Tolvaptan Tablets: Export Supply from India
Tolvaptan is not a molecule you order the way you order a general ward line. It is a hospital-controlled aquaretic carrying a boxed warning that governs where the first dose can be given, and its labelling has narrowed since approval rather than widened. M Care Exports has traded pharmaceuticals out of India since 2003. We stock the hyponatraemia presentation, 15mg and 30mg tablets, and nothing above that, and we would rather tell you that in the first paragraph than after you have sent a specification we cannot fill.
How we source and move tolvaptan
To be direct about what we are: M Care is a merchant-exporter and wholesaler, not a manufacturer. We do not own a plant and we hold no WHO-GMP or EU-GMP certificate, because those belong to the manufacturing site. What we do hold is ISO 9001:2015 for our own trading quality system, and long-standing purchase relationships with Indian tolvaptan lines. India has a genuinely competitive tolvaptan field, Sun Pharma's Natrise among the CDSCO-approved brands, which means we can put more than one qualified source in front of you rather than defending a single tie-up. Our catalogue runs to nineteen tolvaptan SKUs, all of them 15mg or 30mg tablets, across those brands and pack counts.
Sourced from approved Indian lines
We buy from CDSCO-approved tolvaptan manufacturers and can supply from WHO-GMP-listed manufacturing lines where your tender or registration file requires that status. The certificate is issued to the plant, not to us, and we pass it through unaltered.
Hyponatraemia strengths only
Our nineteen SKUs are 15mg and 30mg tablets. We do not stock the 45mg, 60mg or 90mg strengths used in ADPKD regimens, and we will not source them speculatively for a market whose liver-monitoring controls we cannot verify.
Order quantities set at the plant
We do not publish an MOQ, because we do not set one. The floor is the source manufacturer's batch-release minimum for the strength and pack you want, and it moves between the two strengths. We confirm it in writing with your quote.
Pricing on request, per destination
Tolvaptan pricing turns on strength, pack size, batch quantity and destination duty treatment. We do not list prices. Send the destination and volume and you get a costed offer rather than an indicative figure that changes later.
Tolvaptan at a glance for procurement
Active ingredient
Tolvaptan, a selective oral vasopressin V2-receptor antagonist. It blocks V2 receptors in the distal nephron and collecting duct, producing aquaresis (clearance of electrolyte-free water) without driving the electrolyte loss a conventional diuretic causes.
ATC classification
C03XA01, under vasopressin antagonists (C03XA) within the diuretics group. The WHO defined daily dose is 30mg oral. Useful for tender line-item coding and customs classification queries.
Strengths we stock
15mg and 30mg tablets, nineteen SKUs across brands and pack counts. The higher strengths used in ADPKD split-dose regimens are outside our catalogue, so if your specification calls for 45mg, 60mg or 90mg we are not your supplier and will say so at enquiry stage.
Reference brands
Buyers most often benchmark the hyponatraemia presentation against Samsca. Jynarque and Jinarc are the ADPKD brands, named here only so you can place the strengths we do not carry. We supply Indian-manufactured product, not these brands.
Regulatory class
Prescription-only in every market we serve, and hospital-restricted in practice: labelling requires initiation and re-initiation in a setting where serum sodium can be monitored closely. Not listed on the WHO Model List of Essential Medicines.
Handling
Store at 25°C, excursions permitted between 15°C and 30°C, in the original blister and protected from moisture. No cold chain, which keeps airfreight and consolidated sea shipments straightforward compared with our biological lines.
The desks that enquire about tolvaptan
Tolvaptan is a specialist buy, so the enquiries are specific rather than volume-driven. These are the buyer profiles we actually see against the 15mg and 30mg lines, and what each one tends to need before an order closes.
African importers and distributors
Our live search demand includes buyers typing "tolvaptan supplier india to africa" directly. Typical need: modest, repeatable quantities of 15mg for tertiary hospitals, with a CoPP that satisfies the national medicines authority and a source the registration file can name.
Hospital and government tender buyers
Tolvaptan appears on nephrology and cardiology tender lines rather than in general formulary bundles. We supply the documentation set that tender committees score on, and we will tell you plainly if a lot size is below the plant's release minimum instead of accepting the bid and failing on delivery.
GCC and SE Asia specialty distributors
Usually looking to add a nephrology line alongside an existing renal portfolio. These buyers care about continuity of a single source across repeat orders, which is why we confirm the manufacturing site up front rather than substituting between shipments.
