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