Vyndaqel and Vyndamax (tafamidis) are Pfizer's oral transthyretin stabiliser capsules for ATTR cardiomyopathy, stored at room temperature, with two strengths that are not interchangeable mg for mg.
M Care Exports supplies Vyndaqel and Vyndamax (tafamidis), the Pfizer originator, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Vyndaqel 20 mg, Vyndamax 61 mg or Vyndaqel 61 mg, send the destination, the strength and the quantity, and we confirm the registration route before we quote.
Tafamidis exporter and bulk supplier from India.
"We need a partner for tafamidis" is a typical cardiology-centre or importer enquiry. M Care is a merchant-exporter: we source the Pfizer originator against your specification and quote per destination. The first question is which product your regulator has registered, because the same molecule is sold under different names in different markets. In the US, Vyndaqel is the 20 mg tafamidis meglumine capsule and Vyndamax is the 61 mg tafamidis capsule; Drugs@FDA now lists US Vyndaqel as discontinued, while Vyndamax remains a prescription product. In the EU, both the 20 mg and the 61 mg capsule carry the Vyndaqel name. A quote therefore starts with the brand name on your registration, the strength, the pack and the quantity. We confirm the registration position for your destination before we offer a price basis.
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.
Transthyretin (TTR) stabiliser, sourced and documented for export.
Tafamidis is a selective stabiliser of transthyretin (TTR), taken by mouth once daily. The FDA label for Vyndaqel (tafamidis meglumine 20 mg capsules) and Vyndamax (tafamidis 61 mg capsules) gives one indication: cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, to reduce cardiovascular mortality and cardiovascular-related hospitalisation. The US dose is either Vyndaqel 80 mg (four 20 mg capsules) or Vyndamax 61 mg (one capsule) once daily. The EU splits the indications by strength. The Vyndaqel 20 mg SmPC covers adults with stage 1 symptomatic polyneuropathy from transthyretin amyloidosis, to delay peripheral neurologic impairment, at 20 mg once daily. The Vyndaqel 61 mg SmPC covers adults with wild-type or hereditary transthyretin amyloidosis with cardiomyopathy, at one 61 mg capsule once daily. The EU SmPC states that 61 mg of tafamidis corresponds to 80 mg of tafamidis meglumine, and that the two are not interchangeable on a per mg basis. The FDA label lists no contraindications.
Active ingredient
Tafamidis meglumine (20 mg capsule) and tafamidis (61 mg capsule). Transthyretin (TTR) stabiliser.
Forms and strengths
20 mg tafamidis meglumine soft capsule (Vyndaqel; equivalent to 12.2 mg tafamidis); 61 mg tafamidis soft capsule (Vyndamax in the US, Vyndaqel 61 mg in the EU).
Indications
Tafamidis, an oral selective stabiliser of transthyretin, indicated for transthyretin amyloid cardiomyopathy in adults (FDA and EU 61 mg) and, in the EU 20 mg labelling, stage 1 symptomatic transthyretin polyneuropathy. Supplied as the Pfizer originator Vyndaqel and Vyndamax, stored at room temperature.
Administration
Oral. Soft capsule (blister pack).
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 are hospital pharmacists and cardiology or amyloidosis-centre formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Vyndamax 61 mg for a cardiology centre" or "We need a partner for Vyndaqel 20 mg for a tender". Each destination has its own registration route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. Because the capsules come in blister packs with a dated shelf life, buyers also ask for remaining shelf life at arrival.
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 tafamidis.
Several points matter on the ward. First, dose and product must not be mixed up. The FDA label says Vyndamax and Vyndaqel are not substitutable on a per mg basis: the US dose is Vyndaqel 80 mg as four 20 mg capsules, or one Vyndamax 61 mg capsule, once daily. The EU SmPC says the same for tafamidis and tafamidis meglumine. Second, handling is simple: swallow the capsule whole, do not crush or cut it, and in the EU it may be taken with or without food. If vomiting follows a dose and the intact capsule is seen, the EU SmPC advises a further dose if possible; if no capsule is seen, no extra dose is given. Third, tafamidis inhibits the efflux transporter BCRP, so patients on BCRP substrates such as methotrexate, rosuvastatin or imatinib need monitoring. Fourth, the EU SmPC advises contraception during treatment and for one month after stopping, and notes no more than 44 mg of sorbitol per capsule. For the cardiomyopathy indication, the EU SmPC also asks that treatment be started under a physician knowledgeable in amyloidosis or cardiomyopathy.
The documentation pack a regulator actually asks for.
