Letrozole 2.5 mg, Indian WHO-GMP supply for postmenopausal ER-positive breast cancer adjuvant and metastatic therapy.
The non-steroidal third-generation aromatase inhibitor, the global standard of care for postmenopausal hormone-receptor-positive breast cancer across adjuvant (5 years, extended to 7-10 years in higher-risk patients), extended adjuvant after 5 years of tamoxifen, first-line metastatic and neoadjuvant downstaging. Also widely used off-label for ovulation induction in anovulatory infertility per ASRM and ESHRE guidance. Supplied as 2.5 mg film-coated tablets from Indian WHO-GMP-certified manufacturers, the generic equivalent of Femara, off-patent globally. M Care is an exporter, not a manufacturer, and we say so plainly.
WHO-GMP partner lines · 2.5 mg film-coated tablet · WHO EML core · off-patent globally · CTD dossier on file · exporter, not manufacturer.
Active ingredient
Letrozole, a non-steroidal third-generation aromatase inhibitor with high selectivity and potency against the aromatase (CYP19) enzyme. Reduces postmenopausal circulating oestrogen by over 97%, removing the hormonal drive of oestrogen receptor-positive breast cancer. Long half-life (~42 hours) supports once-daily oral dosing with steady-state in 2-6 weeks. Supplied from Indian WHO-GMP-certified manufacturers; M Care does not manufacture.
Strength stocked
2.5 mg film-coated tablet once daily, the sole adult strength globally. Standard across adjuvant, extended adjuvant, metastatic, neoadjuvant and off-label ovulation induction. Lifelong or 5-10 year courses in adjuvant; continuous in metastatic until progression. The 7.5 mg dose used in some early ovulation-induction protocols is achieved by three 2.5 mg tablets.
Indications
Postmenopausal HR+ breast cancer: first-line adjuvant 5 years (extended 7-10 years per MA.17R / ATLAS in higher-risk patients), extended adjuvant after 5 years of tamoxifen, first-line metastatic / locally advanced, neoadjuvant downstaging to enable breast-conserving surgery, second-line metastatic after tamoxifen failure. Off-label: ovulation induction in anovulatory infertility per ASRM/ESHRE.
Monitoring & counselling
Baseline and 1-2 yearly DEXA scan for bone mineral density loss, bisphosphonate or denosumab co-prescription per ASCO 2019 BMD guidance. Counsel on severe arthralgia as the dose-limiting adherence issue (switching between letrozole, anastrozole and exemestane can restore tolerability). Lipid monitoring at baseline and on-treatment. Avoid HRT, use SSRI/SNRI for vasomotor symptoms.
Storage and pack
Store below 30°C in the original Alu-Alu blister or HDPE bottle. Pack 28 / 30 / 56 / 84 tablets for monthly to quarterly dispense, 100-tablet HDPE bottle for institutional supply, 1000-tablet bulk-pharma for hospital re-packing. Shelf life typically 36 months, minimum 24 months at dispatch. Standard ambient dispatch lane, no cold-chain.
Access & pricing
Letrozole is off-patent globally and Indian generic supply has driven the breast cancer adjuvant price down dramatically over the past decade. For LMIC and middle-income breast cancer programmes (Africa, Asia, LATAM), the cost gap between Indian generic and originator Femara is the lever that makes a 5-7 year adjuvant course affordable at population scale. We confirm formulary inclusion and tender award structure per destination on every quote.
NHS oncology pharmacy, GCC tender, African public-sector breast cancer programmes, LATAM and ASEAN, fertility supply.
India is our origin. We do not sell into the Indian market. Letrozole is exported only.
UK NHS oncology and primary-care pharmacy
UK NHS Trust oncology pharmacies dispense letrozole as the standard first-line postmenopausal adjuvant aromatase inhibitor (per NICE TA257 and the BSO/ABS treatment algorithm), with primary care taking continuation under shared-care protocol. We supply through MHRA-approved licensed wholesalers serving the trust and primary-care pharmacy network. The named-patient route covers specific access where the standard supply chain is constrained.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
GCC public-sector procurement runs through NUPCO and SFDA for Saudi Arabia (King Faisal Specialist Hospital and the Princess Noura Oncology Centre carry the largest tender volumes), MoHAP, DHA and DoH for the UAE, and the equivalent ministry tenders in Kuwait, Oman, Qatar and Bahrain. Full CTD for MoH registration and GCC central registration, with destination-Arabic bilingual artwork and SFDA-aligned price-committee submission.
