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
36
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 Hidralazin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hidralazin, including repackagers and relabelers. The FDA regulates Hidralazin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hidralazin 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 Hidralazin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hidralazin supplier is an individual or a company that provides Hidralazin active pharmaceutical ingredient (API) or Hidralazin finished formulations upon request. The Hidralazin suppliers may include Hidralazin API manufacturers, exporters, distributors and traders.
click here to find a list of Hidralazin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hidralazin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hidralazin active pharmaceutical ingredient (API) in detail. Different forms of Hidralazin DMFs exist exist since differing nations have different regulations, such as Hidralazin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hidralazin DMF submitted to regulatory agencies in the US is known as a USDMF. Hidralazin USDMF includes data on Hidralazin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hidralazin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hidralazin suppliers with USDMF on PharmaCompass.
