Trandate (labetalol) is licensed for hypertension, including hypertension in pregnancy and hypertensive emergencies given intravenously, and the molecule is now supplied almost entirely as generic tablets and injection rather than under the original brand.
M Care Exports supplies labetalol hydrochloride, a combined alpha-1 and non-selective beta-adrenergic blocker originated as Trandate, still an actively marketed reference brand for hypertension in pregnancy protocols across the hospitals and tender desks we serve. We are a merchant exporter: we source generic labetalol tablets and IV injection through licensed Indian WHO-GMP channels and dispatch on quote, not from our own manufacturing.
Labetalol exporter and bulk supplier from India.
For hospital, wholesaler and MoH tender orders, M Care quotes labetalol tablets (100 mg, 200 mg) and 5 mg/mL injection ampoules against buyer specification: oral maintenance therapy, obstetric hypertensive-crisis stock, or both. Because labetalol therapy must never be stopped abruptly and the injection is dosed by repeated bolus or infusion, we confirm the receiving unit's protocol, pack format and destination-market registration before we build the quote, 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.
Combined alpha-1 and non-selective beta (beta-1/beta-2) adrenergic receptor antagonist, sourced and documented for export.
Labetalol is a combined alpha-1 and non-selective beta (beta-1 and beta-2) adrenergic receptor blocker, an unusual dual mechanism among antihypertensives that lowers blood pressure through peripheral vasodilation as well as reduced cardiac output, without the reflex tachycardia seen with pure alpha-blockers. The FDA label's core indication is management of hypertension, including hypertension in pregnancy, alone or with other agents. The UK Trandate SmPC additionally licenses mild, moderate or severe hypertension, hypertension in pregnancy, and angina pectoris with coexisting hypertension. Injectable labetalol is licensed for hypertensive emergencies requiring rapid, controlled blood pressure reduction, including severe pre-eclampsia, given by repeated intravenous bolus or continuous infusion in a monitored hospital setting. Labetalol carries a boxed warning: sudden withdrawal of beta-blockers, including labetalol, may result in exacerbation of angina and, in patients with coronary artery disease, may precipitate myocardial infarction, so dosing is always tapered.
Active ingredient
labetalol hydrochloride. Combined alpha-1 and non-selective beta (beta-1/beta-2) adrenergic receptor antagonist.
Forms and strengths
100 mg film-coated tablet; 200 mg film-coated tablet; 400 mg film-coated tablet; 5 mg/mL solution for injection/infusion.
Indications
Labetalol hydrochloride is a combined alpha and beta-adrenergic blocker indicated for hypertension, including hypertension in pregnancy, and given intravenously for hypertensive emergencies. Supplied from Indian WHO-GMP facilities as generic tablets and injection, and where registered, alongside the reference brand Trandate, to regulated and semi-regulated export markets.
Administration
oral, intravenous. Film-coated tablet; solution for injection/infusion.
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 labetalol are hospital obstetric and maternal-medicine pharmacies stocking it as first-line injectable therapy for severe pre-eclampsia and hypertensive emergencies in pregnancy, general-medicine and cardiology outpatient pharmacies dispensing the oral maintenance line, national and regional MoH tender desks running cardiovascular and maternal-health procurement lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation maternal-health programmes where labetalol sits on the essential obstetric-emergency drug tray alongside magnesium sulfate.
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 labetalol.
Oral dosing starts at 100 mg twice daily, titrated in 100 mg increments every 2-3 days to a usual maintenance range of 200-400 mg twice daily; severe hypertension can require up to 2,400 mg a day in divided doses. Never stop labetalol abruptly: the boxed warning covers rebound exacerbation of angina and, in patients with coronary artery disease, reported myocardial infarction on sudden withdrawal, so any switch or discontinuation needs a taper plan on the discharge script. For hypertensive emergency, including severe pre-eclampsia, US labelling describes an initial 20 mg IV dose followed by repeated 40-80 mg boluses at 10-minute intervals (maximum 80 mg per dose); UK injection labelling instead specifies 50 mg boluses repeatable every 5 minutes, or a titrated infusion, so we confirm which protocol the receiving unit follows before dispatch. Ampoules are a clear, colourless-to-pale-yellow solution that should be protected from light and heat; discoloured or particulate solution must be discarded, per both the FDA and UK labelling. Labetalol carries a rare but serious hepatocellular injury signal: a pooled case review found onset from 7 to 365 days after starting therapy (median around 60 days), with reports progressing to hepatic necrosis and, rarely, fulminant liver failure. Baseline and periodic liver function tests are reasonable in longer courses, and the drug should not be restarted after a suspected hepatic event. It is one of the few beta-blockers preferred in pregnancy, having not shown the growth-restriction signal linked to some other agents in the class.
