Bystolic (nebivolol), sold in Europe as Nebilet, is a third-generation, nitric-oxide-potentiating beta-blocker licensed for hypertension and, under the Nebilet label, for chronic heart failure in patients aged seventy and over, and FDA-approved generic nebivolol tablets are available alongside the originator brand.
Nebivolol is a highly beta-1-selective blocker that also triggers nitric-oxide-mediated vasodilation, a mechanism distinct from older beta-blockers such as atenolol or bisoprolol. M Care Exports is a merchant exporter: we source Bystolic/Nebilet and FDA-approved generic nebivolol tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Nebivolol exporter and bulk supplier from India.
For hospital cardiology, wholesaler and tender-desk orders, M Care quotes nebivolol tablets against buyer specification: brand (Bystolic/Nebilet) or generic, strength mix (1.25 mg, 2.5 mg, 5 mg, 10 mg or 20 mg depending on destination-market registration) and the indication the formulary line is written against, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because Nebilet's elderly heart-failure titration ladder differs materially from Bystolic's hypertension-only US dosing, we confirm which indication and which brand's registered dossier the buyer's tender actually specifies before we release a quote, then align CTD/eCTD or country-specific paperwork to the destination regulator.
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.
Third-generation, beta-1-selective adrenergic blocker with nitric-oxide-potentiating vasodilatory action, sourced and documented for export.
Nebivolol is a third-generation, highly beta-1-selective adrenergic blocker that also potentiates nitric-oxide release from vascular endothelium, giving it a vasodilatory action that older, purely beta-1-selective agents such as bisoprolol do not share. Cardioselectivity is dose-dependent: above 10 mg daily, nebivolol loses beta-1 selectivity and also blocks beta-2 receptors, a detail formulary committees flag when setting maximum protocol doses. Bystolic's FDA label covers hypertension only, dosed once daily and titrated at two-week intervals up to 40 mg; Nebilet's EU/UK SmPC additionally covers stable mild-to-moderate chronic heart failure as an add-on to standard therapy, but only in patients aged seventy and over, using a slower 1.25 mg to 10 mg titration ladder. Buyers should check which indication their own market's label actually carries before specifying a tender line. Nebivolol is oral, non-injectable and needs no reconstitution. It is supplied as tablets in 1.25 mg, 2.5 mg, 5 mg, 10 mg and 20 mg strengths across the Bystolic and Nebilet ranges, several of them cross-scored for dose splitting during titration.
Active ingredient
nebivolol hydrochloride. Third-generation, beta-1-selective adrenergic blocker with nitric-oxide-potentiating vasodilatory action.
Forms and strengths
1.25 mg tablet; 2.5 mg tablet; 5 mg tablet; 10 mg tablet; 20 mg tablet.
Indications
Highly beta-1-selective, nitric-oxide-potentiating beta-blocker licensed for hypertension (Bystolic, US) and, under the Nebilet label in Europe and the UK, for chronic heart failure as an add-on therapy in patients aged seventy and over.
Administration
oral. Tablet, taken once daily.
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 nebivolol are mainly hospital cardiology and general-medicine pharmacies managing hypertension protocols where a vasodilating beta-blocker is preferred over an older agent, MoH tender desks running cardiovascular formulary lists, licensed pharmaceutical wholesalers and importers, and elderly-care and geriatric-cardiology services running Nebilet's heart-failure indication under specialist supervision. Because nebivolol sits outside the WHO Model List of Essential Medicines' bisoprolol-anchored beta-blocker recommendation, most orders come from private and semi-private formularies rather than pooled EML procurement.
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 nebivolol.
Nebivolol dosing depends on which indication the prescriber is treating, not a single fixed regimen. For hypertension, Bystolic starts at 5 mg once daily, titrated at two-week intervals to a maximum 40 mg; for chronic heart failure under the Nebilet label, dosing starts far lower, at 1.25 mg once daily, doubling at one-to-two week intervals under close supervision to a 10 mg ceiling, and is restricted to patients aged seventy and over. Abrupt discontinuation is specifically discouraged on both labels: stopping suddenly can provoke transitory worsening of heart failure or, in coronary artery disease, rebound angina, so a one-to-two week taper is the safer dispensing default when a patient switches supply or stops therapy. Hepatic impairment needs particular care at dispensing: moderate impairment calls for a cautious 2.5 mg starting dose with slow titration, and severe impairment (Child-Pugh above B) is an outright contraindication. Nebivolol is metabolised through CYP2D6, so poor metabolisers, a meaningful minority of the population, run higher plasma exposure at a given dose than the label's standard titration assumes.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, nebivolol travels on standard ambient-temperature logistics rather than the cold-chain lanes we validate for biologics and insulins; Nebilet's SmPC states no special storage precautions and a three-year shelf life. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Nebivolol does not appear on the WHO Model List of Essential Medicines; bisoprolol has held the EML's square-box beta-blocker listing since 2011, so nebivolol functions as a formulary-specific, non-EML tender line rather than a pooled-procurement first-line agent, a distinction buyers should factor into how they specify the product. On the brand-versus-generic question, Bystolic/Nebilet remains the originator product, and FDA-approved generic nebivolol tablets from multiple manufacturers have been registered in the US since 2015, so buyers genuinely have a brand-or-generic choice; the UK market also carries generic nebivolol alongside the Nebilet brand. Nebivolol (Bystolic) tablets currently carry an active shortage listing on the FDA drug shortage database in the US, which we treat as a live example of why formulary desks keep a secondary export source on file; M Care quotes brand or generic against the tender specification and destination-market registration 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 nebivolol.
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 nebivolol.
- 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.
Nebivolol supply, the specific questions.
Does a generic version of Bystolic exist?
Yes. FDA-approved generic nebivolol tablets have been registered in the US since 2015, alongside the originator Bystolic brand, and generic nebivolol is also available in the UK alongside Nebilet. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Bystolic or Nebilet to our market?
Yes, on an import basis. We source Bystolic/Nebilet through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy or hospital holds.
What is the difference between Bystolic and Nebilet?
They are the same molecule, nebivolol, but their licensed indications differ by market. Bystolic's US label covers hypertension only. Nebilet's EU and UK label additionally covers stable mild-to-moderate chronic heart failure, but only as an add-on therapy in patients aged seventy and over, using a slower titration ladder. Buyers should confirm which indication their own market's label carries before specifying a tender line.
Is nebivolol on the WHO Essential Medicines List?
No. Bisoprolol has held the WHO Model List's square-box beta-blocker listing since 2011. Nebivolol functions as a formulary-specific, non-EML agent, so most orders come from hospital and private formularies rather than pooled essential-medicines procurement. Tender desks typically specify it by brand or by its distinct vasodilatory mechanism rather than as an EML substitute.
What strengths of nebivolol tablets are available?
1.25 mg, 2.5 mg, 5 mg, 10 mg and 20 mg tablets across the Bystolic and Nebilet ranges, several cross-scored for dose splitting during titration. Tell us your indication (hypertension or heart failure) and titration protocol and we quote the strength mix accordingly.
Why does nebivolol need careful dosing in patients with liver impairment?
Moderate hepatic impairment calls for a cautious lower starting dose with slow titration, and severe hepatic impairment (Child-Pugh above B) is an outright contraindication on the Bystolic label. Nebivolol is also metabolised through CYP2D6, so poor metabolisers can run higher plasma exposure at a given dose, which prescribers factor into titration.
What documentation does M Care provide with a nebivolol shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration before import.
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.