01 1SAFC
01 11,4 DIAMINOBUTANE DIHYDROCHLORIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16479
Submission : 2003-03-19
Status : Inactive
Type : II
A Putrescine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Putrescine Hydrochloride, including repackagers and relabelers. The FDA regulates Putrescine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Putrescine Hydrochloride 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 Putrescine Hydrochloride supplier is an individual or a company that provides Putrescine Hydrochloride active pharmaceutical ingredient (API) or Putrescine Hydrochloride finished formulations upon request. The Putrescine Hydrochloride suppliers may include Putrescine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Putrescine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Putrescine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Putrescine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Putrescine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Putrescine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Putrescine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Putrescine Hydrochloride USDMF includes data on Putrescine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Putrescine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Putrescine Hydrochloride suppliers with USDMF on PharmaCompass.
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