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