Fluconazole API & Manufacturer
Vubrix Pharma | GMP-Certified · India
Leading Fluconazole manufacturer and supplier from India. GMP-certified API for regulated markets.
About Fluconazole
Looking for Fluconazole API & Manufacturer? Vubrix Pharma is a certified Fluconazole API manufacturer in India, supplying GMP-grade material to formulation partners and distributors worldwide.
Fluconazole is a triazole antifungal agent with broad-spectrum activity against various fungal pathogens including Candida species, Cryptococcus neoformans, and dermatophytes. It works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. Vubrix Pharma produces Fluconazole API with exceptional quality control, meeting pharmacopoeial standards (USP/EP/BP) for use in oral and intravenous formulations. Our manufacturing process ensures high purity and low impurity profiles suitable for global pharmaceutical markets.
As a trusted Fluconazole manufacturer, we supply Fluconazole 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
- Treatment of oropharyngeal and esophageal candidiasis
- Systemic candidiasis and cryptococcal meningitis
- Prevention of candidiasis in immunocompromised patients
- Treatment of vaginal candidiasis
- Dermatophyte infections (tinea pedis, corporis, cruris)
Technical Specifications
- Molecular Formula: C13H12F2N6O
- Molecular Weight: 306.27 g/mol
- Appearance: White to off-white crystalline powder
- Purity: ≥99.0% (by HPLC)
- Water Content: ≤0.5% (KF)
- Related Substances: Meets USP/EP requirements
- Heavy Metals: ≤20 ppm
- Assay: 98.0% - 102.0%
Storage & Handling
Storage Conditions
Store in a well-closed container, protected from light and moisture, at controlled room temperature (15-30°C).
Handling Instructions
Handle with appropriate precautions. Avoid inhalation of dust and contact with skin. Use in a well-ventilated area with proper personal protective equipment.
- CAS No.: 86386-73-4
- End Application: Antifungal
- GMP Certified
- DMF Available
- USP/EP/BP Grade
Frequently Asked Questions
1.What is Fluconazole used for?
Fluconazole is primarily used in treatment of oropharyngeal and esophageal candidiasis. It also finds applications in systemic candidiasis and cryptococcal meningitis, prevention of candidiasis in immunocompromised patients, treatment of vaginal candidiasis, dermatophyte infections (tinea pedis, corporis, cruris).
2.Is Fluconazole GMP certified?
Yes, Vubrix Pharma manufactures Fluconazole 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 Fluconazole?
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 Fluconazole?
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 Fluconazole?
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 Fluconazole?
Yes, Vubrix Pharma offers custom synthesis services for Fluconazole 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 Fluconazole API & Manufacturer?
As your Fluconazole API & Manufacturer, we offer GMP-certified manufacturing, DMF/CTD support, multi-ton capacity, and validated supply chain for US, EU, and regulated markets.