Cyclosporine Capsules Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 25 mg, 50 mg, 100 mg

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

Category: Immune Disorder

Cyclosporine Capsules is available in Capsules and strengths such as 25 mg, 50 mg, 100 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Cyclosporine Capsules is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Cyclosporine Capsules can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

Product Description: 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.