African public-sector breast cancer programmes
SAHPRA South Africa (the largest African breast cancer adjuvant programme by tender volume), NAFDAC Nigeria, KEMSA Kenya, FDA Ghana, EFDA Ethiopia, TMDA Tanzania, NDA Uganda. The price gap between Indian generic letrozole and originator Femara is what enables 5-year adjuvant treatment at population scale in these programmes; we supply against the country-level oncology tender cycles. NGO procurement →
LATAM, ASEAN and fertility supply
Brazil (ANVISA), Mexico (COFEPRIS), Philippines (FDA), Vietnam (DAV), Indonesia (BPOM), Malaysia (NPRA) through licensed importers against oncology and reproductive-medicine tenders. Separate fertility-clinic supply across the same territories for the off-label ovulation-induction indication. M Care does not hold US FDA registration for this molecule, confirm the regulatory route on enquiry.
Bone density first, arthralgia is the adherence issue, premenopausal restriction, ovulation-induction off-label.
Letrozole is 2.5 mg once daily orally across every adult indication, taken with or without food, continued for 5 years in standard adjuvant (extended to 7-10 years per MA.17R / ATLAS in higher-risk patients) or until progression in metastatic disease. Two clinical realities govern adherence in adjuvant practice. Severe arthralgia is the dose-limiting issue, with 20-30% of women experiencing significant joint pain and a meaningful subset discontinuing or switching to anastrozole, exemestane or tamoxifen; pre-treatment counselling and an active discussion of the switching options improves long-term completion rates, and switching between the three available aromatase inhibitors sometimes restores tolerability. Bone mineral density loss is the silent long-term effect: baseline DEXA scan, 1-2 yearly reassessment per ASCO 2019 BMD-in-survivors guidance, bisphosphonate or denosumab co-prescription where osteopenia or osteoporosis is established or predicted, and adequate calcium and vitamin D throughout treatment. Vasomotor symptoms (hot flashes) and night sweats are common, manageable with non-pharmacological measures plus SSRIs or SNRIs (venlafaxine has the strongest evidence base in postmenopausal HR+ patients given the tamoxifen drug-drug interaction picture is different); HRT is contraindicated. Dyslipidaemia and modestly elevated cardiovascular event risk warrant baseline lipid panel and on-treatment monitoring per the breast-cancer-survivorship cardio-oncology protocol. Hepatic transaminase elevation is reported, with infrequent need for treatment interruption. Rare but serious events to alert clinicians and patients to include angioedema and severe cutaneous reactions including erythema multiforme and Stevens-Johnson syndrome. Premenopausal use as breast cancer monotherapy is contraindicated; in premenopausal HR+ disease letrozole is used only with concomitant LHRH agonist ovarian function suppression per SOFT/TEXT (the AI+OFS approach). The well-established off-label use in ovulation induction for anovulatory infertility (PCOS) per ASRM and ESHRE uses 2.5-7.5 mg daily for 5 days from cycle day 3, where letrozole's short half-life and lower anti-endometrial effect compared with clomifene are recognised advantages. The destination-language SmPC carries the full table for the receiving oncology pharmacy and fertility clinic.
The documentation pack a regulator actually asks for.
Letrozole is a WHO Essential Medicines List core hormonal oncology adjuvant, off-patent globally, supplied from Indian WHO-GMP-certified facilities. Our role is manufacturer-facing, we sit between the WHO-GMP plant and your procurement, hospital pharmacy or fertility-clinic team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls in eCTD-ready format where accepted. Module 2 quality overall summary included. Polymorph control documented (letrozole has multiple crystalline forms requiring spec control), finished-product specifications, validation data, stability under ICH Zone IVb (30°C / 75% RH for 12 months minimum).
