Neomycin Triamcinolone Acetonide, Nystatin

The combination of Neomycin, Triamcinolone Acetonide, and Nystatin is widely used in dermatology and gynecology for treating mixed bacterial and fungal skin infections, especially those involving inflammation. This triple-combination formulation provides broad-spectrum antimicrobial, anti-inflammatory, and antifungal effects, making it highly effective for topical management of dermatoses and mycotic infections.

At BluepillExpress, we specialize in third-party manufacturing of this potent combination in various topical forms such as cream, ointment, and lotion. Our WHO-GMP certified facility and rigorous quality control systems ensure that the final product meets international regulatory standards, is safe, stable, and clinically effective. We cater to both domestic and global clients looking to launch their own private-label or branded formulations of this essential combination.

Product Overview

The combination of Neomycin, Triamcinolone Acetonide, and Nystatin serves as a comprehensive treatment for mixed infections involving fungal and bacterial agents, especially those accompanied by inflammation or allergic symptoms.

Individual Component Functions:

• Neomycin Sulfate
  • A broad-spectrum aminoglycoside antibiotic
  • Effective against gram-positive and gram-negative bacteria
  • Inhibits protein synthesis in bacteria, leading to cell death
• Triamcinolone Acetonide
  • A medium-potency corticosteroid
  • Reduces inflammation, itching, redness, and swelling
  • Acts locally without significant systemic absorption
• Nystatin
  • A polyene antifungal
  • Active against Candida species
  • Binds to ergosterol in fungal cell membranes, increasing permeability and causing cell leakage

Together, they provide a threefold action: antimicrobial, antifungal, and anti-inflammatory—ideal for dermatoses with mixed etiology.

Therapeutic Indications

This triple-drug formulation is particularly effective for fungal skin infections complicated by inflammation or secondary bacterial infection.

Key Indications Include:

• Candidiasis of the skin
• Intertrigo and diaper rash
• Eczematous dermatoses
• Tinea infections with secondary inflammation
• Allergic fungal dermatitis
• Mixed microbial infections of the perineum, groin, or axilla
• Vulvovaginal candidiasis (topical application)
• Ringworm with superinfection
• Dermatophytosis involving both fungal and bacterial components

This formulation is suitable for both adult and pediatric use (under medical supervision) and is often preferred in primary care, dermatology, and gynecology settings.

Available Dosage Forms

At BluepillExpress, we offer customized formulations of this triple-drug combination based on market requirements and regulatory preferences.

1. Topical Cream

• Composition (typical):
  • Neomycin Sulfate IP 0.5% w/w
  • Triamcinolone Acetonide IP 0.1% w/w
  • Nystatin IP 100,000 IU
• Base: Non-greasy, fast-absorbing emollient
• Packaging:
  • 15 g, 20 g, 30 g aluminum or laminated tubes
  • Lami tubes with tamper-evident seals
• Application: Applied 2–3 times daily to the affected area

2. Topical Ointment

• Base: Petroleum jelly or paraffin-based
• Use Case: Preferred in dry, scaly lesions or when prolonged skin contact is desired
• Packaging: Similar tube configurations, also available in jars

3. Topical Lotion (on request)

• Form: Suspension-based for hairy areas like the scalp
• Bottle Size: 30 ml, 60 ml
• Use: Shake well before use; easy application for sensitive or difficult-to-access areas

Each product type is tested for stability, potency, and patient compatibility, and can be customized for private label or export compliance.

Manufacturing Facility Overview

BluepillExpress operates a WHO-GMP, ISO 9001:2015, and HACCP certified facility, equipped with the latest technology for the manufacturing of topical dermatological products.

Infrastructure Features:

• Automated mixing vessels with homogenizers
• Temperature-controlled blending systems
• Tube-filling and sealing machines with high accuracy
• HEPA-filtered cleanrooms for sterile and semi-sterile processing
• Separate HVAC zones to prevent cross-contamination
• Quality Control labs with HPLC, UV, FTIR, and microbiology facilities
• ERP-enabled batch traceability and inventory management systems

Every product undergoes robust in-process controls, environmental monitoring, and final batch testing to ensure consistency and regulatory compliance.

