Biguanide, Dipeptidyl Peptidase 4 Inhibitor
Where is Linagliptin and Metformin made?
2 companies sell it under their own name and 1 repackager rebottle it. Their labels name 4 factories in Germany, Mexico, Norway and India.
Germany 1Mexico 1Norway 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. Jentadueto, Jentadueto XR2.5 mg / 1000 mg, 2.5 mg / 500 mg, 2.5 mg / 850 mg, 5 mg / 1000 mg · NDC 0597-0148, 0597-0270, 0597-0146 +2 | Boehringer Ingelheim Pharma GmbH and Co. KGMakes it, makes the active ingredient, packages it and labels it | Ingelheim am Rhein, Germany | Problems found, fixed voluntarilyMay 2025 |
| Boehringer Ingelheim Promeco S.A. de C.V.Makes it, tests it, packages it and labels it | Mexico City, Mexico | Problems found, fixed voluntarilyMay 2022 | |
| Vistin Pharma AS avd Kragerø FikkjebakkeMakes the active ingredient | Sannidal, Norway | Problems found, fixed voluntarilyJan 2025 | |
| Novadoz Pharmaceuticals LLC2.5 mg / 1000 mg, 2.5 mg / 500 mg, 2.5 mg / 850 mg · NDC 72205-409, 72205-407, 72205-408 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
Repackaged by
These companies buy Linagliptin and Metformin in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Physicians Total Care, Inc.:
54868-6461
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.