Last updated: April 26, 2026
Who Supplies DUETACT (pioglitazone hydrochloride + glimepiride)?
DUETACT is an oral fixed-dose combination tablet (pioglitazone HCl and glimepiride) marketed in the US by Bristol-Myers Squibb (BMS). The supply chain of the branded product runs through authorized manufacturers listed on the US FDA label and through contract manufacturing/packaging arrangements disclosed in regulatory filings.
What is the DUETACT product and who markets it?
| Item |
Value |
| Drug name |
DUETACT |
| Dosage form |
Oral tablet (fixed-dose combination) |
| Actives |
Pioglitazone hydrochloride + glimepiride |
| US marketing/label holder |
Bristol-Myers Squibb Company (often shown as “Manufactured for”/“Distributed by” on US labeling) |
Which suppliers are named on the US label?
DUETACT product labeling in the US typically identifies the following supplier roles:
- Manufacturer (site that produces tablets)
- Labeler / distributor (company responsible for placing the product on market; for DUETACT this is BMS)
Named label suppliers are the primary “supplier” answer for DUETACT in a patent/R&D diligence context because they are the entities FDA associates with manufacturing and marketing of the specific branded dosage strengths.
What DUETACT strengths exist and how this affects supplier mapping?
DUETACT is marketed in multiple fixed-dose strengths (each strength can be made and/or packaged at one or more distinct sites). Supplier identification must track:
- the strength-specific labeling
- the exact NDC/labeling block (manufacturer/packager line often changes across strengths, even when the labeler stays the same)
| Strength (typical DUETACT presentation) |
Supplier mapping implication |
| Different fixed-dose strengths |
Same brand labeler, but tablet manufacturing and packaging can shift by strength via site assignments |
What manufacturing categories should you treat as “suppliers” for DUETACT?
For due diligence on “suppliers,” treat these as the relevant supplier categories:
- API suppliers for pioglitazone HCl and glimepiride
- Drug product manufacturers for the tablet (formulation + tableting)
- Packagers (bottling, blistering, labeling)
- Labeler/distributor (BMS for the branded product in the US)
API sourcing vs. drug-product manufacturing (why the supplier list differs)
“Suppliers for DUETACT” can mean two different things in practice:
- Regulatory supplier names (manufacturing and packaging sites listed on the label)
- Upstream chemical suppliers (API vendors for pioglitazone HCl and glimepiride), which are usually not named on the public brand label and instead appear in:
- DMFs (Drug Master Files)
- procurement documentation
- supplier quality agreements
- some patent/filing histories and adverse change reports
Because DUETACT public-facing labeling provides the clearest, enforceable supplier mapping, supplier identification in diligence workflows typically starts with the label’s manufacturer/packager line(s) and then moves upstream.
Supplier identification workflow used in patent and diligence work
For branded fixed-dose combinations like DUETACT, supplier mapping normally proceeds in this order:
- Step 1: pull current US label (each strength and NDC)
- Step 2: capture the “Manufactured for” / “Distributed by” lines
- Step 3: capture the tablets manufacturing and packaging site(s
- Step 4: link those sites to:
- regulatory review correspondence
- site-specific change control filings
- patent prosecution or assignment trails where available
DUETACT manufacturer and distributor
Bristol-Myers Squibb Company is the named US labeler/market authorization holder for DUETACT in the branded US product labeling.
Key Takeaways
- DUETACT is marketed in the US under Bristol-Myers Squibb as the label/distributor entity.
- “Suppliers for DUETACT” in diligence terms most reliably starts with the label-identified manufacturer and packager sites for each strength/NDC.
- Upstream API suppliers for pioglitazone HCl and glimepiride are typically not named on the public DUETACT brand label and are tracked via DMFs and regulatory documentation.
FAQs
1) Who is the US labeler/distributor for DUETACT?
Bristol-Myers Squibb Company.
2) Are DUETACT manufacturers the same across all strengths?
Not necessarily. Fixed-dose combinations can have different manufacturing and packaging assignments by strength and NDC.
3) Do DUETACT labels list API suppliers for pioglitazone and glimepiride?
Public DUETACT brand labeling typically does not name API suppliers; drug product manufacturing/packaging and the labeler are the usual public fields.
4) Where do drug-product manufacturer and packager names come from?
From the US prescribing information (labeling) that includes “manufactured for/distributed by” and site-specific manufacturing/packaging references.
5) How do you ensure you capture the correct supplier for a specific DUETACT product?
Use the specific DUETACT strength and NDC from the label and record the corresponding manufacturer/packager lines.
References
[1] U.S. Food and Drug Administration. DUETACT (pioglitazone hydrochloride and glimepiride) prescribing information/labeling (US FDA label documentation).
[2] DailyMed. DUETACT (pioglitazone hydrochloride and glimepiride) drug label (NLM listing with manufacturer/packager and distributor fields).
