Lenalidomide, Indian WHO-GMP supply for the multiple myeloma backbone (VRd / Rd / KRd), MDS with del(5q), MCL and follicular lymphoma.
The immunomodulatory imide drug at the centre of modern multiple myeloma therapy. Supplied as 2.5 to 25 mg hard gelatin capsules for VRd induction (with bortezomib and dexamethasone), Rd and Rd-lite, KRd, DRd, post-ASCT maintenance, MDS with del(5q), relapsed/refractory mantle cell lymphoma, and follicular lymphoma R-squared (with rituximab). The generic equivalent of Revlimid, with patent and licence position verified per destination market before any offer. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 2.5 to 25 mg capsules · generic equivalent of Revlimid · CTD dossier on file · per-market patent verification · exporter, not manufacturer.
Active ingredient
Lenalidomide, an oral immunomodulatory imide drug (IMiD) and thalidomide analogue. Acts via cereblon-dependent ubiquitination of the Aiolos and Ikaros transcription factors, producing combined antineoplastic, antiangiogenic, pro-erythropoietic and T-cell-co-stimulatory activity. Supplied from Indian WHO-GMP-certified manufacturers; M Care does not manufacture.
Strengths stocked
Full myeloma and MDS dosing range: 2.5, 5, 7.5, 10, 15, 20 and 25 mg hard gelatin capsules. The 25 mg is the standard adult full-dose MM (days 1-21 of a 28-day cycle), 10 mg is the standard post-ASCT maintenance and MDS del(5q) dose, lower strengths cover dose reduction for cytopenia and renal impairment.
Indications
Multiple myeloma: VRd / Rd / Rd-lite / KRd / DRd induction, post-ASCT maintenance, relapsed/refractory combinations. MDS with del(5q) cytogenetic abnormality. Relapsed/refractory mantle cell lymphoma after ≥2 prior therapies including bortezomib. Follicular lymphoma R-squared (with rituximab). A specialist haematology-oncology medicine throughout.
Risk Minimisation Programme
Mandatory Pregnancy Prevention Programme integration (UK MHRA PPP, EU national equivalents, GCC and African analogues) before any dispensing: dual-method contraception 4 weeks before through 4 weeks after the last dose in women of childbearing potential, monthly pregnancy testing, semen counselling for male patients. Programme registration carried in every consignment documentation pack.
Storage and pack
Store below 30°C in original Alu-Alu blister or HDPE bottle, protect from light. Standard pack 21 capsules per blister to match the 21-on / 7-off cycle, plus HDPE bottle 30 or 100 capsules for institutional supply. Shelf life typically 24-36 months, minimum 18 months at dispatch. Standard ambient dispatch lane, no cold-chain.
Patent & lawful supply
Position varies by market. Indian domestic supply has been off-patent since the 2012-2015 IPAB decisions; sub-Saharan Africa, ASEAN, LATAM supply is established (often under the BMS-MPP voluntary licence announced in 2022). UK / EU originator patent expired across 2024-2026 with staggered generic launch windows; US patent expired 2027 with the BMS-settlement launch dates. We verify the patent and licence position per destination on every enquiry and quote only where supply is lawful.
Haematology and oncology programmes across the established lawful lanes.
India is our origin. We do not sell into the Indian market. Lenalidomide is exported only, and only where the patent and licence position permits.
Sub-Saharan African public-sector oncology
SAHPRA South Africa (the largest African MM programme by tender volume), NAFDAC Nigeria, KEMSA Kenya, FDA Ghana, EFDA Ethiopia, TMDA Tanzania, NDA Uganda. Many of these markets are covered by the BMS-MPP voluntary licence announced in 2022 for low- and middle-income country supply. The cost gap between Indian generic lenalidomide and originator Revlimid is the lever that makes the 5-7 year adjuvant and maintenance window financially viable at programme scale.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Haematology centres procure through licensed importers against specialist-oncology formulary awards (NUPCO and SFDA, King Faisal Specialist Hospital, MoHAP / DHA / DoH, Kuwait, Qatar including Hamad Medical Corporation NCCCR, Oman, Bahrain MoH). Patent position verified per market before quoting. Full CTD for MoH registration and GCC central registration, with destination-Arabic bilingual artwork and the Pregnancy Prevention Programme annexes pre-built.
