01 1Abiochem Biotechnology
02 1Chiral Quest
01 1(3R)-N-(TERT-BUTOXYCARBONYL)-3-AMINO-4-(2,4,5-TRIFLUOROPHENYL)BUTANOIC ACID (PROCESS II)
02 1(R)-3-(TERT-BUTOXYCARBONYLAMINO)-4-(2,4,5-TRIFLUOROPHENYL) BUTANOIC ACID
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38496
Submission : 2023-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27115
Submission : 2013-04-22
Status : Active
Type : II
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A 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid, including repackagers and relabelers. The FDA regulates 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid 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 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid supplier is an individual or a company that provides 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid active pharmaceutical ingredient (API) or 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid finished formulations upon request. The 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid suppliers may include 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid API manufacturers, exporters, distributors and traders.
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A 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid active pharmaceutical ingredient (API) in detail. Different forms of 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid DMFs exist exist since differing nations have different regulations, such as 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid USDMF includes data on 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 2 companies offering 3R-N-Tert-Butoxycarbonyl-3-Amino-4-2,4,5-Trifluorophenyl-Butanoic Acid
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