01 1NOF CORPORATION
01 1DLINDMA (1,2-DILINOLEYLOXY-N,N-DIMETHYLPROPYLAMINE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25255
Submission : 2011-09-01
Status : Active
Type : II
A DLinDMA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DLinDMA, including repackagers and relabelers. The FDA regulates DLinDMA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DLinDMA 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 DLinDMA supplier is an individual or a company that provides DLinDMA active pharmaceutical ingredient (API) or DLinDMA finished formulations upon request. The DLinDMA suppliers may include DLinDMA API manufacturers, exporters, distributors and traders.
click here to find a list of DLinDMA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DLinDMA DMF (Drug Master File) is a document detailing the whole manufacturing process of DLinDMA active pharmaceutical ingredient (API) in detail. Different forms of DLinDMA DMFs exist exist since differing nations have different regulations, such as DLinDMA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DLinDMA DMF submitted to regulatory agencies in the US is known as a USDMF. DLinDMA USDMF includes data on DLinDMA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DLinDMA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DLinDMA suppliers with USDMF on PharmaCompass.
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