Finished-dose partner supply

Sitagliptin — Finished-Dose Partner Supply

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

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

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor in the established oral class used in type 2 diabetes.

Oral solid, strengths confirmed under CDA.

This page is sitagliptin alone. Sitagliptin with metformin, other fixed-dose combinations, other DPP-4 inhibitors, 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

Partners ask about sitagliptin after that US settlement date when they hold, or plan to hold, the local authorisation. The email should name the company, the territory, and finished-dose supply, dossier support, or both. Strength and pack are not chosen on this page.

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	Sitagliptin
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 exclusivity under patent settlements ran to May 2026; past as of 3 Oct 2026. Not every strength or country is claimed open.

Finished-dose partner supply for importers and distributors

Burrard coordinates sitagliptin 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: May 2026 US settlement date is past

The public fact on this page is narrow. US exclusivity for sitagliptin under patent settlements ran to May 2026. As of 3 October 2026 that date is past. It does not mean every strength is free to supply, or that every country is open. Other patents or local exclusivity can still apply. This page does not review them.

Burrard discusses sitagliptin supply only for a territory where relevant exclusivity has ended. If the territory is still under a live patent or an exclusivity dispute, Burrard does not quote it. A past US settlement date does not travel with the file into a second country. The partner names the territory. Burrard does not fill that gap from this page.

Januvia is named so a partner can identify the originator product. It is not a Burrard trademark and not a Burrard-branded good.

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. Sitagliptin / metformin · Metformin.

Questions

Does Burrard manufacture sitagliptin?

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 sitagliptin FDA-approved, EMA-approved, or Health Canada-approved?

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

What strengths and forms of sitagliptin are stated publicly?

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

Is every sitagliptin strength and every country open because May 2026 has passed?

No. US exclusivity under patent settlements ran to May 2026, and as of 3 October 2026 that date is past. This page does not claim every strength or every country is open. Supply is discussed only where relevant exclusivity has ended. A live patent or exclusivity dispute in the requested territory is not quoted.

How do I request sitagliptin 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 sitagliptin 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.