Enzalutamide has been free of patent protection in India since 2016, years before the US and EU began opening to generic competition.
Enzalutamide's patent story is split by geography. The Indian Patent Office refused composition of matter protection for the molecule in 2016 on inventive step grounds, so Indian manufacturers have built years of generic capsule production experience while the reference brand's US patents run through 2026 and 2027, and European protection remains contested through active patent litigation. M Care Exports sources enzalutamide 40 mg capsules, branded and generic, from CDSCO licensed Indian manufacturers and quotes against your own registered label and destination dossier.
Enzalutamide exporter and bulk supplier from India.
Enzalutamide ships as an oral solid, needing no cold chain, but the soft gelatin capsule shell is moisture sensitive and is packed in alu-alu or HDPE bottle presentations that hold their seal through humid transit ports. M Care Exports prepares the standard merchant-exporter document set for each shipment: certificate of analysis, certificate of origin, GMP certificate for the manufacturing site supplying the order, and a free sale certificate where required. Because enzalutamide's patent status differs by destination, buyers where the reference brand's patents remain active should confirm their own freedom to register a generic dossier before ordering. M Care can supply either the branded product or a generic line once that route is clear; stock position and shipment timing are confirmed at enquiry.
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.
Androgen receptor signalling inhibitor (next-generation antiandrogen), sourced and documented for export.
Enzalutamide is one of the few oncology molecules where India's patent history runs ahead of the West's: the Patent Office rejected the molecule's composition of matter application, filed by the University of California and exclusively licensed to Astellas, in 2016 on inventive step grounds, so Indian generic capsule manufacture has been lawful for close to a decade, while US patents on the reference brand run to 2026 and 2027 and European protection remains contested through active patent litigation. Clinically, enzalutamide is an androgen receptor signalling inhibitor used across metastatic and non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer, dosed orally once daily as 40 mg capsules. It is also a strong CYP3A4 inducer, an interaction direction that runs opposite to most oncology molecules: it lowers the exposure of co-administered drugs rather than being displaced by them, a detail that matters wherever antiretroviral, antitubercular or anticoagulant therapy overlaps with prostate cancer treatment.
Active ingredient
Enzalutamide. Androgen receptor signalling inhibitor (next-generation antiandrogen).
Forms and strengths
40 mg.
Indications
Enzalutamide is an oral androgen receptor signalling inhibitor used in metastatic and non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer, typically dosed as multiple 40 mg capsules to reach a 160 mg once-daily dose.
Administration
Oral. Capsule (soft gelatin).
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 enzalutamide are oncology procurement desks at hospitals and cancer centres, national and regional tender authorities running prostate cancer treatment programmes, and licensed pharmaceutical importers and distributors who register the molecule for their own market. Demand concentrates in the UK and EU, the Gulf and wider GCC, Africa, Latin America, Southeast Asia and the CIS, where destination regulators are working through their own registration and, in several cases, their own patent clearance timelines for enzalutamide. M Care Exports does not sell into India, which is the country of origin for the product, not a served market. Every enquiry is matched to the buyer's own regulatory status and registered brand before a quotation is prepared.
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 enzalutamide.
A reviewing pharmacist should treat enzalutamide primarily as an interaction risk rather than an interaction victim: it is a strong inducer of CYP3A4 and a moderate inducer of CYP2C9 and CYP2C19, so it lowers the plasma exposure of co-administered substrates rather than being displaced by them. That matters for narrow therapeutic index drugs metabolised through those pathways, including tacrolimus and ciclosporin in transplant patients, warfarin and phenytoin, and for antiretroviral and rifamycin-based antitubercular regimens common in high HIV and TB burden markets. Strong CYP3A4 inducers such as rifampin, carbamazepine and phenytoin work the other way and can lower enzalutamide's own exposure, so concomitant use is generally avoided. Seizure has occurred in clinical use, more often in patients with predisposing factors, and posterior reversible encephalopathy syndrome has been reported post marketing. Falls, fractures and an ischemic heart disease signal have also been documented against placebo. None of this is dosing guidance for a patient; it is the interaction and monitoring context a receiving pharmacist checks against the buyer's own label before the product is dispensed.
The documentation pack a regulator actually asks for.
