01 1SIGMA TAU
01 1l ETHYL-3-(3-DIMETHYLAMINOPROPYL) CARBODIIMIDE HCl ST. LOUIS,MO PLANT
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4829
Submission : 1983-01-26
Status : Inactive
Type : II
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PharmaCompass also assists you with knowing the Carbodiimide, Hydrochloride API Price utilized in the formulation of products. Carbodiimide, Hydrochloride API Price is not always fixed or binding as the Carbodiimide, Hydrochloride Price is obtained through a variety of data sources. The Carbodiimide, Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A EDAC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of EDAC, including repackagers and relabelers. The FDA regulates EDAC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. EDAC 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 EDAC supplier is an individual or a company that provides EDAC active pharmaceutical ingredient (API) or EDAC finished formulations upon request. The EDAC suppliers may include EDAC API manufacturers, exporters, distributors and traders.
click here to find a list of EDAC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A EDAC DMF (Drug Master File) is a document detailing the whole manufacturing process of EDAC active pharmaceutical ingredient (API) in detail. Different forms of EDAC DMFs exist exist since differing nations have different regulations, such as EDAC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A EDAC DMF submitted to regulatory agencies in the US is known as a USDMF. EDAC USDMF includes data on EDAC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The EDAC USDMF is kept confidential to protect the manufacturer’s intellectual property.
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