Gemfibrozil API Manufacturer in India

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

Gemfibrozil API Manufacturer and Bulk Supplier in India

Gemfibrozil API (CAS No: 25812-30-0)

 

Gemfibrozil API (CAS No. 25812-30-0) is a synthetic lipid-regulating active pharmaceutical ingredient associated with hypertriglyceridemia, dyslipidemia, and lipid-modifying pharmaceutical formulations.

Gemfibrozil belongs to the fibrate class of lipid-regulating pharmaceutical compounds and is chemically identified as 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid.

Gemfibrozil is associated with reduction of elevated serum triglycerides and very-low-density lipoprotein cholesterol. It may also increase high-density lipoprotein cholesterol levels in appropriate therapeutic applications.

The lipid-modifying activity of Gemfibrozil is associated with effects on lipid metabolism, lipoprotein processing, and triglyceride-rich lipoprotein clearance.

Gemfibrozil is commonly classified as a fibric acid derivative and is associated with modulation of peroxisome proliferator-activated receptor alpha-related lipid metabolic pathways.

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

Because Gemfibrozil is practically insoluble or poorly soluble in water, physical API characteristics such as crystal form and particle size distribution may be important during oral solid dosage-form development.

Gemfibrozil is an achiral pharmaceutical compound. Therefore, chiral purity and specific optical rotation are not normally critical release parameters. Pharmaceutical buyers commonly focus on chromatographic purity, impurity profile, residual solvents, physical characteristics, and formulation-related API consistency.

Swapnroop Drugs and Pharmaceuticals supplies Gemfibrozil API for qualified pharmaceutical research, lipid-regulating drug development, analytical, generic pharmaceutical development, oral solid dosage formulation, and regulated manufacturing requirements with product-specific quality documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.

 

 

Key Features

  • Gemfibrozil API CAS No. 25812-30-0
  • Synthetic lipid-regulating active pharmaceutical ingredient
  • Fibrate pharmaceutical compound
  • Fibric acid derivative
  • Antilipemic pharmaceutical agent
  • Lipid-modifying pharmaceutical ingredient
  • Molecular formula C15H22O3
  • Molecular weight approximately 250.33 g/mol
  • Achiral small-molecule API
  • White or almost white crystalline powder
  • Controlled HPLC purity profile
  • Related substances monitored according to approved specification
  • Process and degradation impurity monitoring
  • Crystal-form consistency evaluation
  • 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 MSDS available as applicable
  • Bulk pharmaceutical supply and export coordination

Applications of Gemfibrozil API

Gemfibrozil API is primarily associated with:

  • Hypertriglyceridemia pharmaceutical formulations
  • Dyslipidemia drug development
  • Lipid-regulating pharmaceutical products
  • Antilipemic pharmaceutical development
  • Fibrate drug formulations
  • Hyperlipoproteinemia pharmaceutical applications
  • Triglyceride-lowering drug development
  • VLDL cholesterol-related pharmaceutical applications
  • Lipid metabolism research
  • Oral tablet formulation development
  • Oral capsule formulation research
  • Generic Gemfibrozil drug development
  • Analytical method development
  • Pharmaceutical formulation research
  • Approved pharmaceutical manufacturing requirements

Gemfibrozil pharmaceutical products are associated with lipid-regulating applications, particularly in selected patients with markedly elevated triglyceride levels and certain dyslipidemia profiles.

Gemfibrozil API for Lipid-Regulating Pharmaceutical Development

Gemfibrozil is a fibrate-class pharmaceutical compound associated with modulation of serum lipid concentrations.

Pharmaceutical companies evaluating Gemfibrozil API may review:

  • API assay
  • HPLC purity
  • Chemical identification
  • Related substance profile
  • Process-related impurities
  • Degradation products
  • Residual solvents
  • Water content
  • Melting characteristics
  • Crystal form
  • Particle size distribution
  • Dissolution-related characteristics
  • Powder flow properties
  • Tablet formulation compatibility
  • Stability data
  • Batch-to-batch consistency
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