01 1Chemi SpA
01 1GIVINOSTAT HYDROCHLORIDE MONOHYDRATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II
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PharmaCompass offers a list of Givinostat HCl 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 Givinostat HCl manufacturer or Givinostat HCl supplier for your needs.
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A Givinostat HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Givinostat HCl, including repackagers and relabelers. The FDA regulates Givinostat HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Givinostat HCl 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 Givinostat HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Givinostat HCl supplier is an individual or a company that provides Givinostat HCl active pharmaceutical ingredient (API) or Givinostat HCl finished formulations upon request. The Givinostat HCl suppliers may include Givinostat HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Givinostat HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Givinostat HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Givinostat HCl active pharmaceutical ingredient (API) in detail. Different forms of Givinostat HCl DMFs exist exist since differing nations have different regulations, such as Givinostat HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Givinostat HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Givinostat HCl USDMF includes data on Givinostat HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Givinostat HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Givinostat HCl suppliers with USDMF on PharmaCompass.
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