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01 12,7-DIMETHYL-FMOC-L-LEUCINE
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9464
Submission : 1991-12-12
Status : Inactive
Type : II
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A 9-Fluorenylmethoxycarbonyl-L-Leucine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 9-Fluorenylmethoxycarbonyl-L-Leucine, including repackagers and relabelers. The FDA regulates 9-Fluorenylmethoxycarbonyl-L-Leucine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 9-Fluorenylmethoxycarbonyl-L-Leucine 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 9-Fluorenylmethoxycarbonyl-L-Leucine supplier is an individual or a company that provides 9-Fluorenylmethoxycarbonyl-L-Leucine active pharmaceutical ingredient (API) or 9-Fluorenylmethoxycarbonyl-L-Leucine finished formulations upon request. The 9-Fluorenylmethoxycarbonyl-L-Leucine suppliers may include 9-Fluorenylmethoxycarbonyl-L-Leucine API manufacturers, exporters, distributors and traders.
click here to find a list of 9-Fluorenylmethoxycarbonyl-L-Leucine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 9-Fluorenylmethoxycarbonyl-L-Leucine DMF (Drug Master File) is a document detailing the whole manufacturing process of 9-Fluorenylmethoxycarbonyl-L-Leucine active pharmaceutical ingredient (API) in detail. Different forms of 9-Fluorenylmethoxycarbonyl-L-Leucine DMFs exist exist since differing nations have different regulations, such as 9-Fluorenylmethoxycarbonyl-L-Leucine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 9-Fluorenylmethoxycarbonyl-L-Leucine DMF submitted to regulatory agencies in the US is known as a USDMF. 9-Fluorenylmethoxycarbonyl-L-Leucine USDMF includes data on 9-Fluorenylmethoxycarbonyl-L-Leucine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 9-Fluorenylmethoxycarbonyl-L-Leucine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 9-Fluorenylmethoxycarbonyl-L-Leucine suppliers with USDMF on PharmaCompass.
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