01 1Nippon Rikagaku Yakuhin
02 1Blank
01 1CARBOCYSTEINE (S-CARBOXYMETHYL-L-CYSTEINE)
02 1S-CARBOXYMATHYL-L-CYSTEINE
01 1Japan
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7276
Submission : 1987-10-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5049
Submission : 1983-06-30
Status : Inactive
Type : II
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A Carbocisteine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbocisteine, including repackagers and relabelers. The FDA regulates Carbocisteine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbocisteine 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 Carbocisteine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbocisteine supplier is an individual or a company that provides Carbocisteine active pharmaceutical ingredient (API) or Carbocisteine finished formulations upon request. The Carbocisteine suppliers may include Carbocisteine API manufacturers, exporters, distributors and traders.
click here to find a list of Carbocisteine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbocisteine DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbocisteine active pharmaceutical ingredient (API) in detail. Different forms of Carbocisteine DMFs exist exist since differing nations have different regulations, such as Carbocisteine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbocisteine DMF submitted to regulatory agencies in the US is known as a USDMF. Carbocisteine USDMF includes data on Carbocisteine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbocisteine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbocisteine suppliers with USDMF on PharmaCompass.
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