Erleada (apalutamide) remains under originator patent protection, so M Care sources it through licensed Indian distribution channels rather than generic manufacture.
Erleada (apalutamide) is Janssen's oral androgen receptor inhibitor for non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer. M Care is a merchant exporter: we move Erleada from licensed Indian distribution channels to hospital pharmacies, MoH tender desks and licensed importers across our served markets, handling CDSCO export documentation and dispatch logistics on quote.
Apalutamide exporter and bulk supplier from India.
For tender-volume or hospital-formulary requirements, the Mumbai desk consolidates Erleada orders through licensed originator distribution channels and coordinates CTD/eCTD-aligned export paperwork per destination market. As a patented originator brand, there is no generic apalutamide to substitute; buyers should plan sourcing on brand-supply lead times and confirm registration status in their own market before committing tender volumes. We do not publish prices; every enquiry is quoted against current stock and destination.
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 inhibitor (next-generation antiandrogen), sourced and documented for export.
Apalutamide is a next-generation androgen receptor inhibitor. It binds directly to the ligand-binding domain of the androgen receptor, blocking receptor translocation to the nucleus, DNA binding and receptor-mediated transcription, without the agonist activity seen with earlier antiandrogens.
Erleada is FDA-approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Patients must remain on a concurrent GnRH analogue or have had a bilateral orchiectomy for the full duration of treatment; apalutamide alone does not substitute for medical or surgical castration.
It is supplied as film-coated tablets in two strengths, 60 mg and 240 mg, taken orally once daily with or without food. Storage is at 20°C to 25°C (room temperature, with permitted excursions to 15°C to 30°C), kept in the original package to protect from light and moisture; this is not a cold-chain product.
Active ingredient
apalutamide. Androgen receptor inhibitor (next-generation antiandrogen).
Forms and strengths
60 mg; 240 mg.
Indications
Oral androgen receptor inhibitor indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), given with concurrent GnRH analogue therapy or bilateral orchiectomy.
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.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Enquiries for Erleada typically come from oncology-stocking hospital pharmacies, MoH tender desks running urology or oncology formularies (particularly across GCC and African markets we serve), licensed importers and wholesalers with an oncology line, and specialist pharmacy chains building a prostate-cancer treatment pathway. As a patented brand, buyers are usually confirming local registration and supply continuity rather than comparing manufacturers.
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 apalutamide.
Standard dosing is 240 mg orally once daily, taken as either one 240 mg tablet or four 60 mg tablets, with or without food. Tablets must be swallowed whole; they should not be chewed, crushed or split, since the film coating is part of the formulation.
Hepatic impairment changes the dose, not just a caution: patients with severe hepatic impairment (Child-Pugh C) should receive a reduced dose of 120 mg once daily, reflecting reduced clearance. Confirm hepatic status is on file before dispensing tender stock into a formulary that includes this population.
Concurrent androgen deprivation is a hard requirement, not an optional add-on. Every patient on Erleada needs either a concurrent GnRH analogue or a documented bilateral orchiectomy for the duration of therapy; a formulary listing Erleada should cross-check that GnRH stock (or surgical pathway) is actually available alongside it, otherwise the tablet alone will not achieve castrate testosterone levels.
Monitoring priorities worth flagging to a receiving pharmacy: falls and fracture risk (both listed among the most common adverse reactions), blood pressure (hypertension is common enough to warrant baseline and periodic checks), and any new seizure history, since apalutamide lowers seizure threshold and is generally avoided in patients with a seizure history unless the benefit clearly outweighs the risk.
The documentation pack a regulator actually asks for.
Erleada moves through M Care's export chain as a patented originator solid-oral product: CDSCO export documentation on the India side, CTD/eCTD-format dossier support where a destination market's registration process requires it, and standard ambient-temperature logistics, since this is a 20°C to 25°C shelf-stable film-coated tablet with no cold-chain handling requirement. Original packaging is maintained through dispatch to preserve the light- and moisture-protection the label specifies.
There is no FDA-licensed generic or biosimilar apalutamide at this time; Erleada is a small-molecule oral product, not a biologic, so the biosimilar pathway does not apply to it in the way it would for a monoclonal antibody. Buyers sourcing apalutamide today are sourcing the originator brand through licensed distribution, and should verify current patent and registration status in their own destination market, since that determines local sourcing timelines rather than manufacturer choice.
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 apalutamide.
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 apalutamide.
- 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.
Apalutamide supply, the specific questions.
Is there a generic version of apalutamide available?
No. Apalutamide is a patented originator molecule and there is currently no FDA-licensed generic on the market. Erleada is sourced through licensed Janssen distribution channels, not from generic manufacturers.
Can M Care supply Erleada to our market?
M Care sources Erleada through licensed Indian distribution channels and exports on a quote basis. Supply is confirmed against your destination market's own registration status and import requirements at enquiry stage; contact the Mumbai desk with your country and required volume.
Does Erleada need cold-chain shipping?
No. Erleada is a film-coated tablet stored at 20°C to 25°C (room temperature, with excursions to 15°C to 30°C permitted). It is shipped and stored using standard ambient logistics, not cold chain, though original packaging should be kept intact to protect it from light and moisture.
What strengths does Erleada come in?
Erleada is available as 60 mg and 240 mg film-coated tablets. The standard 240 mg once-daily dose can be given as one 240 mg tablet or four 60 mg tablets.
What indications is Erleada approved for?
Per FDA labelling, Erleada is indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), always alongside a GnRH analogue or bilateral orchiectomy. Confirm licensed indications against your own destination-country labelling before formulary listing.
Does apalutamide require dose adjustment for organ impairment?
Patients with severe hepatic impairment (Child-Pugh C) receive a reduced dose of 120 mg once daily. No dose adjustment is specified for renal impairment or mild-to-moderate hepatic impairment per the FDA label; confirm current label guidance for your patient population.
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.
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.