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 : 13284
Submission : 1998-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12998
Submission : 1998-05-22
Status : Inactive
Type : II
97
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A D-5665 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-5665, including repackagers and relabelers. The FDA regulates D-5665 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-5665 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 D-5665 supplier is an individual or a company that provides D-5665 active pharmaceutical ingredient (API) or D-5665 finished formulations upon request. The D-5665 suppliers may include D-5665 API manufacturers, exporters, distributors and traders.
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A D-5665 DMF (Drug Master File) is a document detailing the whole manufacturing process of D-5665 active pharmaceutical ingredient (API) in detail. Different forms of D-5665 DMFs exist exist since differing nations have different regulations, such as D-5665 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-5665 DMF submitted to regulatory agencies in the US is known as a USDMF. D-5665 USDMF includes data on D-5665's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-5665 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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