We provide comprehensive regulatory support for fluconazole including DMF filing, ANDA/MAA preparation, GMP certification assistance, and post-approval change management. Our team has extensive experience with FDA, EMA, and other major regulatory authorities.

Yes, we offer complete customization options including private labeling, custom packaging designs, blister packs, bottle sizes, and even dosage strength modifications to meet your market requirements and regulatory needs.

Minimum order quantities vary by partnership level. Basic plan starts at 25kg per order, Standard plan at 100kg, and Premium partners enjoy flexible ordering with no minimum quantities. We also offer sample quantities for quality evaluation and regulatory submissions.

Yes, we provide complete stability data including accelerated (40°C/75% RH) and long-term stability studies for all fluconazole formulations. Our stability packages comply with ICH guidelines and include data for up to 36 months for tablets and 24 months for IV formulations.

We supply fluconazole globally with established distribution networks in North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Our products are registered in over 80 countries and we have experience with diverse regulatory requirements including FDA, EMA, PMDA, TGA, and many others.