UK, EU and the originator-settlement window
UK and EU lenalidomide supply is restricted to the specific Indian generic lines holding launch authorisation under the originator-generic settlements (post-2024 EU/UK patent expiries). Where M Care's WHO-GMP partner lines hold the authorisation we supply through MHRA-approved wholesalers and EU national channels under verified RMP / Pregnancy Prevention Programme integration. The named-patient and MHRA Specials routes cover specific access situations.
ASEAN, LATAM, paediatric haematology
Brazil (ANVISA), Mexico (COFEPRIS), Philippines (FDA), Vietnam (DAV), Indonesia (BPOM), Bangladesh (DGDA), Sri Lanka (NMRA) through licensed importers against specialist-oncology tenders, where the patent position permits. Paediatric haematology supply where the destination protocol allows. M Care does not hold US FDA registration in our own name for this molecule; US supply is via the Indian-generic-line authorisation routes.
Risk Minimisation first, VTE prophylaxis, myelosuppression management, and the cluster regimen position.
Lenalidomide is dosed 25 mg once daily on days 1-21 of a 28-day cycle in standard adult myeloma induction (Rd, VRd, KRd, DRd) and in Rd-lite-style approaches the dose drops to 15 mg or 10 mg by frailty and renal function; post-ASCT maintenance is typically 10 mg daily continuous, MDS with del(5q) is 10 mg daily on days 1-21, mantle cell lymphoma is 25 mg daily on days 1-21, follicular R-squared is 20 mg daily on days 1-21 with rituximab on a separate schedule. Renal impairment dose-reduces step-wise: CrCl 30-60 to 10 mg, CrCl <30 to 7.5 mg daily or 15 mg alternate days, dialysis 5 mg post-dialysis-day. The two non-negotiable safety levers are Pregnancy Prevention Programme registration and venous thromboembolism prophylaxis. The PPP / RMP framework is mandatory in every jurisdiction we supply into: women of childbearing potential need confirmed dual-method contraception 4 weeks before through 4 weeks after the last dose, monthly pregnancy testing inside the prescription cycle, and dispensing-pharmacy verification of the PPP-compliant prescription form; male patients receive semen-counselling because lenalidomide is detectable in semen. VTE prophylaxis is aspirin 75-100 mg daily in standard-risk patients and prophylactic LMWH (enoxaparin 40 mg sub-cut daily or equivalent) in high-risk (prior VTE, immobility, BMI >30, central venous catheter, high-dose dexamethasone) and warfarin where the dispensing system allows. Myelosuppression is the dose-limiting on-target toxicity: weekly FBC for the first 8 weeks of each treatment course and monthly thereafter, with cycle-day-15 cytopenia management dictating dose reduction; G-CSF and PRBC transfusion support are routine on prolonged maintenance. Counsel on the small but real secondary primary malignancy risk on prolonged maintenance (sAML / MDS, sometimes solid tumours), the rare serious cutaneous reactions including Stevens-Johnson and TEN with early treatment-interruption discipline, the rare progressive multifocal leukoencephalopathy, the rare tumour lysis syndrome in bulky disease at cycle 1 (allopurinol prophylaxis), and the recognised hepatotoxicity warranting baseline and on-treatment LFTs. The destination-language SmPC carries the full table for the receiving haematology service and dispensing pharmacy.
The documentation pack a regulator actually asks for.
Lenalidomide is supplied from Indian WHO-GMP-certified facilities under per-market patent and licence verification. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your procurement, hospital pharmacy or programme team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls in eCTD-ready format. Polymorph control documented, finished-product specifications, validation data, stability under ICH Zone IVb (30°C / 75% RH for 12 months minimum). Capsule-specific dissolution and content-uniformity validation.
Bioequivalence
Comparative bioequivalence study reports against Revlimid reference product for new registrations. Lenalidomide BE is well-characterised, with reliable AUC, Cmax and Tmax demonstration against the originator.
Patent + licence pack per market
BMS-MPP voluntary licence reference where applicable, originator-generic settlement launch-date documentation where supply is via the authorised generic route, per-destination patent verification opinion appended to every quote. We refuse to supply where lawful supply has not opened.
