01 1United Chemical
01 1BROMPHENIRAMINE
01 1Pakistan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15711
Submission : 2001-11-08
Status : Inactive
Type : II
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A Bromfenex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromfenex, including repackagers and relabelers. The FDA regulates Bromfenex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromfenex 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 Bromfenex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bromfenex supplier is an individual or a company that provides Bromfenex active pharmaceutical ingredient (API) or Bromfenex finished formulations upon request. The Bromfenex suppliers may include Bromfenex API manufacturers, exporters, distributors and traders.
click here to find a list of Bromfenex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bromfenex DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromfenex active pharmaceutical ingredient (API) in detail. Different forms of Bromfenex DMFs exist exist since differing nations have different regulations, such as Bromfenex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromfenex DMF submitted to regulatory agencies in the US is known as a USDMF. Bromfenex USDMF includes data on Bromfenex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromfenex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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