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