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 inhibit calcineurin, reducing T-cell activation and cytokine production. This immunosuppressant prevents organ rejection in transplant patients and treats autoimmune conditions. Benefits include improved graft survival, decreased immune response, and effective disease control, supporting long-term transplant success and autoimmune disease management.
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.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
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.
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