01 1Abbott Laboratories
01 19-(S)-ERYTHROMYCYLAMINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9266
Submission : 1991-07-30
Status : Inactive
Type : II
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A Erythromyclamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromyclamine, including repackagers and relabelers. The FDA regulates Erythromyclamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromyclamine 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 Erythromyclamine supplier is an individual or a company that provides Erythromyclamine active pharmaceutical ingredient (API) or Erythromyclamine finished formulations upon request. The Erythromyclamine suppliers may include Erythromyclamine API manufacturers, exporters, distributors and traders.
click here to find a list of Erythromyclamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Erythromyclamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Erythromyclamine active pharmaceutical ingredient (API) in detail. Different forms of Erythromyclamine DMFs exist exist since differing nations have different regulations, such as Erythromyclamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Erythromyclamine DMF submitted to regulatory agencies in the US is known as a USDMF. Erythromyclamine USDMF includes data on Erythromyclamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Erythromyclamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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