Storage is not a cold-chain issue. The FDA label sets storage at controlled room temperature, 20 to 25 °C, with excursions permitted to 15 to 30 °C. The EU SmPC lists no special storage precautions for the 61 mg capsule and says not to store above 25 °C for the 20 mg capsule, with a shelf life of 2 years for both. The US packs are blister cartons, for example 30 capsules of Vyndamax 61 mg, and the EU packs are perforated unit-dose blisters of 30 x 1 capsules, with a 90-capsule multipack; the SmPC notes not all pack sizes may be marketed. The EU SmPC names Pfizer Europe MA EEIG as marketing authorisation holder, and the FDA label directs adverse-event reports to Pfizer Inc. The EMA lists Vyndaqel as authorised in the EU since 16 November 2011 and under additional monitoring, with the polyneuropathy indication authorised under exceptional circumstances. M Care documentation covers batch certificates of analysis and destination-aligned dossier support where the regulator requires it.
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.
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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 tafamidis.
- 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.
Tafamidis supply, the specific questions.
What does Vyndaqel or Vyndamax cost, and what sets the price for an importer?
We do not publish prices, so we cannot give a Vyndamax 61 mg price or a Vyndaqel cost here. The landed cost of tafamidis depends on which brand and strength your registration names (Vyndaqel 20 mg, Vyndaqel 61 mg or Vyndamax 61 mg), the pack size, the quantity, the destination's registration route, the Incoterms and the freight lane. Both products are stored at room temperature, so there is no refrigerated freight line, but a tender may still ask for shelf-life and batch documents. M Care Exports quotes per destination once you send the brand, strength, volume and country.
Vyndaqel vs Vyndamax: how do the labels differ?
On the FDA label, both are transthyretin stabilisers for ATTR-CM in adults. Vyndaqel is tafamidis meglumine 20 mg capsules, dosed at 80 mg as four capsules once daily. Vyndamax is tafamidis 61 mg capsules, dosed as one capsule once daily. The label says they are not substitutable on a per mg basis. Drugs@FDA lists US Vyndaqel as discontinued and Vyndamax as a prescription product. In the EU there is no separate Vyndamax name: the 20 mg capsule (tafamidis meglumine) and the 61 mg capsule (tafamidis) are both Vyndaqel, with different indications. This is a comparison of label facts, not a recommendation. Your prescriber and your registered label decide which product is used.
What are Vyndaqel 20 mg and Vyndaqel 61 mg, and what is each indicated for?
Per the EU SmPC, Vyndaqel 20 mg soft capsules contain 20 mg of tafamidis meglumine, equivalent to 12.2 mg tafamidis, and are indicated for adults with stage 1 symptomatic transthyretin polyneuropathy, at 20 mg once daily. Vyndaqel 61 mg soft capsules contain 61 mg of tafamidis and are indicated for wild-type or hereditary transthyretin amyloidosis in adults with cardiomyopathy. The same SmPC document also lists a 61 mg film-coated tablet, indicated for wild-type transthyretin amyloidosis in adults with cardiomyopathy. In the US, the FDA label lists only the cardiomyopathy indication, for Vyndaqel 20 mg and Vyndamax 61 mg. Check which indication your destination's registration carries before you order.
Is there a generic tafamidis or Vyndamax generic, and what is its generic name and drug class?
The generic name is tafamidis (tafamidis meglumine for the 20 mg product), and the class is a transthyretin stabiliser. In the EU, the EMA lists Tafamidis Accord (Accord Healthcare S.L.U.) as a generic of Vyndaqel, with a CHMP opinion on 23 July 2026 and an EU marketing authorisation issued on 18 September 2026, for hereditary ATTR cardiomyopathy. For the US, we have not confirmed an FDA-approved generic from a fetched FDA source, so check the FDA Orange Book for the current position. For India we have no regulator source to cite, so we state no position. We do not claim any generic is registered in your destination.
Has Vyndaqel been discontinued?
In the US, Drugs@FDA lists Vyndaqel (tafamidis meglumine 20 mg capsules) as discontinued, and the DailyMed listing gives a marketing end date of 31 July 2027 for the 120-capsule carton. Vyndamax 61 mg remains listed as a prescription product. In the EU, the EMA lists Vyndaqel, in both the 20 mg and 61 mg strengths, as authorised. Availability can differ by market and pack, and the EU SmPC notes that not all pack sizes may be marketed. Tell us the brand, strength and destination, and we confirm current supply before quoting.
Does tafamidis need cold-chain shipping, and who makes it?
No. The FDA label sets storage at 20 to 25 °C, with excursions permitted to 15 to 30 °C. The EU SmPC lists no special precautions for the 61 mg capsule, and not above 25 °C for the 20 mg capsule, with a 2-year shelf life. Pfizer is the originator: the FDA label directs reports to Pfizer Inc., and the EU marketing authorisation holder is Pfizer Europe MA EEIG. M Care Exports is a merchant-exporter and does not manufacture. We supply the finished product against your specification and check remaining shelf life and batch documents for each shipment.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.
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