01 2Pfizer Inc
01 2TROLEANDOMYCIN
01 2U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13708
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13491
Submission : 1998-09-01
Status : Inactive
Type : II
30
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A Evramicina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Evramicina, including repackagers and relabelers. The FDA regulates Evramicina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Evramicina 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 Evramicina supplier is an individual or a company that provides Evramicina active pharmaceutical ingredient (API) or Evramicina finished formulations upon request. The Evramicina suppliers may include Evramicina API manufacturers, exporters, distributors and traders.
click here to find a list of Evramicina suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Evramicina DMF (Drug Master File) is a document detailing the whole manufacturing process of Evramicina active pharmaceutical ingredient (API) in detail. Different forms of Evramicina DMFs exist exist since differing nations have different regulations, such as Evramicina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Evramicina DMF submitted to regulatory agencies in the US is known as a USDMF. Evramicina USDMF includes data on Evramicina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Evramicina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Evramicina suppliers with USDMF on PharmaCompass.
