Ketoconazole

Fungal infections affect millions of people worldwide, ranging from common skin infections to severe systemic mycoses. Ketoconazole, a broad-spectrum antifungal agent from the imidazole class, has been a cornerstone in the treatment of a variety of fungal infections for decades. Its efficacy against dermatophytes, yeasts, and molds makes it a versatile antifungal in dermatology, gynecology, and internal medicine.

At BluepillExpress, we specialize in the third-party manufacturing of Ketoconazole formulations under strict WHO-GMP guidelines. Our modern infrastructure, strong quality assurance practices, and international regulatory capabilities enable us to supply high-quality Ketoconazole products to companies, institutions, and governments across multiple continents.

Product Overview

Generic Name: Ketoconazole
Therapeutic Category: Antifungal
Pharmacological Class: Imidazole Derivative

Available Dosage Forms:

• Ketoconazole Cream
• Ketoconazole Shampoo
• Ketoconazole Tablets
• Ketoconazole Soap (on request)

Common Strengths:

• Cream: 2% w/w
• Shampoo: 1% and 2%
• Tablets: 200 mg
• Soap: 2% (as per market requirements)

Packaging Options:

• Cream: 15 g / 30 g aluminum or laminated tubes
• Shampoo: 50 mL / 100 mL / 150 mL HDPE bottles
• Tablets: 10x1x10 blister or Alu-Alu pack
• Soap: 75 g / 100 g bars in laminated wrappers
• Packaging with multilingual labeling and serialization available

Pharmacopoeial Standards: IP / BP / USP / EP (as per client’s regulatory needs)

Mechanism of Action

Ketoconazole works by inhibiting the enzyme lanosterol 14α-demethylase, a critical component in fungal ergosterol synthesis. Ergosterol is essential for maintaining fungal cell membrane integrity.

By disrupting ergosterol production:

• Cell membrane permeability increases
• Inhibits fungal growth and reproduction
• Causes leakage of essential intracellular components
• Leads to fungistatic or fungicidal effects, depending on concentration and organism

Indications

Topical Forms (Cream, Shampoo, Soap):

• Tinea corporis (body ringworm)
• Tinea cruris (jock itch)
• Tinea pedis (athlete’s foot)
• Seborrheic dermatitis
• Dandruff and scalp fungal infections
• Cutaneous candidiasis
• Pityriasis versicolor

Oral Form (Tablets):

• Systemic fungal infections (only in specific cases due to hepatotoxicity risk)
• Chronic mucocutaneous candidiasis
• Refractory dermatophytoses
• Fungal infections in immunocompromised patients (with caution)

Dosage and Administration

Cream 2%:

• Apply thin layer to affected area once or twice daily
• Treatment typically lasts 2–4 weeks depending on the condition
• Continue for a few days post symptom resolution to avoid relapse

Shampoo 1% or 2%:

• Use twice weekly for dandruff or seborrheic dermatitis
• For pityriasis versicolor, apply daily for 5–7 days
• Leave lather for 5 minutes before rinsing

Tablets 200 mg:

• Typical adult dose: One 200 mg tablet once daily with food
• For severe or systemic infections: Dose may be increased under physician supervision
• Treatment duration: 2–6 weeks depending on fungal burden
• Note: Requires liver function monitoring due to rare but serious hepatotoxicity

Pharmacokinetics

Topical (Cream/Shampoo):

• Minimal systemic absorption
• Localized action, effective for superficial fungal infections

Oral (Tablet):

• Bioavailability: ~37% (increased with acidic pH and food)
• Protein binding: >99%
• Metabolized in liver via CYP3A4
• Half-life: ~8 hours
• Excretion: Mainly fecal; minor renal elimination

Clinical Advantages

• Broad-spectrum efficacy against dermatophytes, Candida, Malassezia, and other fungi
• Available in multiple delivery forms for convenience and therapeutic need
• Topical formulations provide effective treatment with minimal systemic exposure
• Shampoo form ideal for treating dandruff and scalp conditions
• Cost-effective option for emerging markets and high-prevalence regions
• Suitable for pediatric and adult use (with age-specific dosing considerations)

Why Choose BluepillExpress for Ketoconazole Manufacturing?

