Thalidomide, sold as Thalomid in the US and as licensed capsules in the UK and EU for multiple myeloma with melphalan and prednisone, moves solely through pregnancy-prevention-programme controlled distribution, and M Care supplies capsules against a buyer's own restricted-distribution registration.
M Care Exports is a merchant exporter for thalidomide, the immunomodulatory agent marketed by Bristol Myers Squibb as Thalomid in the US and, in the UK, sold as separate generic-branded capsules from Zentiva and Eugia alongside the now-discontinued Thalidomide BMS line. In the UK and EU the licensed use is multiple myeloma in combination with melphalan and prednisone; the erythema nodosum leprosum indication carried on the US label is not licensed in UK/EU labelling. Every market runs a mandatory pregnancy-prevention programme, and M Care dispatches only against the buyer's own restricted-distribution registration, never as open-market stock.
Thalidomide exporter and bulk supplier from India.
For hospital oncology pharmacy and MoH tender orders, M Care quotes thalidomide capsules against a buyer's confirmed registration under their own market's pregnancy-prevention or restricted-distribution scheme, since thalidomide cannot be dispatched, stocked or dispensed outside that controlled pathway. Thalomid and the UK product lines move only through the registered programme of each market, so we confirm which licensed generic line (Zentiva or Eugia format) or, where a market runs its own registered originator, which product the buyer's programme permits, then align CTD/eCTD or country-specific dossier paperwork so the destination regulator's own controlled-drug requirements are met before a single capsule moves.
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.
Immunomodulatory and anti-angiogenic agent, sourced and documented for export.
Thalidomide is an immunomodulatory and anti-angiogenic agent whose exact mechanism in multiple myeloma is not fully defined, but includes inhibition of tumour necrosis factor-alpha, modulation of cell-adhesion molecules and suppression of new blood-vessel growth feeding the myeloma cell niche. In the UK and EU it is licensed only in combination with melphalan and prednisone as first-line treatment of untreated multiple myeloma in patients aged 65 or over, or otherwise ineligible for high-dose chemotherapy; the US FDA label additionally licenses thalidomide, there in combination with dexamethasone for newly diagnosed multiple myeloma, and separately for acute cutaneous manifestations of moderate to severe erythema nodosum leprosum and as ENL maintenance therapy, an indication not carried on UK/EU labelling. It is an oral, hard-gelatin capsule, taken once daily at bedtime to offset somnolence, needing no reconstitution or cold-chain handling. UK-marketed capsules are supplied in 50 mg strength; the wider international range includes 100 mg, 150 mg and 200 mg capsules used chiefly under the US dosing schedule. Every pack carries pregnancy-prevention-programme labelling and moves only through a prescriber, pharmacy and patient registered on that scheme.
Active ingredient
Thalidomide. Immunomodulatory and anti-angiogenic agent.
Forms and strengths
50 mg hard capsule; 100 mg hard capsule; 150 mg hard capsule; 200 mg hard capsule.
Indications
Thalidomide, an immunomodulatory and anti-angiogenic agent licensed in the UK and EU for first-line multiple myeloma with melphalan and prednisone, and in the US, as Thalomid, also for multiple myeloma and erythema nodosum leprosum. Every market restricts distribution to a registered pregnancy-prevention programme; M Care supplies against the buyer's own restricted-distribution registration only.
Administration
Oral. Hard capsule.
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 thalidomide are hospital haematology-oncology pharmacists managing multiple myeloma patients on melphalan-prednisone-thalidomide regimens, national and regional MoH tender desks running myeloma treatment protocols where a controlled-distribution registration is already in place, licensed importers and wholesalers holding the relevant restricted-medicines authorisation, and NGO or foundation procurement programmes supporting myeloma treatment access where local pregnancy-prevention infrastructure exists. Because of the mandatory pregnancy-prevention programme, M Care will not quote into a market or a buyer without confirmed registration under that scheme.
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 thalidomide.
