Rapaflo (silodosin) is licensed for the signs and symptoms of benign prostatic hyperplasia, and FDA-approved generic silodosin capsules now sit alongside it as a stocked alternative.
Rapaflo (silodosin), an alpha-1A selective adrenoreceptor antagonist originated by Watson/Allergan in the US and marketed as Urorec and Silodyx by Recordati across Europe, is prescribed for BPH symptom relief, not hypertension. M Care Exports is a merchant exporter: we source Rapaflo and FDA-approved generic silodosin capsules through licensed Indian channels and dispatch against a buyer's own specification, not from our own manufacturing.
Silodosin exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk orders, M Care quotes silodosin capsules against buyer specification: brand (Rapaflo) or generic, strength mix (4mg, 8mg), pack count and destination-market regulatory documentation. We confirm the receiving country's registration status for the strength requested before booking a line, since some markets carry only the 8mg presentation on their formulary list, 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-1A selective adrenoreceptor antagonist, sourced and documented for export.
Silodosin is a highly uroselective alpha-1A adrenoreceptor antagonist. It relaxes smooth muscle in the prostate, bladder neck and urethra without the broader alpha-1B vascular blockade that drives blood-pressure side effects in older, less selective agents in the same class.
Its labelled indication is the signs and symptoms of benign prostatic hyperplasia; it carries no licensed hypertension indication and should never be substituted for an antihypertensive. Destination-country labelling should always be checked against the local regulator's approved text before a tender response goes out.
Silodosin is supplied as 4mg and 8mg hard gelatin capsules, taken orally, once daily with a meal, swallowed whole. It is a solid oral dosage form at controlled room temperature, not a cold-chain product, which keeps freight and customs handling simpler than the biologics and cytotoxics that share a hospital's wider procurement list.
Active ingredient
silodosin. Alpha-1A selective adrenoreceptor antagonist.
Forms and strengths
4 mg capsule; 8 mg capsule.
Indications
Uroselective alpha-1A adrenoreceptor antagonist licensed for the signs and symptoms of benign prostatic hyperplasia, taken once daily with a meal; not licensed for hypertension.
Administration
oral. Capsule, swallowed whole with a meal.
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 silodosin are chiefly urology and general-medicine outpatient pharmacies in hospitals, national and regional MoH tender desks running genitourinary or chronic-disease procurement lists, licensed pharmaceutical wholesalers and importers serving ageing-population markets, and private hospital groups stocking a BPH line alongside tamsulosin and 5-alpha-reductase inhibitors on the same formulary tier.
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 silodosin.
Standard dosing is 8mg orally once daily with a meal; food improves tolerability and reduces the peak-concentration effect linked to first-dose hypotension. In moderate renal impairment (creatinine clearance 30 to 50 mL/min), step the dose down to 4mg once daily with a meal. Silodosin is contraindicated outright in severe renal impairment (CrCl below 30 mL/min), severe hepatic impairment (Child-Pugh score above 10), and in patients on strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, itraconazole or ritonavir, since co-administration raises silodosin exposure several-fold. Flag Intraoperative Floppy Iris Syndrome on any dispensing record where cataract surgery is on the patient's near-term calendar; the ophthalmologist needs advance notice regardless of whether the drug is stopped. Counsel on orthostatic hypotension at initiation and after any dose interruption longer than a few days, since the first-dose effect can recur. Capsules are swallowed whole with a meal; there is no reconstitution step and no cold-chain requirement, so storage discipline is limited to controlled room temperature, protected from light and moisture.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, silodosin travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for injectable biologics. It is not a controlled substance in any market we currently review, so the documentation load sits closer to a conventional generic capsule than to a scheduled drug: import licence, batch-specific CoA, and destination-language pack inserts, without the added controlled-drug import permits that slow down opioid or benzodiazepine lines.
On the brand-versus-generic question, Rapaflo remains the originator product, developed by Watson and now held within the AbbVie/Allergan portfolio in the US, while Recordati holds the EU centralised authorisations for Urorec and Silodyx (authorised 29 January 2010). FDA-approved generic silodosin capsules from manufacturers including Lupin and Alembic have been registered in the US since December 2018, so buyers have a genuine brand-or-generic choice; M Care quotes either against the tender specification and the destination market's own registration status, since generic approval timing varies by country and is not automatic once a US or EU approval exists.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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 silodosin.
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 silodosin.
- 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.
Silodosin supply, the specific questions.
Does a generic version of Rapaflo exist?
Yes. FDA-approved generic silodosin capsules, including lines from Lupin and Alembic, have been registered and marketed in the US alongside Rapaflo since 2018. Registration status for generic silodosin varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
What is silodosin licensed to treat?
Silodosin is licensed for the signs and symptoms of benign prostatic hyperplasia. It carries no licensed indication for hypertension and should not be used as a blood-pressure medicine. Check the exact approved wording against your destination-country label before a tender submission.
What strengths of silodosin capsules does M Care supply?
4mg and 8mg hard gelatin capsules, matching the labelled Rapaflo and Urorec strengths. Tell us your formulary's dosing protocol, including whether a renal-impairment 4mg presentation is needed, and we quote the strength mix accordingly.
Does silodosin need cold-chain shipping?
No. It is an oral capsule stored at controlled room temperature, protected from light and moisture, so it moves on standard ambient logistics rather than the validated cold-chain lanes we use for biologics and vaccines.
Is silodosin a controlled substance?
No. Silodosin is not scheduled as a controlled drug in the markets we currently review, which keeps the import paperwork closer to a standard generic capsule line than to an opioid or benzodiazepine shipment.
Can M Care supply silodosin to our market?
Yes, on an import basis. We source Rapaflo and FDA-approved generic silodosin through licensed Indian distribution and manufacturing channels and dispatch against your import authorisation and the destination regulator's registration requirements for the strength requested, with CTD/eCTD-aligned dossier documentation and batch-specific certificates of analysis provided alongside the shipment.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
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.