01 1Avanti Polar Lipids
01 1CHOLESTERYL PALMITATE (730155)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31603
Submission : 2017-04-04
Status : Inactive
Type : II
A Cholesteryl Palmitate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cholesteryl Palmitate, including repackagers and relabelers. The FDA regulates Cholesteryl Palmitate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cholesteryl Palmitate 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 Cholesteryl Palmitate supplier is an individual or a company that provides Cholesteryl Palmitate active pharmaceutical ingredient (API) or Cholesteryl Palmitate finished formulations upon request. The Cholesteryl Palmitate suppliers may include Cholesteryl Palmitate API manufacturers, exporters, distributors and traders.
click here to find a list of Cholesteryl Palmitate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cholesteryl Palmitate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cholesteryl Palmitate active pharmaceutical ingredient (API) in detail. Different forms of Cholesteryl Palmitate DMFs exist exist since differing nations have different regulations, such as Cholesteryl Palmitate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cholesteryl Palmitate DMF submitted to regulatory agencies in the US is known as a USDMF. Cholesteryl Palmitate USDMF includes data on Cholesteryl Palmitate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cholesteryl Palmitate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cholesteryl Palmitate suppliers with USDMF on PharmaCompass.
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