Cyclosporine Capsules

Form: Capsules

Strength: 25 mg, 50 mg, 100 mg

Reference Brands: Neoral, Sandimmune, Restasis, Celexet(US)

Category: Immune Disorder

Cyclosporine capsules, marketed as Neoral and Sandimmune, are approved in the US by the FDA and in the EU via EMA for preventing transplant rejection and autoimmune disorders. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality data, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of cyclosporine capsules worldwide, supporting optimal transplant and autoimmune patient care.