01 1MERCK & CIE
01 11, 2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHLINE (DOPC)
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24819
Submission : 2011-04-04
Status : Active
Type : IV
A DOPG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DOPG, including repackagers and relabelers. The FDA regulates DOPG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DOPG 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 DOPG supplier is an individual or a company that provides DOPG active pharmaceutical ingredient (API) or DOPG finished formulations upon request. The DOPG suppliers may include DOPG API manufacturers, exporters, distributors and traders.
click here to find a list of DOPG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DOPG DMF (Drug Master File) is a document detailing the whole manufacturing process of DOPG active pharmaceutical ingredient (API) in detail. Different forms of DOPG DMFs exist exist since differing nations have different regulations, such as DOPG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DOPG DMF submitted to regulatory agencies in the US is known as a USDMF. DOPG USDMF includes data on DOPG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DOPG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DOPG suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?