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