Clotrimazole Vaginal

Clotrimazole is an antifungal agent used extensively in the treatment of vaginal yeast infections (vulvovaginal candidiasis). As a broad-spectrum imidazole derivative, Clotrimazole is effective against Candida albicans and other fungal pathogens responsible for vaginal infections. It is considered a first-line treatment due to its local action, rapid symptom relief, and excellent safety profile.

At BluepillExpress, we specialize in the third-party manufacturing of Clotrimazole vaginal formulations, offering high-quality products in multiple dosage forms, including vaginal tablets, creams, and pessaries, manufactured under WHO-GMP and ISO 9001:2015 certified conditions. With global-standard facilities, robust quality control systems, and extensive regulatory support, we serve pharmaceutical companies, healthcare brands, and international importers seeking reliable and scalable Clotrimazole manufacturing services.

About Clotrimazole Vaginal

Clotrimazole is a synthetic antifungal that works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. By disrupting membrane integrity, Clotrimazole leads to fungal cell lysis and eventual death.

Pharmacological Class:

• Antifungal (Imidazole derivative)
• Topical and local use in gynecology

Mechanism of Action:

• Inhibits lanosterol 14α-demethylase, an enzyme required for ergosterol synthesis
• Causes loss of membrane permeability, resulting in fungal cell death
• Exhibits fungistatic and fungicidal activity depending on concentration and duration

Clotrimazole is well-absorbed locally in the vaginal mucosa with minimal systemic absorption, making it safe for most women, including pregnant patients when used under medical guidance.

Indications and Therapeutic Applications

Clotrimazole vaginal products are indicated for a wide range of fungal and yeast-related gynecological conditions, including:

• Vulvovaginal candidiasis (VVC)
• Monilial vaginitis
• Fungal superinfections following antibiotic use
• Non-specific vaginitis caused by fungal pathogens
• Adjunct treatment for recurrent vaginal infections
• Relief from associated symptoms such as itching, burning, and discharge

Clotrimazole offers effective relief within 3 to 7 days, depending on the formulation and dosing regimen, making it a preferred treatment in both OTC and prescription segments.

Why Partner with BluepillExpress for Manufacturing?

At BluepillExpress, we provide turnkey third-party manufacturing services for Clotrimazole vaginal formulations, offering expertise, compliance, and confidentiality to pharmaceutical clients around the world.

Key Advantages:

• WHO-GMP and ISO 9001:2015 certified production units
• Validated manufacturing processes for all vaginal dosage forms
• Low MOQs, ideal for startups, brands, and global distributors
• Dossier support and regulatory documentation for international registration
• Customizable formulation and packaging options
• Pediatric, adult, and pregnancy-safe versions
• Private label and white label manufacturing
• Global supply chain management and export assistance

We ensure high therapeutic efficacy, batch-to-batch consistency, and complete compliance with pharmacopoeial standards (IP/BP/USP/EP).

Clotrimazole Vaginal Formulations Available

We offer Clotrimazole vaginal formulations in multiple dosage forms tailored for domestic retail, institutional supply, and international tenders.

1. Clotrimazole Vaginal Tablets / Pessaries

• Strengths: 100 mg, 200 mg, 500 mg
• Dosage:
  • 100 mg for 6 consecutive nights
  • 200 mg for 3 consecutive nights
  • 500 mg as a single-dose therapy
• Form: Compressed or molded suppository-style tablets
• Packaging:
  • Blister packs (1’s, 3’s, 6’s) with applicator
  • Aluminum-aluminum or PVC blistering
• Shelf Life: 24–36 months
• Applications: Deep intravaginal antifungal therapy

These formulations are suitable for self-administered home therapy, offering rapid resolution of symptoms and improved compliance.

2. Clotrimazole Vaginal Cream

• Strength: 2% w/w
• Base: Smooth, non-greasy emollient base
• Packaging:
  • 20 g, 30 g, 35 g, 50 g aluminum or laminated tubes
  • Supplied with reusable or single-use vaginal applicators
• Indication:
  • External and intravaginal fungal infections
  • Relief of vulvar symptoms associated with candidiasis
• Usage: Applied once or twice daily for 3–7 days

This formulation is ideal for women with external irritation, vulvar itching, and discomfort due to fungal overgrowth.

3. Combination Formulations (on request)

• Clotrimazole + Metronidazole + Lactobacillus
  For mixed infections and restoration of vaginal flora
• Clotrimazole + Tinidazole
  Dual-action against yeast and protozoa

These products are developed under customized R&D projects for clients targeting niche gynecological markets.

Manufacturing Infrastructure

Our state-of-the-art manufacturing plant is fully equipped to handle sensitive formulations such as vaginal antifungal medications, with dedicated lines for hormone-free, sterile, and high-care formulations.