Bioequivalence
Comparative bioequivalence study reports against Femara reference product for new registrations. Letrozole BE is a well-established CMC template, with reliable AUC, Cmax and Tmax demonstration against the originator.
CoA + MoA, per batch
HPLC letrozole assay, related substances per Ph.Eur./USP, water content by Karl Fischer, dissolution profile, content uniformity, hardness, friability. Signed by the manufacturer's authorised QC head.
CoPP, GMP, MFG licence
Issued by CDSCO (India), apostilled where required, notarised copies in the shipping pack. M Care does not hold US FDA registration for this molecule, confirm the regulatory route on enquiry. EU-GMP capable line available for NHS and EU supply.
Tender-pack discipline
NUPCO, MoHAP, SAHPRA, NAFDAC tender awards typically require destination-language pack insert, Arabic bilingual artwork for GCC, price-committee documentation, and DEXA-monitoring and bisphosphonate co-prescription protocol annexes. We pre-build these.
Pharmacovigilance
Named PV contact in the destination market against registration, PSURs to ICH E2C. Bone mineral density loss, severe arthralgia, dyslipidaemia, hepatic transaminase elevation and rare angioedema / Stevens-Johnson are the priority signals for ADR routing.
The breast cancer hormonal and cytotoxic shelf.
Letrozole sits inside the postmenopausal HR+ breast cancer treatment algorithm, alongside the agents that travel on the same oncology tenders.
Trastuzumab biosimilar
Anti-HER2 monoclonal antibody. Adjuvant and metastatic HER2+ breast cancer, often co-tendered with letrozole for HR+/HER2+ disease.
Paclitaxel
Taxane cytotoxic. Adjuvant and neoadjuvant breast cancer (AC-T, dose-dense, weekly), pre-letrozole sequence in HR+/HER2- early disease.
Docetaxel
Taxane cytotoxic. Adjuvant TC, TAC and CMF-alternative regimens preceding adjuvant hormonal therapy.
Cyclophosphamide
Alkylating agent. AC and TC adjuvant chemo backbone before hormonal switch.
All oncology →
150+ oncology SKUs: cytotoxics, targeted therapies, hormonal agents, monoclonal antibodies and supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Tablet volume, destination, channel (NHS oncology pharmacy / GCC tender / African public-sector breast cancer programme / LATAM / ASEAN / fertility-clinic), and target delivery window. Flag any pack-format or artwork requirement (Arabic bilingual for GCC, French for francophone Africa).
- We confirm the route. EU-GMP-capable line for NHS oncology pharmacy, SFDA-experienced line for NUPCO tender, SAHPRA-registered line for South African oncology tender, local-formulary-matched line for African breast cancer programmes.
- Commercial and regulatory offer. FOB / CIF price, lead time, dossier and bioequivalence status, full documentation pack, inside one working day.
- Order, produce, release, ship. QC release on the Indian side, ambient dispatch (no cold-chain), in-transit logging and on-arrival inspection. Typical 4-8 weeks for made-to-order batches, in-stock lines ship within 7-14 days.
- After delivery. Batch records, CoA and stability data archived for the full shelf life. PV contact opened on registration, ADR routing established. Re-supply cadence agreed for 5-year adjuvant supply continuity.
Letrozole supply, the specific questions.
What strengths and pack formats of letrozole do you supply?
2.5 mg film-coated tablet once daily, the sole adult strength globally and the standard dose across all indications (adjuvant, extended adjuvant, metastatic, neoadjuvant downstaging, off-label ovulation induction). Pack formats: Alu-Alu blister 28 or 30 tablets per pack for the standard monthly outpatient dispense, 56 or 84 tablets for 2-3 month dispense, 100-tablet HDPE bottle for institutional and tender supply, 1000-tablet bulk-pharma pack for hospital re-packing. All from Indian WHO-GMP-certified facilities. Destination-language outer carton, blister-foil overprint per importer.
Is M Care a letrozole manufacturer?
