Clotrimazole

Fungal infections, both superficial and mucosal, are common across all age groups and geographic regions. They are caused by dermatophytes, yeasts, and other fungi that thrive in warm, moist environments. The need for effective, affordable, and safe antifungal treatments has never been greater, particularly in tropical and subtropical climates.

Clotrimazole is a well-established antifungal agent, recognized globally for its broad-spectrum activity against dermatophytes, yeasts (including Candida), and molds. It is widely used in topical, vaginal, and oral formulations for treating skin infections, vaginal candidiasis, and oral thrush.

BluepillExpress, a WHO-GMP certified pharmaceutical manufacturer, offers comprehensive third-party manufacturing solutions for Clotrimazole, tailored to meet the needs of private labels, hospitals, export businesses, and government procurement programs. We deliver customized, scalable, and compliant products supported by regulatory documentation and global logistics.

What is Clotrimazole?

Clotrimazole is an imidazole antifungal agent that works by inhibiting the biosynthesis of ergosterol, an essential component of fungal cell membranes. This disruption results in increased membrane permeability and leakage of essential intracellular components, leading to the death of fungal cells.

Due to its broad-spectrum fungistatic and fungicidal activity, Clotrimazole is used for a wide range of infections including athlete’s foot, ringworm, jock itch, candidiasis, and pityriasis versicolor. It is also commonly found in vaginal and oral antifungal formulations.

Therapeutic Class

• Antifungal (Imidazole derivative)
• Topical and mucosal antimicrobial agent
• Dermatological / Gynecological / ENT treatment class

Key Benefits of Clotrimazole

1. Broad-Spectrum Antifungal Activity

Effective against Trichophyton, Microsporum, Epidermophyton, Candida, Malassezia, and Aspergillus species.

2. Multiple Routes of Administration

Available in cream, lotion, powder, vaginal tablet, oral troche/lozenge, and solution forms.

3. Fast Symptom Relief

Provides relief from itching, redness, scaling, and discomfort typically within a few days of consistent use.

4. Minimal Side Effects

Well-tolerated on skin and mucosa; low systemic absorption reduces the risk of side effects.

5. OTC and Prescription Compatibility

Approved and marketed both as an over-the-counter product and under prescription strength in different markets.

Indications

Clotrimazole is indicated for the treatment of:

• Dermatophytosis (tinea pedis, tinea cruris, tinea corporis)
• Cutaneous candidiasis
• Pityriasis versicolor (Tinea versicolor)
• Vaginal candidiasis (vaginal yeast infection)
• Oral thrush (oropharyngeal candidiasis)
• Otomycosis (fungal ear infection, topical solution form)
• Intertrigo and fungal diaper rash (pediatric use under supervision)

Available Dosage Forms and Strengths

BluepillExpress manufactures Clotrimazole in a wide variety of formulations, customized to therapeutic needs and regulatory standards across different countries.

Topical Formulations

• Clotrimazole 1% Cream
• Clotrimazole 1% Lotion
• Clotrimazole 1% Powder
• Clotrimazole 1% Solution or Spray

Vaginal Formulations

• Clotrimazole 100 mg vaginal tablets
• Clotrimazole 500 mg vaginal tablet (single-dose treatment)
• Clotrimazole 2% vaginal cream

Oral Formulations

• Clotrimazole 10 mg lozenges/troches (for oral candidiasis)
• Sugar-free and flavored options available for pediatric use

All products are manufactured with high-purity APIs, in accordance with USP, BP, IP, or Ph.Eur standards.

Dosage and Administration

Topical Cream/Lotion/Powder

• Apply a thin layer to the affected area 2–3 times daily
• Continue for 2–4 weeks, even if symptoms improve earlier

Vaginal Tablets/Creams

• Insert 100 mg tablets once daily for 6–7 days, or
• Use 500 mg tablet as a single dose for uncomplicated candidiasis
• Cream: Apply intravaginally once daily for 3–7 days depending on severity

Oral Troche/Lozenge

• Dissolve 1 lozenge in mouth 5 times daily for 14 days (standard adult dose for oropharyngeal candidiasis)

Note: Dosage and duration may vary by infection type, location, and severity. Always use under medical supervision for optimal results.

Mechanism of Action

Clotrimazole inhibits fungal ergosterol synthesis by blocking the enzyme lanosterol 14-α-demethylase, disrupting cell membrane integrity. The compromised membrane allows leakage of intracellular contents and ultimately leads to fungal cell death.

