01 1PROMETIC BIOSCIENCES LTD
01 1P-AMINOBENZAMIDINE AGAROSE 6XL
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16139
Submission : 2002-09-17
Status : Inactive
Type : II
A Benzamidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzamidine, including repackagers and relabelers. The FDA regulates Benzamidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzamidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzamidine supplier is an individual or a company that provides Benzamidine active pharmaceutical ingredient (API) or Benzamidine finished formulations upon request. The Benzamidine suppliers may include Benzamidine API manufacturers, exporters, distributors and traders.
click here to find a list of Benzamidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzamidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzamidine active pharmaceutical ingredient (API) in detail. Different forms of Benzamidine DMFs exist exist since differing nations have different regulations, such as Benzamidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzamidine DMF submitted to regulatory agencies in the US is known as a USDMF. Benzamidine USDMF includes data on Benzamidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzamidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzamidine suppliers with USDMF on PharmaCompass.
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