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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A Carbodiimide, Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbodiimide, Hydrochloride, including repackagers and relabelers. The FDA regulates Carbodiimide, Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbodiimide, Hydrochloride 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 Carbodiimide, Hydrochloride supplier is an individual or a company that provides Carbodiimide, Hydrochloride active pharmaceutical ingredient (API) or Carbodiimide, Hydrochloride finished formulations upon request. The Carbodiimide, Hydrochloride suppliers may include Carbodiimide, Hydrochloride API manufacturers, exporters, distributors and traders.
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A Carbodiimide, Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbodiimide, Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Carbodiimide, Hydrochloride DMFs exist exist since differing nations have different regulations, such as Carbodiimide, Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbodiimide, Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Carbodiimide, Hydrochloride USDMF includes data on Carbodiimide, Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbodiimide, Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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