01 1SIGMA TAU
01 1L-CYSTEINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9990
Submission : 1992-11-25
Status : Inactive
Type : II
A L-Cysteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cysteine, including repackagers and relabelers. The FDA regulates L-Cysteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Cysteine 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-Cysteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cysteine supplier is an individual or a company that provides L-Cysteine active pharmaceutical ingredient (API) or L-Cysteine finished formulations upon request. The L-Cysteine suppliers may include L-Cysteine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Cysteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Cysteine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Cysteine active pharmaceutical ingredient (API) in detail. Different forms of L-Cysteine DMFs exist exist since differing nations have different regulations, such as L-Cysteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Cysteine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Cysteine USDMF includes data on L-Cysteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Cysteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Cysteine suppliers with USDMF on PharmaCompass.
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