01 1SIMS Srl
01 1HYDRALAZINE CHLORIDRATE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5131
Submission : 1983-06-30
Status : Inactive
Type : II
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PharmaCompass offers a list of Hydralazine 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 Hydralazine manufacturer or Hydralazine supplier for your needs.
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A Hydralazin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydralazin, including repackagers and relabelers. The FDA regulates Hydralazin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydralazin 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 Hydralazin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hydralazin supplier is an individual or a company that provides Hydralazin active pharmaceutical ingredient (API) or Hydralazin finished formulations upon request. The Hydralazin suppliers may include Hydralazin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydralazin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hydralazin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydralazin active pharmaceutical ingredient (API) in detail. Different forms of Hydralazin DMFs exist exist since differing nations have different regulations, such as Hydralazin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydralazin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydralazin USDMF includes data on Hydralazin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydralazin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydralazin suppliers with USDMF on PharmaCompass.
