GIVINOSTAT API manufacturer in India.

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

 

Givinostat API (CAS No. 497833-27-9) is a synthetic small-molecule histone deacetylase inhibitor active pharmaceutical ingredient associated with Duchenne muscular dystrophy, neuromuscular disease, epigenetic modulation, and rare disease pharmaceutical development.

Givinostat, also known by the development code ITF2357, belongs to the histone deacetylase inhibitor class of pharmaceutical compounds.

Histone deacetylases, commonly abbreviated as HDACs, are enzymes involved in the regulation of chromatin structure, gene transcription, and multiple cellular signaling processes.

Givinostat inhibits histone deacetylase activity.

The precise mechanism by which Givinostat produces its therapeutic effect in patients with Duchenne muscular dystrophy is not fully understood.

Givinostat is associated with modulation of pathogenic processes involved in dystrophic muscle, including processes related to inflammation, muscle degeneration, fibrosis, and replacement of muscle tissue by fat.

Givinostat represents a nonsteroidal pharmaceutical approach to Duchenne muscular dystrophy treatment.

The compound is associated with pharmaceutical treatment across DMD genetic variants rather than being restricted to a specific exon-skipping-amenable mutation.

Givinostat-related pharmaceutical products are administered orally and are associated with Duchenne muscular dystrophy treatment in patients six years of age and older.

Pharmaceutical companies sourcing Givinostat API commonly evaluate assay, HPLC purity, related substances, process-related impurities, degradation products, residual solvents, water content, crystal form, polymorphic characteristics, particle size distribution, and batch-to-batch consistency.

Givinostat free base and Givinostat Hydrochloride Monohydrate should be treated as separate pharmaceutical material identities.

The approved oral pharmaceutical product uses Givinostat Hydrochloride Monohydrate.

Procurement, formulation, quality, and regulatory teams should confirm whether Givinostat free base or Givinostat Hydrochloride Monohydrate is required before commercial sourcing.

Swapnroop Drugs and Pharmaceuticals supplies Givinostat API for qualified pharmaceutical research, HDAC inhibitor development, Duchenne muscular dystrophy pharmaceutical development, rare disease research, analytical requirements, formulation development, and regulated pharmaceutical manufacturing requirements with product-specific quality documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.

Key Features

  • Givinostat API CAS No. 497833-27-9
  • Also known as ITF2357
  • Synthetic small-molecule pharmaceutical ingredient
  • Histone deacetylase inhibitor
  • HDAC inhibitor API
  • Duchenne muscular dystrophy-associated pharmaceutical compound
  • Neuromuscular pharmaceutical ingredient
  • Rare disease pharmaceutical development compound
  • Nonsteroidal DMD pharmaceutical agent
  • Hydroxamic acid derivative
  • Molecular formula C24H27N3O4
  • Molecular weight approximately 421.49 g/mol
  • Controlled HPLC purity profile
  • Related substance monitoring
  • Process impurity control
  • Degradation product monitoring
  • Crystal-form characterization
  • Hydrate-profile evaluation as applicable
  • Particle size requirements coordinated as applicable
  • Residual solvents controlled according to applicable ICH Q3C requirements
  • Elemental impurities evaluated according to applicable ICH Q3D requirements
  • Pharmaceutical-grade packaging
  • COA and SDS available as applicable
  • Bulk pharmaceutical supply and export coordination

Applications of Givinostat API

Givinostat API is primarily associated with:

  • Duchenne muscular dystrophy pharmaceutical development
  • DMD drug development
  • Histone deacetylase inhibitor development
  • HDAC inhibitor pharmaceutical research
  • Neuromuscular disease pharmaceutical research
  • Rare disease drug development
  • Muscular dystrophy pharmaceutical development
  • Epigenetic pharmaceutical research
  • Muscle degeneration research
  • Muscle fibrosis research
  • Inflammation-related muscular disease research
  • Oral suspension formulation development
  • Givinostat Hydrochloride Monohydrate development
  • Analytical method development
  • Related substance method development
  • Approved pharmaceutical manufacturing requirements

Givinostat-related pharmaceutical products are associated with treatment of Duchenne muscular dystrophy in patients six years of age and older.

Givinostat API for Duchenne Muscular Dystrophy Pharmaceutical Development

Duchenne muscular dystrophy is a progressive neuromuscular disease associated with muscle degeneration and loss of muscle function.

Givinostat represents a histone deacetylase inhibitor pharmaceutical approach to DMD treatment.

 

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