Nystatin Vaginal

Nystatin is a polyene antifungal medication widely used in the treatment of vaginal candidiasis, a common fungal infection caused primarily by Candida albicans. As part of essential gynecological care, Nystatin Vaginal formulations play a vital role in the management of acute and recurrent yeast infections. It is favored for its high local efficacy, minimal systemic absorption, and excellent safety profile.

At BluepillExpress, we are proud to offer WHO-GMP certified third-party manufacturing of Nystatin Vaginal products, designed to meet global regulatory standards and tailored for clients seeking quality, affordability, and branding flexibility. With advanced manufacturing capabilities, full regulatory documentation, and export logistics, we serve pharmaceutical companies, government healthcare initiatives, and distributors worldwide.

About BluepillExpress

BluepillExpress is a global pharmaceutical manufacturer and third-party supplier, offering end-to-end production and export services to over 25 countries across Africa, Asia, Latin America, CIS, and the Middle East. With WHO-GMP, ISO 9001:2015, and GLP-certified facilities, we specialize in the development, formulation, and supply of high-quality generic and branded pharmaceuticals.

Our service offerings include:

• Custom formulation development
• Contract and private label manufacturing
• Complete regulatory dossier preparation
• Flexible batch sizes and MOQs
• Export-compliant packaging and global shipping

Our production and export infrastructure is built to support pharmaceutical companies and healthcare institutions looking to expand their offerings in the women’s health segment.

Product Overview: Nystatin Vaginal

Nystatin is a polyene antifungal agent that binds to ergosterol in fungal cell membranes, causing increased permeability and cell death. It is highly effective against a variety of Candida species, particularly Candida albicans, without being absorbed systemically—making it ideal for local vaginal application.

Nystatin Vaginal formulations are widely used for:

• Treatment of vaginal yeast infections
• Prophylaxis in immunocompromised women
• Management of candidiasis during pregnancy (under supervision)
• Supportive antifungal therapy during antibiotic use

Nystatin’s localized action ensures high therapeutic concentration at the site of infection with negligible systemic side effects, making it a gold-standard treatment in gynecological practice.

Mechanism of Action

Nystatin works by:

• Binding to ergosterol, a key component of fungal cell membranes
• Creating pores in the membrane that lead to leakage of cellular contents
• Causing fungicidal activity against yeast and other fungi

Due to its poor gastrointestinal and vaginal mucosal absorption, Nystatin acts locally, making it safe for long-term use, especially in sensitive populations such as pregnant or breastfeeding women when clinically appropriate.

Therapeutic Indications

• Vaginal candidiasis (acute or recurrent)
• Candida vaginitis in immunocompromised patients
• Fungal infections caused by Candida glabrata, Candida tropicalis (with sensitivity)
• Adjunctive antifungal therapy during antibiotic courses
• Fungal prophylaxis in women prone to recurrent infections

Available Dosage Forms

BluepillExpress offers a range of Nystatin Vaginal formulations to meet the varying needs of different healthcare settings and patient preferences. All products are manufactured in line with IP, USP, BP, and Ph. Eur. standards.

1. Nystatin Vaginal Tablets/Pessaries

• Each pessary/tablet contains 100,000 to 200,000 IU of Nystatin
• Designed for intravaginal insertion
• Formulated for optimal dissolution and mucosal retention
• Packed in individually sealed strips or blister packs

2. Nystatin Vaginal Cream (on request)

• Nystatin 100,000 IU per gram
• Available in 15 g and 30 g tubes with applicator
• Used for direct application in cases of external vulvovaginal involvement

3. Nystatin Vaginal Suppositories (on request)

• Molded in a base that melts at body temperature
• Suitable for women who prefer non-tablet insertions
• Convenient for nighttime use

Each product is available with custom packaging and branding options to suit both retail and institutional clients.

Packaging Options

BluepillExpress ensures secure, export-ready packaging with a focus on stability, usability, and brand presentation.

Standard Packaging for Vaginal Tablets/Pessaries:

• Blister packs or strip packs of 6, 7, or 10 units
• Individually sealed pessaries for hygiene and protection
• Outer carton with product instructions and branding
• Multilingual printing for international markets
• Optional inclusion of applicators (on request)

For Creams and Suppositories:

• Aluminum or laminated tubes for cream
• Plastic or foil-sealed trays for suppositories
• Carton packaging with patient instruction leaflet

Packaging is tamper-evident, moisture-resistant, and validated for product stability during transportation and storage.

