Resolor (prucalopride), sold in the US as Motegrity, is a once-daily 5-HT4 receptor agonist for chronic constipation once laxatives have failed, and FDA-approved generic prucalopride tablets now stand alongside the Takeda originator brand.
Resolor (prucalopride), marketed by Takeda as Resolor in Europe and Motegrity in the United States, is an oral serotonin 5-HT4 receptor agonist taken once daily to restore bowel motility in chronic constipation. M Care Exports is a merchant exporter: we source the Takeda brand and FDA-approved generic prucalopride tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Prucalopride exporter and bulk supplier from India.
For hospital gastroenterology, wholesaler and tender-desk orders, M Care quotes prucalopride tablets against buyer specification: brand (Resolor/Motegrity) or generic, strength mix (1 mg, 2 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because EU/UK labelling positions prucalopride as a second-line agent for patients in whom laxatives have already failed while the US label simply states chronic idiopathic constipation, we confirm the buyer's intended formulary tier 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.
Selective serotonin 5-HT4 receptor agonist; gastrointestinal prokinetic, sourced and documented for export.
Prucalopride is a selective serotonin 5-HT4 receptor agonist that stimulates colonic propulsive motility, distinct from the stimulant and osmotic laxatives that dominate most constipation formularies. It is dosed orally, not injected, and needs no reconstitution. The EU/UK SmPC's flagship indication is symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief, a second-line positioning; the FDA label instead licenses prucalopride for chronic idiopathic constipation in adults without that laxative-failure gate, a labelling difference worth flagging when a tender specification is drafted against one regulator's wording rather than the other's. Resolor/Motegrity is supplied as 1 mg and 2 mg film-coated tablets, taken once daily with or without food; the 1 mg strength is also the standard starting and renal-adjusted dose.
Active ingredient
Prucalopride succinate. Selective serotonin 5-HT4 receptor agonist; gastrointestinal prokinetic.
Forms and strengths
1 mg film-coated tablet; 2 mg film-coated tablet.
Indications
Prucalopride, selective serotonin 5-HT4 receptor agonist licensed for chronic constipation in adults, second-line after laxative failure under EU/UK labelling and for chronic idiopathic constipation under US labelling. Supplied as originator Resolor/Motegrity 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 prucalopride are mainly hospital gastroenterology and colorectal outpatient pharmacies managing chronic constipation refractory to first-line laxatives, national and regional MoH tender desks maintaining gastroenterology or NCD formulary lists, licensed pharmaceutical wholesalers and importers, and specialist pharmacy chains stocking second-line motility agents 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 prucalopride.
Prucalopride dosing starts at 2 mg once daily in most adults, but patients over 65 typically start at 1 mg once daily, with an increase to 2 mg only if needed once response has been assessed; exceeding 2 mg daily is not expected to add efficacy given the drug's mode of action. Severe renal impairment (eGFR below 30) also caps the dose at 1 mg once daily, and dialysis-dependent patients are contraindicated under EU/UK labelling. The US label carries a specific caution, not a boxed warning, on suicidal ideation and behaviour, self-injurious ideation and new-onset or worsening depression reported within the first few weeks of treatment, so pharmacies dispensing a first fill should counsel patients and caregivers to watch for mood change and report it promptly. Prucalopride is not licensed under 18 years of age; EU/UK labelling excludes pregnancy as not recommended and flags excretion into breast milk. No cold-chain handling or reconstitution is required; tablets are moisture-sensitive and should stay in the original blister until use.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, prucalopride travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; the EU SmPC sets a 4-year shelf life with storage in the original blister to protect from moisture, and batch documentation should confirm dispatch well inside that window. Prucalopride does not appear on the current WHO Model List of Essential Medicines; bisacodyl and senna are the laxatives WHO lists for constipation management, so buyers should treat prucalopride as a formulary-specific second-line agent rather than an EML first-line option when building a tender specification. On the brand-versus-generic question, Resolor (EU/UK) and Motegrity (US) remain the Takeda-marketed originator products, and FDA-approved generic prucalopride tablets reached the US market for the first time in January 2025, while UK pharmacies also list generic prucalopride tablets alongside Resolor; buyers genuinely have a brand-or-generic choice in these markets, though destination-market registration status should always be confirmed before a quote is finalised. What buyers need 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.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
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 prucalopride.
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 prucalopride.
- 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.
Prucalopride supply, the specific questions.
Does a generic version of Resolor/Motegrity exist?
Yes. FDA-approved generic prucalopride tablets reached the US market for the first time in January 2025, and generic prucalopride tablets are also listed alongside Resolor in the UK. Buyers can specify either the Takeda brand or a licensed generic; M Care confirms current registration status in the destination market before quoting either option.
Can M Care supply Resolor or Motegrity to our market?
We quote against your registration status and formulary need. M Care is a merchant exporter, not the brand owner, so we source Takeda-marketed Resolor/Motegrity or FDA/MHRA-approved generic prucalopride through licensed Indian distribution and manufacturing channels and confirm destination-market import documentation before dispatch.
What strengths of prucalopride tablets are available?
Prucalopride is supplied as 1 mg and 2 mg film-coated tablets. The 2 mg strength is the standard adult once-daily dose; 1 mg is the recommended starting dose for patients over 65 and the capped dose for severe renal impairment. M Care quotes strength mix against your buyer specification.
How does prucalopride differ from standard laxative therapy?
Prucalopride is a selective serotonin 5-HT4 receptor agonist that stimulates colonic propulsive motility directly, a different mechanism from stimulant or osmotic laxatives. EU/UK labelling positions it for patients in whom laxatives have already failed to provide adequate relief, making it a second-line formulary addition rather than a first-line laxative replacement.
Are there any mood-related warnings for prucalopride?
Yes. US labelling notes that suicidal ideation and behaviour, self-injurious ideation and new-onset or worsening depression have been reported, mostly within the first few weeks of treatment, though a causal link has not been established. Dispensing pharmacies should counsel patients and caregivers to watch for and report any mood change promptly.
What documentation does M Care provide with a prucalopride shipment?
Every shipment carries batch-level certificate of analysis, CDSCO export documentation, and CTD or eCTD-format dossier support where the destination regulator requires it. Storage guidance reflects the EU SmPC's 4-year shelf life and moisture-sensitive, original-blister storage; no cold-chain handling is needed for this oral tablet.
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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