01 1Novo Nordisk
01 1SUBTILISIN A
01 1Denmark
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8133
Submission : 1989-07-14
Status : Inactive
Type : II
A SUBTILISIN A SUBSTRATE I manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUBTILISIN A SUBSTRATE I, including repackagers and relabelers. The FDA regulates SUBTILISIN A SUBSTRATE I manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUBTILISIN A SUBSTRATE I API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A SUBTILISIN A SUBSTRATE I supplier is an individual or a company that provides SUBTILISIN A SUBSTRATE I active pharmaceutical ingredient (API) or SUBTILISIN A SUBSTRATE I finished formulations upon request. The SUBTILISIN A SUBSTRATE I suppliers may include SUBTILISIN A SUBSTRATE I API manufacturers, exporters, distributors and traders.
click here to find a list of SUBTILISIN A SUBSTRATE I suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUBTILISIN A SUBSTRATE I DMF (Drug Master File) is a document detailing the whole manufacturing process of SUBTILISIN A SUBSTRATE I active pharmaceutical ingredient (API) in detail. Different forms of SUBTILISIN A SUBSTRATE I DMFs exist exist since differing nations have different regulations, such as SUBTILISIN A SUBSTRATE I USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUBTILISIN A SUBSTRATE I DMF submitted to regulatory agencies in the US is known as a USDMF. SUBTILISIN A SUBSTRATE I USDMF includes data on SUBTILISIN A SUBSTRATE I's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUBTILISIN A SUBSTRATE I USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUBTILISIN A SUBSTRATE I suppliers with USDMF on PharmaCompass.
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