01 1Kyowa Hakko Bio
02 1Mitsubishi Tanabe Pharma
03 1Nippon Protein Co Ltd
04 1Nippon Rikagaku Yakuhin
05 1Taenaka Kogyo
01 1CYSTEINE HYDROCHLORIDE
02 1L-CYSTEINE HYDROCHLORIDE MONOHYDRATE
03 2L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE
04 1L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-ACETYL-L-CYSTEIN
01 5Japan
01 2Active
02 3Inactive
01 2Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2753
Submission : 1976-10-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1930
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 21364
Submission : 2008-02-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10741
Submission : 1994-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-03-14
DMF Number : 8866
Submission : 1990-11-30
Status : Active
Type : II
A L-Cysteine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Cysteine Hydrochloride, including repackagers and relabelers. The FDA regulates L-Cysteine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Cysteine 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-Cysteine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Cysteine Hydrochloride supplier is an individual or a company that provides L-Cysteine Hydrochloride active pharmaceutical ingredient (API) or L-Cysteine Hydrochloride finished formulations upon request. The L-Cysteine Hydrochloride suppliers may include L-Cysteine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Cysteine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Cysteine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Cysteine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L-Cysteine Hydrochloride DMFs exist exist since differing nations have different regulations, such as L-Cysteine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Cysteine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L-Cysteine Hydrochloride USDMF includes data on L-Cysteine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Cysteine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Cysteine Hydrochloride suppliers with USDMF on PharmaCompass.
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