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