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