Nubeqa (darolutamide) is licensed for non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, and no generic version exists in any major market.
Nubeqa (darolutamide) is Bayer's oral androgen receptor inhibitor for nmCRPC and mHSPC. M Care sources it through licensed Indian distribution channels as a merchant exporter, not a manufacturer, and quotes bulk and tender orders on an import basis for buyers in our served markets.
Darolutamide exporter and bulk supplier from India.
Nubeqa moves through hospital oncology formularies and government tender lists rather than retail pharmacy, so M Care structures supply around MoH tender cycles, NGO procurement frameworks and direct hospital purchasing in the GCC and African markets we serve. As an originator brand under patent, every unit we quote is sourced through Bayer's licensed Indian distribution chain and documented back to that chain; we do not substitute an unlicensed alternative. Order volumes, lead times and CTD/eCTD-aligned documentation are confirmed against the specific destination country's import requirements before we quote.
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.
Second-generation androgen receptor (AR) inhibitor, sourced and documented for export.
Darolutamide is a second-generation androgen receptor (AR) inhibitor. It binds the AR ligand-binding domain, blocking AR nuclear translocation and AR-mediated transcription, and has a distinct chemical structure from other AR inhibitors in its class.
Per EMA labelling, Nubeqa is indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of developing metastatic disease, and for metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy, with or without docetaxel. FDA labelling covers the same patient populations under the terms nmCRPC and metastatic castration-sensitive prostate cancer (mCSPC); mHSPC and mCSPC describe the same disease state under the two regulators' differing terminology. Patients who have not had surgical castration must continue a GnRH agonist or antagonist concurrently.
Nubeqa is supplied as 300 mg film-coated tablets. It is a solid oral dosage form stored at controlled room temperature, 20-25C, with excursions permitted between 15-30C; the bottle should be kept tightly closed after first opening. There is no cold-chain requirement, which simplifies dispatch logistics compared with M Care's biologic lines.
Active ingredient
darolutamide. Second-generation androgen receptor (AR) inhibitor.
Forms and strengths
300 mg.
Indications
Oral androgen receptor inhibitor licensed for non-metastatic castration-resistant prostate cancer and, in combination with androgen deprivation therapy with or without docetaxel, for metastatic hormone-sensitive/castration-sensitive prostate 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.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
M Care's Nubeqa enquiries come mainly from hospital oncology pharmacies, MoH tender desks in the GCC and East and West Africa, and licensed importers and wholesalers who hold the distribution registration for a given market. Because darolutamide is an originator brand for a serious oncology indication, we also see enquiries from NGO and donor-funded procurement bodies sourcing cancer therapeutics for public hospital networks; each of these is handled on the same import-basis, licensed-channel framework.
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 darolutamide.
Standard dosing is 600 mg (two 300 mg tablets) taken orally twice daily, for a total daily dose of 1,200 mg, and should be taken with food; absorption is markedly lower in the fasted state, so counsel patients to take both doses with a meal rather than on an empty stomach. Dose reduction to 300 mg twice daily applies in severe renal impairment (eGFR 15-29 mL/min/1.73m2) and in moderate hepatic impairment (Child-Pugh B); Nubeqa has not been studied in severe hepatic impairment.
Nubeqa is a solid oral tablet with no reconstitution step and no infusion-reaction protocol; the practical counselling points are food-timing and adherence to the twice-daily interval rather than administration technique. Patients who have not undergone bilateral orchiectomy must continue a GnRH agonist or antagonist for the duration of treatment; confirm this is prescribed alongside dispensing, since darolutamide is never used as monotherapy in an intact patient.
Baseline and periodic monitoring should include cardiovascular risk assessment, since ischaemic heart disease and heart failure have been reported; pharmacists dispensing to tender or hospital formularies should flag this in counselling material for prescribers managing patients with existing cardiac risk factors. There is no FDA- or EMA-licensed generic darolutamide at present; as a small-molecule originator, darolutamide also has no biosimilar pathway to speak of, since biosimilars apply to biologic medicines. Nubeqa is the only marketed product and remains under patent protection in the major markets M Care serves.
Store at controlled room temperature (20-25C, excursions 15-30C) and keep the bottle tightly closed between doses; there is no refrigeration or cold-chain requirement, which is a meaningful logistics advantage over M Care's biologic oncology lines for buyers weighing dispatch cost to landlocked or high-ambient-temperature markets.
The documentation pack a regulator actually asks for.
As an oral solid originator brand, Nubeqa's documentation chain runs through Bayer's licensed Indian distribution channel rather than a WHO-GMP manufacturing dossier of our own; M Care's role is verifying that chain of custody, batch documentation and import licensing at the destination country, and authoring the CTD/eCTD-aligned paperwork tender desks and MoH registration bodies require. We do not hold WHO-GMP or WHO-PQ certification ourselves and do not manufacture darolutamide; those certifications sit with Bayer's manufacturing sites.
There is currently no licensed generic darolutamide in the FDA, EMA or comparable regulatory frameworks, and no biosimilar pathway applies to a small-molecule originator of this kind, so there is no brand-versus-generic choice to present to buyers today. Every Nubeqa quote M Care issues is for the originator brand, sourced through licensed channels and confirmed against the importing country's own registration and tender requirements before dispatch.
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 darolutamide.
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 darolutamide.
- 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.
Darolutamide supply, the specific questions.
Is there a generic or biosimilar version of darolutamide?
No. Nubeqa is a patented originator small molecule with no FDA- or EMA-licensed generic currently on the market, and biosimilar pathways do not apply to a small-molecule drug like darolutamide (they apply to biologic medicines). Every unit M Care supplies is the Bayer originator brand, sourced through licensed Indian distribution channels.
Does Nubeqa require cold-chain storage?
No. Nubeqa tablets are stored at controlled room temperature, 20-25C with excursions to 15-30C permitted, so dispatch does not need refrigerated logistics. This differs from many of M Care's biologic oncology lines.
Can M Care supply Nubeqa to our market?
Yes, on an import basis through licensed Indian distribution channels. We confirm the destination country's import registration and tender requirements before quoting, and structure documentation around each market's own regulatory framework rather than assuming uniform requirements across markets.
What is Nubeqa licensed to treat?
Per EMA labelling, Nubeqa is indicated for non-metastatic castration-resistant prostate cancer at high risk of metastasis, and for metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy, with or without docetaxel. FDA labelling covers the same populations under the terms nmCRPC and metastatic castration-sensitive prostate cancer (mCSPC).
What dosing should hospital pharmacies expect on tender documentation?
The standard adult dose is 600 mg (two 300 mg tablets) taken orally twice daily with food. Dose reduction to 300 mg twice daily applies for severe renal or moderate hepatic impairment per the label.
Does M Care hold WHO-GMP or manufacture Nubeqa itself?
No. M Care is a merchant exporter, not a manufacturer. We source Nubeqa through Bayer's licensed Indian distribution channels and verify that chain of custody; manufacturing-site certifications sit with Bayer, not with M Care.
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.