Nystatin

Fungal infections, both superficial and mucosal, are increasingly common across the globe, especially among immunocompromised patients, infants, and the elderly. Nystatin, a polyene antifungal antibiotic, stands as one of the most trusted medications for the effective treatment and prevention of Candida infections affecting the skin, mouth, vagina, and gastrointestinal tract.

At BluepillExpress, we provide third-party manufacturing services for Nystatin in a range of dosage forms. Leveraging WHO-GMP certified facilities and regulatory expertise, we manufacture high-quality, cost-effective Nystatin formulations that cater to institutional, retail, and global tender markets.

Product Overview

Generic Name: Nystatin
Therapeutic Category: Antifungal
Pharmacological Class: Polyene Macrolide Antibiotic

Available Dosage Forms:

• Nystatin Oral Suspension
• Nystatin Cream / Ointment
• Nystatin Vaginal Tablets / Suppositories
• Nystatin Oral Tablets (available on demand)

Common Strengths:

• Oral Suspension: 100,000 IU/mL
• Topical Cream/Ointment: 100,000 IU/g
• Vaginal Tablets: 100,000 IU or 500,000 IU
• Oral Tablets (if applicable): 500,000 IU

Packaging Options:

• Suspension: Amber HDPE bottles (30 mL, 60 mL, 100 mL) with calibrated dropper
• Topical Cream/Ointment: Aluminum or laminated tubes (15 g, 30 g) in mono-cartons
• Vaginal Tablets: Strip packing in blister/alu-alu with applicator (optional)
• All packs comply with international labeling and serialization requirements

Pharmacopoeial Compliance: IP / BP / USP / EP (as per client market)

Mechanism of Action

Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane, particularly ergosterol. This interaction leads to formation of pores in the membrane, resulting in:

• Increased cell membrane permeability
• Leakage of intracellular contents
• Fungal cell lysis and death

Nystatin is fungistatic or fungicidal, depending on concentration and fungal load. It is not systemically absorbed, making it exceptionally safe for topical, vaginal, and oral mucosal use.

Indications

Nystatin is indicated for the treatment and prevention of:

• Oral candidiasis (thrush), especially in infants and denture users
• Cutaneous candidiasis involving moist skin folds
• Vaginal candidiasis
• Intestinal candidiasis, including prophylaxis in long-term antibiotic therapy
• Candidiasis in immunocompromised or cancer patients
• Fungal diaper rash

Dosage and Administration

Oral Suspension (100,000 IU/mL):

• Infants: 1–2 mL, 4 times daily
• Children and adults: 4–6 mL, 4 times daily
• Should be held in the mouth as long as possible before swallowing
• Treatment usually lasts for 5–7 days or as directed

Topical Cream/Ointment:

• Apply a thin layer to affected area 2–3 times daily
• Use for 7–14 days, or until healing is complete
• Ideal for intertriginous and moist skin infections

Vaginal Tablets:

• Insert one tablet (100,000 IU or 500,000 IU) vaginally at bedtime for 14 days
• Applicator optional
• Suitable for use during pregnancy under medical guidance

Special Populations:

• Safe for use in infants, children, and pregnant women
• No dose adjustment needed for renal or hepatic impairment due to lack of systemic absorption

Pharmacokinetics

• Absorption: Not absorbed from skin, vagina, or GI tract when used topically or orally
• Onset of Action: 24–48 hours after initiation
• Duration: Continues with regular application; complete resolution in 7–14 days
• Excretion: Feces (unchanged for oral formulations)

This unique pharmacokinetic profile ensures high local efficacy with minimal risk of systemic side effects or interactions.

Clinical Advantages

• Localized action with no systemic absorption
• Safe for long-term use in high-risk populations
• No known microbial resistance when used appropriately
• Effective against most Candida species
• Available in multiple dosage forms to suit all age groups
• Can be used prophylactically in antibiotic or corticosteroid-treated patients

Why Choose BluepillExpress for Nystatin Manufacturing?

