01 1Avanti Polar Lipids
01 11,2-DIERUCOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DEPC)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14604
Submission : 1999-12-01
Status : Active
Type : II
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PharmaCompass offers a list of DEPC API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right DEPC manufacturer or DEPC supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred DEPC manufacturer or DEPC supplier.
A DEPC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEPC, including repackagers and relabelers. The FDA regulates DEPC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEPC 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 DEPC supplier is an individual or a company that provides DEPC active pharmaceutical ingredient (API) or DEPC finished formulations upon request. The DEPC suppliers may include DEPC API manufacturers, exporters, distributors and traders.
click here to find a list of DEPC suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A DEPC DMF (Drug Master File) is a document detailing the whole manufacturing process of DEPC active pharmaceutical ingredient (API) in detail. Different forms of DEPC DMFs exist exist since differing nations have different regulations, such as DEPC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DEPC DMF submitted to regulatory agencies in the US is known as a USDMF. DEPC USDMF includes data on DEPC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DEPC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DEPC suppliers with USDMF on PharmaCompass.
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