Finished-dose partner supply

Sitagliptin / metformin — Finished-Dose Partner Supply

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

Request sitagliptin / metformin 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 / metformin. Janumet, including Janumet XR is named for identification only and is not a Burrard trademark or a Burrard-branded good.

Sitagliptin with metformin pairs a DPP-4 inhibitor with metformin in the established oral class used in type 2 diabetes.

Oral solid, strengths confirmed under CDA.

Sitagliptin alone is a separate programme. Other metformin combinations, other DPP-4 combinations, and salts or release profiles 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

A partner writing about this combination should say whether the interest is the extended-release originator presentation, the immediate-release presentation, or not yet known. Burrard will not treat those as the same quote. Company, territory, and finished-dose supply, dossier support, or both belong in the same email.

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 / metformin
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	Janumet XR US settlement exclusivity ran to July 2026; past as of 3 Oct 2026. Immediate-release Janumet is not given a date here.

Finished-dose partner supply for importers and distributors

Burrard coordinates sitagliptin / metformin 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: July 2026 is a Janumet XR US date only

The only dated exclusivity fact on this page is for Janumet XR. US settlement exclusivity for Janumet XR ran to July 2026. As of 3 October 2026 that date is past. The date is not applied here to immediate-release Janumet. This page does not say immediate-release Janumet is open, and it does not say it is closed. It is not confirmed on this public page.

July 2026 is not a worldwide clearance and not a clearance of every strength. Extended-release and immediate-release are different quotes until a territory file says otherwise. Supply is discussed only where relevant exclusivity for that presentation has ended.

Janumet and Janumet XR are originator names used for identification only. They are not Burrard trademarks or Burrard-branded goods.

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.

Questions

Does Burrard manufacture sitagliptin / metformin?

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 / metformin FDA-approved, EMA-approved, or Health Canada-approved?

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

What strengths and forms of sitagliptin / metformin are stated publicly?

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

Does the July 2026 date mean both Janumet and Janumet XR are open in every country?

No. The dated fact on this page is Janumet XR US settlement exclusivity to July 2026, which is past as of 3 October 2026. Immediate-release Janumet is not given that date here. Not every strength and not every country is claimed open. Supply is discussed only where relevant exclusivity has ended.

How do I request sitagliptin / metformin 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 / metformin 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.