Faslodex (fulvestrant) is a selective estrogen receptor degrader dosed by intramuscular injection on a fixed loading schedule, and both the originator brand and licensed generic fulvestrant pre-filled syringes move through M Care's cold-chain export lanes.
Faslodex (fulvestrant), originated by AstraZeneca, is a selective estrogen receptor degrader given by intramuscular injection for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. M Care Exports is a merchant exporter: we source the AstraZeneca brand and licensed generic fulvestrant pre-filled syringes through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Fulvestrant exporter and bulk supplier from India.
For hospital oncology pharmacy, importer and tender-desk orders, M Care quotes fulvestrant against buyer specification: brand (Faslodex) or generic, single or twin-syringe pack, and destination-market regulatory documentation, drawn from WHO-GMP sourced manufacturer lines on the M Care roster. Because fulvestrant ships and stores under 2-8C refrigeration rather than at ambient temperature, we confirm the buyer's cold-chain receiving capability and validate the transit lane before booking 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.
Selective estrogen receptor degrader (SERD); estrogen receptor antagonist, sourced and documented for export.
Fulvestrant is a selective estrogen receptor degrader (SERD): it binds the oestrogen receptor, blocks it and accelerates its degradation, unlike tamoxifen and the aromatase inhibitors it is often positioned against on a formulary, which act by receptor blockade or by cutting oestrogen synthesis rather than by removing the receptor itself. It has no oral form. Each 5 mL pre-filled syringe delivers 250 mg fulvestrant, and the licensed regimen is two syringes (500 mg) given as one intramuscular injection into each buttock. Dosing runs on a fixed loading schedule rather than a simple once-monthly repeat: Day 1, Day 15, Day 29, then monthly. Patients with moderate hepatic impairment step down to 250 mg on the same schedule; the EU and UK SmPCs list severe hepatic impairment as a contraindication. It carries no WHO Model List of Essential Medicines listing.
Active ingredient
Fulvestrant. Selective estrogen receptor degrader (SERD); estrogen receptor antagonist.
Forms and strengths
250 mg/5 mL solution for injection (pre-filled syringe).
Indications
Fulvestrant, a selective estrogen receptor degrader indicated for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, given alone or with a targeted agent per destination-market labelling. Supplied as originator Faslodex and, in the EU and UK, licensed generic pre-filled syringes from Indian and partner WHO-GMP sourced channels to regulated and semi-regulated markets outside India.
Administration
Intramuscular. Solution for injection in pre-filled syringe.
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 fulvestrant are hospital oncology and haematology-oncology pharmacies dispensing intramuscular endocrine therapy for postmenopausal HR-positive breast cancer, national and regional MoH tender desks running oncology formulary lists in GCC and African markets, licensed pharmaceutical importers and wholesalers with validated cold-chain receiving, and NGO or foundation procurement programmes supporting breast-cancer treatment access where local registration for either the brand or a licensed generic is already 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 fulvestrant.
Fulvestrant's loading-dose schedule, Day 1, Day 15, Day 29, then monthly, is the detail buyers most often get wrong when planning pack quantities: a patient's first month needs three syringe pairs, not one, so opening-order sizing should reflect that front-loaded pattern rather than a flat monthly run rate. Each 500 mg dose is given as two separate 5 mL intramuscular injections, one per buttock, administered slowly over one to two minutes per injection because of the formulation's viscosity; caution is needed at the dorsogluteal site given the proximity of the sciatic nerve. Use fulvestrant cautiously in patients with bleeding diatheses, thrombocytopenia or on anticoagulants, given the intramuscular route and injection volume. It carries no boxed warning, but it can cause fetal harm, so patients of reproductive potential need counselling on effective contraception before the first dose. Cold-chain integrity matters more here than for most oncology injectables on our roster: fulvestrant ships and stores at 2-8C, with excursions above 25C limited to a cumulative 28 days and never above 30C, so buyers should confirm receiving-site refrigeration before we book transit.
The documentation pack a regulator actually asks for.
Fulvestrant travels on a validated cold-chain lane rather than standard ambient logistics: storage and transport at 2-8C, protected from light in its original carton, with a four-year shelf life when kept within range. What buyers need alongside that is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Fulvestrant is not on the current WHO Model List of Essential Medicines: WHO's Cancer Medicines Working Group reviewed an application to add it in 2021 and did not support inclusion, citing modest and heterogeneous overall-survival benefit against already-listed endocrine agents such as tamoxifen and the aromatase inhibitors, high price and variable cost-effectiveness findings across a large eligible patient population, so tender desks should treat fulvestrant as a formulary-specific second-line choice rather than an EML first-line hormonal therapy. On the brand-versus-generic question, Faslodex remains the AstraZeneca originator; the EMA and MHRA have separately licensed generic fulvestrant 250 mg pre-filled syringes from other manufacturers in the EU and UK, so buyers in those markets genuinely have a brand-or-generic choice, while destination-specific registration should be checked before a tender submission elsewhere. Fulvestrant is increasingly quoted alongside a targeted agent rather than as monotherapy, but the licensed combination partner varies by market: the EU product licence covers fulvestrant plus palbociclib, the current UK SmPC additionally lists capivasertib, and other regulators, including the US label, licence combination with ribociclib or abemaciclib as well. It is not a controlled substance in the markets we currently review.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 fulvestrant.
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 fulvestrant.
- 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.
Fulvestrant supply, the specific questions.
Does a generic version of Faslodex exist?
Yes, in some markets. The EMA and MHRA have licensed generic fulvestrant 250 mg pre-filled syringes from manufacturers other than AstraZeneca for the EU and UK. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
What is the dosing schedule for fulvestrant, and why does it matter for order sizing?
500 mg (two 250 mg syringes) is given by intramuscular injection on Day 1, Day 15, Day 29, and then once monthly. Because the first month needs three syringe pairs rather than one, opening orders should be sized for that loading pattern, not a flat monthly quantity.
Does fulvestrant need cold-chain shipping?
Yes. Fulvestrant is stored and transported at 2-8C, protected from light, with a four-year shelf life within that range and limited tolerance for excursions above 25C. Confirm your site's refrigerated receiving capability before we book transit.
Is fulvestrant on the WHO Essential Medicines List?
No. WHO's Cancer Medicines Working Group reviewed an application to add fulvestrant in 2021 and did not support it, citing modest and heterogeneous overall-survival benefit over already-listed hormonal therapies, high price and variable cost-effectiveness across a large eligible patient population. Tender desks should treat it as a formulary-specific second-line option.
Can fulvestrant be combined with other oncology medicines M Care supplies?
Yes, though the licensed combination partner varies by market. The EU product licence covers fulvestrant plus palbociclib, the current UK SmPC also lists capivasertib, and other regulators, including the US label, additionally licence combination with ribociclib or abemaciclib. M Care checks the destination-market label before quoting a combination regimen, and combination ordering now accounts for a large share of hospital demand alongside fulvestrant monotherapy.
What documentation does M Care provide with a fulvestrant shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, cold-chain transit validation records confirming the 2-8C lane was maintained, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.