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 API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Givinostat manufacturer or Givinostat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Givinostat manufacturer or Givinostat supplier.
PharmaCompass also assists you with knowing the Givinostat API Price utilized in the formulation of products. Givinostat API Price is not always fixed or binding as the Givinostat Price is obtained through a variety of data sources. The Givinostat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Givinostat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Givinostat, including repackagers and relabelers. The FDA regulates Givinostat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Givinostat 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Givinostat supplier is an individual or a company that provides Givinostat active pharmaceutical ingredient (API) or Givinostat finished formulations upon request. The Givinostat suppliers may include Givinostat API manufacturers, exporters, distributors and traders.
click here to find a list of Givinostat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Givinostat DMF (Drug Master File) is a document detailing the whole manufacturing process of Givinostat active pharmaceutical ingredient (API) in detail. Different forms of Givinostat DMFs exist exist since differing nations have different regulations, such as Givinostat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Givinostat DMF submitted to regulatory agencies in the US is known as a USDMF. Givinostat USDMF includes data on Givinostat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Givinostat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Givinostat suppliers with USDMF on PharmaCompass.
