Xatral (alfuzosin), marketed in the United States as Uroxatral, is a uroselective alpha-1 blocker licensed for the functional symptoms of benign prostatic hyperplasia, and FDA and MHRA-approved generic alfuzosin tablets are available alongside the originator brand.
Xatral, originated by Sanofi and sold in the United States as Uroxatral, is an oral alpha-1 adrenergic antagonist dosed once daily to relieve the urinary symptoms of benign prostatic hyperplasia (BPH). M Care Exports is a merchant exporter: we source the Sanofi brand and FDA and MHRA-approved generic alfuzosin tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Alfuzosin exporter and bulk supplier from India.
For hospital urology, wholesaler and tender-desk orders, M Care quotes alfuzosin tablets against buyer specification: brand (Xatral/Uroxatral) or generic, dosage form (2.5 mg immediate-release or 10 mg prolonged-release), and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the 2.5 mg immediate-release tablet is dosed three times daily while the 10 mg prolonged-release tablet is once daily and must not be crushed or split, we confirm the buyer's intended formulation before 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.
Alpha-1 adrenergic receptor antagonist (uroselective alpha blocker), sourced and documented for export.
Alfuzosin is a quinazoline-derived alpha-1 adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, easing urine flow in men with benign prostatic hyperplasia without the blood-pressure-lowering effect of older, non-selective alpha blockers. It is dosed orally, not injected, and needs no reconstitution. The flagship licensed indication, per both the FDA label and the UK SmPC, is the functional symptoms of BPH; UK labelling additionally licenses the 10 mg prolonged-release tablet, in patients aged 65 and over, taken from the first day of catheterisation for 3-4 days, to help restore spontaneous voiding after acute urinary retention associated with BPH (no benefit is established under 65 or beyond 4 days of treatment). Alfuzosin is not indicated for hypertension. Xatral/Uroxatral is supplied as a 10 mg prolonged-release tablet taken once daily with food; an older 2.5 mg immediate-release tablet, dosed three times daily, remains available as a generic in some markets for patients who need slower titration.
Active ingredient
Alfuzosin hydrochloride. Alpha-1 adrenergic receptor antagonist (uroselective alpha blocker).
Forms and strengths
2.5 mg tablet (immediate-release, three-times-daily dosing); 10 mg prolonged-release tablet (once-daily dosing).
Indications
Alfuzosin, a uroselective alpha-1 adrenergic antagonist licensed for the functional symptoms of benign prostatic hyperplasia and, in the UK, for restoring voiding after catheter-related acute urinary retention. Supplied as originator Xatral/Uroxatral and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Prolonged-release tablet (also available as immediate-release 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 alfuzosin are mainly hospital urology outpatient pharmacies and day-surgery units managing BPH and post-catheter voiding trials, national and regional MoH tender desks running non-communicable and urology formulary lists, licensed pharmaceutical wholesalers and importers, and community-pharmacy chains restocking a long-run maintenance therapy 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 alfuzosin.
Alfuzosin's two dosage forms are not interchangeable on the ward: the 10 mg prolonged-release tablet is once daily with food and must be swallowed whole, never crushed, split or chewed, while the older 2.5 mg immediate-release tablet is dosed three times daily (twice daily at initiation in elderly or hypertensive patients), so a substitution between brand and generic should be checked against the exact SKU, not just the molecule name. Orthostatic hypotension and syncope are the main early-dose risk, particularly with concurrent antihypertensives, nitrates or PDE5 inhibitors; counsel patients to sit or lie down at the first sign of dizziness. Alfuzosin is contraindicated with moderate-to-severe hepatic impairment and with potent CYP3A4 inhibitors such as ketoconazole, itraconazole or ritonavir, which raise exposure two- to three-fold. Any patient on or previously treated with alfuzosin should tell their ophthalmologist before cataract surgery, given the recognised risk of intraoperative floppy iris syndrome (IFIS). No cold-chain handling or reconstitution is required.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, alfuzosin travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; the UK SmPC sets a 3-year shelf life stored below 30 degrees Celsius, protected from light and moisture in the original pack. 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. Alfuzosin does not appear on the current WHO Model List of Essential Medicines; BPH pharmacotherapy sits outside the EML's priority list, so buyers should treat alfuzosin as a formulary-specific urology line rather than an EML-listed molecule when building a tender specification. On the brand-versus-generic question, Xatral (UK/EU) and Uroxatral (US) remain the Sanofi originator products; the FDA approved generic alfuzosin extended-release 10 mg tablets in 2011, and MHRA-approved generic alfuzosin (both 2.5 mg and 10 mg strengths) is separately registered in the UK and EU, so buyers genuinely have a brand-or-generic choice. Alfuzosin is not a scheduled or controlled substance in the markets M Care serves.
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 alfuzosin.
Flavoxate
Another urology & nephrology line ordered on the same formularies.
Mirabegron
Another urology & nephrology line ordered on the same formularies.
Sevelamer
Another urology & nephrology line ordered on the same formularies.
All urology & nephrology
The full category listing for procurement desks.
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 alfuzosin.
- 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.
Alfuzosin supply, the specific questions.
Does a generic version of Xatral/Uroxatral exist?
Yes. The FDA approved generic alfuzosin extended-release 10 mg tablets in 2011, and MHRA-approved generic alfuzosin tablets are separately registered in the UK and EU. M Care can quote the Sanofi originator brand or a licensed generic against the buyer's tender specification.
What is the difference between the 2.5 mg and 10 mg alfuzosin tablets?
The 2.5 mg tablet is an older immediate-release formulation dosed three times daily (twice daily at the start of treatment in elderly or hypertensive patients), while the 10 mg tablet is a prolonged-release formulation dosed once daily with food. The two are not interchangeable pack for pack, and the 10 mg tablet must be swallowed whole, never crushed or split.
What is alfuzosin licensed to treat?
Alfuzosin is licensed for the functional symptoms of benign prostatic hyperplasia (BPH) in adult men. In the UK, the 10 mg prolonged-release tablet also carries a licence, in patients aged 65 and over, to help restore spontaneous voiding after acute urinary retention associated with BPH, started on the first day of catheterisation; no benefit is established under 65 or beyond 4 days of treatment. Alfuzosin is not licensed for hypertension.
Is alfuzosin a controlled or scheduled medicine?
No. Alfuzosin is not a scheduled or controlled substance in the markets M Care serves, so it moves through standard pharmaceutical import channels rather than narcotics or psychotropics licensing, though destination-country product registration still applies.
Does alfuzosin need cold-chain handling?
No. Alfuzosin tablets are stored at standard room temperature, not above 30 degrees Celsius, and protected from light and moisture in the original pack. No refrigeration or cold-chain lane is required for storage or transit.
What should a buyer know about alfuzosin's safety profile before a tender?
Alfuzosin is contraindicated in patients with moderate-to-severe hepatic impairment and in those taking potent CYP3A4 inhibitors such as ketoconazole, itraconazole or ritonavir. Orthostatic hypotension is the main early-treatment risk, and prescribers are advised to flag prior alfuzosin use before a patient undergoes cataract surgery, given the recognised risk of intraoperative floppy iris syndrome.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.
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