No. M Care is a merchant exporter. We supply letrozole from Indian WHO-GMP-certified manufacturers and handle export, documentation, country-level registration support, freight and pharmacovigilance routing. 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 (the EU-GMP-capable line for NHS oncology pharmacy supply, the SFDA-experienced line for NUPCO tender, the SAHPRA-registered line for South African oncology tender) and carry the regulatory and logistics paperwork.
What is letrozole used for clinically?
The non-steroidal third-generation aromatase inhibitor for postmenopausal hormone-receptor-positive breast cancer. Five established indications: (1) first-line adjuvant for early invasive HR+ breast cancer (standard 5-year course, extended to 7-10 years per MA.17R / ATLAS in higher-risk patients); (2) extended adjuvant after 5 years of tamoxifen for patients still at recurrence risk; (3) first-line metastatic / locally advanced HR+ disease; (4) neoadjuvant downstaging in postmenopausal HR+ patients to enable breast-conserving surgery; (5) second-line metastatic after tamoxifen failure. Off-label, letrozole is widely used for ovulation induction in anovulatory infertility (PCOS) per ASRM and ESHRE guidance.
What are the key safety points for letrozole adjuvant treatment?
Six priority signals. Bone mineral density loss is the dose-limiting long-term effect: baseline DEXA scan, 1-2 yearly reassessment per ASCO 2019 BMD-in-survivors guidance, bisphosphonate or denosumab co-prescription where indicated. Severe arthralgia is the dose-limiting adherence issue (20-30% discontinuation or switching to anastrozole or exemestane). Hot flashes and vasomotor symptoms (SSRI/SNRI counselling; HRT contraindicated). Dyslipidaemia and modestly elevated CV event risk (baseline + on-treatment lipid monitoring). Hepatic transaminase elevation. Rare angioedema and severe cutaneous reactions including erythema multiforme and Stevens-Johnson syndrome.
Can letrozole be used in premenopausal women?
Not as breast cancer monotherapy without concomitant ovarian function suppression. Aromatase inhibitors are designed for postmenopausal physiology and rely on the absence of ovarian aromatase-driven oestrogen production. In premenopausal HR+ breast cancer they are used only in combination with LHRH agonist suppression (goserelin, leuprolide) per SOFT and TEXT trial evidence (the AI+OFS approach), and not alone. Separately, letrozole is widely used off-label for ovulation induction in premenopausal women with anovulatory infertility (PCOS) at 2.5-7.5 mg daily for 5 days starting day 3 of the cycle, per ASRM and ESHRE guidance.
Which markets can you ship letrozole into?
UK NHS oncology and primary-care pharmacy supply (under shared-care protocol); EU hospital and outpatient pharmacy; GCC public sector (NUPCO and SFDA, MoHAP, DHA, DoH, Kuwait, Qatar, Oman, Bahrain MoH); African public-sector breast cancer programmes (SAHPRA South Africa, NAFDAC Nigeria, KEMSA Kenya, FDA Ghana, EFDA Ethiopia, TMDA Tanzania, NDA Uganda); LATAM (ANVISA Brazil, COFEPRIS Mexico) and ASEAN (Philippines FDA, Vietnam DAV, Indonesia BPOM, Malaysia NPRA). Fertility-clinic supply across the same territories under separate procurement. We do not supply into India. M Care does not hold US FDA registration for this molecule. Full coverage at markets.
What documentation ships with a letrozole consignment?
Batch-specific Certificate of Analysis (HPLC letrozole assay, related substances per Ph.Eur./USP, water content, dissolution profile, content uniformity, hardness, friability), Method of Analysis, bioequivalence study report against Femara reference (for first registrations), Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with the bone-density, arthralgia, vasomotor, dyslipidaemia, hepatic, premenopausal-restriction and ovulation-induction-off-label labelling text per the receiving regulator, and temperature/humidity logs from pre-dispatch through on-arrival. Full CTD Module 3 dossier available against NDA, see dossier preparation.
Send the specifics. You'll have a price inside one working day.
Tablet volume, destination, channel (NHS oncology / GCC tender / African public-sector breast cancer / fertility), and target delivery. We pre-build the documentation pack and the bisphosphonate / DEXA-monitoring protocol annex where the tender requires it. Everything else is on us.