Fluconazole API Manufacturer & Supplier India
GMP-Certified · API Exporter India · Surat, Gujarat
Broad-spectrum antifungal used for the treatment of fungal infections. Request a quotation for bulk Fluconazole supply to regulated global markets.
Fluconazole Product Overview
Vubrix Pharma is a premier global manufacturer and exporter of Fluconazole Active Pharmaceutical Ingredient (API). Recognized for our commitment to quality, we supply pharmaceutical grade Fluconazole to formulation companies and distributors worldwide, ensuring strict compliance with USP, EP, and BP pharmacopeial standards.
Fluconazole (CAS No: 86386-73-4) is a highly effective, broad-spectrum triazole antifungal agent. It is widely used in the treatment of superficial and systemic fungal infections.
Chemical Name: 2-(2,4-Difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol. Appearance: White or almost white crystalline powder. Molecular Formula: C13H12F2N6O. Solubility: Slightly soluble in water, freely soluble in methanol.
Applications
- Candidiasis: Treatment of vaginal, oropharyngeal, and esophageal candidiasis.
- Cryptococcal Meningitis: Crucial therapy for cryptococcal meningitis, especially in immunocompromised patients (e.g., HIV/AIDS).
- Prophylaxis: Used to prevent fungal infections in patients undergoing bone marrow transplantation or chemotherapy.
- Systemic Infections: Effective against various systemic Candida infections including candidemia.
Technical Specifications
- Purity: NLT 99.0% - 101.0% (anhydrous basis)
- Grades Available: Oral Grade and Injectable Grade.
- Documentation: CoA, MOA, MSDS, and DMF available for regulatory support.
Manufacturing Process
Mechanism of Action: Fluconazole is primarily fungistatic. It exerts its effect by highly selective inhibition of fungal cytochrome P450-dependent enzyme lanosterol 14-α-demethylase. This inhibition prevents the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane, leading to increased cellular permeability and inhibition of fungal growth.
Vubrix Pharma's Fluconazole is produced in cutting-edge WHO-GMP facilities, ensuring strict batch-to-batch consistency and elimination of unwanted impurities.
Learn more about our manufacturing capabilities and quality assurance systems.
Packaging Information
Standard Packaging: 25 Kg HDPE drums with double inner polyethylene bags.
Storage Information
Storage Conditions: Store in well-closed containers at room temperature, protected from light and moisture.
Quality Standards
Quality is maintained through rigorous adherence to ICH guidelines, particularly concerning residual solvents and related substances. We provide comprehensive analytical support for our partners.
Export Markets
We are a trusted export partner for pharmaceutical buyers in over 40 countries across North America, Europe, Latin America, Africa, and Asia. Our robust supply chain ensures uninterrupted delivery of bulk Fluconazole API.
Why Choose Vubrix Pharma
Generic Pharmaceutical Manufacturers, Hospital Supply CMOs, and International API Importers rely on Vubrix Pharma for our dual capability in providing both standard oral and highly purified injectable grades of Fluconazole.
- CAS No.: 86386-73-4
- End Application: Antifungal
- GMP Certified
- DMF Available
- USP/EP/BP Grade
Frequently Asked Questions about Fluconazole
What is Fluconazole API used for?
Fluconazole API is used to formulate antifungal medications to treat infections like candidiasis and cryptococcal meningitis.
Is your Fluconazole API GMP certified?
Yes, our Fluconazole is manufactured in WHO-GMP certified facilities.
What pharmacopeias does Vubrix Pharma's Fluconazole comply with?
Our product complies with USP, EP, and BP standards.
What is the CAS number for Fluconazole?
The CAS number is 86386-73-4.
Do you supply Injectable Grade Fluconazole?
Yes, we manufacture highly purified Fluconazole suitable for intravenous (IV) formulations.
What is the minimum order quantity (MOQ) for Fluconazole?
The standard MOQ is 25 kg, packed in fiber drums.
Is a Drug Master File (DMF) available for Fluconazole?
Yes, we provide DMF support for regulatory submissions in target markets.
How does Fluconazole work?
It inhibits the fungal enzyme lanosterol 14-α-demethylase, disrupting ergosterol synthesis and fungal cell membrane formation.
What is the shelf life of your Fluconazole API?
The standard shelf life is 36 to 48 months when stored properly in original packaging.
Do you export Fluconazole API to Africa and Latin America?
Yes, we have a strong export presence in both regions and understand local regulatory requirements.
Can Vubrix Pharma provide finished Fluconazole tablets?
Yes, we offer contract manufacturing for Fluconazole tablets and capsules.
How is the API packaged?
It is securely packaged in double poly bags inside robust 25 kg HDPE drums.
Are residual solvents monitored in your Fluconazole?
Yes, residual solvents are strictly controlled in accordance with ICH guidelines.
What is the visual appearance of the API?
It is a white or almost white crystalline powder.
Can I receive a sample for laboratory testing?
Yes, commercial samples with CoA are available for qualified B2B buyers.
How long does shipping take for bulk orders?
Shipping times vary by destination, typically ranging from 1 to 4 weeks via air or sea freight.
Do you supply veterinary grade Fluconazole?
Yes, we can supply API suitable for veterinary formulations.
What are your payment terms for international buyers?
We accept standard terms including LC and advance TT, subject to buyer verification.
How do you ensure batch-to-batch consistency?
Through rigorous adherence to GMP, automated process controls, and exhaustive quality control testing.
How can I get a quote for bulk Fluconazole?
You can request a quote via the inquiry form on this page or by contacting us on WhatsApp.
Request a Quote for Fluconazole
Get pricing, MOQ, lead time, and documentation for Fluconazole. Our team responds within 24 hours.