1. WHO-GMP Certified Manufacturing Infrastructure

Our facilities include:

• Dedicated lines for topical, oral solid, and liquid dosage forms
• In-house blending, emulsification, and homogenization equipment
• Fully automated filling and packing machines
• Microbiological and stability chambers for product validation
• Adherence to cGMP and GDP across all production stages

2. Broad Formulation Capabilities

We offer:

• Alcohol-free and fragrance-free creams for sensitive skin
• SLS-free shampoo variants on request
• Sugar-free tablets for diabetic compatibility
• Custom colors, scents, and packaging styles
• Formulations tailored to OTC, prescription, or institutional markets

3. Comprehensive Regulatory Support

We provide:

• Dossiers in CTD, ACTD, or country-specific formats
• Certificates: GMP, FSC, COA, COPP, Stability data
• Regulatory assistance for MOH submission and tenders
• Labeling compliance in multilingual formats
• QR coding, serialization, and tamper-evident packaging

4. Strong Global Export Network

Our Ketoconazole formulations are exported to:

• Africa: Kenya, Ethiopia, Nigeria, Sudan
• Asia: Myanmar, Sri Lanka, Vietnam, Bangladesh
• Middle East: Yemen, Iraq, UAE, Jordan
• Latin America & CIS: Bolivia, Kazakhstan, Uzbekistan

We support:

• Tender participation and institutional procurement
• Private-label manufacturing for pharma marketing companies
• Flexible MOQs and timely dispatch for diverse client requirements

Quality Control and Assurance

BluepillExpress maintains a strong in-house quality control team to ensure every batch meets international standards.

Tests Conducted:

• Assay & Identification: HPLC, UV Spectroscopy
• Topical QC: Viscosity, Spreadability, pH, Emulsion stability
• Tablet QC: Dissolution, Disintegration, Friability, Uniformity of content
• Microbial Load Testing: Bacterial and fungal contamination
• Stability Testing: Real-time and accelerated (as per ICH guidelines)

All testing is supported by certified analytical methods and validated processes.

Manufacturing Workflow at BluepillExpress

1. Client Engagement & Specification Finalization:
   Discussion of dosage form, strength, target market, and regulatory scope.
2. Sampling & Product Approval:
   Pilot batch developed and submitted for approval with complete COA and specifications.
3. Production & Quality Control:
   Commercial batch manufactured under WHO-GMP conditions with full QA supervision.
4. Packaging & Labeling:
   Executed as per country requirements with multilingual, barcoded, and serialized labeling.
5. Dispatch & Documentation:
   Shipping coordinated with FSC, COA, Stability data, and other legal documentation.
6. Post-Manufacture Support:
   Assistance with product registration, renewals, variations, and tenders.

Target Clients

Our Ketoconazole manufacturing services are ideal for:

• Pharma marketing companies looking to expand their antifungal range
• Dermatology and cosmetic brands (OTC and Rx)
• Hospital and institutional buyers
• NGOs and international aid organizations
• Government tender authorities and MOH contractors
• Exporters serving regulated and semi-regulated markets

Global Market Overview

• The global antifungal drug market is projected to reach USD 20+ billion by 2028.
• Topical antifungal products account for a large share, especially in tropical and developing regions where fungal infections are endemic.
• Ketoconazole remains a first-line option in dermatological and anti-dandruff treatments.
• Generic Ketoconazole enjoys widespread demand due to cost-effectiveness, broad spectrum, and OTC adaptability in many regions.

BluepillExpress meets this growing demand with scalable production, customizable packaging, and end-to-end export logistics.

Conclusion

Ketoconazole is a dependable and well-established antifungal agent with multiple therapeutic applications. Whether used as a topical cream, medicated shampoo, or oral tablet, it offers rapid relief and long-lasting efficacy against common fungal infections.

At BluepillExpress, we combine scientific precision, global compliance, and customer-centric services to deliver high-quality third-party Ketoconazole manufacturing. Our scalable infrastructure and regulatory expertise make us the preferred choice for pharmaceutical companies seeking quality, affordability, and global reach.