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