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Fungal infections, particularly vulvovaginal candidiasis (VVC), affect millions of women worldwide. Among the most trusted and effective antifungal agents used for intravaginal therapy is Clotrimazole—a broad-spectrum imidazole antifungal known for its high efficacy and local action. Available in various forms, Clotrimazole pessaries are especially preferred for targeted treatment of vaginal yeast infections, providing rapid symptom relief and sustained therapeutic activity.
At BluepillExpress, we specialize in the third-party manufacturing of Clotrimazole pessaries, offering clients access to WHO-GMP certified production infrastructure, robust quality controls, and customizable packaging solutions. Our capabilities extend to both domestic and international markets, making us the ideal partner for pharmaceutical companies, public health organizations, and global health procurement agencies seeking reliable, scalable, and compliant manufacturing solutions for antifungal formulations.
About Clotrimazole Pessaries
Clotrimazole is an imidazole derivative antifungal agent that works by inhibiting the synthesis of ergosterol, a key component of fungal cell membranes. This disruption leads to increased membrane permeability and eventual cell death. Clotrimazole is effective against a broad range of fungal pathogens, especially Candida albicans, the leading cause of vulvovaginal candidiasis.
Clotrimazole pessaries are solid vaginal suppositories designed for intravaginal insertion. They deliver high concentrations of the active ingredient directly to the infection site, ensuring fast relief from symptoms such as itching, discharge, burning, and irritation.
Primary Indications:
- Vulvovaginal candidiasis (yeast infection)
- Fungal superinfections associated with other vaginal conditions
- Maintenance therapy to prevent recurrence in chronic candidiasis
Advantages of Pessary Formulation:
- Localized action with minimal systemic absorption
- High patient compliance due to once-daily dosing
- Stable and easy-to-use formulation
- Reduced risk of drug interactions
Why Choose BluepillExpress for Clotrimazole Pessary Manufacturing?
1. WHO-GMP Certified Production Facilities
Our state-of-the-art facilities comply with WHO-GMP, ISO 9001:2015, and Schedule M guidelines, ensuring safe, effective, and high-quality production of intravaginal dosage forms.
- Dedicated cleanrooms for sterile and semi-solid formulations
- Strict environmental controls (temperature, humidity)
- Qualified personnel trained in specialized vaginal product handling
- Validated equipment and standard operating procedures (SOPs)
2. Full Customization and Formulation Options
We offer flexible options for Clotrimazole pessaries, including:
- Strengths Available: 100 mg, 200 mg, 500 mg
- Dosage Duration: 6-day (100 mg), 3-day (200 mg), or 1-day (500 mg) therapy
- Packaging Options: Blister packs (1’s, 3’s, 6’s), strip packs, PVC/PE inserts
- Form Standards: IP, BP, USP, or WHO monographs
We work with clients to develop custom branding, artwork, and dosage formats based on target market needs and regulatory requirements.
3. Turnkey Third-Party Manufacturing Solutions
BluepillExpress offers end-to-end support for your Clotrimazole pessary brand:
- Formulation R&D and analytical development
- Raw material procurement and assay standardization
- Batch production, validation, and stability studies
- Regulatory documentation and dossier preparation
- Custom packaging, labeling, and global logistics
Product Specifications
| Product Name | Clotrimazole Pessaries |
|---|---|
| Strengths Available | 100 mg, 200 mg, 500 mg |
| Dosage Form | Solid vaginal pessary |
| Route of Administration | Intravaginal |
| Packaging Options | Blister strips, PVC molds with applicator |
| Shelf Life | 24 to 36 months |
| Pharmacopoeial Standards | IP / BP / USP / WHO |
| Storage Conditions | Below 25°C, protected from light and moisture |
Therapeutic Benefits and Use Cases
1. Treatment of Vulvovaginal Candidiasis (VVC)
Clotrimazole provides fast, local relief from fungal infections in the vagina caused predominantly by Candida albicans. Pessaries provide effective delivery with minimal systemic exposure.
2. Relief from Common Symptoms
Itching, burning, soreness, and abnormal discharge are rapidly alleviated with proper use of Clotrimazole pessaries, improving patient comfort and quality of life.
3. Single or Multiple Dose Regimens
With 100 mg pessaries recommended for 6-day therapy, 200 mg for 3-day, and 500 mg for single-dose treatment, the formulation allows flexible prescribing patterns based on infection severity and patient compliance.
4. Ideal for Community and Institutional Settings
Clotrimazole pessaries are widely used in both over-the-counter (OTC) markets and government health initiatives targeting women’s reproductive health in developing regions.
Manufacturing Process Overview
Manufacturing of vaginal pessaries at BluepillExpress involves GMP-compliant, precision-controlled processes to ensure consistent quality and therapeutic efficacy.
