01 1Procos
01 1ALVERINE CITRATE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29917
Submission : 2015-10-06
Status : Inactive
Type : II
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A Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate, including repackagers and relabelers. The FDA regulates Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate supplier is an individual or a company that provides Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate active pharmaceutical ingredient (API) or Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate finished formulations upon request. The Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate suppliers may include Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate active pharmaceutical ingredient (API) in detail. Different forms of Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate DMFs exist exist since differing nations have different regulations, such as Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate USDMF includes data on Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipropylamine, N-ethyl-3,3'-diphenyl-, citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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