01 1Harman Finochem
01 1DESETHYLOXYBUTYNIN HYDROCHLORIDE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35084
Submission : 2020-09-10
Status : Active
Type : II
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A N-Desethyloxybutynin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Desethyloxybutynin, including repackagers and relabelers. The FDA regulates N-Desethyloxybutynin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Desethyloxybutynin 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 N-Desethyloxybutynin supplier is an individual or a company that provides N-Desethyloxybutynin active pharmaceutical ingredient (API) or N-Desethyloxybutynin finished formulations upon request. The N-Desethyloxybutynin suppliers may include N-Desethyloxybutynin API manufacturers, exporters, distributors and traders.
click here to find a list of N-Desethyloxybutynin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A N-Desethyloxybutynin DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Desethyloxybutynin active pharmaceutical ingredient (API) in detail. Different forms of N-Desethyloxybutynin DMFs exist exist since differing nations have different regulations, such as N-Desethyloxybutynin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Desethyloxybutynin DMF submitted to regulatory agencies in the US is known as a USDMF. N-Desethyloxybutynin USDMF includes data on N-Desethyloxybutynin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Desethyloxybutynin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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