Requip (ropinirole) is licensed for Parkinson's disease and moderate-to-severe restless legs syndrome, and FDA and MHRA-approved generic ropinirole tablets from multiple manufacturers sit alongside the originator brand on hospital and neurology formularies.
M Care Exports supplies Requip (ropinirole), a non-ergoline dopamine agonist originated by GlaxoSmithKline (formerly SmithKline Beecham), alongside FDA and MHRA-approved generic ropinirole tablets from manufacturers including Glenmark, Accord, Alembic and Dr Reddy's. It is prescribed for Parkinson's disease as monotherapy or with levodopa, and separately for moderate-to-severe primary restless legs syndrome at a different, lower dose range. M Care is a merchant exporter: we source Requip and generic ropinirole through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Ropinirole exporter and bulk supplier from India.
For hospital neurology, wholesaler and tender-desk orders, M Care quotes ropinirole against buyer specification: brand (Requip or Requip XL) or generic, immediate-release or prolonged-release, strength mix and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the Parkinson's disease titration schedule and the restless legs syndrome dose ceiling differ substantially, and because severe renal or any hepatic impairment changes prescribing, we confirm the buyer's intended indication and patient population 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.
Non-ergoline dopamine agonist; D2/D3 receptor agonist, sourced and documented for export.
Ropinirole is a non-ergoline dopamine agonist that stimulates striatal D2/D3 dopamine receptors, easing the motor symptoms of Parkinson's disease without the ergot-related fibrotic risks of older dopamine agonists. It is dosed orally, not injected, and needs no reconstitution. The MHRA-approved SmPC's flagship indication is Parkinson's disease, used as monotherapy (typically to delay levodopa introduction) or in combination with levodopa when levodopa control becomes inconsistent through the disease course. A second, distinct licensed indication covers moderate-to-severe primary restless legs syndrome, dosed once daily before bedtime at a far lower ceiling than the Parkinson's regimen, so the two indications should never be quoted against the same dose band. Requip is supplied as 0.25mg, 0.5mg, 1mg, 2mg and 5mg film-coated immediate-release tablets, taken three times daily with meals for Parkinson's disease to improve gastrointestinal tolerance; a separate prolonged-release Requip XL tablet exists for once-daily Parkinson's dosing.
Active ingredient
ropinirole hydrochloride. Non-ergoline dopamine agonist; D2/D3 receptor agonist.
Forms and strengths
0.25 mg film-coated tablet; 0.5 mg film-coated tablet; 1 mg film-coated tablet; 2 mg film-coated tablet; 5 mg film-coated tablet.
Indications
Non-ergoline dopamine agonist licensed for Parkinson's disease, as monotherapy or with levodopa, and separately for moderate-to-severe primary restless legs syndrome at a lower dose band.
Administration
oral. Film-coated tablet (immediate-release) and prolonged-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 ropinirole are hospital neurology and movement-disorder pharmacies managing Parkinson's disease caseloads, sleep and restless-legs clinics prescribing the lower RLS dose band, national and regional MoH tender desks running neurology and CNS procurement lists, licensed pharmaceutical wholesalers and importers, and retail pharmacy chains across our GCC and African markets stocking a neurology range where local scheduling permits.
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 ropinirole.
Parkinson's disease dosing starts at 0.25mg three times daily, titrated upward in small weekly increments to a typical maintenance range, with a licensed ceiling of 24mg/day; restless legs syndrome dosing is unrelated and much lower, starting at 0.25mg once daily before bedtime with a ceiling around 4mg/day, so confirm which indication a tender line is for before dispensing against the wrong dose band. Severe renal impairment without dialysis is contraindicated per the SmPC, and any hepatic impairment is also contraindicated, since ropinirole is hepatically cleared; mild-to-moderate renal impairment needs no adjustment. Sudden onset of sleep during daily activities, sometimes without warning, is a labelled risk across both indications, and patients should be counselled against driving until their individual response is known. Impulse control disorders, including pathological gambling, hypersexuality, compulsive spending and binge eating, are a recognised dopamine-agonist class effect and warrant monitoring at every dispensing review, alongside the risk of postural hypotension, particularly during dose escalation. No reconstitution, admixture or cold chain applies; tablets store at controlled room temperature (not above 25°C) and out of direct light, per the Requip SmPC.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, ropinirole travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics. 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; UK shelf life for Requip XL 8mg tablets runs three years in the original package, per the MHRA-approved SmPC. Ropinirole is not on the WHO Model List of Essential Medicines: the WHO list for parkinsonism covers biperiden or trihexyphenidyl, and levodopa combined with carbidopa or benserazide, and a 2015 application to add ropinirole to a national essential medicines list was reviewed and not carried onto the WHO Model List itself, so tender desks should treat ropinirole as a formulary-specific second-line or adjunct choice rather than an EML first-line Parkinson's therapy. On the brand-versus-generic question, Requip (and Requip XL for the prolonged-release tablet) remains the originator line internationally, developed and marketed by GlaxoSmithKline; FDA-approved generic ropinirole tablets from multiple manufacturers, including Glenmark, Accord Healthcare, Alembic and Dr Reddy's, and MHRA-licensed generic ropinirole in the UK, are separately registered and marketed alongside the brand. Buyers genuinely have a brand-or-generic choice on formulary; M Care quotes either against the tender specification and destination-market registration status. Ropinirole is not a controlled substance in the markets we currently review.
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 ropinirole.
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 ropinirole.
- 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.
Ropinirole supply, the specific questions.
Does a generic version of Requip exist?
Yes. FDA-approved generic ropinirole tablets from multiple manufacturers, including Glenmark, Accord Healthcare, Alembic and Dr Reddy's, are registered and marketed in the US alongside the branded Requip and Requip XL lines. MHRA-licensed generic ropinirole is also available in the UK alongside the Requip brand. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
What is ropinirole licensed to treat?
Ropinirole is licensed for Parkinson's disease, used as monotherapy or in combination with levodopa when levodopa control becomes inconsistent, and separately for moderate-to-severe primary restless legs syndrome. The two indications use different, non-interchangeable dose bands, so confirm which indication a buyer needs before quoting a strength mix.
What strengths and forms of ropinirole does M Care supply?
Immediate-release film-coated tablets in 0.25mg, 0.5mg, 1mg, 2mg and 5mg strengths, taken three times daily with meals for Parkinson's disease. A prolonged-release Requip XL tablet also exists for once-daily Parkinson's dosing. Tell us your buyer mix, hospital neurology or restless-legs clinic, and we quote the strength and pack format accordingly.
Is ropinirole on the WHO Essential Medicines List?
No. The WHO Model List for parkinsonism covers biperiden or trihexyphenidyl, and levodopa combined with carbidopa or benserazide; ropinirole is not on the WHO Model List. Tender desks typically specify ropinirole as a formulary-specific second-line or adjunct Parkinson's therapy, or for restless legs syndrome, rather than an EML first-line option.
What monitoring does ropinirole require during dispensing?
Sudden onset of sleep during daily activities is a labelled risk, so patients should be counselled on driving until their response is known. Impulse control disorders, including pathological gambling, hypersexuality and compulsive spending, are a recognised dopamine-agonist class effect that should be reviewed at every dispensing. Severe renal impairment without dialysis and any hepatic impairment are contraindications per the SmPC.
What documentation does M Care provide with a ropinirole shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import, along with confirmation of which brand or generic product and which indication-strength a shipment is intended for.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.