Ibrance (palbociclib) remains under primary US patent protection until March 2027, so no FDA-approved generic exists yet and every legitimate supply route runs through Pfizer's licensed distribution chain.
Ibrance (palbociclib) is Pfizer's CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer, and M Care sources it as a merchant exporter through licensed Indian distribution channels, not from a generic manufacturer. We dispatch to hospital pharmacies, MoH tender desks and licensed importers across our 49 served markets, with full CTD-standard documentation for each shipment.
Palbociclib exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care confirms batch-specific certificates of analysis, Pfizer-sourced chain-of-custody documentation and destination-country import licensing before any consignment moves. Because palbociclib is still patent-protected, volumes are matched to verified originator stock through our licensed channels rather than pooled generic manufacturing lines; the Mumbai desk quotes lead times against confirmed availability, not catalogue assumption.
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.
CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor, sourced and documented for export.
Palbociclib is a CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor that blocks the retinoblastoma protein pathway controlling cell-cycle progression from G1 to S phase, slowing proliferation of hormone receptor-driven breast cancer cells.
Ibrance is licensed for HR-positive, HER2-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor as initial endocrine-based therapy, or in combination with fulvestrant in patients with disease progression after prior endocrine therapy. It also carries a licensed indication in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for HR-positive, HER2-positive metastatic breast cancer maintenance, and a further licensed indication in combination with inavolisib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative advanced or metastatic breast cancer following recurrence on or after adjuvant endocrine therapy. Other licensed indications follow destination-country labelling.
Ibrance is supplied as capsules and film-coated tablets in 75 mg, 100 mg and 125 mg strengths. It is a room-temperature oral solid, stored at 20-25C with excursions permitted to 15-30C; there is no cold-chain requirement.
Active ingredient
palbociclib. CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor.
Forms and strengths
75 mg; 100 mg; 125 mg.
Indications
Licensed for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant; for HR-positive, HER2-positive metastatic breast cancer maintenance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy; and for PIK3CA-mutated, HR-positive, HER2-negative advanced or metastatic breast cancer in combination with inavolisib and fulvestrant.
Administration
oral. Capsules and film-coated tablets.
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.
Hospital oncology pharmacies, private oncology centre importers, MoH cancer-treatment tender desks across GCC and African markets, and licensed wholesalers stocking breast cancer regimens turn to M Care for palbociclib. Because it is an originator brand rather than a generic, buyers are typically licensed importers already holding the product on a national essential-cancer-medicines or reimbursement list, or tender desks sourcing against a named-brand specification.
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 palbociclib.
Ibrance is dosed at 125 mg orally once daily for 21 consecutive days, followed by 7 days off, making a 28-day cycle; it is taken with food when given as capsules (the film-coated tablet may be taken with or without food). The 75 mg and 100 mg strengths exist for dose reduction after toxicity, not as separate starting doses, except in severe hepatic impairment (Child-Pugh class C), where 75 mg once daily on the same 21/7 schedule is the recommended starting dose.
If a patient vomits or misses a dose, no replacement dose is given that day; the next dose is taken at the normal scheduled time. This matters at dispensing counselling because patients often ask whether to double up.
Neutropenia is the principal monitoring concern. Complete blood counts should be checked before starting treatment, at the start of each cycle, on day 15 of the first two cycles, and thereafter as clinically indicated, with dose interruption or reduction guided by grade 3/4 neutropenia per the label's dose-modification tables.
Palbociclib is a CYP3A substrate. Strong CYP3A inhibitors should be avoided; if co-administration is unavoidable, the palbociclib dose should be reduced to 75 mg once daily. Strong CYP3A inducers and grapefruit products should also be avoided, as both alter exposure meaningfully at this once-daily oral dosing schedule.
The documentation pack a regulator actually asks for.
As an oral solid originator brand, palbociclib carries no cold-chain requirement; the documentation chain that matters for import clearance is batch-level chain-of-custody back to Pfizer's licensed distribution network, plus destination-country marketing authorisation or named-patient import approval where the brand is not yet locally registered. M Care assembles CTD-format dossier support and certificates of analysis against each consignment for MoH and customs review.
No FDA-approved generic palbociclib exists as of this writing. The key US patent, extended under a Patent Term Extension certificate, runs to March 2027, and while several manufacturers hold tentative FDA approvals for palbociclib tablets, none can market in the US until that patent position resolves. Buyers asking for 'generic Ibrance' today are asking for a product that is not yet legally available in the US market; M Care supplies the originator brand through licensed channels rather than substituting an unapproved product.
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 palbociclib.
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 palbociclib.
- 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.
Palbociclib supply, the specific questions.
Is there a generic version of Ibrance (palbociclib) we can source instead?
Not yet in most major markets. The key US patent covering palbociclib is extended to March 2027 under a Patent Term Extension certificate, and while several manufacturers hold tentative FDA approvals, none can market a generic in the US until that patent position resolves. M Care supplies the originator brand, Ibrance, through Pfizer's licensed Indian distribution channels.
Can M Care supply Ibrance to our market even if it isn't locally registered yet?
Yes, through the applicable import basis for your jurisdiction, typically named-patient or hospital exemption import where local marketing authorisation is pending, or standard tender import where Ibrance already holds registration. The Mumbai desk confirms the correct route against your country's regulator before dispatch.
Does Ibrance need cold-chain shipping?
No. Palbociclib capsules and tablets are stored at 20-25C with excursions permitted to 15-30C, so shipments move as standard ambient pharmaceutical cargo rather than requiring validated cold-chain lanes.
What strengths and forms does M Care supply?
75 mg, 100 mg and 125 mg, in capsule or film-coated tablet form depending on current originator supply. The 125 mg strength is the standard starting dose; 100 mg and 75 mg cover dose reductions and the hepatic-impairment starting dose.
What documentation does M Care provide for a tender submission?
Batch-specific certificates of analysis, chain-of-custody documentation tracing back to Pfizer's licensed distribution channel, and CTD-format dossier support for destination-country MoH or customs review.
Who typically orders palbociclib through M Care?
Hospital oncology pharmacies, private oncology centre importers and MoH cancer-treatment tender desks across our GCC and African markets, generally licensed importers already holding or seeking national registration for the brand.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-26.
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.