Itraconazole

Itraconazole is a broad-spectrum triazole antifungal agent widely used for the treatment of systemic and superficial fungal infections, including dermatophytosis, candidiasis, aspergillosis, and histoplasmosis. With its high tissue affinity, potent fungistatic activity, and favorable safety profile, Itraconazole is essential in dermatology, infectious diseases, and transplant medicine.

BluepillExpress, a WHO-GMP certified third-party manufacturing company, provides end-to-end solutions for Itraconazole formulations. From high-potency capsules to sustained-release pellets and combination therapies, our manufacturing capabilities support global brands, hospitals, NGOs, and pharmaceutical marketing companies in delivering clinically effective antifungal solutions with complete regulatory compliance.

Product Overview

Generic Name: Itraconazole
Therapeutic Class: Antifungal (Triazole Class)
Pharmacological Action: Inhibitor of fungal cytochrome P450 enzyme (lanosterol 14α-demethylase), impairing ergosterol synthesis

Available Dosage Forms and Strengths

• Capsules:
  • Itraconazole 100 mg
  • Itraconazole 200 mg
• Sustained Release (SR) Capsules / Pellets:
  • Itraconazole SR 100 mg (Pellets with specific dissolution profiles)
• Oral Solution:
  • Itraconazole Oral Solution 10 mg/mL (on demand)
• Topical Formulations:
  • Itraconazole Cream or Gel (available on request)

Packaging Options

• Alu-Alu blister packs (10×10 capsules)
• HDPE bottles (hospital supply or bulk packaging)
• Mono-cartons with or without inserts
• Export-ready packaging with multilingual labeling
• Private label and institutional branding services

Therapeutic Indications

Itraconazole is effective in treating a wide range of fungal infections, including:

• Dermatophytosis (tinea corporis, tinea cruris, tinea pedis, tinea capitis)
• Onychomycosis (fungal nail infection)
• Oropharyngeal and esophageal candidiasis
• Systemic mycoses: histoplasmosis, blastomycosis, aspergillosis
• Vulvovaginal candidiasis
• Prophylaxis in neutropenic or immunocompromised patients (e.g., post-transplant)

Its broad antifungal spectrum, tissue penetration, and long half-life make it suitable for both acute and chronic fungal conditions.

Mechanism of Action

Itraconazole functions by inhibiting the fungal cytochrome P450 enzyme—14α-demethylase—responsible for the synthesis of ergosterol, an essential component of fungal cell membranes. This leads to:

• Disruption of fungal membrane structure and function
• Impaired cell growth and replication
• Fungal cell death or growth inhibition depending on concentration

Itraconazole has fungistatic activity against Candida, Aspergillus, Histoplasma, Cryptococcus, and dermatophytes.

Pharmacokinetics and Bioavailability

• Absorption: Enhanced when taken with food (especially fatty meals)
• Bioavailability: 55% (capsule), higher with oral solution
• Protein Binding: >99%
• Distribution: High tissue penetration (skin, nails, lungs)
• Metabolism: Extensive hepatic metabolism via CYP3A4
• Half-life: 24–42 hours; accumulates with chronic dosing
• Excretion: Biliary and renal routes (mostly metabolites)

Because of its unique pharmacokinetics, pulse dosing regimens are effective for some superficial infections (e.g., onychomycosis, tinea).

Why Choose BluepillExpress for Itraconazole Manufacturing?

1. WHO-GMP Certified Manufacturing Infrastructure

BluepillExpress manufactures Itraconazole under strict quality and regulatory frameworks, including:

• WHO-GMP, ISO 9001:2015, and Schedule M compliance
• Dedicated cleanrooms for oral solid dosage forms
• Fluid bed processors and extrusion-spheronization lines for pellet manufacturing
• Pelleting and coating equipment for SR and taste-masked products
• High-precision capsule filling lines and blister packaging

We ensure every product batch meets international pharmaceutical quality standards.

2. Formulation Capabilities and Customization

Our in-house R&D team offers customized formulation solutions, such as:

• Pellet-filled capsules (multiple dissolution profiles)
• Itraconazole capsules with bioenhancers for better absorption
• Sustained-release pellets for improved dosing compliance
• Combination products (e.g., Itraconazole + Terbinafine)
• Pediatric suspensions or oral solutions (on request)

We also assist with bioequivalence studies, formulation feasibility, and scale-up batches for regulated markets.

