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01 1MECHLORETHAMINE HYDROCHLORIDE
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01 1Active
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37687
Submission : 2023-04-14
Status : Active
Type : II
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A N-Methylbis(2-chloroethyl)amine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Methylbis(2-chloroethyl)amine hydrochloride, including repackagers and relabelers. The FDA regulates N-Methylbis(2-chloroethyl)amine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Methylbis(2-chloroethyl)amine 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.
click here to find a list of N-Methylbis(2-chloroethyl)amine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A N-Methylbis(2-chloroethyl)amine hydrochloride supplier is an individual or a company that provides N-Methylbis(2-chloroethyl)amine hydrochloride active pharmaceutical ingredient (API) or N-Methylbis(2-chloroethyl)amine hydrochloride finished formulations upon request. The N-Methylbis(2-chloroethyl)amine hydrochloride suppliers may include N-Methylbis(2-chloroethyl)amine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of N-Methylbis(2-chloroethyl)amine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A N-Methylbis(2-chloroethyl)amine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of N-Methylbis(2-chloroethyl)amine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of N-Methylbis(2-chloroethyl)amine hydrochloride DMFs exist exist since differing nations have different regulations, such as N-Methylbis(2-chloroethyl)amine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-Methylbis(2-chloroethyl)amine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. N-Methylbis(2-chloroethyl)amine hydrochloride USDMF includes data on N-Methylbis(2-chloroethyl)amine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-Methylbis(2-chloroethyl)amine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-Methylbis(2-chloroethyl)amine hydrochloride suppliers with USDMF on PharmaCompass.
