01 1SIGMA TAU
02 1Synthelabo Tanabe Chimie
01 1A-KETOISOCAPROIC ACID, SODIUM SALT
02 1KETOLEUCINE L-LYSINE SALT
01 1France
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7771
Submission : 1988-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5920
Submission : 1985-07-05
Status : Inactive
Type : II
A Ketoleucine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketoleucine, including repackagers and relabelers. The FDA regulates Ketoleucine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketoleucine 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 Ketoleucine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketoleucine supplier is an individual or a company that provides Ketoleucine active pharmaceutical ingredient (API) or Ketoleucine finished formulations upon request. The Ketoleucine suppliers may include Ketoleucine API manufacturers, exporters, distributors and traders.
click here to find a list of Ketoleucine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketoleucine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketoleucine active pharmaceutical ingredient (API) in detail. Different forms of Ketoleucine DMFs exist exist since differing nations have different regulations, such as Ketoleucine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketoleucine DMF submitted to regulatory agencies in the US is known as a USDMF. Ketoleucine USDMF includes data on Ketoleucine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketoleucine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketoleucine suppliers with USDMF on PharmaCompass.
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