LatAm and EU registration-stage partners
Buyers who need the CTD dossier assembled alongside their own filing. Worth noting early that EU labelling for the hyponatraemia presentation is narrower than the US version, covering SIADH, so check your target scope before the file is built. We compile the dossier and CoPP with you. We do not file in your name and we do not claim a regulator relationship we do not have.
Safety profile your clinical and regulatory teams must read
The hyponatraemia presentation carries a boxed warning, and its first requirement is a logistical one your prescribing network has to satisfy: tolvaptan should be initiated and re-initiated only in a hospital where serum sodium can be monitored closely. This is not a precaution that can be managed in an outpatient setting. Correcting hyponatraemia too quickly (a rise faster than roughly 12 mEq/L in 24 hours) can cause osmotic demyelination, whose labelled consequences include dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. Tolvaptan is also not for an urgent rise in serum sodium: it is not a rescue therapy for acutely symptomatic severe hyponatraemia, and procurement teams should not position it as one.
Two label facts are routinely missed in enquiries, and both cut against how tolvaptan is sometimes marketed. First, treatment is capped at 30 days to limit the risk of liver injury, so it is not a maintenance line and your volume modelling should not assume chronic dosing. Second, and despite what older references still say, use should be avoided in patients with underlying liver disease, including cirrhosis, because the ability to recover from liver injury may be impaired. Cirrhotic hyponatraemia appeared in the original indication and was removed. If a supplier or a legacy datasheet still lists cirrhosis as an indication for tolvaptan, that document is out of date.
The ADPKD indication sits behind a separate boxed warning for serious and potentially fatal liver injury, with post-marketing reports of acute liver failure requiring transplantation, and in the United States it is confined to a restricted-distribution programme (the Tolvaptan for ADPKD Shared System REMS) with liver enzyme and bilirubin testing at baseline, at two and four weeks, monthly through 18 months and quarterly thereafter. That obligation is one reason we hold no ADPKD strengths. Further points for your teams: tolvaptan is contraindicated with strong CYP3A inhibitors, and concomitant moderate CYP3A inhibitors should be avoided. It is also contraindicated in anuria, in hypovolaemic hyponatraemia, and in patients unable to sense or respond to thirst. This page is written for pharmaceutical procurement professionals as reference context on a product we trade. Any figure above is drawn from approved labelling and is not dosing guidance. Prescribing and monitoring decisions belong to the treating clinician working from the approved label in your market.
"Written for professional buyers and importers, not as medical advice. Prescribing decisions sit with the treating clinician and the approved label in your market.
Documentation we issue with tolvaptan consignments
Tolvaptan registration files get scrutinised harder than a general-ward molecule, largely because of the hepatotoxicity signal that shaped the label. Here is what we genuinely provide, and where the line sits between our work and the manufacturer's.
CTD dossier compilation
We assemble the Common Technical Document with you, working from the manufacturer's technical content. The dossier is compiled alongside your filing team. We are not the applicant and we do not submit on your behalf.
Certificate of Pharmaceutical Product (CoPP)
Obtained from the manufacturing site's licensing authority in the WHO format most national regulators expect. We coordinate the request and legalisation, and pass the certificate to you as issued.
Batch-specific CoA and manufacturer's release documents
Certificate of Analysis against the declared specification for the exact batch shipped, plus the manufacturing site's GMP certificate. These are the plant's documents, issued in the plant's name, and we forward them unaltered.
Approved labelling and the boxed warning
Pack inserts carrying the boxed warning text, the hospital-initiation requirement, the 30-day duration limit and the contraindications as the source label states them. We will not strip or soften a warning to ease a registration, and we will say so if asked.
Export and shipment paperwork
Commercial invoice, packing list, certificate of origin, and the export licence documentation your customs authority requires. Free-sale and legalisation support arranged per destination.
Molecules buyers source alongside Tolvaptan.
Meropenem
Carbapenem injection, frequently on the same tertiary-hospital and ICU tender lines that carry tolvaptan.
Spironolactone
Aldosterone antagonist, and a genuinely different mechanism: it clears sodium with the water, where tolvaptan clears free water alone. Buyers stock both across heart-failure portfolios.
Tranexamic Acid
Antifibrinolytic, commonly bundled into the same hospital supply contracts by our distributor buyers.
How ordering works.
- Send the strength, quantity and destination country. Our tolvaptan catalogue is 15mg and 30mg. If your specification calls for an ADPKD strength, that single line tells us immediately that we are not the right supplier, and we will say so rather than quote around it.
- We confirm source, availability and the real order floor. You get the named manufacturing site, the current stock position across our nineteen SKUs, the plant's batch-release minimum for your strength, and a costed offer against your destination. No indicative pricing that moves later.
