Finished-dose partner supply

Valsartan — Finished-Dose Partner Supply

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

Request 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 valsartan. Diovan is named for identification only and is not a Burrard trademark or a Burrard-branded good.

Valsartan is an angiotensin II receptor blocker in the established oral cardiovascular class.

Oral solid, strengths confirmed under CDA.

Sacubitril/valsartan is a separate programme. Hydrochlorothiazide combinations, other combinations, and salts 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

Write valsartan if you mean valsartan. Write the combination only if you mean the combination, and expect it to be handled off this page. Company, territory, and finished-dose supply, dossier support, or both are the opening facts.

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	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 generic valsartan (Diovan) entered in September 2012. Sacubitril/valsartan is not covered by that date.

Finished-dose partner supply for importers and distributors

Burrard coordinates 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: US generic entry September 2012 for valsartan alone

US generic valsartan entered in September 2012. That date is for valsartan, not for sacubitril/valsartan. The combination has its own page. Do not merge the two files.

This page does not say valsartan is patent-free worldwide. Combination products are out of scope. Impurity controls for the sartan class are a quality-pack question under CDA. This page does not claim a test result, a limit, or a clean bill for any batch.

Burrard discusses supply only where relevant exclusivity has ended. Diovan is an originator name for identification 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. Losartan · Sacubitril / valsartan.

Questions

Does Burrard manufacture 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 valsartan FDA-approved, EMA-approved, or Health Canada-approved?

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

What strengths and forms of 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 cover sacubitril/valsartan?

No. This page is valsartan alone. US generic valsartan entered in September 2012. Sacubitril/valsartan is a separate programme. Combinations with hydrochlorothiazide are out of scope. Supply is discussed only where relevant exclusivity has ended. Impurity controls are not claimed on this page.

How do I request 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 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.