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 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt), including repackagers and relabelers. The FDA regulates 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) 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 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) supplier is an individual or a company that provides 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) active pharmaceutical ingredient (API) or 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) finished formulations upon request. The 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) suppliers may include 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) active pharmaceutical ingredient (API) in detail. Different forms of 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) DMFs exist exist since differing nations have different regulations, such as 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) USDMF includes data on 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2-di-(9Z-octadecenoyl)-sn-glycero-3-phospho-(1'-rac-glycerol) (sodium salt) suppliers with USDMF on PharmaCompass.
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