• Fungistatic at low concentrations
• Fungicidal at high concentrations
• Active at both acidic and neutral pH, making it versatile for various body sites

Manufacturing Capabilities

BluepillExpress operates advanced manufacturing lines suitable for dermatological, gynecological, and ENT formulations, adhering strictly to GMP and ISO standards.

Facilities Include:

• Cream and ointment processing units with vacuum homogenizers
• Tablet compression and film-coating machines
• Liquid bottling and tube-filling lines (aluminum and laminated)
• Sterile zones for vaginal product packaging
• Dedicated air-handling systems to maintain product purity

We support OEM/private label manufacturing, bulk supply for institutional procurement, and custom dosage development upon request.

Packaging and Labeling

Our packaging solutions are customizable, tamper-proof, and export-ready, with multilingual artwork support.

Topical Forms:

• Aluminum tubes (5g, 15g, 30g)
• Laminated tubes and HDPE jars
• Mono cartons with or without leaflets

Vaginal Forms:

• Blister packs (1s, 3s, 6s)
• Applicator kits included if required
• Creams in calibrated tubes for accurate dosing

Oral Forms:

• Blister strips for lozenges/troches
• Sugar-free labeled cartons for pediatric formulations

We also offer serialization, QR coding, and barcoding to meet global regulatory requirements.

Quality Assurance and Regulatory Compliance

Every batch of Clotrimazole produced by BluepillExpress undergoes rigorous quality testing and regulatory validation.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (for applicable formats)
• Indian FDA
• Dossier-ready formulations (CTD, ACTD)

Quality Control Parameters:

• Assay and content uniformity
• Microbial limit testing
• Viscosity and pH (for creams/lotions)
• Disintegration and dissolution (for tablets/lozenges)
• Stability testing under ICH Zone II and IV conditions

All batches are accompanied by a Certificate of Analysis (CoA) and Batch Manufacturing Record (BMR).

Regulatory Support and Documentation

We offer end-to-end documentation and regulatory support for seamless product registration across global markets.

Available Documents:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• CTD/ACTD dossiers (Modules 1–5)
• Material Safety Data Sheet (MSDS)
• Real-time and accelerated stability data
• Packaging and label artwork files

We assist with registration processes, renewals, and product variations for international partners in Africa, Asia, LATAM, CIS, and the Middle East.

Export and Logistics

Our logistics services ensure on-time, secure, and compliant shipment of Clotrimazole products.

• Export packing (palletized and shrink-wrapped)
• Sea, air, and road freight coordination
• Incoterms: EXW, FOB, CIF, DDP
• Temperature-controlled transport (if required)
• Documentation and customs clearance support

We work with experienced freight partners for global supply chain management.

Minimum Order Quantities and Lead Times

Formulation Type	MOQ	Lead Time
Cream/Lotion/Powder	50,000 tubes	20–25 working days
Vaginal Tablets/Creams	100,000 units	20–25 working days
Lozenges/Troches	100,000 lozenges	20–30 working days
Sample Batches	20–50 units	7–10 working days

Market Demand and Growth Opportunity

Clotrimazole is listed in the World Health Organization (WHO) Model List of Essential Medicines and enjoys year-round global demand for:

• OTC retail products
• Hospital and clinic prescriptions
• E-commerce pharmacy sales
• NGO and government health kits
• Public sector tenders and institutional supply

Its affordability, effectiveness, and multi-indication use ensure steady market growth and strong patient acceptance.

Ideal Business Partners

We collaborate with:

• Generic pharmaceutical companies
• OTC product marketers
• Hospital supply and institutional procurement teams
• E-pharmacy platforms
• Exporters and tender contractors
• NGO and government program vendors

Whether you’re launching a branded dermatology line or seeking bulk white-label supply, BluepillExpress is your reliable partner.

Why Choose BluepillExpress?

• WHO-GMP certified and export-oriented
• Comprehensive range of Clotrimazole formulations
• Customizable branding and flexible batch sizes
• Full regulatory and quality documentation
• Efficient global logistics and timely delivery
• Trusted by clients in 30+ international markets

Conclusion

Clotrimazole remains one of the most versatile and effective antifungal agents, trusted by healthcare providers and consumers alike. Its broad spectrum, safety profile, and affordability make it a staple in antifungal therapy.

With BluepillExpress as your third-party manufacturing partner, you gain access to regulatory-compliant, globally accepted, and competitively priced Clotrimazole formulations. Whether for prescription, OTC, or institutional use, we ensure your product reaches the market with confidence and consistency.