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01 1SAFC
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01 1CORTISOL-9, 11, 12, 12-D4, FOR EARLY CLINICAL TRIALS
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01 1U.S.A
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01 1Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23059
Submission : 2009-08-20
Status : Inactive
Type : II
A Cortisol-9,11,12,12-D4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cortisol-9,11,12,12-D4, including repackagers and relabelers. The FDA regulates Cortisol-9,11,12,12-D4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cortisol-9,11,12,12-D4 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 Cortisol-9,11,12,12-D4 supplier is an individual or a company that provides Cortisol-9,11,12,12-D4 active pharmaceutical ingredient (API) or Cortisol-9,11,12,12-D4 finished formulations upon request. The Cortisol-9,11,12,12-D4 suppliers may include Cortisol-9,11,12,12-D4 API manufacturers, exporters, distributors and traders.
click here to find a list of Cortisol-9,11,12,12-D4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cortisol-9,11,12,12-D4 DMF (Drug Master File) is a document detailing the whole manufacturing process of Cortisol-9,11,12,12-D4 active pharmaceutical ingredient (API) in detail. Different forms of Cortisol-9,11,12,12-D4 DMFs exist exist since differing nations have different regulations, such as Cortisol-9,11,12,12-D4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cortisol-9,11,12,12-D4 DMF submitted to regulatory agencies in the US is known as a USDMF. Cortisol-9,11,12,12-D4 USDMF includes data on Cortisol-9,11,12,12-D4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cortisol-9,11,12,12-D4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cortisol-9,11,12,12-D4 suppliers with USDMF on PharmaCompass.
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