01 2Avanti Polar Lipids
02 2DISHMAN NETHERLANDS B.V.
03 1SIGMA TAU
04 1Sigma-Aldrich Corporation
01 1CHOLESTEROL
02 1CHOLESTEROL (770000)
03 1CHOLESTEROL (SEMI-SYNTHETIC)
04 2CHOLESTEROL HP
05 1CHOLESTREROL, PRODUCT NUMBER W 5179-2
01 2Netherlands
02 4U.S.A
01 2Active
02 4Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23761
Submission : 2010-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9285
Submission : 1991-08-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25382
Submission : 2011-10-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14346
Submission : 1999-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5146
Submission : 1983-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11492
Submission : 1995-04-26
Status : Inactive
Type : II
A Cholesterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cholesterol, including repackagers and relabelers. The FDA regulates Cholesterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cholesterol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cholesterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cholesterol supplier is an individual or a company that provides Cholesterol active pharmaceutical ingredient (API) or Cholesterol finished formulations upon request. The Cholesterol suppliers may include Cholesterol API manufacturers, exporters, distributors and traders.
click here to find a list of Cholesterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cholesterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Cholesterol active pharmaceutical ingredient (API) in detail. Different forms of Cholesterol DMFs exist exist since differing nations have different regulations, such as Cholesterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cholesterol DMF submitted to regulatory agencies in the US is known as a USDMF. Cholesterol USDMF includes data on Cholesterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cholesterol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cholesterol suppliers with USDMF on PharmaCompass.
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