01 1UCB Pharma S.A
01 1BUCLIZINE HCL
01 1Belgium
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3874
Submission : 1980-06-27
Status : Inactive
Type : II
A buclizine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of buclizine, including repackagers and relabelers. The FDA regulates buclizine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. buclizine 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 buclizine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A buclizine supplier is an individual or a company that provides buclizine active pharmaceutical ingredient (API) or buclizine finished formulations upon request. The buclizine suppliers may include buclizine API manufacturers, exporters, distributors and traders.
click here to find a list of buclizine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A buclizine DMF (Drug Master File) is a document detailing the whole manufacturing process of buclizine active pharmaceutical ingredient (API) in detail. Different forms of buclizine DMFs exist exist since differing nations have different regulations, such as buclizine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A buclizine DMF submitted to regulatory agencies in the US is known as a USDMF. buclizine USDMF includes data on buclizine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The buclizine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of buclizine suppliers with USDMF on PharmaCompass.
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