01 1Novartis Pharmaceuticals Corporation
01 1TINOSORB(TM) MBBT
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17025
Submission : 2003-12-15
Status : Inactive
Type : II
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A MBBT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MBBT, including repackagers and relabelers. The FDA regulates MBBT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MBBT 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 MBBT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MBBT supplier is an individual or a company that provides MBBT active pharmaceutical ingredient (API) or MBBT finished formulations upon request. The MBBT suppliers may include MBBT API manufacturers, exporters, distributors and traders.
click here to find a list of MBBT suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A MBBT DMF (Drug Master File) is a document detailing the whole manufacturing process of MBBT active pharmaceutical ingredient (API) in detail. Different forms of MBBT DMFs exist exist since differing nations have different regulations, such as MBBT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MBBT DMF submitted to regulatory agencies in the US is known as a USDMF. MBBT USDMF includes data on MBBT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MBBT USDMF is kept confidential to protect the manufacturer’s intellectual property.
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