Ganaxolone API Manufacturer in India

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Ganaxolone API Manufacturer and Bulk Supplier in India

Ganaxolone API (CAS No: 38398-32-2)

Neuroactive Steroid and GABA-A Receptor Positive Modulator API for Antiseizure Pharmaceutical Formulations

Ganaxolone API (CAS No. 38398-32-2) is a synthetic neuroactive steroid pharmaceutical active ingredient associated with antiseizure and neurological pharmaceutical development. Ganaxolone is a 3β-methyl-substituted analog of the endogenous neurosteroid allopregnanolone and belongs to the neurosteroid class of GABA-A receptor modulators.

Ganaxolone acts as a positive allosteric modulator of gamma-aminobutyric acid type A (GABA-A) receptors in the central nervous system. Its anticonvulsant activity is associated with enhancement of inhibitory GABAergic neurotransmission and modulation of neuronal excitability.

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

Ganaxolone has low aqueous solubility. Therefore, particle size distribution, crystalline characteristics, and API dispersion properties are important considerations during oral suspension and other formulation-development programs. Pharmaceutical buyers may evaluate micronization requirements and solid-state consistency according to the intended dosage form.

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

 

 

Critical Quality Requirements for Ganaxolone API

Pharmaceutical companies evaluating Ganaxolone API commonly focus on:

  • HPLC assay and chromatographic purity
  • Chemical identity
  • Stereochemical identity
  • Chiral purity
  • Specific optical rotation
  • Related substances
  • Process-related impurity control
  • Degradation product monitoring
  • Residual solvent profile
  • Water and moisture content
  • Elemental impurity assessment
  • Crystal-form consistency
  • Particle size distribution
  • Micronization characteristics
  • Powder dispersion properties
  • Batch-to-batch consistency
  • Stability under recommended storage conditions

Because Ganaxolone is a steroidal chiral molecule, stereochemical consistency is an important consideration during API qualification.

Low aqueous solubility is also an important formulation consideration. Particle size and solid-state properties may influence dispersion, dissolution behavior, and oral suspension development.

Key Features

  • Ganaxolone API CAS No. 38398-32-2
  • Synthetic neuroactive steroid pharmaceutical ingredient
  • GABA-A receptor positive allosteric modulator
  • 3β-methyl analog of allopregnanolone
  • Molecular formula C22H36O2
  • Molecular weight 332.53 g/mol
  • White to off-white crystalline powder
  • Controlled HPLC purity profile
  • Stereochemical identity monitoring
  • Chiral purity evaluation as applicable
  • Related substances controlled according to approved specification
  • 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 Ganaxolone API

Ganaxolone API is primarily associated with:

  • Antiseizure pharmaceutical development
  • Epilepsy-related pharmaceutical research
  • CDKL5 deficiency disorder seizure product development
  • Neuroactive steroid pharmaceutical research
  • GABA-A receptor modulator development
  • Neurological pharmaceutical formulations
  • Oral suspension development
  • CNS pharmaceutical research
  • Neurosteroid analytical research
  • Particle-size optimized formulation development
  • Generic and specialty pharmaceutical research
  • Approved pharmaceutical manufacturing requirements

Ganaxolone is associated with pharmaceutical products developed for seizures related to CDKL5 deficiency disorder.

Ganaxolone API for Neurological Pharmaceutical Development

Ganaxolone is a neuroactive steroid associated with modulation of inhibitory neurotransmission through GABA-A receptors.

Pharmaceutical formulation companies evaluating Ganaxolone API may review:

  • API assay
  • HPLC purity
  • Stereochemical identity
  • Chiral purity
  • Specific rotation
  • Related substance profile
  • Residual solvents
  • Moisture content
  • Crystal form
  • Particle size distribution
  • Micronization characteristics
  • Dispersion behavior
  • Formulation compatibility
  • Stability data
  • Batch-to-batch consistency

Product-specific API specifications should be evaluated according to the intended dosage form, target regulatory market, formulation technology, and approved pharmaceutical development requirements.

Ganaxolone API and Low Aqueous Solubility

Ganaxolone is characterized by low aqueous solubility, making physical API properties particularly relevant during formulation development.

Pharmaceutical companies developing Ganaxolone oral formulations may evaluate particle size distribution and dispersion characteristics to support consistent drug-product performance.

Micronized or particle-size-controlled API requirements should be confirmed according to the customer's formulation process and approved product specification.

Why Choose Swapnroop for Ganaxolone API?

Swapnroop Drugs and Pharmaceuticals supports qualified pharmaceutical and research customers with:

  • Reliable Ganaxolone API supply coordination
  • Product-specific specification support
  • COA and MSDS availability as applicable
  • Technical documentation coordination
  • Secure pharmaceutical-grade packaging
  • Bulk quantity supply support
  • Particle size requirement coordination as applicable
  • Micronized material requirement coordination as applicable
  • Export documentation assistance
  • Global pharmaceutical supply coordination
  • Dedicated commercial enquiry support
  • Support for pharmaceutical research and formulation development requirements

Packaging & Supply

Ganaxolone API is supplied in secure pharmaceutical-grade packaging selected according to product quantity, stability requirements, moisture protection requirements, and customer specifications.

Product-appropriate inner polyethylene liners and approved pharmaceutical-grade outer containers or HDPE drums may be used according to the supplied material specification.

Available packaging configurations may include:

  • 1 kg packaging
  • 5 kg packaging
  • 10 kg packaging
  • 25 kg packaging
  • Customer-specific packaging as applicable

Packaging configuration, MOQ, commercial quantity, particle size requirements, and shipment conditions are confirmed according to the approved product specification and customer enquiry.

Storage and Handling

Store Ganaxolone API in tightly closed and appropriately labeled containers under recommended controlled storage conditions.

Protect the material from excessive moisture, heat, direct light, and unsuitable environmental exposure.

Handling should be performed by trained personnel using approved pharmaceutical raw material handling procedures and applicable safety documentation.

Product-specific storage requirements should be confirmed from the approved COA, SDS, specification, and stability documentation.

Ganaxolone API Manufacturer and Supplier in India

Swapnroop Drugs and Pharmaceuticals provides Ganaxolone API bulk supply and export support in India for qualified pharmaceutical manufacturers, formulation developers, neurological drug-development organizations, analytical laboratories, research companies, and pharmaceutical procurement customers.

For Ganaxolone API price, CAS No. 38398-32-2, specification, HPLC purity, particle size, micronization requirements, COA availability, MOQ, packaging, and export enquiries, contact our pharmaceutical sales team.

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