01 1Rhodia Organique SAS
01 1ETHOPROPAZINE
01 1France
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 536
Submission : 1963-04-12
Status : Inactive
Type : II
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A ETHOPROPAZINE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ETHOPROPAZINE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates ETHOPROPAZINE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ETHOPROPAZINE 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 ETHOPROPAZINE HYDROCHLORIDE supplier is an individual or a company that provides ETHOPROPAZINE HYDROCHLORIDE active pharmaceutical ingredient (API) or ETHOPROPAZINE HYDROCHLORIDE finished formulations upon request. The ETHOPROPAZINE HYDROCHLORIDE suppliers may include ETHOPROPAZINE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of ETHOPROPAZINE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ETHOPROPAZINE HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of ETHOPROPAZINE HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of ETHOPROPAZINE HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as ETHOPROPAZINE HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ETHOPROPAZINE HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. ETHOPROPAZINE HYDROCHLORIDE USDMF includes data on ETHOPROPAZINE HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ETHOPROPAZINE HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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