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01 1ETHYL 4-(BUTYLAMINO) BENZOATE - CARLSTADT AND PENNSVILLE, NJ
02 1ETHYL-4-N(n-BUTYLAMINO) BENZOATE
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8970
Submission : 1991-02-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9093
Submission : 1991-04-29
Status : Inactive
Type : II
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A Ethyl 4-Butylamino-Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethyl 4-Butylamino-Benzoate, including repackagers and relabelers. The FDA regulates Ethyl 4-Butylamino-Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethyl 4-Butylamino-Benzoate 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 Ethyl 4-Butylamino-Benzoate supplier is an individual or a company that provides Ethyl 4-Butylamino-Benzoate active pharmaceutical ingredient (API) or Ethyl 4-Butylamino-Benzoate finished formulations upon request. The Ethyl 4-Butylamino-Benzoate suppliers may include Ethyl 4-Butylamino-Benzoate API manufacturers, exporters, distributors and traders.
click here to find a list of Ethyl 4-Butylamino-Benzoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethyl 4-Butylamino-Benzoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethyl 4-Butylamino-Benzoate active pharmaceutical ingredient (API) in detail. Different forms of Ethyl 4-Butylamino-Benzoate DMFs exist exist since differing nations have different regulations, such as Ethyl 4-Butylamino-Benzoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethyl 4-Butylamino-Benzoate DMF submitted to regulatory agencies in the US is known as a USDMF. Ethyl 4-Butylamino-Benzoate USDMF includes data on Ethyl 4-Butylamino-Benzoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethyl 4-Butylamino-Benzoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethyl 4-Butylamino-Benzoate suppliers with USDMF on PharmaCompass.
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