01 1Koei Chemical
01 1PAA-HC1 [4-PIPERIDYL ACETIC ACID-HCL]
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15641
Submission : 2001-10-01
Status : Inactive
Type : II
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A Methyl 4-Piperidineacetate HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methyl 4-Piperidineacetate HCl, including repackagers and relabelers. The FDA regulates Methyl 4-Piperidineacetate HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methyl 4-Piperidineacetate HCl 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 Methyl 4-Piperidineacetate HCl supplier is an individual or a company that provides Methyl 4-Piperidineacetate HCl active pharmaceutical ingredient (API) or Methyl 4-Piperidineacetate HCl finished formulations upon request. The Methyl 4-Piperidineacetate HCl suppliers may include Methyl 4-Piperidineacetate HCl API manufacturers, exporters, distributors and traders.
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A Methyl 4-Piperidineacetate HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Methyl 4-Piperidineacetate HCl active pharmaceutical ingredient (API) in detail. Different forms of Methyl 4-Piperidineacetate HCl DMFs exist exist since differing nations have different regulations, such as Methyl 4-Piperidineacetate HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methyl 4-Piperidineacetate HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Methyl 4-Piperidineacetate HCl USDMF includes data on Methyl 4-Piperidineacetate HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methyl 4-Piperidineacetate HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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