Quality Assurance and Quality Control

Our comprehensive QA/QC processes cover:

• Assay and dissolution profile of active ingredients
• Pellet size and uniformity, coating thickness, and release profiles
• Microbial and endotoxin testing
• Content uniformity, weight variation, and capsule integrity
• Stability studies under ICH guidelines (Zone II and IV)
• Heavy metals, residual solvents, and impurity profiling

All analytical procedures follow IP, USP, and Ph. Eur. specifications and are performed in fully equipped laboratories with validated instruments.

Regulatory Documentation and Dossier Support

We offer comprehensive regulatory and technical documentation, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Free Sale Certificate (FSC)
• Certificate of Origin (CoO)
• Method of Analysis (MoA)
• Material Safety Data Sheet (MSDS)
• Common Technical Document (CTD) or ACTD Dossier
• Bioequivalence and stability data (if required)
• WHO-GMP and ISO Certifications

Our team supports product registrations in Africa, Latin America, Southeast Asia, Middle East, CIS, and other international markets.

Private Label and Export Services

BluepillExpress supports private label manufacturing of Itraconazole with:

• Custom branding and logo placement
• Labeling in regional languages (Arabic, French, Spanish, etc.)
• Multilingual inserts and packaging inserts for export markets
• Tamper-proof packaging with serialization and QR code (if needed)
• Institutionally branded packaging for government tenders or hospital supply

We ensure compliance with global export standards and regulatory requirements for pharmaceutical labeling and branding.

Global Export and Distribution Capabilities

We manage the entire export lifecycle with precision:

• International shipping via air or sea
• Support with customs clearance and documentation
• Coordination with inspection agencies (SGS, Intertek, Bureau Veritas)
• Cold chain or temperature-controlled logistics (if applicable)
• Packaging tailored to withstand long-distance transit

We’ve successfully exported Itraconazole and other antifungals to over 35 countries with a record of timely delivery and zero compromise on product integrity.

Third-Party Manufacturing Workflow

Our streamlined process includes:

1. Requirement Gathering
   • Client discusses formulation type, quantity, packaging, and regulatory targets
2. Quotation and Agreement
   • NDA signing, commercial terms, and cost estimation finalized
3. Sample Development (if required)
   • Trial batches of SR pellets or capsules provided for client approval
4. Artwork and Packaging Customization
   • Design approvals for cartons, labels, and inserts
5. Commercial Production
   • WHO-GMP batch production, QA validation, and documentation
6. Quality Testing
   • CoA, batch release, and dispatch readiness
7. Logistics and Delivery
   • Shipping, documentation, and client coordination until final delivery

Lead Time: Approx. 30–45 working days after artwork confirmation and regulatory clearance

Client Profiles and Market Segments Served

BluepillExpress offers Itraconazole manufacturing to:

• Generic drug marketing companies
• OTC and prescription medicine suppliers
• Dermatology product marketers
• Hospital and institutional procurement bodies
• International NGOs and public health agencies
• Online pharmacies and wellness brands

Whether supplying small-volume clinical programs or high-volume national tenders, we adapt our manufacturing and supply systems to client demands.

Advantages of Partnering with BluepillExpress

• WHO-GMP and ISO 9001:2015 certified facilities
• Complete dosage form flexibility: IR/SR capsules, oral solutions, topicals
• Competitive pricing and low minimum order quantities
• Full support with branding, packaging, and regulatory registration
• In-house QA/QC and documentation team
• Proven record of exporting to regulated and semi-regulated markets
• Transparent processes and long-term business commitment

Conclusion

Itraconazole plays a critical role in the modern treatment of fungal infections, offering broad-spectrum antifungal coverage with long-lasting action. As fungal resistance increases and healthcare systems seek reliable antifungal solutions, manufacturers must provide quality, compliance, and innovation.

At BluepillExpress, we offer everything you need to succeed in the antifungal market—custom formulation development, WHO-GMP production, regulatory readiness, and private label packaging. From bulk exports to boutique pharmaceutical lines, we ensure your brand delivers safe, effective, and affordable Itraconazole-based solutions to patients across the globe.