail. Different forms of Aureobasidin E DMFs exist exist since differing nations have different regulations, such as Aureobasidin E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aureobasidin E DMF submitted to regulatory agencies in the US is known as a USDMF. Aureobasidin E USDMF includes data on Aureobasidin E's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aureobasidin E USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aureobasidin E suppliers with USDMF on PharmaCompass.
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