Ketoconazole API Manufacturer in India

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

About Ketoconazole API

High-Purity Ketoconazole API for Antifungal Therapy

Ketoconazole API is a pharmaceutical-grade imidazole antifungal agent widely used in the treatment of superficial fungal infections affecting the skin, scalp, and mucous membranes. It inhibits fungal growth by blocking the synthesis of ergosterol, an essential component of the fungal cell membrane, resulting in increased membrane permeability and fungal cell death.

Ketoconazole is extensively formulated into creams, shampoos, lotions, gels, foams, and oral dosage forms for the treatment of seborrheic dermatitis, dandruff, tinea infections, cutaneous candidiasis, pityriasis versicolor, and other fungal disorders. Due to potential systemic adverse effects, oral ketoconazole use is limited in many countries, while topical formulations remain widely utilized.

Manufactured under WHO-GMP-certified facilities, our Ketoconazole API is produced using advanced pharmaceutical manufacturing technologies to ensure exceptional purity, stability, and batch-to-batch consistency. Every batch undergoes rigorous analytical testing and is supplied with complete documentation, including Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and Product Specifications.

Key Features

  • High-purity pharmaceutical-grade API
  • Broad-spectrum imidazole antifungal
  • Excellent antifungal activity
  • Suitable for topical and oral formulations
  • High chemical stability
  • Low impurity profile
  • WHO-GMP certified manufacturing
  • Complete CoA, MSDS & TDS
  • Batch-to-batch consistency
  • Worldwide bulk supply

Applications

  • Seborrheic dermatitis
  • Dandruff
  • Tinea corporis
  • Tinea pedis
  • Tinea cruris
  • Cutaneous candidiasis
  • Pityriasis versicolor
  • Dermatological pharmaceutical formulations

Why Choose Swapnroop Pharma

  • WHO-GMP Certified Manufacturing
  • Advanced Antifungal API Manufacturing
  • High-Purity Pharmaceutical APIs
  • Comprehensive Quality Control
  • Complete Regulatory Documentation
  • Competitive Bulk Pricing
  • Reliable Worldwide Export
  • Technical & Regulatory Support
  • Consistent Product Quality
  • Customized Packaging Solutions

Packaging & Supply

Available Packaging

  • 1 kg
  • 5 kg
  • 10 kg
  • 25 kg
  • Custom Bulk Packaging Available

Documentation Provided

  • Certificate of Analysis (CoA)
  • Material Safety Data Sheet (MSDS)
  • Technical Data Sheet (TDS)
  • Product Specification Sheet
  • Batch Manufacturing Record

Frequently Asked Questions (FAQs)

1. What is Ketoconazole API used for?

Ketoconazole API is used in pharmaceutical formulations for treating fungal skin infections, dandruff, seborrheic dermatitis, candidiasis, and other dermatological fungal disorders.

2. How does Ketoconazole work?

Ketoconazole inhibits the fungal enzyme responsible for ergosterol synthesis, disrupting fungal cell membrane formation and leading to fungal cell death.

3. Is regulatory documentation available?

Yes. We provide CoA, MSDS, Technical Data Sheet (TDS), Product Specifications, and complete regulatory documentation with every shipment.

4. Is bulk commercial supply available?

Yes. We supply Ketoconazole API in commercial quantities with worldwide export support and customized packaging.

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