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