Manufacturing Infrastructure

BluepillExpress operates state-of-the-art manufacturing facilities designed for non-sterile dosage forms, including semi-solids, tablets, pessaries, and suppositories. Our infrastructure includes:

• Dedicated cleanrooms for hormone- and antifungal-based formulations
• Dehumidified production zones for pessary/tablet preparation
• Precision mixing and granulation equipment
• Suppository molding and filling machines
• Tube filling and crimping lines (for creams)
• Automated blister packing and batch coding systems

Our manufacturing complies with GMP protocols, including HEPA-filtered air systems, validated water systems, and electronic batch control for traceability.

Quality Assurance and Control

We maintain a robust Quality Management System (QMS) ensuring that every Nystatin batch meets international standards for identity, strength, safety, and performance.

Quality Control Measures Include:

• Raw material testing (identity, purity, microbial load)
• Granule analysis for tablet uniformity
• Finished product testing:
  • Content uniformity and assay
  • Microbiological testing (yeast/fungal resistance)
  • Disintegration and dissolution
  • Stability studies (real-time and accelerated)
• Container closure integrity and packaging validation

All products are released only after thorough quality checks, with Certificate of Analysis (CoA) and Certificate of Compliance (CoC) provided for each batch.

Regulatory Documentation Support

To facilitate market access and product registration, BluepillExpress offers a comprehensive set of regulatory documents, including:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Free Sale Certificate
• Stability Data and Shelf-Life Reports
• Material Safety Data Sheet (MSDS)
• CTD or ACTD Dossiers (as required)
• Batch Manufacturing Records (BMR)
• Product Artwork and Multilingual Inserts

We work closely with clients to ensure compliance with country-specific regulatory frameworks, from FDA and TGA to NAFDAC, PPB, and ANVISA.

Global Export and Logistics

With a well-established global logistics network, BluepillExpress offers fast and compliant delivery services for Nystatin Vaginal products to a wide variety of destinations.

Our Export Services Include:

• Custom labeling and country-specific artwork
• Flexible incoterms: FOB, CIF, DDP
• Air and sea freight options
• Temperature-controlled shipping (if required)
• Documentation for customs clearance and import licenses
• Serialization and tamper-evidence features (where mandated)

We have successful export partnerships across:

• Africa: Nigeria, Kenya, Ghana, South Africa
• Asia: Bangladesh, Vietnam, Sri Lanka, Myanmar
• CIS: Uzbekistan, Kazakhstan, Kyrgyzstan
• Latin America: Bolivia, Peru, Dominican Republic
• Middle East: Iraq, UAE, Yemen, Jordan

Target Clients and Applications

BluepillExpress is equipped to support:

• Generic pharmaceutical companies
• OTC and personal care brands in women’s health
• Hospital and gynecology clinics
• NGOs and government tender participants
• Community pharmacies and health programs
• E-commerce and telehealth platforms offering intimate care

We support both low MOQ requests for niche or pilot markets and bulk production for large tenders and public health campaigns.

Why Choose BluepillExpress?

1. WHO-GMP Certified Facilities
   Global standards for hygiene, compliance, and production quality.
2. Formulation Expertise in Women’s Health
   Specialized knowledge in vaginal and gynecological product lines.
3. Flexible Manufacturing Solutions
   Custom dosage forms, branding, and packing formats.
4. Comprehensive Regulatory Documentation
   Ready-to-submit CTD/ACTD dossiers and certifications.
5. Global Export Network
   Proven supply track record in 25+ countries with full logistics support.
6. Competitive Pricing and Responsive Timelines
   Affordable manufacturing with commitment to on-time delivery.
7. Private Label and Brand Building Support
   Artwork design, custom printing, and compliance labeling.

Conclusion

Nystatin Vaginal continues to be a cornerstone in the treatment of vaginal yeast infections, offering effective, localized antifungal therapy with a long-standing safety profile. As awareness grows around women’s health and hygiene, demand for antifungal vaginal products is expected to rise across global markets.

With BluepillExpress as your third-party manufacturing partner, you receive quality-assured, export-ready Nystatin formulations backed by regulatory expertise, production efficiency, and global logistics. Whether launching your brand or expanding your product line, we deliver end-to-end support to help you succeed in women’s health markets.