- Registration and documentation work runs in parallel. If you are filing, we begin CTD compilation and the CoPP request while commercial terms are settled, rather than starting the paperwork after the PO lands. Confirm your target indication scope first, since EU and US labelling differ here.
- Dispatch, with the document set travelling ahead. Ambient shipment by air or consolidated sea. Batch CoA, labelling and clearance documents go to your broker before the consignment arrives, so nothing sits at the port waiting on an email.
Tolvaptan supply, the specific questions.
Do you supply the 45mg, 60mg and 90mg tolvaptan strengths for ADPKD?
No. Our tolvaptan catalogue is nineteen SKUs of 15mg and 30mg tablets, the hyponatraemia presentation. We hold no ADPKD strengths. Those regimens are dosed as a split pair, a larger morning dose plus a smaller dose about eight hours later, and they sit behind a boxed warning for serious liver injury with a mandatory enzyme-monitoring schedule. In the United States they move only through the Tolvaptan for ADPKD Shared System REMS, which a merchant-exporter cannot supply into. We would rather turn the enquiry away than source into a market whose monitoring controls we cannot verify. If an exporter offers you ADPKD tolvaptan for the US outside the REMS, that is a signal to walk away.
Can tolvaptan be registered for hyponatraemia in cirrhosis?
Not on current labelling, and this is the single most common error we see in tolvaptan enquiries. Cirrhotic hyponatraemia was part of the original indication and was subsequently removed. The label now directs that use be avoided in patients with underlying liver disease, including cirrhosis, because the ability to recover from liver injury may be impaired. Older datasheets, distributor catalogues and secondary references still repeat the original wording, so if your file was drafted from one of those it needs checking before submission. Verify against the approved label in your target market rather than against a trader's product sheet, ours included.
Is tolvaptan on the WHO Essential Medicines List?
No, tolvaptan is not on the WHO Model List of Essential Medicines. We mention this because buyers sometimes assume EML status will carry a tender justification or a duty concession. It will not here. Tolvaptan is procured as a specialist nephrology and cardiology line on clinical need, and your tender documentation should be built on that basis rather than on an EML reference.
Does M Care hold WHO-GMP or WHO prequalification for tolvaptan?
No, and no exporter honestly can. GMP certification and WHO prequalification are granted to a manufacturing site, never to a trading company. M Care is a merchant-exporter. Our own credential is ISO 9001:2015, covering our trading and quality processes. What we can say accurately is that we supply from WHO-GMP-listed manufacturing lines and pass the plant's certificates through to you unaltered. Treat any exporter claiming WHO-GMP in its own name with caution.
What is the minimum order quantity, and what does tolvaptan cost?
We publish neither, and the reason is the same for both. The order floor is set by the source manufacturer's batch-release minimum for the strength and pack you want, so it is not ours to invent, and it varies across our nineteen SKUs. Price turns on strength, pack size, batch quantity and destination duty treatment. Send us the strength, quantity and destination country, and you receive a firm costed offer with the confirmed order floor in writing.
We are an African importer. What should be in place before we register tolvaptan?
Three things, in this order. First, confirm your prescribing network is hospital-based, because labelling requires initiation and re-initiation where serum sodium can be monitored closely, and a registration that assumes outpatient supply will not survive contact with the label. Second, model the demand against a 30-day treatment cap rather than chronic dosing, since that changes your volume forecast substantially. Third, confirm your national authority's CoPP format and legalisation route, because that determines our lead time more than anything on the manufacturing side. Get those settled and the commercial side is comparatively simple.
Can we choose the manufacturing source, or do you substitute between shipments?
You choose, and we do not substitute silently. India has several CDSCO-approved tolvaptan lines, which is an advantage for you: we can present more than one qualified source rather than defending a single tie-up. Once your registration file names a site, that site stays named. If a source cannot meet a repeat order, we tell you and re-quote rather than shipping an equivalent from elsewhere, because a substituted site invalidates a registration.
Send us the strength and the destination
Tolvaptan quotes go wrong when the enquiry says only "tolvaptan, best price". Tell us the strength, the quantity and the destination country, and our team returns a costed offer with the named manufacturing site and the plant's confirmed order floor. Our catalogue is 15mg and 30mg tablets. If you need an ADPKD strength, we will tell you that at the first reply rather than the fifth. If you are at registration stage, we start the CTD and CoPP work alongside the commercial conversation rather than after it. Trading from India since 2003, ISO 9001:2015.