Finished-dose partner supply

Sacubitril / valsartan — Finished-Dose Partner Supply

Burrard Pharmaceuticals Enterprises Ltd., Vancouver, Canada, supports importers, distributors, and local marketing-authorisation holders seeking sacubitril / valsartan finished-dose supply through a partner-site model.

Request sacubitril / valsartan quality pack Contact page

Email bd@burrardpharma.com with your company, territory, and finished-dose supply, dossier support, or both.

Burrard does not manufacture in-house. Manufacture for this programme is placed with a qualified partner GMP site named under CDA.

Site GMP evidence is shared in the quality pack under CDA. Site GMP is not product approval.

This page discusses the INN sacubitril / valsartan. Entresto is named for identification only and is not a Burrard trademark or a Burrard-branded good.

Sacubitril/valsartan is an angiotensin receptor-neprilysin inhibitor in the established oral class used in chronic heart failure.

Oral solid, strengths confirmed under CDA.

Valsartan alone is a separate programme. Sacubitril alone, other products in the same class, and salts or combinations not named on this page are out of scope unless separately confirmed under CDA.

Who this is for

Importers evaluating finished-dose supply for a named territory
Distributors whose registration or tender team needs documents before a commercial call
Local marketing-authorisation holders who will hold the destination authorisation themselves

Partners should say whether they mean the combination, not valsartan tablets alone. Valsartan without sacubitril is a different page and a different quote. Company, territory, and finished-dose supply, dossier support, or both are the three items that start the file.

How Burrard works on this programme

You name the territory. This page does not assume one.
CDA comes before the site name, batch certificates, or a dossier pack.
The partner GMP site is named under CDA.
The quality pack then holds the batch and site evidence that is actually available.
The local MAH or importer holds marketing authorisation. Burrard does not.

Programme attributes

Scope table. Public copy only. Strengths, packs, stability, and dossier status are confirmed under CDA, not on this page.

INN	Sacubitril / valsartan
Dosage form	Oral solid, strengths confirmed under CDA
Strengths	Confirmed under CDA / quality pack
Pack sizes	Confirmed under CDA / quality pack
Stability / climate zone	Not stated. Confirmed under CDA.
Dossier format	Not asserted. Confirmed under CDA if a file is offered.
Facility class	Named site, in the quality pack.
WHO prequalification	Not claimed
Bioequivalence	Not claimed
MOQ / Incoterms	Confirmed under CDA
Exclusivity note	US market exclusivity lost and multiple generics FDA-approved. Not patent-free worldwide. No generic companies named.

Finished-dose partner supply for importers and distributors

Burrard coordinates sacubitril / valsartan finished-dose supply for commercial partners. Manufacture is at a qualified partner GMP site named under CDA, not at a Burrard plant. The reader is a partner, not a patient. This page is not a dose and not a superiority claim. Price and pack count are not published. The order of work is the quality pack, then site and batch evidence under CDA, then a short supply call.

What is in the quality pack?

A batch certificate of analysis, if one is available for the named configuration
GMP evidence for the named partner site
API documentation as applicable
Dossier-format availability only if confirmed, which is not a local approval
Pack, strength, and stability only for that named configuration

The pack is a B2B qualification file. It is not a marketing authorisation and not a patient leaflet.

Site GMP is not product approval

GMP or API documents describe the named site or the API. They are not Burrard product approval in the United States, the European Union, Canada, or elsewhere. This page claims no FDA, EMA, or Health Canada product approval and no country-of-origin marketing authorisation. The local MAH or importer holds the destination authorisation.

Exclusivity: not a worldwide clearance

US market exclusivity for this combination had been lost and multiple generics were FDA-approved. This page says that, and stops there. It does not name those generic companies. It does not list strengths. It does not say the combination is patent-free worldwide. It does not say every presentation is open.

FDA approval of other companies' generics is not approval of a Burrard product. Burrard does not claim FDA, EMA, or Health Canada product approval for sacubitril/valsartan supplied under this programme. Destination marketing authorisation, where a supply proceeds, is held by the local MAH or importer.

A live patent or exclusivity dispute in the requested territory is not quoted. Entresto is an identification name only, not a Burrard trademark.

Burrard does not quote a molecule under a live patent or exclusivity dispute in the requested territory. Supply is discussed only where relevant exclusivity has ended.

Related oral programmes

Each link is a separate finished-dose programme with its own exclusivity note. Valsartan.

Questions

Does Burrard manufacture sacubitril / valsartan?

No. Burrard does not manufacture in-house. Manufacture is placed with a qualified partner GMP site named under CDA. The site is named in the quality pack after CDA.

Is Burrard's sacubitril / valsartan FDA-approved, EMA-approved, or Health Canada-approved?

No. This page does not claim FDA, EMA, or Health Canada product approval for sacubitril / valsartan. The local MAH or importer holds destination marketing authorisation. Site GMP evidence is not product approval.

What strengths and forms of sacubitril / valsartan are stated publicly?

Oral solid, strengths confirmed under CDA. Pack size, stability zone, and CTD or ACTD status are not stated here.

Does this page mean sacubitril/valsartan is patent-free worldwide, or that Burrard is FDA-approved?

No. US market exclusivity had been lost and multiple generics were FDA-approved. This page does not name those companies, does not say patent-free worldwide, and does not claim Burrard product approval. Other companies' FDA approvals are not a Burrard marketing authorisation. Supply is discussed only where relevant exclusivity has ended.

How do I request sacubitril / valsartan finished-dose supply?

Email bd@burrardpharma.com with your company, territory, and whether you need finished-dose supply, dossier support, or both. The quality pack and a short supply call follow CDA.

Request the quality pack

Email bd@burrardpharma.com with company, territory, and finished-dose supply, dossier support, or both. You can also use the contact page.

Request sacubitril / valsartan quality pack Contact page

Disclaimer

For importers, distributors, and local marketing-authorisation holders only. Not patient information, not dosing guidance, and not an offer or a price. Burrard Pharmaceuticals Enterprises Ltd. does not manufacture in-house and does not claim FDA, EMA, or Health Canada product approval. Site GMP is not product approval. The local MAH or importer holds destination authorisation. Supply is discussed only where relevant exclusivity has ended. Strengths, packs, stability zones, and CTD status are confirmed under CDA, not here. Brand names are for identification only.