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 : 5924
Submission : 1985-07-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9816
Submission : 1992-08-14
Status : Inactive
Type : II
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PharmaCompass offers a list of Ornithine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ornithine manufacturer or Ornithine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ornithine manufacturer or Ornithine supplier.
PharmaCompass also assists you with knowing the Ornithine API Price utilized in the formulation of products. Ornithine API Price is not always fixed or binding as the Ornithine Price is obtained through a variety of data sources. The Ornithine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ORN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ORN, including repackagers and relabelers. The FDA regulates ORN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ORN 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 ORN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ORN supplier is an individual or a company that provides ORN active pharmaceutical ingredient (API) or ORN finished formulations upon request. The ORN suppliers may include ORN API manufacturers, exporters, distributors and traders.
click here to find a list of ORN suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ORN DMF (Drug Master File) is a document detailing the whole manufacturing process of ORN active pharmaceutical ingredient (API) in detail. Different forms of ORN DMFs exist exist since differing nations have different regulations, such as ORN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ORN DMF submitted to regulatory agencies in the US is known as a USDMF. ORN USDMF includes data on ORN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ORN USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ORN suppliers with USDMF on PharmaCompass.
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