01 1Abbott Laboratories
01 1ETHCHLORVYNOL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4782
Submission : 1982-12-27
Status : Inactive
Type : II
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A Serenil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serenil, including repackagers and relabelers. The FDA regulates Serenil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serenil 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 Serenil supplier is an individual or a company that provides Serenil active pharmaceutical ingredient (API) or Serenil finished formulations upon request. The Serenil suppliers may include Serenil API manufacturers, exporters, distributors and traders.
click here to find a list of Serenil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Serenil DMF (Drug Master File) is a document detailing the whole manufacturing process of Serenil active pharmaceutical ingredient (API) in detail. Different forms of Serenil DMFs exist exist since differing nations have different regulations, such as Serenil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Serenil DMF submitted to regulatory agencies in the US is known as a USDMF. Serenil USDMF includes data on Serenil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Serenil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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