1. WHO-GMP Certified Production Facilities

Our facilities include:

• Dedicated topical and liquid oral manufacturing zones
• Advanced homogenization and emulsification equipment
• In-house filling, sealing, and tube-lamination units
• Cleanroom environment for contamination-sensitive formulations
• Microbiological labs for stringent QC testing

2. Wide Range of Formulations

We offer:

• Sugar-free suspensions for diabetic or pediatric use
• Fragrance-free creams for sensitive skin types
• Suppositories and vaginal tablets with or without applicators
• Custom strengths and pack sizes as per market demand

3. Full Regulatory & Documentation Support

Our regulatory services include:

• Product dossiers in CTD/ACTD format
• Certificates: GMP, FSC, COA, MOA, COPP
• Stability data (real-time & accelerated)
• Country-specific labeling and artwork development
• Assistance with MOH submissions and WHO PQ (upon request)

4. Global Supply and Logistics Network

We export to:

• Africa: Nigeria, Sudan, Ghana, Tanzania
• Asia: Bangladesh, Myanmar, Vietnam, Sri Lanka
• Middle East: Iraq, Yemen, Jordan
• Latin America & CIS: Bolivia, Uzbekistan, Peru

We ensure:

• Multilingual labeling and serial coding
• Temperature-controlled shipping (where required)
• Flexible lead times and minimum order quantities

Quality Control and Assurance

BluepillExpress maintains rigorous QC procedures for all Nystatin batches:

Raw Material Testing:

• Identification of API (UV, FTIR)
• Microbial load testing
• Excipient compatibility

In-Process Controls:

• pH, viscosity, density (for suspension and creams)
• Homogeneity and emulsion stability
• Uniformity of content and mass (for tablets)

Finished Product Testing:

• Assay (Potency by HPLC or microbiological assay)
• Microbial contamination test
• Stability studies under ICH Zones I–IV
• Packaging integrity and leakage testing

Manufacturing Process Overview

Step 1: Client Onboarding & Specification Finalization
Define product format, dosage, artwork, regulatory requirements, and commercial terms.

Step 2: Product Development and Sampling
Pilot batch prepared and shared for client evaluation along with COA.

Step 3: Batch Manufacturing and Quality Control
WHO-GMP batch manufactured with in-process and final product testing.

Step 4: Packaging and Labeling
Printed with approved artwork and country-specific compliance details.

Step 5: Shipping and Post-Production Support
Export documentation, COAs, and stability reports shared. Assistance for registration/tenders is offered post-dispatch.

Ideal Customer Segments

Our Nystatin formulations are suitable for:

• Pharmaceutical marketing companies targeting antifungal therapy
• Pediatric and gynecology-focused brands
• Government health programs and tenders
• Hospital supply chains and institutional purchase teams
• Humanitarian aid programs and NGOs
• Exporters to developing and semi-regulated markets

Global Market Outlook

• The global antifungal drugs market is expected to exceed USD 20 billion by 2028, with growing demand for topical and oral antifungals in developing economies.
• Candida infections remain highly prevalent in hospital and community settings, driving demand for localized antifungal therapy.
• Nystatin’s affordability, efficacy, and safety profile make it a first-line treatment in pediatric, dental, gynecological, and geriatric medicine.

BluepillExpress is strategically positioned to deliver scalable, regulatory-compliant Nystatin formulations with tailored packaging and prompt logistics.

Conclusion

Nystatin remains a gold-standard antifungal therapy with broad utility across age groups and patient settings. Its unique safety profile, coupled with its local action and wide-spectrum antifungal activity, makes it indispensable in modern healthcare.

BluepillExpress offers end-to-end third-party manufacturing for Nystatin in oral, topical, and vaginal dosage forms. Whether you are building a dermatology or gynecology brand, fulfilling a government tender, or sourcing for global export, we ensure quality, compliance, and consistency every step of the way.