1. Raw Material Dispensing and Blending
- Pharmaceutical-grade Clotrimazole and excipients (e.g., polyethylene glycol, hard fats)
- Accurate micro-dosing and homogenous blending
- Use of moisture-resistant APIs and excipients
2. Melting and Homogenization
- Excipients are melted in stainless steel vessels at controlled temperatures
- Clotrimazole is added and mixed uniformly to achieve consistent dispersion
3. Molding and Solidification
- Homogeneous liquid mass is poured into sterile PVC or aluminum molds
- Cooled rapidly under controlled conditions to ensure uniform shape and weight
4. Packaging and Labeling
- Pessaries are de-molded and packed into blister packs or strips
- Secondary packaging includes printed cartons, multilingual leaflets, and optional applicators
- Serial numbers, barcodes, and tamper-evident seals applied as required
5. Quality Control Testing
- Uniformity of weight and content
- Melting point consistency
- Microbial limits and stability studies
- Dissolution and release profiling
Quality Assurance and Regulatory Compliance
BluepillExpress follows strict QA/QC protocols at every step of production. All batches undergo thorough validation and analytical testing.
Quality Control Parameters:
- Identity, purity, and assay of Clotrimazole
- Uniformity of dosage units
- Microbial contamination checks (total aerobic count, yeast & mold count)
- Visual inspection for shape, size, and physical integrity
- Disintegration and in vitro dissolution testing
Documentation Provided:
- Certificate of Analysis (CoA)
- Batch Manufacturing Record (BMR)
- Method of Analysis (MoA)
- Stability data as per ICH guidelines
- Product dossier in CTD/eCTD format (on request)
We assist clients with registration dossiers, labeling compliance, and export documentation as required for their target markets.
Packaging Solutions
We offer multiple packaging options tailored to the brand’s market segment:
- Blister Packs: Alu-PVC or Alu-Alu blisters, individually sealed units
- Strip Packs: Foil-based, cost-effective formats for institutional buyers
- Cartons and Inserts: Custom-designed for private labels, with dosing instructions
- Applicators: Available for inclusion with each unit or pack
- Multi-language Labels and Leaflets: Supporting global distribution
Export and Global Supply Reach
BluepillExpress currently exports Clotrimazole pessaries and related antifungal products to over 30 countries, including:
- Africa: Nigeria, Kenya, Ethiopia, Uganda
- Asia: Vietnam, Myanmar, Nepal, Sri Lanka
- Middle East: Iraq, Yemen, Jordan
- Latin America: Bolivia, Guatemala, Honduras
- Caribbean & Pacific Islands: On request
Support for Export Clients Includes:
- Preparation of CTD/eCTD dossiers
- Free Sale Certificates (FSC) and CoPP
- Certificate of Origin (COO)
- Local registration and regulatory support
- Logistics assistance and Incoterms flexibility (FOB, CIF, DDP)
We are also equipped to support government tenders, NGO procurement programs, and public health initiatives.
Client Segments We Serve
Our third-party manufacturing of Clotrimazole pessaries is ideal for:
- Generic and branded pharmaceutical companies
- Retail pharmacy chains and e-pharmacies
- Women’s health-focused brands
- Government health departments and tender suppliers
- International NGOs and humanitarian aid organizations
- Hospital procurement systems and institutional buyers
We support low MOQs for start-ups and bulk production for high-volume distributors.
Research & Development Capabilities
Our formulation scientists and analytical experts offer R&D support in:
- Novel combination pessaries (e.g., Clotrimazole + Metronidazole)
- Controlled-release and fast-dissolving pessary designs
- Improved stability and shelf-life optimization
- Bioequivalence studies and pilot batch development
- Custom shapes (oval, torpedo) and fragrance-free variants
We also support technology transfer, scale-up, and method validation for proprietary product lines.
Sustainability and Ethical Manufacturing
At BluepillExpress, we prioritize ethical, safe, and environmentally responsible production, including:
- Zero Liquid Discharge (ZLD) systems
- Eco-friendly packaging materials
- Compliance with occupational health and safety norms
- No animal testing
- Fair labor practices and inclusive workforce policies
We are aligned with global reproductive health goals and sustainable development objectives.
Confidentiality and Partnership
We value your brand’s confidentiality and offer full protection of intellectual property:
- Non-Disclosure Agreements (NDAs)
- Exclusive manufacturing agreements (on request)
- Custom labeling, artwork, and branding support
- Post-manufacturing technical and marketing support
- Transparent pricing and timely production schedules
Our goal is to build long-term partnerships based on trust, quality, and growth.
Conclusion
Clotrimazole pessaries remain a cornerstone treatment for vaginal fungal infections, offering reliable and localized therapy with a favorable safety profile. As awareness about women’s health expands globally, the demand for high-quality antifungal products continues to rise.
BluepillExpress offers scalable, compliant, and customizable third-party manufacturing of Clotrimazole pessaries to help our partners meet this growing demand efficiently. With our advanced infrastructure, quality commitment, and regulatory expertise, we are your ideal partner in building a strong women’s health product portfolio.
