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