GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6744
Submission : 1986-12-22
Status : Inactive
Type : II
A L-Leucine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Leucine Hydrochloride, including repackagers and relabelers. The FDA regulates L-Leucine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Leucine 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 L-Leucine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Leucine Hydrochloride supplier is an individual or a company that provides L-Leucine Hydrochloride active pharmaceutical ingredient (API) or L-Leucine Hydrochloride finished formulations upon request. The L-Leucine Hydrochloride suppliers may include L-Leucine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Leucine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Leucine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Leucine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L-Leucine Hydrochloride DMFs exist exist since differing nations have different regulations, such as L-Leucine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Leucine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L-Leucine Hydrochloride USDMF includes data on L-Leucine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Leucine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Leucine Hydrochloride suppliers with USDMF on PharmaCompass.
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