WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Verzenio (abemaciclib) is dosed twice daily, every day without a rest week, which is the label detail that separates it from every other CDK4/6 inhibitor on a tender desk's shelf.

Eli Lilly's Verzenio (abemaciclib) is prescribed continuously, morning and evening, with no scheduled treatment break. M Care sources Verzenio through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and moves validated stock to hospital pharmacies, importers and tender desks across our 49 export markets.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Abemaciclib exporter and bulk supplier from India.

For hospital and tender-scale requirements, the Mumbai desk quotes Verzenio by pack count and tablet strength against your indication and treatment-duration forecast, whether that is a two-year adjuvant course or an open-ended metastatic regimen. We work from CTD/eCTD-ready documentation and route consignments down cold-chain-validated as well as ambient lanes, sized to a single hospital order or a ministry-of-health tender lot. Contact the desk with your destination country, required strength mix and delivery window and we will confirm sourcing and lead time.

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.

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At a glance

CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor, sourced and documented for export.

Abemaciclib is a small-molecule cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. It blocks the CDK4/6-Rb pathway that drives cell-cycle progression in hormone receptor-positive breast cancer.

Verzenio is licensed, per the FDA label, in three related settings: in combination with an aromatase inhibitor or with tamoxifen for adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence; in combination with an aromatase inhibitor or with fulvestrant for HR-positive, HER2-negative advanced or metastatic breast cancer; and as monotherapy after prior endocrine therapy and chemotherapy in the metastatic setting. Other licensed indications may apply per destination-country labelling.

Verzenio is an oral film-coated tablet in 50 mg, 100 mg, 150 mg and 200 mg strengths. It is stored at room temperature, 20-25C (68-77F), with excursions permitted to 15-30C. No cold chain is required for this product; that distinguishes it from the biologic oncology lines M Care also exports.

Active ingredient

abemaciclib. CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor.

Forms and strengths

50 mg; 100 mg; 150 mg; 200 mg.

Indications

Indicated in combination with endocrine therapy for adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor or fulvestrant, or as monotherapy, for HR-positive, HER2-negative advanced or metastatic breast cancer.

Administration

oral. Film-coated tablet.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Hospital pharmacy and oncology-unit buyers stocking a CDK4/6 inhibitor formulary line, licensed importers and wholesalers serving private oncology clinics, ministry-of-health and NHS trust tender desks procuring breast cancer treatment protocols, and NGO or donor-programme procurement officers sourcing endocrine-combination oncology regimens for their target population.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on abemaciclib.

Confirm the regimen before you quote strength mix. Combination therapy (with an aromatase inhibitor, tamoxifen, or fulvestrant) starts at 150 mg twice daily; monotherapy starts at 200 mg twice daily. Unlike palbociclib and ribociclib, abemaciclib is dosed continuously, with no scheduled 7-day rest period, so a patient's monthly pack requirement is calculated straight through rather than against a 21-days-on cycle.

Diarrhoea is the most common adverse reaction and the one that drives most dose interruptions. Per the label, Grade 1 diarrhoea needs no dose change; Grade 2 lasting more than 24 hours despite antidiarrhoeal treatment means suspending the dose until it resolves, then resuming at the same level; Grade 3-4 events require suspension until resolution to Grade 1 or lower, followed by resumption at the next lower dose tier. Pharmacy teams dispensing Verzenio should counsel patients to start loperamide at the first sign of loose stool and maintain hydration.

For patients with severe hepatic impairment (Child-Pugh C), the label calls for reducing dosing frequency to once daily rather than reducing the tablet strength, so mild and moderate impairment (Child-Pugh A/B) need no adjustment. Liver function should be monitored every two weeks for the first two months, then monthly for the next two months, and periodically thereafter.

Watch for interstitial lung disease and pneumonitis, which the label flags as capable of being severe, life-threatening or fatal, and for venous thromboembolic events, reported in 2-5% of patients across trials. Both warrant baseline counselling for a hospital dispensing this on a two-year adjuvant course.

Regulatory & quality

The documentation pack a regulator actually asks for.

Verzenio is an oral solid dose, so the documentation chain M Care builds around it is batch release testing, CDSCO export licensure, and CTD/eCTD-ready dossier support rather than cold-chain validation; ambient, humidity-controlled logistics are standard for this product, with no vaccine-style cold-chain lane required.

There is no licensed generic or biosimilar equivalent of abemaciclib available in any major market; it remains under patent, and the only regulatory-compliant route to supply is Eli Lilly's own branded Verzenio moving through licensed Indian distribution channels. Buyers should verify Verzenio's registration status with their own national regulator (for example MHRA in the UK, SFDA in Saudi Arabia, NAFDAC in Nigeria) before placing a tender order, and M Care's documentation is built to support that registration check.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for abemaciclib.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Abemaciclib supply, the specific questions.

Is there a generic or biosimilar version of abemaciclib we can source instead of Verzenio?

No. Abemaciclib is a small molecule still under patent protection in every major market, so no licensed generic exists yet. Small-molecule oncology drugs do not have biosimilars; that pathway applies only to biologics. The only compliant supply route today is branded Verzenio through Eli Lilly's licensed distribution channels.

Does Verzenio need cold-chain shipping?

No. Verzenio is an oral film-coated tablet stored at room temperature, 20-25C, with excursions permitted to 15-30C. It does not require the 2-8C cold chain that biologic oncology products need, which simplifies logistics for tender-scale orders.

Can M Care supply Verzenio to our market?

Yes. M Care sources Verzenio through licensed Indian distribution channels and exports it as a merchant exporter under CDSCO export licensure. We do not manufacture Verzenio; we move product to your market against your import basis, whether that is a direct hospital order, a licensed wholesaler relationship, or a ministry-of-health tender.

What strengths and pack sizes can we order?

Verzenio tablets are available in 50 mg, 100 mg, 150 mg and 200 mg strengths, matching the combination-therapy (150 mg) and monotherapy (200 mg) starting doses and the lower strengths used for dose reductions. Tell the Mumbai desk your regimen mix and forecast volume and we will confirm the strength split and lead time.

What documentation does M Care provide for a tender submission?

We support CTD/eCTD-ready dossier documentation, CDSCO export licensure papers, and batch-level quality documentation from the licensed distribution channel. Buyers should independently verify Verzenio's registration status with their own national regulator before finalising a tender submission.

How is Verzenio dosed, and does that affect our reorder cycle?

Verzenio is dosed continuously, twice daily with no rest week, unlike some other CDK4/6 inhibitors that follow a 21-days-on, 7-days-off cycle. That means monthly pack requirements should be calculated on a straight-through basis rather than against a cyclical schedule.

Sources and review

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.

Abemaciclib enquiry

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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.

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