The documentation pack for an enzalutamide shipment centres on the manufacturing site's own GMP evidence (M Care does not hold WHO-GMP or WHO-PQ itself and does not claim to), a certificate of analysis matched to the batch, a certificate of origin, and a free sale certificate where the destination market asks for one. Because enzalutamide's composition of matter patent was refused in India in 2016 while the reference brand's US patents run to 2026 and 2027 and European protection remains contested through active patent litigation, the genuinely molecule-specific document a buyer should hold on file is evidence of their own destination's patent and regulatory clearance to register a generic, alongside their marketing authorisation dossier. M Care Exports operates under a CDSCO export licence and ISO 9001:2015 quality management certification, and quotes every enquiry against the buyer's own registered label rather than a generic template, since indication wording, approved strength and package leaflet content for enzalutamide vary by destination market and by whether the buyer is registering the branded or a generic 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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Prescription-only oncology therapy: not for patient self-medication or direct-to-consumer sale
Seizure has occurred in clinical use; predisposing medications are reviewed by the prescriber before treatment, this is not patient dosing guidance
Posterior reversible encephalopathy syndrome (PRES) reported in post-marketing use
Ischemic heart disease and falls/fractures signal documented against placebo in trials
Embryo-fetal toxicity: contraceptive precautions required where a partner could become pregnant; capsules should not be handled by pregnant women
Strong CYP3A4 inducer with moderate CYP2C9/CYP2C19 induction: major drug-drug interaction potential with narrow therapeutic index co-medications
Adjacent lines procurement desks order alongside enzalutamide.
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 enzalutamide.
- 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.
Enzalutamide supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Enzalutamide capsules are sourced from Indian manufacturing sites that hold their own WHO-GMP and, where relevant, WHO-PQ status. M Care's own credentials are ISO 9001:2015 quality management certification and a CDSCO export licence, and manufacturing-site GMP evidence is supplied with every quotation.
Why does India have a long-established generic enzalutamide supply base while the US and EU are only now opening to competition?
The Indian Patent Office refused the molecule's composition of matter application, filed by the University of California and exclusively licensed to Astellas, in 2016 on inventive step grounds, so Indian manufacture has been lawful since then. The reference brand's US patents run to 2026 and 2027, with the first US generic only approved in 2026, and European protection remains contested through active patent litigation, so the timing of open competition differs sharply by market.
What should a tender desk check about enzalutamide's drug interaction profile before listing it?
Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer, so it lowers the exposure of co-administered drugs rather than being displaced by them. That is relevant wherever antiretroviral, rifamycin-based antitubercular or warfarin therapy overlaps with prostate cancer treatment, which a formulary reviewer should flag before adding the line.
Which reference brand should we quote against for enzalutamide?
The originator brand is Xtandi, marketed by Astellas and, in some markets, Pfizer. M Care Exports names it for buyer reference and quotes against your own registered label and destination dossier, whether you are sourcing the branded product or a generic line, rather than against a generic template.
What indications is enzalutamide approved for?
Enzalutamide is an androgen receptor signalling inhibitor approved across metastatic and non-metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, and, in some markets, non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. Exact approved wording and label scope vary by destination regulator and should be checked against the buyer's own registration.
What packaging and stability handling does enzalutamide capsule product need?
Enzalutamide is supplied as an oral soft gelatin capsule, packed in alu-alu blister or HDPE bottle presentations that protect against moisture and temperature exposure. It needs no cold chain, but packaging integrity through humid transit routes and correct ambient storage on arrival matter more than for a standard tablet.
Can M Care supply enzalutamide tablets as well as capsules, and other brands beyond the originator?
Yes. M Care Exports can source enzalutamide as branded or generic product, in any presentation genuinely marketed for the molecule, from across its Indian manufacturer network, since it is not limited to a fixed catalogue. Availability of a specific brand, strength or presentation is confirmed at enquiry against your destination registration.
What safety information does a buyer's regulatory file need to carry for enzalutamide?
The approved label carries warnings for seizure, posterior reversible encephalopathy syndrome, ischemic heart disease, falls and fractures, and embryo-fetal toxicity requiring contraceptive precautions. These are prescriber and pharmacovigilance matters for the buyer's own market, not patient dosing advice, and should be reflected in the destination package leaflet.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.