Pomalyst (pomalidomide) is licensed for relapsed or refractory multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor, and FDA-approved generic pomalidomide capsules are now on the market alongside it.
Pomalyst (pomalidomide), from Bristol Myers Squibb, is an oral IMiD used with dexamethasone in relapsed or refractory multiple myeloma. M Care is a merchant exporter: we source Pomalyst and FDA-approved generic pomalidomide capsules through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Pomalidomide exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes pomalidomide capsules against buyer specification: brand (Pomalyst) or generic, pack size, strength mix (1 mg, 2 mg, 3 mg, 4 mg) and destination-market regulatory documentation. Because pomalidomide sits under a restricted REMS-style distribution programme in the US and equivalent controlled-distribution rules in most licensed markets, we confirm the buyer's import authorisation and prescriber/pharmacy registration status before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Thalidomide analogue; immunomodulatory drug (IMiD) with antineoplastic and antiangiogenic activity, sourced and documented for export.
Pomalidomide is a thalidomide analogue, an immunomodulatory drug (IMiD) with antineoplastic, antiangiogenic and immune-modulating activity. It is dosed orally, not injected, and needs no reconstitution.
Pomalyst's FDA-labelled indication is multiple myeloma in patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, with demonstrated disease progression on or within 60 days of completing the last therapy, given in combination with dexamethasone. A second FDA indication covers AIDS-related Kaposi sarcoma after HAART failure, or in HIV-negative Kaposi sarcoma patients; destination-country labelling may differ, so buyers should check other licensed indications per their own regulator's approved label.
Pomalyst is supplied as 1 mg, 2 mg, 3 mg and 4 mg capsules, swallowed whole with water and never opened, broken or chewed. It is a solid oral dosage form stored at controlled room temperature, not a cold-chain product, which simplifies freight compared with biologics on the same order.
Active ingredient
pomalidomide. Thalidomide analogue; immunomodulatory drug (IMiD) with antineoplastic and antiangiogenic activity.
Forms and strengths
1 mg capsule; 2 mg capsule; 3 mg capsule; 4 mg capsule.
Indications
Oral IMiD indicated with dexamethasone for relapsed or refractory multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor, and separately for AIDS-related Kaposi sarcoma after HAART failure.
Administration
oral. Capsule, swallowed whole.
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 pomalidomide are mainly haemato-oncology units in private and NHS-linked hospitals, national and regional MoH tender desks running oncology procurement lists, licensed pharmaceutical wholesalers and importers serving cancer centres, and NGO or foundation procurement programmes supporting myeloma treatment access 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 pomalidomide.
Pomalidomide is dosed at 4 mg orally once daily on Days 1 to 21 of a repeating 28-day cycle for multiple myeloma, taken with dexamethasone (40 mg on Days 1, 8, 15 and 22, reduced to 20 mg in patients over 75) until disease progression. The Kaposi sarcoma dose is 5 mg daily on the same Days 1-21/28-day schedule. Confirm which indication and dose a tender specification is quoting against before packing, since the two regimens use different strengths.
Capsules must be swallowed whole. Counsel dispensing staff and patients not to break, chew or open them, and to handle with gloves if a capsule is accidentally opened or damaged, consistent with cytotoxic handling precautions for IMiDs.
Pomalidomide carries a boxed warning for embryo-fetal toxicity as a thalidomide analogue: it is contraindicated in pregnancy and distributed in the US only through the PS-Pomalidomide REMS restricted programme, with equivalent pregnancy-prevention and controlled-access requirements enforced in most other licensed markets. A second boxed warning covers venous and arterial thromboembolism (DVT, pulmonary embolism, myocardial infarction, stroke); thromboprophylaxis is recommended for the duration of therapy. Receiving pharmacies should have their REMS-equivalent or local controlled-distribution registration current before we dispatch, since import clearance in several of our markets checks this at the border.
Because it is an oral solid with no reconstitution step, cold-chain validation is not required for this product; standard ambient, moisture-controlled freight and storage documentation applies instead, which we confirm as part of the shipping dossier.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, pomalidomide travels on standard ambient-temperature logistics rather than the cold-chain lanes we validate for biologics. What buyers need instead is REMS-equivalent controlled-distribution paperwork: proof that the receiving pharmacy or hospital is registered to dispense a teratogenic IMiD under their national pregnancy-prevention programme, alongside the usual import licence, CoA and batch documentation M Care compiles for every shipment.
On the brand-versus-generic question, Pomalyst remains the originator product from Bristol Myers Squibb, sourced through BMS's licensed Indian distribution channels. FDA-approved generic pomalidomide capsules from multiple manufacturers, including Teva and Aurobindo, are now separately registered and marketed in the US, so buyers genuinely have a brand-or-generic choice; M Care quotes either against the tender specification and destination-market registration status, since generic approval status can differ by country.
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 pomalidomide.
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 pomalidomide.
- 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.
Pomalidomide supply, the specific questions.
Does a generic version of Pomalyst exist?
Yes. FDA-approved generic pomalidomide capsules are now registered and marketed in the US alongside Bristol Myers Squibb's Pomalyst. Registration status for generic pomalidomide varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Pomalyst to our market?
Yes, on an import basis. We source Pomalyst through Bristol Myers Squibb's licensed Indian distribution channels and dispatch against your import authorisation and any REMS-equivalent controlled-distribution registration your pharmacy or hospital holds.
What strengths of pomalidomide capsules are available?
1 mg, 2 mg, 3 mg and 4 mg capsules, matching the FDA-labelled Pomalyst strengths. Tell us your dosing protocol and we quote the strength mix accordingly.
What documentation does M Care provide with a pomalidomide shipment?
CTD/eCTD-aligned dossier documentation, certificates of analysis, batch records and CDSCO export paperwork from the Indian side, plus confirmation that your receiving pharmacy's controlled-distribution registration is in order before dispatch.
Does pomalidomide need cold-chain shipping?
No. It is an oral capsule stored at controlled room temperature, so it moves on standard ambient, moisture-controlled logistics rather than the validated cold-chain lanes we use for biologics and vaccines.
What is pomalidomide licensed to treat?
Its FDA-labelled indication is relapsed or refractory multiple myeloma in patients who have had at least two prior therapies including lenalidomide and a proteasome inhibitor, used with dexamethasone. A separate indication covers AIDS-related Kaposi sarcoma after HAART failure. Check other licensed indications per your destination-country labelling.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.