Thalidomide dosing in UK/EU practice is 200 mg orally once daily with melphalan and prednisone, for a maximum of twelve six-week cycles; patients over 75 start at a reduced 100 mg daily. Capsules are taken as a single bedtime dose, whole and unopened, to limit daytime somnolence, and must never be crushed or opened given teratogenic risk from powder exposure. Every dispensing sits inside a pregnancy-prevention programme: women of childbearing potential need effective contraception from four weeks before treatment to four weeks after, with medically supervised pregnancy tests at defined intervals and prescriptions capped at a four-week supply; male patients use condoms during treatment and for seven days after stopping, regardless of partner fertility status. Venous thromboembolism risk rises sharply on thalidomide-dexamethasone combinations, so concurrent thromboprophylaxis is standard practice and should be confirmed at order stage. No cold-chain handling or reconstitution applies; the constraint is entirely the controlled-distribution pathway, not the physical product.
The documentation pack a regulator actually asks for.
Thalidomide has sat on the WHO Model List of Essential Medicines since 2019 (TRS 1021), listed for plasma cell myeloma, reflecting its role as a lower-cost induction option ahead of stem-cell transplant in settings where bortezomib-based regimens are unaffordable. It is not itself a scheduled controlled drug in the UK or EU; the restriction operates through each market's own pregnancy-prevention or risk-management programme rather than narcotics-control legislation, and every licence holder, prescriber and dispensing pharmacy must be registered on that programme before a pack moves. In the UK, thalidomide has been marketed under several separate licences: the now-discontinued Thalidomide BMS line, and currently marketed generic capsules from Zentiva Pharma UK Limited and Eugia (UK) Limited; each carries the same first-line multiple myeloma indication with melphalan and prednisone and the same pregnancy-prevention-programme conditions. M Care supplies thalidomide against a buyer's own restricted-distribution registration once that registration and the destination market's programme requirements are confirmed. M Care does not manufacture thalidomide and holds no WHO-GMP or WHO-PQ certification in its own name; each shipment carries its manufacturing partner's own certification and batch-level documentation.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 thalidomide.
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 thalidomide.
- 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.
Thalidomide supply, the specific questions.
Is Thalomid the same medicine as generic thalidomide?
Thalomid is Bristol Myers Squibb's originator brand, marketed in the United States. In the UK, thalidomide is currently supplied as generic-branded capsules from Zentiva and Eugia, following the discontinuation of the Thalidomide BMS line; all carry the same licensed multiple myeloma indication and the same pregnancy-prevention-programme conditions.
What is thalidomide licensed to treat in the UK and EU?
In the UK and EU, thalidomide is licensed only in combination with melphalan and prednisone as first-line treatment of untreated multiple myeloma in patients aged 65 or over, or otherwise ineligible for high-dose chemotherapy. The erythema nodosum leprosum indication on the US FDA label is not licensed in UK or EU labelling.
Can M Care supply thalidomide to our market?
Only against a confirmed restricted-distribution registration. Thalidomide moves exclusively through each market's own pregnancy-prevention programme, so we quote and dispatch once your hospital, wholesaler or MoH tender desk holds that registration, and every line, whether Thalomid, a UK generic or another market registered product, is confirmed against that programme before dispatch.
What strengths of thalidomide capsules are available?
UK-marketed capsules are supplied in 50 mg strength. The wider international range used chiefly under US dosing includes 100 mg, 150 mg and 200 mg capsules. Tell us your regimen and destination market and we confirm which strength and registered line applies.
Is thalidomide on the WHO Essential Medicines List?
Yes. Thalidomide was added to the WHO Model List of Essential Medicines in 2019 (TRS 1021) for plasma cell myeloma, reflecting its use as an affordable induction option ahead of stem-cell transplant where bortezomib-based regimens are not accessible.
Why does thalidomide need such strict distribution controls?
Thalidomide causes severe birth defects or fetal death from even a single dose taken during pregnancy. Every market therefore runs a mandatory pregnancy-prevention programme covering contraception, scheduled pregnancy testing and capped prescription lengths, and no pack can be dispensed to a patient, pharmacy or prescriber outside that registered scheme.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.
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