Urispas (flavoxate) is an older urinary spasmolytic that NICE guidance for overactive bladder has largely moved past, yet it stays on GCC and African MoH tender lists as the standard symptomatic add-on alongside antibacterial therapy for cystitis and urethritis.
Urispas (flavoxate hydrochloride), now off patent everywhere it is sold, relieves the dysuria, urgency, frequency and suprapubic pain of cystitis, urethritis and prostatitis without treating the underlying infection itself. M Care Exports is a merchant exporter: we source Urispas and licensed generic flavoxate tablets through India's WHO-GMP manufacturer network and dispatch on buyer specification, never from our own production.
Flavoxate exporter and bulk supplier from India.
Flavoxate's specification isn't standard worldwide, so M Care confirms strength before quoting: 100 mg tablets built for the (now generic-only) US-pattern market, or 200 mg tablets matching the Urispas brand sold across the UK, EU, GCC and most of the markets we export to. We quote against multiple Indian WHO-GMP partner lines carrying flavoxate hydrochloride, matched to the buyer's strength, pack format and destination-country labelling, with CTD or eCTD dossier support where the receiving regulator asks for local registration.
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.
Musculotropic urinary antispasmodic (direct bladder smooth-muscle relaxant with mild anticholinergic and local-anaesthetic activity), sourced and documented for export.
Flavoxate hydrochloride is a musculotropic urinary spasmolytic. Rather than blocking muscarinic receptors the way newer overactive-bladder drugs do, it acts directly on bladder smooth muscle, raising intracellular cyclic AMP and blocking calcium influx to relax the detrusor and increase bladder capacity, with only mild antimuscarinic and local-anaesthetic activity alongside that direct effect.
It is licensed for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence in cystitis, prostatitis, urethritis and urethrotrigonitis, and, in UK labelling, for bladder spasm after catheterisation. It is not a treatment for the underlying infection: the SmPC is explicit that flavoxate is meant to run alongside, not instead of, antibacterial therapy.
It is dispensed as a plain film-coated tablet, taken orally, three or four times a day after food to reduce nausea. There is no injectable presentation and no reconstitution step, which keeps it out of cold-chain territory entirely.
Active ingredient
flavoxate hydrochloride. Musculotropic urinary antispasmodic (direct bladder smooth-muscle relaxant with mild anticholinergic and local-anaesthetic activity).
Forms and strengths
100 mg film-coated tablet; 200 mg film-coated tablet.
Indications
Urinary spasmolytic for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence in cystitis, prostatitis and urethritis, used alongside antibacterial therapy rather than as a treatment for the underlying infection.
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 flavoxate are mostly hospital and community pharmacy wholesalers, MoH tender desks in the GCC and Africa that still list it as the standard symptomatic-relief item on urology and general-medicine formularies, licensed importers stocking UTI-adjunct lines alongside antibacterials, and NHS-linked or private urology pharmacies filling named-patient orders. It sits at the older, lower-cost end of the bladder-spasmolytic category, so tender desks tend to specify it by brand name (Urispas, or a local equivalent such as or) rather than by INN, which is why we always confirm strength and market before quoting.
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 flavoxate.
Confirm the market before packing: US-pattern generic flavoxate is dosed as one or two 100 mg tablets three to four times daily, while Urispas as sold in the UK, EU and most of our GCC and African markets is a 200 mg tablet taken three times daily after meals, continued for as long as symptoms require. These are not interchangeable strengths, and a tender written against one will reject the other on dispensing. It is not recommended under 12 years of age, and UK labelling adds glaucoma, myasthenia gravis, urinary retention and gastrointestinal obstruction to the contraindication list alongside the achalasia and pyloric-obstruction warnings common to both labels. There is no boxed warning, no controlled-substance status and no cold-chain requirement: flavoxate ships and stores as an ordinary ambient-temperature tablet, which is worth flagging to buyers assembling a mixed UTI-care order alongside temperature-sensitive antibacterial injectables in the same shipment.
The documentation pack a regulator actually asks for.
As an oral solid with no cold-chain requirement, flavoxate's documentation load is lighter than a biologic's: batch-specific certificate of analysis, WHO-GMP site documentation from the manufacturing partner, and CDSCO export paperwork from the Indian side, with CTD or eCTD dossier support where a destination regulator such as MHRA, SFDA, MOHAP or NAFDAC requires local registration before import. We do not hold WHO-GMP or WHO-PQ status ourselves; the certification travels with the manufacturing partner, and we pass it through rather than claim it. Flavoxate is off patent, and there is no single global brand story here. Urispas remains marketed by Recordati across the UK, EU and several GCC and Gulf-adjacent markets, while the same molecule trades under a long list of local names elsewhere and among them. In the US, the Urispas brand itself has been discontinued and only generic 100 mg flavoxate hydrochloride is on the market. We map every enquiry back to the INN and confirm which brand or generic line the destination market actually recognises before quoting, rather than assuming Urispas is the name a buyer's own regulator will accept.
The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.
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 flavoxate.
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 flavoxate.
- 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.
Flavoxate supply, the specific questions.
Is there a generic version of Urispas (flavoxate)?
Yes. In the US, the Urispas brand has been discontinued and only generic flavoxate hydrochloride 100 mg tablets are marketed. In the UK, EU and most of the markets M Care serves, Urispas 200 mg remains on sale from Recordati alongside generic flavoxate lines. We quote whichever the tender specifies.
What strength of flavoxate tablets does M Care supply, 100 mg or 200 mg?
Both, depending on the destination market. US-pattern generic flavoxate is 100 mg; Urispas as sold in the UK, EU, GCC and most of our other markets is 200 mg. The two strengths are dosed differently and are not interchangeable, so we confirm which one your market's regulator recognises before quoting.
Can M Care supply Urispas to our market?
Yes, on an import basis. We source Urispas and licensed generic flavoxate through India's WHO-GMP manufacturer network and dispatch against your import authorisation and destination-country registration; import basis and local requirements are confirmed with you before dispatch.
Does flavoxate need cold-chain shipping?
No. Flavoxate is a film-coated tablet with no reconstitution step and no cold-chain requirement. It ships and stores at standard ambient conditions, which simplifies freight against injectable or biologic lines on the same order.
What is flavoxate licensed to treat?
It is licensed for the symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence in cystitis, prostatitis, urethritis and urethrotrigonitis, and in UK labelling for bladder spasm after catheterisation. It is a symptomatic adjunct, not a treatment for the underlying infection, and is meant to be used alongside antibacterial therapy where one is indicated.
Is flavoxate a controlled substance, or does it need special import authorisation?
No. Flavoxate carries no controlled-substance status and no boxed warning. Standard pharmaceutical import documentation applies: certificate of analysis, WHO-GMP site documentation from the manufacturer, CDSCO export paperwork, and CTD/eCTD dossier support where your regulator requires local registration.
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.