01 2Chemi SpA
01 1DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE)
02 1DMPC STANDARD
01 2Italy
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12998
Submission : 1998-05-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13284
Submission : 1998-10-20
Status : Inactive
Type : II
A Dimyristoyl Lecithin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dimyristoyl Lecithin, including repackagers and relabelers. The FDA regulates Dimyristoyl Lecithin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dimyristoyl Lecithin 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 Dimyristoyl Lecithin supplier is an individual or a company that provides Dimyristoyl Lecithin active pharmaceutical ingredient (API) or Dimyristoyl Lecithin finished formulations upon request. The Dimyristoyl Lecithin suppliers may include Dimyristoyl Lecithin API manufacturers, exporters, distributors and traders.
click here to find a list of Dimyristoyl Lecithin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dimyristoyl Lecithin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dimyristoyl Lecithin active pharmaceutical ingredient (API) in detail. Different forms of Dimyristoyl Lecithin DMFs exist exist since differing nations have different regulations, such as Dimyristoyl Lecithin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dimyristoyl Lecithin DMF submitted to regulatory agencies in the US is known as a USDMF. Dimyristoyl Lecithin USDMF includes data on Dimyristoyl Lecithin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dimyristoyl Lecithin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dimyristoyl Lecithin suppliers with USDMF on PharmaCompass.
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