Facility Highlights:

• Precision tablet compression for vaginal pessaries
• Homogenizers and planetary mixers for cream manufacturing
• Cleanrooms with HEPA-filtered air supply (ISO 7 and ISO 8 zones)
• SS 316L contact equipment for non-contaminated processing
• In-line tube filling, sealing, and batch-coding machinery
• Fully automated blister packing and visual inspection
• Stability chambers compliant with ICH Zone II–IV guidelines
• Separate HVAC and water purification (WFI/RO) systems

We maintain full traceability, batch documentation, and compliance with cGMP protocols throughout the manufacturing process.

Quality Control and Quality Assurance

BluepillExpress maintains a rigorous quality management system across all stages of manufacturing, ensuring that every product meets global safety and efficacy standards.

Key QC Tests Conducted:

• API assay and identity (Clotrimazole content)
• Uniformity of weight and content (tablets/pessaries)
• Disintegration and dissolution (vaginal tablets)
• Cream spreadability and viscosity (creams)
• Microbial contamination and sterility testing
• pH and appearance (for topical creams)
• Stability testing under real-time and accelerated conditions

Every batch is released with a comprehensive:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Stability Summary Report
• Method of Analysis (MOA)
• Raw material and packaging traceability log

Our dedicated QA team ensures adherence to internal SOPs and international GMP standards.

Regulatory Documentation Support

BluepillExpress provides complete regulatory assistance to support product registration and marketing authorization across global territories.

We Offer:

• CTD/ACTD dossier preparation
• WHO-GMP certification and CoPP
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Site Master File (SMF)
• Method of Analysis and validation reports
• Artwork, label, and packaging design files
• Stability studies and packaging specifications

Our experience covers successful regulatory submissions in Africa, Southeast Asia, CIS countries, Middle East, and Latin America.

Custom Packaging and Labeling

We provide a wide range of custom packaging solutions that meet branding and regulatory requirements in both prescription (Rx) and over-the-counter (OTC) segments.

Packaging Options:

• PVC, PVDC, or Alu-Alu blister packs
• Multilingual outer cartons
• Tubes with tamper-proof seals
• Applicator kits with instruction leaflets
• QR-coded packs for digital traceability
• Branding and regulatory layouts for target countries

We also offer private label design services, where our in-house design team collaborates to build your brand’s visual identity from scratch.

Private Label and White Label Services

BluepillExpress supports pharmaceutical companies, distributors, and healthcare startups in launching their own branded Clotrimazole products.

Our Services Include:

• Custom branding and design
• Trademark and brand name clearance (supportive)
• Confidential production agreements
• Sample development for marketing
• Promotional material printing (optional)
• Low and medium MOQ flexibility
• Confidentiality & IP protection under NDAs

This model is ideal for companies looking to quickly enter the market without investing in manufacturing infrastructure.

Export Services

We have a dedicated export division managing regulatory exports and commercial shipping logistics for clients in over 35+ countries.

Export Capabilities:

• Air and sea freight coordination
• Documentation: COO, CoPP, MSDS, FSC
• Pharmacovigilance and post-market support
• Global labeling compliance (French, Arabic, Russian, etc.)
• Temperature-controlled shipping (if required)
• DDP/FOB/CIF delivery terms based on client preference

We also assist with registration tenders, NGO programs, and government supply chains for antifungal therapies.

Minimum Order Quantity (MOQ)

To accommodate varying business sizes, we offer flexible MOQ models:

• Low MOQ: For startups, pilot launches, or trial registrations
• Medium MOQ: For distributors or private label brand owners
• High-volume MOQ: For hospitals, institutional supply, or government tenders

MOQ may vary depending on formulation type, packaging, and regulatory documentation required.

Client Testimonials

“BluepillExpress helped us successfully launch our Clotrimazole vaginal cream in two African countries. Their end-to-end support—from formulation to export—was seamless.”
— Regulatory Head, East Africa

“The pessaries we sourced from BluepillExpress had excellent patient compliance. Their private label team worked closely with our design brief and delivered outstanding results.”
— Brand Owner, Southeast Asia

“We were impressed by their flexible MOQs and quick turnaround time, enabling us to register and launch rapidly in our domestic market.”
— Business Development Manager, CIS Region

Conclusion

Clotrimazole vaginal formulations are a cornerstone in the management of fungal infections affecting women, with proven safety, rapid efficacy, and high patient acceptance. As global demand continues to grow in both prescription and OTC categories, there is significant potential for pharmaceutical companies to expand into this therapeutic area.

At BluepillExpress, we provide a comprehensive third-party manufacturing solution for Clotrimazole vaginal products—combining formulation expertise, regulatory compliance, superior quality assurance, and customizable branding—to help you bring trusted antifungal therapies to markets worldwide.