Physiotens (moxonidine) is licensed across the UK and the wider EU as an add-on antihypertensive, but it was never granted FDA approval, so every generic line we quote traces to a European regulatory file, not a US one.
Physiotens (moxonidine), originated by Solvay and now marketed in the UK by Viatris, is a centrally-acting imidazoline I1-receptor agonist used as add-on therapy in essential hypertension once first-line agents are insufficient. M Care Exports sources Physiotens and generic moxonidine tablets through licensed Indian distribution channels and dispatches against buyer specification, never from our own manufacturing.
Moxonidine exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes moxonidine tablets against buyer specification: brand (Physiotens) or generic, strength mix (200 mcg, 300 mcg, 400 mcg) and destination-market regulatory documentation. Because moxonidine's titration ladder and renal dose caps differ from most antihypertensives, we confirm the buyer's target strength split before packing, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements. As an oral solid dosage form, it needs no cold-chain validation, which keeps freight simple against the GCC and African tender lanes we already run for the rest of the cardiovascular range.
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.
Centrally-acting antihypertensive; selective imidazoline I1-receptor agonist, sourced and documented for export.
Moxonidine is a centrally-acting antihypertensive: a selective agonist at imidazoline I1-receptors in the rostral ventrolateral medulla, which reduces peripheral sympathetic outflow and lowers blood pressure without the reflex tachycardia seen with some vasodilators. It is a second-line add-on, not typically a first prescribed agent.
Per the UK SmPC, Physiotens is indicated for mild to moderate essential (primary) hypertension. It sits alongside, not instead of, thiazides, ACE inhibitors, calcium-channel blockers and other first-line classes on most formularies; destination-country labelling should be checked before a tender quote assumes broader use.
Physiotens and generic moxonidine are supplied as 200 mcg, 300 mcg and 400 mcg film-coated tablets, titrated upward over successive three-week intervals rather than started at a fixed maintenance dose. Store below 25 degrees C; shelf life is 2 years from manufacture. It is an oral solid with no cold-chain requirement, packed in cartons of 14, 28 or 84 tablets.
Active ingredient
moxonidine. Centrally-acting antihypertensive; selective imidazoline I1-receptor agonist.
Forms and strengths
200 mcg film-coated tablet; 300 mcg film-coated tablet; 400 mcg film-coated tablet.
Indications
Centrally-acting imidazoline I1-receptor agonist indicated as add-on therapy for mild to moderate essential hypertension, supplied as 200 mcg, 300 mcg and 400 mcg film-coated tablets. Licensed in the UK and the wider EU; never approved by the FDA. Supplied from Indian WHO-GMP partner sites to regulated and semi-regulated markets.
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 moxonidine are chiefly hospital and specialist cardiology pharmacies managing resistant or difficult-to-control hypertension, licensed wholesalers and importers stocking a full antihypertensive range for private and semi-private markets, and MoH tender desks in the GCC building out second-line hypertension formulary lines. Moxonidine does not sit on the WHO Essential Medicines List, so NGO and public-programme demand is lower than for first-line agents; most enquiries come from hospital pharmacists and importers completing an existing cardiovascular catalogue rather than public-sector bulk tenders.
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 moxonidine.
Moxonidine is titrated, not started at target dose: 200 mcg once daily in the morning for the first three weeks, stepping to 400 mcg (single or divided) if control is inadequate, and only then to a maximum 600 mcg daily in divided doses after a further three weeks. A single dose must never exceed 400 mcg. In renal impairment with a GFR of 30 to 60 mL/min, cap the single dose at 200 mcg and the daily total at 400 mcg; below a GFR of 30 mL/min moxonidine is contraindicated outright, so confirm renal function before a hospital dispenses a first pack. Abrupt discontinuation is not advisable; reduce the dose gradually over two weeks to avoid a rebound rise in blood pressure and sympathetic activity, the same caution that applies to clonidine. Where a patient is also on a beta-blocker and both are being withdrawn, stop the beta-blocker first, then moxonidine a few days later, not the reverse. It is contraindicated in pregnancy and should not be used during breastfeeding, since moxonidine is secreted in breast milk. As an oral solid stored below 25 degrees C, it carries no cold-chain requirement, which is worth flagging separately from the dosing caution above when a buyer is assembling a mixed cardiovascular shipment.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, moxonidine ships on standard ambient-temperature logistics rather than the cold-chain lanes we validate for biologics. M Care's documentation chain for this product covers batch-specific certificates of analysis, CDSCO export paperwork from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration ahead of tender participation; we source through WHO-GMP partner sites and pass on that manufacturer's own certification rather than claiming it as our own.
On the brand-versus-generic question: Physiotens is the Viatris-marketed brand in the UK, and moxonidine is off-patent, with generic film-coated tablets separately licensed under the INN in the UK and the wider EU. Moxonidine has never been submitted for, or received, FDA approval, so there is no US-approved generic pathway to point buyers toward; every generic line M Care quotes traces to a European marketing authorisation, not an American one. Buyers should confirm which authorisation their own market recognises before a tender quote 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 moxonidine.
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 moxonidine.
- 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.
Moxonidine supply, the specific questions.
Is there a generic version of Physiotens (moxonidine)?
Yes. Moxonidine is off-patent and generic film-coated tablets are separately licensed under the INN in the UK and the wider EU, alongside the Viatris-marketed brand Physiotens. M Care can quote either against a confirmed purchase order and your market's registration status.
Can M Care supply Physiotens or moxonidine to our market?
Yes, on an import basis. We source Physiotens and generic moxonidine tablets through licensed Indian distribution channels and dispatch against your import authorisation and destination-market documentation requirements; we do not manufacture the product ourselves.
Is moxonidine approved by the FDA in the United States?
No. Moxonidine has never received FDA approval and is not marketed in the US. It is licensed in the UK and the wider EU. Buyers sourcing a US-recognised regulatory file for moxonidine will not find one; M Care's supply traces to European authorisations instead.
What strengths of moxonidine tablets are available?
200 mcg, 300 mcg and 400 mcg film-coated tablets, matching the licensed Physiotens and generic moxonidine strengths used across the titration ladder from initial 200 mcg dosing up to a 600 mcg daily maximum in divided doses.
Does moxonidine need cold-chain shipping?
No. It is an oral film-coated tablet stored below 25 degrees C with a 2-year shelf life, so it moves on standard ambient logistics rather than the validated cold-chain lanes we use for biologics and vaccines.
What documentation does M Care provide with a moxonidine shipment?
Batch-specific certificates of analysis, CDSCO export paperwork from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import or tender participation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
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.