Casodex (bicalutamide) is a non-steroidal antiandrogen used with an LHRH analogue for advanced prostate cancer, with a separate 150mg licence in the EU and UK for locally advanced disease, and licensed generic bicalutamide tablets are widely registered alongside the originator brand.
M Care Exports supplies Casodex (bicalutamide), a non-steroidal antiandrogen originated by AstraZeneca, alongside FDA and MHRA-approved generic bicalutamide tablets. It blocks androgen receptor binding in prostate tumour tissue and is dosed once daily as part of a combination or, in some markets, a monotherapy regimen. M Care is a merchant exporter: we source Casodex and generic bicalutamide through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Bicalutamide exporter and bulk supplier from India.
For hospital oncology pharmacy, wholesaler and tender-desk orders, M Care quotes bicalutamide tablets against buyer specification: brand (Casodex) or generic, strength (50mg or 150mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the 150mg strength carries a narrower, region-specific licence than the 50mg combination-therapy dose, we confirm the buyer's intended indication and destination-country labelling before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the 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.
Non-steroidal antiandrogen; androgen receptor inhibitor, sourced and documented for export.
Bicalutamide is a non-steroidal antiandrogen that competitively blocks androgen receptor binding in prostate tumour tissue, reducing the growth-driving effect of testosterone and dihydrotestosterone without the hormonal side effects of surgical or medical castration alone. In the United States, the FDA label licenses only the 50mg strength, taken once daily in combination with an LHRH analogue for Stage D2 metastatic prostate cancer; the 150mg strength is not FDA-approved. In the UK and EU, the SmPC licenses 50mg once daily for combination therapy or total androgen blockade alongside an LHRH analogue or surgical castration, and separately licenses 150mg once daily, taken alone or as an adjuvant to radical prostatectomy or radiotherapy, for locally advanced, non-metastatic prostate cancer at high risk of progression. It is an oral-only therapy needing no reconstitution. Casodex and generic bicalutamide are supplied as 50mg and 150mg film-coated tablets.
Active ingredient
Bicalutamide. Non-steroidal antiandrogen; androgen receptor inhibitor.
Forms and strengths
50 mg film-coated tablet; 150 mg film-coated tablet.
Indications
Bicalutamide, a non-steroidal antiandrogen that blocks androgen receptor binding in prostate tumour tissue, licensed for use with an LHRH analogue in advanced prostate cancer and, at 150mg in the EU and UK, for locally advanced disease. Supplied as originator Casodex and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
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.
Buyers for bicalutamide are hospital urology and oncology pharmacies managing prostate cancer patients on combination or total androgen blockade regimens, national and regional MoH tender desks running oncology and non-communicable disease formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting cancer-care access in markets where local registration is 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 bicalutamide.
Bicalutamide dosing splits by strength and region: the FDA label licenses only 50mg once daily, started at least three days before or alongside LHRH analogue therapy, while the EU/UK SmPC additionally licenses 150mg once daily as monotherapy or adjuvant treatment for locally advanced disease, continued for at least two years or until progression. Casodex 150mg's own SmPC states that in trials of the Early Prostate Cancer programme there was no significant overall-survival benefit in patients with localised disease, so the benefit-risk profile for that population is not considered favourable and 150mg is not licensed for localised, early-stage disease; a tender specifying 150mg should be checked against the locally advanced indication rather than early-stage or localised disease. Bicalutamide carries a liver-injury warning: cases of hepatic failure, including fatalities, have been reported post-marketing, so serum transaminases should be measured before starting treatment, regularly for the first four months and periodically thereafter. No dose adjustment is needed for renal impairment or mild hepatic impairment. No reconstitution and no cold chain are required; tablets store at controlled room temperature.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, bicalutamide travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics and insulins. What buyers need instead 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; the Casodex 150mg SmPC gives a four-year shelf life stored below 30 degrees Celsius, while the 50mg SmPC gives five years stored below 30 degrees Celsius. Bicalutamide appears on the WHO Model List of Essential Medicines, listed under hormones and antihormones as a 50mg oral solid formulation for malignant neoplasms of the prostate, added to the list in 2015, which gives tender desks a formulary anchor the 150mg strength does not share. On the brand-versus-generic question, Casodex remains the originator product, developed and marketed by AstraZeneca; FDA and MHRA-approved generic bicalutamide tablets from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice, and M Care checks current destination-market registration status before quoting either against a tender. Bicalutamide is not a controlled substance in the markets we currently review.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
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 bicalutamide.
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 bicalutamide.
- 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.
Bicalutamide supply, the specific questions.
Does a generic version of Casodex exist?
Yes. FDA and MHRA-approved generic bicalutamide tablets from multiple manufacturers are registered and marketed in the US, UK and EU alongside the originator Casodex brand. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Casodex to our market?
Yes, on an import basis. We source Casodex through AstraZeneca's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of bicalutamide tablets are available?
50mg and 150mg film-coated tablets, matching the Casodex strengths. Tell us your indication, combination therapy or locally advanced monotherapy, and destination-country labelling and we quote the strength split accordingly.
Is bicalutamide 150mg licensed in every market?
No. The FDA label licenses only the 50mg strength, for combination therapy with an LHRH analogue. The 150mg strength carries a licence in the UK and EU for locally advanced, non-metastatic prostate cancer, either alone or as an adjuvant to radical prostatectomy or radiotherapy. Its own SmPC states the benefit-risk profile is not considered favourable for localised, early-stage disease, based on Early Prostate Cancer programme trial data showing no significant survival benefit in that population, so it is not licensed for early-stage use. Destination-country labelling should be confirmed before a tender submission.
What liver monitoring does bicalutamide require?
Cases of hepatic failure, including fatalities, have been reported post-marketing with bicalutamide. Prescribing information calls for serum transaminase measurement before starting treatment, at regular intervals for the first four months, and periodically thereafter, with immediate testing if symptoms such as jaundice, dark urine or abdominal pain appear.
What documentation does M Care provide with a bicalutamide shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, CTD/eCTD-aligned dossier support where the destination regulator requires local registration, and confirmation of which brand or generic product a shipment contains.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.
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.