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