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List of Drug Master Files (DMF) of Givinostat Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 GIVINOSTAT HYDROCHLORIDE MONOHYDRATE (1)

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37344
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2023-04-04
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Looking for 497833-27-9 / Givinostat API manufacturers, exporters & distributors?

Givinostat manufacturers, exporters & distributors 1

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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.

API | Excipient name

Givinostat

Synonyms

497833-27-9, Itf2357, Givinostat [inn], Givinostat free base, Itf-2357, [6-(diethylaminomethyl)naphthalen-2-yl]methyl n-[4-(hydroxycarbamoyl)phenyl]carbamate

Cas Number

497833-27-9

Unique Ingredient Identifier (UNII)

5P60F84FBH

About Givinostat

Givinostat is an orally bioavailable hydroxymate inhibitor of histone deacetylase (HDAC) with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities. Givinostat inhibits class I and class II HDACs, resulting in an accumulation of highly acetylated histones, followed by the induction of chromatin remodeling and an altered pattern of gene expression. At low, nonapoptotic concentrations, this agent inhibits the production of pro-inflammatory cytokines such as tumor necrosis factor- (TNF-), interleukin-1 (IL-1), IL-6 and interferon-gamma. Givinostat has also been shown to activate the intrinsic apoptotic pathway, inducing apoptosis in hepatoma cells and leukemic cells. This agent may also exhibit anti-angiogenic activity, inhibiting the production of angiogenic factors such as IL-6 and vascular endothelial cell growth factor (VEGF) by bone marrow stromal cells.

Givinostat Manufacturers

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.

Givinostat Suppliers

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.

Givinostat USDMF

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.

Givinostat Manufacturers | Traders | Suppliers

Givinostat Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Givinostat

Get in contact with the supplier of your choice:

  1. Chemi SpA
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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