01 1Procos
01 1PRENILAMINE LACTATE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3553
Submission : 1979-07-03
Status : Inactive
Type : II
A Prenylamine Lactate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prenylamine Lactate, including repackagers and relabelers. The FDA regulates Prenylamine Lactate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prenylamine Lactate 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 Prenylamine Lactate supplier is an individual or a company that provides Prenylamine Lactate active pharmaceutical ingredient (API) or Prenylamine Lactate finished formulations upon request. The Prenylamine Lactate suppliers may include Prenylamine Lactate API manufacturers, exporters, distributors and traders.
click here to find a list of Prenylamine Lactate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prenylamine Lactate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prenylamine Lactate active pharmaceutical ingredient (API) in detail. Different forms of Prenylamine Lactate DMFs exist exist since differing nations have different regulations, such as Prenylamine Lactate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prenylamine Lactate DMF submitted to regulatory agencies in the US is known as a USDMF. Prenylamine Lactate USDMF includes data on Prenylamine Lactate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prenylamine Lactate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prenylamine Lactate suppliers with USDMF on PharmaCompass.
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