Duvadilan (isoxsuprine), a beta-2 adrenergic agonist used across the GCC, Africa and Southeast Asia as a tocolytic in threatened preterm labour and as a peripheral vasodilator, has lost its US marketing approval and current UK licensing for want of adequate controlled-trial evidence, yet remains a CDSCO-approved first-line tocolytic in Indian obstetric practice and a routinely stocked originator-plus-generic molecule across the markets M Care serves.
M Care Exports supplies isoxsuprine hydrochloride, the beta-2 adrenergic agonist marketed internationally under the originator brand Duvadilan, as tablets, sustained-release capsules and injection. It is used as a tocolytic in threatened or active preterm labour and, historically, as a peripheral vasodilator, sourced through licensed Indian manufacturing and distribution channels and dispatched on quote to hospital pharmacies, importers and tender desks outside India.
Isoxsuprine exporter and bulk supplier from India.
For hospital obstetric units, wholesalers and tender desks, M Care quotes isoxsuprine tablets, sustained-release capsules and injection against buyer specification: brand (Duvadilan) or generic, strength mix and destination-market regulatory documentation, drawn from WHO-GMP manufacturer lines on the M Care roster. Because isoxsuprine no longer holds an approved US indication and obstetric dosing follows an intravenous-to-oral titration protocol rather than a single fixed dose, we confirm the buyer's intended clinical use and destination labelling before dispatch, then align CTD or country-specific dossier paperwork to the 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-2 adrenergic agonist; peripheral and uterine smooth-muscle vasodilator (tocolytic), sourced and documented for export.
Isoxsuprine is a beta-2 adrenergic agonist that relaxes vascular and uterine smooth muscle, widening peripheral blood vessels and reducing uterine contractility. Two distinct clinical uses persist across different markets: as a tocolytic to arrest or delay threatened and active preterm labour, and as a vasodilator historically used for peripheral vascular disease, cerebrovascular insufficiency symptoms and Raynaud's phenomenon, though that latter use has fallen out of regulated-market favour for want of controlled-trial evidence. It is dosed orally, intramuscularly and intravenously depending on clinical urgency, with intravenous infusion titrated stepwise and stepped down to intramuscular then oral maintenance dosing once contractions settle. Duvadilan is supplied as 10 mg tablets, 40 mg sustained-release capsules and 10 mg injection ampoules.
Active ingredient
Isoxsuprine hydrochloride. Beta-2 adrenergic agonist; peripheral and uterine smooth-muscle vasodilator (tocolytic).
Forms and strengths
10 mg tablet; 40 mg sustained-release capsule; 10 mg injection ampoule.
Indications
Isoxsuprine, a beta-2 adrenergic agonist used as a tocolytic in threatened and active preterm labour and, historically, as a peripheral vasodilator. Supplied as originator Duvadilan and generic isoxsuprine hydrochloride from Indian manufacturing channels to regulated and semi-regulated markets outside India where the molecule remains registered.
Administration
Oral, Intramuscular, Intravenous. Tablet, sustained-release capsule and injection.
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 isoxsuprine are chiefly hospital obstetric and maternity-unit pharmacies managing threatened or active preterm labour, national and regional MoH tender desks running maternal-health and essential-obstetric-drug formularies, licensed pharmaceutical wholesalers and importers across the GCC, Africa and Southeast Asia, and NGO or donor-funded maternal-health programmes procuring tocolytic or peripheral-vasodilator stock for markets where isoxsuprine remains registered.
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 isoxsuprine.
Isoxsuprine dosing for preterm labour follows a titration protocol rather than a fixed dose: intravenous infusion typically starts low and is increased stepwise at intervals until uterine contractions settle, then steps down to intramuscular and finally oral maintenance dosing, continued until term or as the treating obstetrician directs. This staged approach lets clinicians find the lowest effective dose and limits maternal tachycardia, palpitation and hypotension, the most frequently reported adverse effects. Isoxsuprine should not be given immediately after childbirth or when arterial bleeding is present, and infusion is normally given with the patient positioned in the left lateral position to reduce postural hypotension. Beta-adrenergic tocolytics of this class can cause maternal and fetal tachycardia, and neonatal hypoglycaemia or hypocalcaemia has been reported after prolonged maternal use close to delivery, so neonatal teams should be informed when isoxsuprine has been used for tocolysis. Isoxsuprine tablets, capsules and ampoules need no cold-chain handling; ambient, moisture-protected storage is standard across the range.
The documentation pack a regulator actually asks for.
