Neoral (ciclosporin) is licensed for prophylaxis of organ rejection after kidney, liver and heart transplant, and buyers can specify brand or a licensed generic modified-ciclosporin capsule against the same tender line.
Neoral (ciclosporin), originated by Novartis, is an oral calcineurin-inhibitor immunosuppressant built around a microemulsion formulation that transplant units, dermatology clinics and rheumatology services depend on for consistent absorption. M Care Exports is a merchant exporter: we source Neoral and licensed generic modified-ciclosporin capsules through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Ciclosporin exporter and bulk supplier from India.
Tell us the strength mix, pack size, brand-or-generic preference and destination market, and we quote against your specification. Because Neoral and the older Sandimmun formulation are not bioequivalent and cannot be substituted for one another without clinical supervision, we confirm which formulation a tender or formulary line actually specifies before we release a quote, then align the CTD/eCTD or country-specific dossier paperwork to the destination regulator.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Calcineurin-inhibitor immunosuppressant; cyclic polypeptide, sourced and documented for export.
Ciclosporin is a cyclic polypeptide calcineurin inhibitor. It suppresses T-lymphocyte activation and interleukin-2 production, which is what makes it useful for preventing transplant rejection and for damping the T-cell-driven inflammation behind severe psoriasis and rheumatoid arthritis. Neoral's flagship licensed use is prophylaxis of organ rejection following kidney, liver and heart allogeneic transplant, usually alongside corticosteroids and other immunosuppressants. It also carries a licensed indication for severe active rheumatoid arthritis unresponsive to methotrexate, and for severe, recalcitrant plaque psoriasis in adults who are not immunocompromised; destination-country labelling can extend further into nephrology and ophthalmic dermatology, so buyers should check the specific licensed indications on their own market's approved label. Ciclosporin is an oral, non-injectable therapy for the great majority of prescriptions. Neoral is supplied as soft gelatin capsules (10mg, 25mg, 50mg and 100mg) and as an oral solution (100mg/mL), both built on the microemulsion technology that gives Neoral more predictable absorption than the older Sandimmun formulation.
Active ingredient
ciclosporin (cyclosporine). Calcineurin-inhibitor immunosuppressant; cyclic polypeptide.
Forms and strengths
10 mg soft gelatin capsule; 25 mg soft gelatin capsule; 50 mg soft gelatin capsule; 100 mg soft gelatin capsule; 100 mg/mL oral solution.
Indications
Oral calcineurin-inhibitor immunosuppressant indicated for prophylaxis of organ rejection after kidney, liver and heart transplant, and separately licensed for severe rheumatoid arthritis unresponsive to methotrexate and severe recalcitrant plaque psoriasis.
Administration
oral. Soft gelatin capsule (microemulsion) and oral solution.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for ciclosporin are transplant-unit pharmacists managing lifelong post-transplant immunosuppression, dermatology and rheumatology services prescribing it for severe psoriasis or treatment-resistant rheumatoid arthritis, national and regional MoH tender desks running transplant-medicine and immunology procurement lists, licensed pharmaceutical wholesalers and importers serving hospital renal and hepatology units, and NGO or foundation programmes supporting transplant-access initiatives in markets where local registration is in place.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on ciclosporin.
Ciclosporin dosing in transplant patients is individualised to trough (or C2) blood concentration, not a fixed mg/kg schedule, so specify which monitoring protocol the receiving unit uses before we confirm a strength mix; under- or over-shooting the target range is the difference between rejection and nephrotoxicity. Counsel patients to take Neoral at a consistent time of day and consistent relation to meals, since a high-fat meal measurably reduces absorption, and to avoid grapefruit juice, which raises ciclosporin levels. Neoral and Sandimmun are not bioequivalent and must never be substituted for one another, or between generic modified-ciclosporin products, without the prescribing team's sign-off; flag this explicitly on any dispensing label change. Oral solution should be diluted in orange or apple juice at room temperature immediately before dosing and taken from a glass, not plastic, container. At transplant doses, ciclosporin increases susceptibility to infection and malignancy, and systemic hypertension and nephrotoxicity both track with dose and duration, so renal function and blood pressure need routine review alongside trough levels.
The documentation pack a regulator actually asks for.
Ciclosporin capsules and oral solution are an oral solid or oral liquid dosage form, so they travel on standard ambient, moisture- and light-controlled logistics rather than the validated cold-chain lanes M Care runs for biologics; the WHO Model List also carries a parenteral concentrate-for-injection form, though that injectable presentation is no longer routinely marketed and current M Care supply is capsule and oral-solution only. On the brand-versus-generic question, Neoral remains the originator microemulsion product from Novartis. Licensed generic modified-ciclosporin capsules are separately registered and marketed in both the US and UK (multiple ANDA holders in the US; Capimune, Deximune and Capsorin in the UK), so buyers genuinely have a brand-or-generic choice on formulary. What they do not have is free interchangeability between those products: UK and US labelling both treat a brand or generic modified-ciclosporin change as a clinical decision requiring specialist sign-off, so M Care confirms exactly which named product a tender specifies rather than substituting on our own initiative.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside ciclosporin.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Dupilumab
Another allergy & immunology line ordered on the same formularies.
Etanercept
Another allergy & immunology line ordered on the same formularies.
All allergy & immunology
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for ciclosporin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Ciclosporin supply, the specific questions.
Can Neoral and generic ciclosporin capsules be substituted for each other?
Not without the prescribing team's sign-off. Neoral, Sandimmun and generic modified-ciclosporin products are not automatically bioequivalent or interchangeable, so UK and US labelling both treat a brand or manufacturer change as a clinical decision, not a routine dispensing substitution. M Care always confirms which named product a tender or formulary line specifies before quoting.
What is ciclosporin licensed to treat?
Its flagship licensed use is prophylaxis of organ rejection after kidney, liver or heart transplant, usually combined with corticosteroids and other immunosuppressants. It also carries licensed indications for severe rheumatoid arthritis unresponsive to methotrexate and severe, recalcitrant plaque psoriasis in non-immunocompromised adults. Check other licensed indications per your destination-country labelling.
Does ciclosporin need cold-chain shipping?
No. Neoral capsules and oral solution are stored at controlled room temperature and move on standard ambient, moisture-controlled logistics, not the validated cold-chain lanes we use for biologics. The parenteral concentrate form listed on the WHO Model List is a separate consideration if a tender specifies injectable ciclosporin.
What strengths of ciclosporin capsules can M Care supply?
Tell us your strength mix and brand-or-generic preference and we quote against it.
Is ciclosporin on the WHO Essential Medicines List?
Yes. Ciclosporin has been on the WHO Model List of Essential Medicines since 1991, listed among the immunomodulators for non-malignant disease, covering oral capsule, oral liquid and parenteral concentrate forms.
What documentation does M Care provide with a ciclosporin shipment?
CTD/eCTD-aligned dossier documentation, certificates of analysis, batch records and CDSCO export paperwork from the Indian side, plus confirmation of exactly which brand or generic product a shipment contains, given that ciclosporin products are not freely interchangeable.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.