Myrbetriq (mirabegron), sold in Europe as Betmiga, is licensed for overactive bladder in adults and, since 2021, for neurogenic detrusor overactivity in children aged three and over, with FDA-approved generic mirabegron now on the market alongside the Astellas brand.
M Care Exports supplies Myrbetriq, originated by Astellas Pharma and sold in the EU as Betmiga, an extended-release beta-3 adrenergic agonist that relaxes the bladder detrusor muscle to treat overactive bladder without the cognitive burden older antimuscarinic agents carry in elderly patients. As a merchant exporter, we source both the Astellas brand and FDA-approved generic mirabegron tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Mirabegron exporter and bulk supplier from India.
For hospital urology, wholesaler and MoH tender orders, M Care quotes mirabegron extended-release tablets against buyer specification: brand (Myrbetriq/Betmiga) or generic, strength (25 mg, 50 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because mirabegron carries dose caps in renal and hepatic impairment and a moderate CYP2D6-inhibition interaction with drugs such as digoxin, we confirm the buyer's intended formulary co-listing 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.
Beta-3 adrenergic receptor agonist, sourced and documented for export.
Mirabegron is a selective agonist at the human beta-3 adrenoceptor, the receptor subtype dominant in the bladder detrusor muscle. Activating it relaxes the detrusor during the storage phase, increasing bladder capacity without impairing the contraction needed to void, which is mechanistically distinct from the muscarinic-receptor blockade that gives older overactive-bladder drugs their dry-mouth and cognitive side-effect profile. Myrbetriq's FDA-labelled indication is overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, used alone or in combination with the muscarinic antagonist solifenacin succinate; a 2021 label extension added neurogenic detrusor overactivity in paediatric patients aged three years and above. Betmiga carries the equivalent EU indication for adult overactive bladder syndrome and the same paediatric neurogenic detrusor overactivity extension. It is dosed orally, needs no reconstitution for the adult tablet form, and travels on standard ambient logistics. Myrbetriq/Betmiga is supplied as 25 mg and 50 mg extended-release film-coated tablets for adults weighing 35 kg or more, and as an 8 mg/mL oral granule for suspension for weight-based paediatric dosing below that threshold.
Active ingredient
mirabegron. Beta-3 adrenergic receptor agonist.
Forms and strengths
25 mg extended-release tablet; 50 mg extended-release tablet; 8 mg/mL oral granule for suspension.
Indications
Selective beta-3 adrenoceptor agonist indicated for overactive bladder with urge incontinence, urgency and frequency in adults, and, since 2021, for neurogenic detrusor overactivity in children aged three and above. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated markets.
Administration
oral. Extended-release film-coated tablet; oral granule for suspension (paediatric weight-based dosing).
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 mirabegron are hospital urology and continence-service pharmacists managing adult overactive bladder caseloads where antimuscarinic side effects limit therapy, especially in frail or cognitively vulnerable elderly patients, paediatric neurology and urology units treating neurogenic detrusor overactivity from spina bifida or spinal-cord conditions, national and regional MoH tender desks running urology and continence-care formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting continence care 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 mirabegron.
Adult dosing starts at 25 mg once daily, stepped up to 50 mg once daily after 4 to 8 weeks if symptom control is inadequate and the patient tolerates the lower dose; the tablet is extended-release and must be swallowed whole, never crushed or chewed. Renal and hepatic impairment both cap the ceiling: severe renal impairment (eGFR 15-29 mL/min/1.73m2) and moderate hepatic impairment limit dosing to 25 mg daily, while end-stage renal disease, dialysis and severe hepatic impairment are not recommended at all. Mirabegron is a moderate CYP2D6 inhibitor, so digoxin and other narrow-therapeutic-index CYP2D6 substrates need dose review and monitoring, and the lowest effective digoxin dose should be used at initiation. Periodic blood pressure checks are worth building into the dispensing routine, since mirabegron can raise blood pressure and is not recommended in patients with severe uncontrolled hypertension. Angioedema of the face, lips, tongue or larynx has been reported and warrants immediate discontinuation and referral if it occurs. Paediatric NDO dosing for the granule suspension is weight-banded rather than fixed, so confirm the child's weight band against the label's dosing table before a pack-mix order is finalised.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, mirabegron travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics; the reconstituted paediatric granule suspension is the one presentation with a defined in-use shelf life, stable for up to 28 days once mixed and stored at 20-25C. 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. Mirabegron does not appear on the WHO Model List of Essential Medicines; overactive-bladder pharmacotherapy generally sits outside the EML, so tender desks should treat it as a formulary-specific line rather than an EML first-line agent when specifying a urology procurement list. On the brand-versus-generic question, Myrbetriq/Betmiga remains the originator product from Astellas Pharma. FDA-approved generic mirabegron extended-release tablets are now separately registered and marketed in the US, with Lupin Pharmaceuticals and Zydus Pharmaceuticals both receiving first-wave generic approvals in late September 2022, so buyers genuinely have a brand-or-generic choice for the adult tablet strengths; M Care quotes either against the tender specification and destination-market registration status. The paediatric granule presentation and the neurogenic detrusor overactivity indication remain more recent additions to the label, so buyers building a paediatric-continence tender should confirm generic registration status for that specific presentation before specifying it.
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 mirabegron.
Flavoxate
Another urology & nephrology line ordered on the same formularies.
Silodosin
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Tolvaptan
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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 mirabegron.
- 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.
Mirabegron supply, the specific questions.
Does a generic version of Myrbetriq exist?
Yes. FDA-approved generic mirabegron extended-release tablets are registered and marketed in the US alongside Astellas's Myrbetriq, with Lupin Pharmaceuticals and Zydus Pharmaceuticals both receiving first-wave generic approvals in late September 2022. Registration status for generic mirabegron varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Myrbetriq or Betmiga to our market?
Yes, on an import basis. We source Myrbetriq/Betmiga through Astellas's licensed Indian distribution channels, or a generic mirabegron line, and dispatch against your import authorisation and any local registration your pharmacy or hospital holds.
What strengths of mirabegron are available?
25 mg and 50 mg extended-release tablets for adult overactive bladder dosing, matching the Myrbetriq/Betmiga strengths, plus an 8 mg/mL oral granule for suspension used for weight-based paediatric dosing in neurogenic detrusor overactivity. Tell us your dosing protocol and patient population and we quote the strength mix accordingly.
Is mirabegron licensed for use in children?
Yes, since a 2021 US label extension and the equivalent EU authorisation. Mirabegron is licensed for neurogenic detrusor overactivity in paediatric patients aged three years and above, dosed by weight band using the oral granule suspension or, once the child weighs 35 kg or more, the adult tablet. It is not licensed for adult overactive bladder use in children.
Does mirabegron interact with digoxin?
Yes. Mirabegron is a moderate CYP2D6 inhibitor and increases digoxin exposure, so the label recommends starting digoxin at its lowest dose and monitoring serum concentrations when the two are co-prescribed. Medicines reconciliation should flag this before mirabegron is dispensed alongside digoxin or other CYP2D6-metabolised drugs.
Why might a hospital choose mirabegron over an antimuscarinic for overactive bladder?
Mirabegron works through a different mechanism, beta-3 adrenoceptor agonism rather than muscarinic blockade, so it avoids the dry mouth, constipation and cognitive impairment that limit antimuscarinic use in frail or elderly patients. It does require blood pressure monitoring and is not recommended in severe uncontrolled hypertension, so the choice depends on the patient's cardiovascular and cognitive risk profile.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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.