Isoxsuprine's regulatory position is unusual among the cardiovascular molecules M Care ships: it no longer holds a US marketing approval. Originally approved in 1959 as Vasodilan for safety only, its efficacy for peripheral vascular disease and dementia-related symptoms was reviewed under FDA's Drug Efficacy Study Implementation programme and found not supported by adequate, controlled studies; FDA's final decision closed that docket in July 2020, and the agency wrote to remaining unapproved-listing holders in August 2021 confirming isoxsuprine hydrochloride tablets could no longer lawfully be distributed in US interstate commerce. We found no current UK-licensed isoxsuprine product on the MHRA/emc register either, and isoxsuprine does not appear on the WHO Model List of Essential Medicines. The molecule's active use is concentrated where it remains registered: in India isoxsuprine is one of only three tocolytics, alongside ritodrine and atosiban, approved by the Central Drugs Standard Control Organisation for preterm labour, and the Abbott-marketed originator Duvadilan, plus several generic isoxsuprine hydrochloride manufacturers, is stocked across pharmacies in the Philippines and other Asian and African markets M Care serves. India itself is not an M Care export market; buyers should treat isoxsuprine as a formulary-specific, destination-registered molecule rather than a globally standardised one, and confirm local registration status before a tender specification is finalised.
How a licensed importer actually brings a consignment like this in is covered once, in the licensed import route guide, rather than repeated on every molecule page.
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 isoxsuprine.
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 isoxsuprine.
- 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.
Isoxsuprine supply, the specific questions.
Does M Care supply Duvadilan or generic isoxsuprine?
Both. Duvadilan, the Abbott-marketed originator, and generic isoxsuprine hydrochloride from other Indian WHO-GMP manufacturers are both available through M Care's sourcing channels. Tell us whether your tender or hospital formulary specifies the brand or is open to generic, and we quote accordingly, matching strength and dosage form to your destination market's registration.
Why is isoxsuprine no longer marketed in the United States?
Isoxsuprine (Vasodilan, NDA 11832) was approved in 1959 for safety only. FDA's Drug Efficacy Study Implementation review found no adequate, well-controlled studies proving it effective for peripheral vascular disease or dementia-related symptoms, and a July 2020 Federal Register notice made that finding final. FDA wrote to remaining unapproved-listing holders in August 2021 confirming the product could no longer lawfully be distributed in US interstate commerce.
What is isoxsuprine used for?
Isoxsuprine is a beta-2 adrenergic agonist with two distinct uses. In obstetric practice across India, the Philippines and other Asian markets it is used as a tocolytic to arrest or delay threatened and active preterm labour. Historically it was also used as a peripheral vasodilator for arteriosclerosis obliterans, Buerger's disease, Raynaud's phenomenon and cerebrovascular insufficiency symptoms, though regulators in the US and UK no longer consider that evidence base adequate.
What strengths and dosage forms does M Care supply?
Duvadilan and generic isoxsuprine hydrochloride are supplied as 10 mg tablets, 40 mg sustained-release capsules for oral maintenance dosing, and 10 mg injection ampoules for intramuscular or intravenous use. Tell us your indication, obstetric tocolysis or peripheral-vascular use, and we quote the pack mix your protocol requires.
Is isoxsuprine safe to use immediately after childbirth?
No. Labelling states isoxsuprine should not be given immediately postpartum or when arterial bleeding is present. Intravenous tocolytic use is titrated stepwise and stopped once uterine contractions settle, with the patient kept in the left lateral position to reduce postural hypotension; maternal tachycardia, palpitation and low blood pressure are the most frequently reported effects, and neonatal teams should be told when isoxsuprine has been used close to delivery.
Is isoxsuprine on the WHO Essential Medicines List?
No. Isoxsuprine does not appear on the current WHO Model List of Essential Medicines, and it is not an antibiotic, so the WHO AWaRe classification does not apply to it. Its continued clinical use is destination-specific: in India it is one of only three tocolytics, alongside ritodrine and atosiban, approved by the Central Drugs Standard Control Organisation for preterm labour, a regulatory context that shapes the manufacturing base rather than an M Care sales market, since India is not a market we export to.
Does isoxsuprine need cold-chain handling?
No. Isoxsuprine tablets, sustained-release capsules and injection ampoules are ambient, moisture-protected products and travel on standard logistics rather than the validated cold-chain lanes M Care uses for biologics and insulins. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD-aligned dossier support.
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.
Send the specifics. You'll have a price inside one working day.
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