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