01 1SAFC
01 1CHOLESTEROL-3,4-(13)C(2), FOR PHASE I CLINICAL STUDIES
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21282
Submission : 2008-01-18
Status : Inactive
Type : II
A Cholesterol-3,4-13C2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cholesterol-3,4-13C2, including repackagers and relabelers. The FDA regulates Cholesterol-3,4-13C2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cholesterol-3,4-13C2 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 Cholesterol-3,4-13C2 supplier is an individual or a company that provides Cholesterol-3,4-13C2 active pharmaceutical ingredient (API) or Cholesterol-3,4-13C2 finished formulations upon request. The Cholesterol-3,4-13C2 suppliers may include Cholesterol-3,4-13C2 API manufacturers, exporters, distributors and traders.
click here to find a list of Cholesterol-3,4-13C2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cholesterol-3,4-13C2 DMF (Drug Master File) is a document detailing the whole manufacturing process of Cholesterol-3,4-13C2 active pharmaceutical ingredient (API) in detail. Different forms of Cholesterol-3,4-13C2 DMFs exist exist since differing nations have different regulations, such as Cholesterol-3,4-13C2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cholesterol-3,4-13C2 DMF submitted to regulatory agencies in the US is known as a USDMF. Cholesterol-3,4-13C2 USDMF includes data on Cholesterol-3,4-13C2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cholesterol-3,4-13C2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cholesterol-3,4-13C2 suppliers with USDMF on PharmaCompass.
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