Risk Minimisation Programme integration
Pre-built Pregnancy Prevention Programme annex pack matched to the destination regulator (MHRA PPP, EU national schemes, GCC and African analogues). Dispensing-pharmacy training pack and patient counselling card in destination language.
CoA + WHO-GMP per batch
HPLC lenalidomide assay, related substances per Ph.Eur./USP, water content, dissolution profile, content uniformity, capsule weight variation. Signed by the manufacturer's authorised QC head. CoPP issued by CDSCO India, apostilled where required.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C. Pregnancy / teratogenicity, VTE, myelosuppression, secondary primary malignancies, serious cutaneous reactions and hepatotoxicity are the priority signals for ADR routing.
The MM induction backbone, maintenance shelf and supportive care.
Lenalidomide is rarely a standalone in modern MM practice. VRd induction pairs with bortezomib and dexamethasone; KRd with carfilzomib; DRd with daratumumab; maintenance often single-agent. We carry the supporting cluster.
Bortezomib
Proteasome inhibitor, the V of VRd. The standard induction partner with lenalidomide and dexamethasone for newly diagnosed multiple myeloma. 2 mg / 3.5 mg lyophilised vials.
Rituximab biosimilar
Anti-CD20 monoclonal antibody. The R of the R-squared regimen with lenalidomide for follicular lymphoma. 100mg / 500mg vials.
Cyclophosphamide
Alkylating agent. VCd induction with bortezomib and dexamethasone where lenalidomide is contraindicated or unavailable. 200mg / 500mg / 1g / 2g vials.
Filgrastim biosimilar
G-CSF. Stem-cell mobilisation pre-ASCT and neutrophil recovery on lenalidomide-induced cytopenia. 300mcg / 480mcg pre-filled syringe.
Enoxaparin
LMWH. Prophylactic VTE cover on lenalidomide where aspirin is insufficient (prior VTE, immobility, BMI >30, high-dose dexamethasone).
All oncology →
150+ oncology SKUs: cytotoxics, targeted therapies, immunomodulators, monoclonal antibodies, hormonal agents and supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength mix (2.5 / 5 / 7.5 / 10 / 15 / 20 / 25 mg), monthly patient count, destination, channel: haematology centre, MM programme, MDS clinic, fertility / RMP-integrated dispensing pharmacy. Flag the indication (MM induction or maintenance, MDS, MCL, FL R-squared) for the right documentation pack.
- We verify patent / licence and route. Per-destination patent verification opinion, BMS-MPP voluntary licence applicability check, originator-generic settlement launch-date check where applicable. We will not quote into a market where supply is not lawful.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status, Risk Minimisation Programme integration plan, full documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch, in-transit logging and on-arrival inspection. Typical 4-8 weeks for made-to-order batches.
- After delivery. Batch records, CoA and stability data archived for the full shelf life. PV contact opened on registration, ADR routing established, RMP / PPP-compliant dispensing tracker linked to the importer's pharmacy.
Lenalidomide supply, the specific questions.
What strengths and pack formats of lenalidomide do you supply?
Hard gelatin capsules across the full myeloma and MDS dosing range: 2.5, 5, 7.5, 10, 15, 20 and 25 mg. The 25 mg is the standard full-dose adult myeloma capsule taken once daily on days 1-21 of a 28-day cycle (Rd / VRd / KRd induction); 10 mg is the common Rd-lite and post-ASCT maintenance dose; 5 mg is the standard MDS del(5q) dose; the lower strengths (2.5 / 5 / 7.5) support dose reduction for renal impairment and cytopenia management. Pack formats: Alu-Alu blister 21 capsules per pack matched to the 21-on / 7-off cycle, plus HDPE bottle 30 or 100 capsules for institutional and tender supply. All from Indian WHO-GMP-certified facilities.
Is M Care a lenalidomide manufacturer?
No. M Care is a merchant exporter. We supply lenalidomide from Indian WHO-GMP-certified manufacturers (the major Indian generic lines include Natco, Cipla, Dr Reddy's, Sun, Lupin and others) and handle export, documentation, registration support, freight, and Risk Minimisation Programme support. We do not run a manufacturing plant ourselves. For a buyer that means we route each order to the right WHO-GMP line for the destination (EU-GMP-capable line where the destination requires it, MPP-licensed line for the relevant LMIC supply, the specific line that matches your local pregnancy-prevention-programme integration) and carry the regulatory and logistics paperwork.