The documentation pack a regulator actually asks for.
Labetalol tablets travel on standard ambient-temperature logistics; the injection is a room-temperature aqueous solution that should be kept out of direct light but, again, needs no validated cold-chain lane. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires it, CTD or eCTD-format dossier support for local registration. On brand versus generic: Trandate remains an actively marketed reference product in the UK, currently authorised to RPH Pharmaceuticals AB (PL 36301/0053) and historically sold as 50 mg, 100 mg, 200 mg and 400 mg tablets, though the 50 mg tablet was discontinued from July 2025, with a Specials-order labetalol oral suspension proposed as a bridge for patients unable to switch strength; the 5 mg/mL injection is unaffected. In the US, Drugs@FDA shows all Trandate tablet strengths (100 mg, 200 mg, 300 mg and 400 mg) as discontinued, not for safety or efficacy reasons, and labetalol is now supplied there as generic tablets and injection from multiple manufacturers. Buyers should specify generic labetalol for US-pattern registration and either brand or generic for UK, EU and GCC markets, since Trandate is still an active reference listing there. The UK Trandate supply notification is a live example of why formulary desks keep a secondary export source qualified. Labetalol does not appear on the current WHO Model List of Essential Medicines, though it is named as a first-line option for hypertension in pregnancy and hypertensive emergency in national and international obstetric guidelines, and tender desks in our markets frequently specify it on that clinical basis regardless of EML status.
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 labetalol.
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 labetalol.
- 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.
Labetalol supply, the specific questions.
Is Trandate still available, or is labetalol generic-only now?
It depends on the market. Trandate remains an actively marketed reference brand in the UK, historically supplied as 50 mg, 100 mg, 200 mg and 400 mg tablets plus 5 mg/mL injection, though the 50 mg tablet was discontinued from July 2025. In the US, Drugs@FDA lists all Trandate tablet strengths as discontinued and labetalol is supplied only as generic tablets and injection from multiple manufacturers. M Care quotes against whichever registration pattern your destination market requires.
Why is labetalol used in pregnancy specifically?
Labetalol's combined alpha and beta-blocking action lowers blood pressure without the growth-restriction signal reported with some older beta-blockers, which is why it is named as a first-line oral agent for hypertensive disorders of pregnancy, and as a standard intravenous option for severe pre-eclampsia and hypertensive emergency, in national and international obstetric guidelines.
Can labetalol be stopped abruptly if a patient changes therapy?
No. Labetalol carries a boxed warning against sudden discontinuation, which can precipitate exacerbation of angina and, in patients with coronary artery disease, myocardial infarction. Any switch off labetalol needs a tapering schedule, which should be flagged clearly on discharge and transfer paperwork.
Does labetalol injection need cold-chain shipping?
No. The 5 mg/mL injection is a room-temperature aqueous solution that should be protected from light and heat. Discoloured or particulate solution should be discarded, per both FDA and UK labelling.
Is labetalol on the WHO Essential Medicines List?
No. Labetalol is not on the current WHO Model List of Essential Medicines, but it is a standard first-line agent in national and international obstetric hypertension guidelines, and many of our tender desks specify it on that clinical basis.
What liver monitoring does labetalol therapy need?
Labetalol carries a rare hepatocellular injury signal. A pooled case review found onset from 7 days to 12 months after starting therapy, with a median around 60 days, and reports of hepatic necrosis and, rarely, liver failure. Baseline and periodic liver function tests are reasonable for longer courses, and labelling advises against restarting labetalol after a suspected liver event without another confirmed cause.
What strengths and pack formats does M Care supply for labetalol?
Oral film-coated tablets, typically 100 mg and 200 mg for maintenance dosing, and 5 mg/mL injection ampoules for hypertensive-emergency and obstetric use. Tell us your dosing protocol and whether you need the oral line, the injectable, or both, and we quote the strength mix and pack count accordingly.
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.