01 1Hzymes Biotech
02 1Novoprotein
01 2RNASE INHIBITOR
01 1China
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36854
Submission : 2022-04-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36355
Submission : 2021-09-29
Status : Active
Type : II
A L-Carnosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Carnosine, including repackagers and relabelers. The FDA regulates L-Carnosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Carnosine 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-Carnosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Carnosine supplier is an individual or a company that provides L-Carnosine active pharmaceutical ingredient (API) or L-Carnosine finished formulations upon request. The L-Carnosine suppliers may include L-Carnosine API manufacturers, exporters, distributors and traders.
click here to find a list of L-Carnosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Carnosine DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Carnosine active pharmaceutical ingredient (API) in detail. Different forms of L-Carnosine DMFs exist exist since differing nations have different regulations, such as L-Carnosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Carnosine DMF submitted to regulatory agencies in the US is known as a USDMF. L-Carnosine USDMF includes data on L-Carnosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Carnosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Carnosine suppliers with USDMF on PharmaCompass.
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