What is the patent and licence position by destination market?
Complex and verified per market on every quote. Indian domestic supply has been off-patent since the 2012-2015 IPAB decisions invalidating the originator patents in India. US originator patent expired in 2027 with staggered authorised-generic launch dates per the BMS settlements with Natco, Dr Reddy's, Cipla and others. UK and EU patents expired across 2024-2026 with similar generic-launch windows. The Medicines Patent Pool announced a BMS-MPP lenalidomide voluntary licence in 2022 for low- and middle-income country supply through approved generic licensees. Generic supply is well-established in India, much of sub-Saharan Africa, ASEAN and Latin America. We verify the patent and licence position for the specific destination on every enquiry and supply only where it is lawful.
What is lenalidomide used for clinically?
Lenalidomide is the backbone of modern multiple myeloma therapy. Multiple myeloma: induction in newly diagnosed disease (VRd with bortezomib and dexamethasone is the global standard of care in transplant-eligible patients; Rd-lite for transplant-ineligible; KRd and DRd in higher-risk and selected first-line settings), maintenance after autologous stem-cell transplant, and relapsed/refractory combinations (with daratumumab, elotuzumab, ixazomib, carfilzomib). MDS with del(5q) cytogenetic abnormality at 10 mg daily 21-on / 7-off. Relapsed/refractory mantle cell lymphoma after at least two prior therapies including bortezomib. Follicular lymphoma R-squared (with rituximab). A specialist haematology-oncology medicine throughout, with mandatory Risk Minimisation Programme integration.
What are the key safety points for lenalidomide?
Seven priority signals. Severe teratogenicity (Category X; mandatory Pregnancy Prevention Programme: dual-method contraception 4 weeks before through 4 weeks after, monthly pregnancy testing; semen counselling in male patients). VTE prophylaxis (aspirin in low-risk, LMWH in high-risk). Dose-limiting myelosuppression (weekly FBC first 8 weeks then monthly). Secondary primary malignancies (sAML/MDS on prolonged maintenance). Serious infections (PJP prophylaxis on prolonged courses). Hepatotoxicity. Severe cutaneous reactions including Stevens-Johnson and toxic epidermal necrolysis. Rare progressive multifocal leukoencephalopathy. Rare tumour lysis syndrome in bulky disease at initiation.
Which markets can you ship lenalidomide into?
Subject to per-market patent and licence verification, the established lawful lanes are broad. Sub-Saharan African public-sector oncology (SAHPRA, NAFDAC, KEMSA, FDA Ghana, EFDA, TMDA, NDA, many under the BMS-MPP voluntary licence). ASEAN and South Asia (Philippines FDA, Vietnam DAV, Indonesia BPOM, Bangladesh DGDA, Sri Lanka NMRA). Latin America (ANVISA, COFEPRIS). GCC (NUPCO and SFDA, MoHAP / DHA / DoH, Kuwait, Qatar, Oman, Bahrain MoH) under verified patent position. UK, EU, US supply is restricted to the specific Indian generic lines holding launch authorisation under the originator-generic settlements. We do not supply into India. Full coverage at markets.
What documentation ships with a lenalidomide consignment?
Batch-specific Certificate of Analysis (HPLC lenalidomide assay, related substances per Ph.Eur./USP, water content, dissolution profile, content uniformity, capsule weight variation), Method of Analysis, bioequivalence study report against Revlimid reference (for first registrations), Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, MPP licence reference where supply is under the BMS-MPP voluntary licence, originator-generic settlement reference where the launch authorisation applies, Certificate of Origin, destination-language pack insert with the Pregnancy Prevention Programme integration, VTE prophylaxis, myelosuppression-monitoring and secondary-primary-malignancy counselling text. Risk Minimisation Programme registration support and dispensing-pharmacy training pack available on enquiry. CTD Module 3 dossier available against NDA, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength mix, monthly patient count, destination, channel and indication (MM induction or maintenance, MDS, MCL, FL R-squared). We verify the patent and licence position per destination as part of the quote and we include the Risk Minimisation Programme integration plan in every offer. Everything else is on us.