Quality Control and Assurance

Our QA/QC systems are designed to meet stringent global standards across all parameters, ensuring the safety and efficacy of each batch of the Neomycin–Triamcinolone–Nystatin combination.

QC Tests Conducted:

• Identification and assay of each active ingredient
• Viscosity and spreadability (for creams and lotions)
• pH value and appearance testing
• Uniformity of content and dosage
• Microbial contamination (bacteria and fungi)
• Stability under accelerated and long-term conditions
• Preservative efficacy testing
• Tube integrity and leak test (for packaged products)

Documentation Provided:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Stability data (real-time and accelerated)
• Validation reports (process, method, and cleaning)
• Product specifications and MSDS

Regulatory & Dossier Support

At BluepillExpress, we understand the complexities involved in global regulatory registrations and support our clients with comprehensive dossier preparation and compliance documentation.

Available Regulatory Support:

• CTD/ACTD Dossier
• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• Stability Study Reports
• Site Master File (SMF)
• Labeling and artwork compliant with target market regulations

We have supported successful product registrations in Africa, Southeast Asia, the Middle East, CIS countries, and Latin America.

Private Label & Customization Options

We provide private label manufacturing for pharmaceutical companies, distributors, and startups looking to launch their own dermatological or gynecological brand.

Services Include:

• Custom product name and branding
• Tube and carton design with multilingual labeling
• MOQ flexibility for new brand launches
• IP confidentiality agreements (NDA signing)
• Batch samples for testing and marketing
• Exclusive distribution arrangements (based on geography)

Whether launching in retail pharmacies or hospitals, our private-label model supports your brand’s success with reliable supply, excellent quality, and fast turnaround.

Packaging Solutions

We offer a range of packaging formats to cater to different market requirements and aesthetic preferences.

Primary Packaging:

• Aluminum tubes with inner lacquer
• Laminated tubes with tamper-evident caps
• HDPE jars for institutional use
• Screw caps, flip-top applicators, or nozzles

Secondary Packaging:

• Printed folding cartons
• Patient information leaflets (PILs)
• Multilingual labeling for exports
• Tamper-proof outer seals
• Barcoding and serialization (optional)

Packaging is conducted in controlled environments to ensure hygiene, product protection, and regulatory conformity.

Export Services

BluepillExpress is a trusted exporter of pharmaceutical formulations, serving clients in over 35+ countries. Our dedicated international division ensures efficient handling of documentation, logistics, and compliance.

Export Support Includes:

• Door-to-door shipping
• CIF, FOB, DDP, and EXW terms
• Pre-shipment inspection coordination
• Temperature-controlled logistics (if required)
• Export documentation: COO, CoPP, FSC, invoice, packing list
• Product registration and distributor onboarding assistance

Our experienced logistics partners ensure timely delivery, regulatory customs clearance, and product integrity across all climates.

Minimum Order Quantities (MOQs)

We accommodate businesses of all sizes with flexible MOQ options, suitable for both emerging and established brands.

• Low MOQ: Ideal for startups or sample-based market entry
• Medium MOQ: Suitable for regional distribution networks
• High-volume production: For tenders or institutional contracts

Our commercial team will advise you on the MOQ structure best suited to your packaging, destination market, and formulation.

Client Testimonials

“We worked with BluepillExpress to manufacture our private label combination cream. Their quality and support during registration helped us enter a competitive dermatology market.”
— Managing Director, East Africa

“We found their Neomycin–Triamcinolone–Nystatin cream to be stable, effective, and well-packaged. It’s been well-received by dermatologists and patients alike.”
— Product Manager, Southeast Asia

“From documentation to branding, BluepillExpress helped us every step of the way. Their team is responsive and committed to compliance.”
— Regulatory Consultant, Middle East

Conclusion

The combination of Neomycin, Triamcinolone Acetonide, and Nystatin is a cornerstone in the treatment of mixed infections with inflammation, widely used in both dermatology and gynecology. As global demand grows for topical antifungal-antibacterial treatments with corticosteroids, the need for a reliable and compliant manufacturing partner becomes critical.

At BluepillExpress, we combine quality, customization, and compliance to deliver third-party manufacturing services you can trust. Whether you’re launching a new brand, expanding your dermatology range, or seeking a proven product for export, we’re here to support your growth every step of the way.