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