Itraconazole API & Manufacturer
Vubrix Pharma | GMP-Certified · India
Leading Itraconazole manufacturer and supplier from India. GMP-certified API for regulated markets.
About Itraconazole
Looking for Itraconazole API & Manufacturer? Vubrix Pharma is a certified Itraconazole API manufacturer in India, supplying GMP-grade material to formulation partners and distributors worldwide.
Triazole antifungal API used for systemic and superficial fungal infections. Vubrix Pharma manufactures Itraconazole Active Pharmaceutical Ingredient in compliance with Good Manufacturing Practices (GMP) standards. Our state-of-the-art facility in Surat, Gujarat, India, produces high-quality pharmaceutical-grade material suitable for use in regulated markets worldwide. We maintain strict quality control throughout the manufacturing process, ensuring consistent purity, low impurity profiles, and compliance with pharmacopoeial standards (USP/EP/BP). Our Itraconazole is manufactured with scale-up capability and full regulatory documentation support, including DMF/CTD preparation for US, EU, and other international regulatory submissions.
As a trusted Itraconazole manufacturer, we supply Itraconazole API from our facility in Surat, Gujarat, with scale-up capability and full regulatory documentation (DMF/CTD) support for US, EU, and regulated markets.
Applications
- Itraconazole is used as a pharmaceutical active ingredient in the production of triazole antifungal api used for systemic and superficial fungal infections.
- Manufacturing of pharmaceutical formulations requiring Itraconazole
- Research and development applications in pharmaceutical synthesis
- Custom synthesis projects and contract manufacturing
Technical Specifications
- CAS Number: Available on request
- Type: API
- Category: apis
- Purity: Meets pharmacopoeial standards
- Quality: GMP certified
- Packaging: Available in various sizes
Storage & Handling
Storage Conditions
Store in a cool, dry place in a tightly closed container, protected from light and moisture, at controlled room temperature (15-30°C).
Handling Instructions
Handle with appropriate safety measures. Avoid contact with skin and eyes. Use in a well-ventilated area with proper personal protective equipment. Refer to Material Safety Data Sheet (MSDS) for detailed handling instructions.
- Therapeutic class: Antifungal
- End application: Oral and parenteral antifungal formulations
Frequently Asked Questions
1.What is Itraconazole used for?
Itraconazole is primarily used in itraconazole is used as a pharmaceutical active ingredient in the production of triazole antifungal api used for systemic and superficial fungal infections.. It also finds applications in manufacturing of pharmaceutical formulations requiring itraconazole, research and development applications in pharmaceutical synthesis, custom synthesis projects and contract manufacturing.
2.Is Itraconazole GMP certified?
Yes, Vubrix Pharma manufactures Itraconazole in compliance with Good Manufacturing Practices (GMP) standards. Our facility is GMP-certified and we supply pharmaceutical-grade material suitable for use in regulated markets including US, EU, and other international markets.
3.What documentation do you provide with Itraconazole?
We provide comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), DMF/CTD support documents, and regulatory documentation as required. For APIs, we can provide Drug Master Files (DMF) for US FDA and European regulatory submissions.
4.What is the minimum order quantity for Itraconazole?
Minimum order quantities vary based on the product and your specific requirements. We offer flexible ordering options from laboratory-scale quantities for R&D purposes to commercial-scale multi-ton supplies. Please contact our sales team for detailed pricing and MOQ information.
5.How do you ensure quality of Itraconazole?
Quality assurance is integral to our manufacturing process. We employ rigorous quality control measures including HPLC analysis, GC-MS, NMR spectroscopy, and other advanced analytical techniques. All batches undergo comprehensive testing against pharmacopoeial standards (USP/EP/BP) before release. Our quality management system is ISO certified and follows ICH guidelines.
6.Can you provide custom synthesis of Itraconazole?
Yes, Vubrix Pharma offers custom synthesis services for Itraconazole and related compounds. Our R&D team can develop optimized synthetic routes, scale up processes, and provide custom modifications to meet your specific requirements. We work closely with clients from development through commercial production.
Why choose Vubrix Pharma as your Itraconazole API & Manufacturer?
As your Itraconazole API & Manufacturer, we offer GMP-certified manufacturing, DMF/CTD support, multi-ton capacity, and validated supply chain for US, EU, and regulated markets.