01 2Synthelabo Tanabe Chimie
01 1KETOISOLEUCINE L-ORNITHINE SALT
02 1PRECLINICAL ANIMAL STUDIES FOR TRIPTOSINE
01 2France
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9816
Submission : 1992-08-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5924
Submission : 1985-07-05
Status : Inactive
Type : II
A Ornithine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ornithine, including repackagers and relabelers. The FDA regulates Ornithine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ornithine 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 Ornithine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ornithine supplier is an individual or a company that provides Ornithine active pharmaceutical ingredient (API) or Ornithine finished formulations upon request. The Ornithine suppliers may include Ornithine API manufacturers, exporters, distributors and traders.
click here to find a list of Ornithine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ornithine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ornithine active pharmaceutical ingredient (API) in detail. Different forms of Ornithine DMFs exist exist since differing nations have different regulations, such as Ornithine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ornithine DMF submitted to regulatory agencies in the US is known as a USDMF. Ornithine USDMF includes data on Ornithine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ornithine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ornithine suppliers with USDMF on PharmaCompass.
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