Entresto (sacubitril/valsartan) is a twice-daily oral treatment for chronic heart failure, stored at room temperature, with an originator brand and generic tablets for importers to choose between.
M Care Exports supplies Entresto (sacubitril/valsartan), the originator brand from Novartis, and sacubitril/valsartan generic tablets where the destination allows them. It is an angiotensin receptor-neprilysin inhibitor taken by mouth twice a day, with no cold chain. M Care is a merchant exporter: we source through licensed Indian and international channels and dispatch on quote, not from our own manufacturing.
Sacubitril/valsartan exporter and bulk supplier from India.
I'm looking for Entresto for a hospital cardiology formulary, and we need a partner who can quote both the originator and a generic. M Care Exports quotes per destination against your specification: Entresto or generic sacubitril/valsartan, film-coated tablet strength (24/26 mg, 49/51 mg or 97/103 mg on the US label), pack configuration, quantity and the registration route in your market. Because the product is ambient and oral, logistics are simple; the real variables are which presentation your regulator has authorised, whether your tender specifies brand or INN, and which pack your pharmacy dispenses. We confirm these with you before any quote is issued.
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.
Angiotensin receptor-neprilysin inhibitor (ARNI), sourced and documented for export.
Sacubitril/valsartan combines a neprilysin inhibitor (sacubitril) with an angiotensin II receptor blocker (valsartan) in one tablet. The US label describes film-coated tablets of 24/26 mg, 49/51 mg and 97/103 mg, plus Entresto Sprinkle, oral pellets in capsules of 6/6 mg and 15/16 mg, for children. The US indication is to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure, and for symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. In the EU, Novartis Europharm holds authorisations for both Entresto (19 November 2015) and Neparvis (26 May 2016), with the EMA stating that Neparvis is the same as Entresto; the EU indication is symptomatic chronic heart failure with reduced ejection fraction in adults, and in children and adolescents aged one year or older with left ventricular systolic dysfunction. The US label gives a usual adult start of 49/51 mg twice daily, doubled after 2 to 4 weeks as tolerated to the 97/103 mg target. Storage is 20 to 25 degrees Celsius with protection from moisture, so no refrigeration is needed.
Active ingredient
Sacubitril; valsartan. Angiotensin receptor-neprilysin inhibitor (ARNI).
Forms and strengths
24/26 mg film-coated tablet; 49/51 mg film-coated tablet; 97/103 mg film-coated tablet; 6/6 mg oral pellets in capsule (Entresto Sprinkle); 15/16 mg oral pellets in capsule (Entresto Sprinkle).
Indications
Fixed-dose combination of a neprilysin inhibitor and an angiotensin II receptor blocker, taken twice daily for chronic heart failure.
Administration
Oral. Film-coated tablet; oral pellets in capsule.
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 sacubitril/valsartan are mainly hospital cardiology and heart-failure clinic pharmacists, MoH and hospital tender desks in the GCC and Africa, UK dispensing and homecare channels, and licensed importers and distributors who hold the local registration. A typical enquiry opens with a need for a partner for Entresto, often followed by a question on whether a generic is acceptable under the same tender. Because this is a specialist-led chronic therapy, buyers think in months of continuous supply per patient, not single batches.
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 sacubitril/valsartan.
The dosing points that matter at the dispensing desk are on the US label. Do not combine with an ACE inhibitor: that is a contraindication, and the label requires a 36-hour washout when switching to or from one. A reduced starting dose of 24/26 mg twice daily applies to patients not taking an ACE inhibitor or ARB or on low doses of them, to severe renal impairment (eGFR below 30 mL/min/1.73 m2) and to moderate hepatic impairment (Child-Pugh B); use is not recommended in severe hepatic impairment (Child-Pugh C). History of angioedema with prior ACE inhibitor or ARB therapy is a contraindication, as is aliskiren use in patients with diabetes. A boxed warning on fetal toxicity says to discontinue as soon as pregnancy is detected. For children, the US label sets weight-based dosing, with Entresto Sprinkle pellets dosed from a separate table; the prepared oral suspension is stable for up to 15 days, not above 25 degrees Celsius, and is not refrigerated. The US label lists bottles of 60 and 180 tablets and 60 pellet capsules; pack sizes are market-specific, so confirm the pack your dispensing system expects.
The documentation pack a regulator actually asks for.
Sacubitril/valsartan travels on ambient lanes, so there is no cold-chain validation to price in; what buyers need instead is the paperwork. We supply batch certificate of analysis and export documentation, and align CTD or country-specific dossier support to what the destination regulator asks for. Registration status differs by market, and we do not assume that Entresto, Neparvis or any generic is authorised in your country; confirm with your regulator, and we will quote only presentations your import licence covers. On the generic landscape, DailyMed lists multiple generic sacubitril and valsartan film-coated tablet labels in the US from labellers including Alembic, Aurobindo, Dr. Reddy's, Lupin and Biocon. The EMA EPAR pages we reviewed describe only Entresto and Neparvis, both held by Novartis Europharm, and name no generic, so EU generic status should be checked per member state. India is not a market we serve. M Care Exports is a merchant exporter and does not claim WHO-GMP or WHO prequalification for itself; where WHO-GMP status matters, we state the manufacturer's position for the specific lot.
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 sacubitril/valsartan.
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 sacubitril/valsartan.
- 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.
Sacubitril/valsartan supply, the specific questions.
What sets the Entresto price for an importer?
We do not publish prices. For an importer, the landed price depends on whether you buy the originator or a generic, the tablet strength and pack, the quantity, your country's registration route, and the Incoterms. Because the product stores at room temperature, cold-chain cost is not a factor. M Care Exports quotes per destination once we know these points.
Is there an Entresto generic, and what is the generic name?
The generic name is sacubitril/valsartan, also written sacubitril and valsartan. DailyMed lists multiple US generic sacubitril and valsartan film-coated tablet labels from labellers including Alembic, Aurobindo, Dr. Reddy's and Lupin. The EMA pages we reviewed name only Entresto and Neparvis as authorised products. Whether a generic is accepted in your market depends on local registration, which we help you check before quoting.
Is Entresto available in Nigeria, and what does a Nigerian importer need?
"We are looking for Entresto in Nigeria" is a common request. We first confirm the product's registration status with the importer's licensed partner and the national regulator, and we do not assume any presentation is registered. M Care Exports then quotes the originator or a generic against the registration your import licence supports, with batch documents and dossier support.
What is Entresto used for, and what are the indications?
On the US label, Entresto is indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure, and for symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. The EU wording is symptomatic chronic heart failure with reduced ejection fraction in adults, and left ventricular systolic dysfunction in children and adolescents aged one year or older. Destination-country labelling governs what you may supply.
What strengths and doses does Entresto come in, such as 24/26, 49/51 and 97/103?
The US label lists film-coated tablets of 24/26 mg, 49/51 mg and 97/103 mg (sacubitril/valsartan), plus Entresto Sprinkle pellets of 6/6 mg and 15/16 mg. The adult label dose starts at 49/51 mg twice daily and doubles after 2 to 4 weeks to 97/103 mg as tolerated; lower starting doses apply in defined groups. EU strengths and pack sizes depend on the market authorisation, so confirm them for your destination.
What are the main side effects and warnings buyers should know?
The US label carries a boxed warning on fetal toxicity: discontinue as soon as pregnancy is detected. Contraindications include concomitant ACE inhibitor use, prior angioedema with ACE inhibitor or ARB therapy, and aliskiren in patients with diabetes. The EMA page lists high potassium, low blood pressure and reduced kidney function among the most common side effects. Refer prescribers to the destination SmPC or label for the full list.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
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.