01 1NOF CORPORATION
01 1DIOLEOYL PHOSPHATIDYLCHOLINE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16808
Submission : 2003-08-29
Status : Active
Type : II
A DOPC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DOPC, including repackagers and relabelers. The FDA regulates DOPC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DOPC 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 DOPC supplier is an individual or a company that provides DOPC active pharmaceutical ingredient (API) or DOPC finished formulations upon request. The DOPC suppliers may include DOPC API manufacturers, exporters, distributors and traders.
click here to find a list of DOPC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DOPC DMF (Drug Master File) is a document detailing the whole manufacturing process of DOPC active pharmaceutical ingredient (API) in detail. Different forms of DOPC DMFs exist exist since differing nations have different regulations, such as DOPC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DOPC DMF submitted to regulatory agencies in the US is known as a USDMF. DOPC USDMF includes data on DOPC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DOPC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DOPC suppliers with USDMF on PharmaCompass.
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