Biguanide, Sodium-Glucose Cotransporter 2 Inhibitor
Where is Dapagliflozin and Metformin made?
9 companies sell it under their own name and 1 repackager rebottle it. Their labels name 8 factories in India and the United States.
India 6United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 67877-622, 67877-621, 67877-620 +1 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 59651-157, 59651-156, 59651-155 +1 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.5 mg / 1000 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 63304-028, 63304-027, 63304-026 | Ohm Laboratories Inc.Makes it and tests it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| Lupin Pharmaceuticals, Inc.5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 70748-104, 70748-103, 70748-102 +1 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Macleods Pharmaceuticals Limited5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 33342-409, 33342-407, 33342-408 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Micro Labs Limited5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 42571-323, 42571-321, 42571-322 +1 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Novadoz Pharmaceuticals LLC5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 72205-437, 72205-436, 72205-435 +1 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Prasco Laboratories5 mg / 1000 mg, 10 mg / 1000 mg · NDC 66993-362, 66993-361 | AstraZeneca Pharmaceuticals LPMakes it, tests it and packages it | Mount Vernon, IN, United States | Problems found, fixed voluntarilySep 2023 |
| AstraZeneca Pharmaceuticals LP Xigduoxr2.5 mg / 1000 mg, 5 mg / 1000 mg, 5 mg / 500 mg, 10 mg / 1000 mg, 10 mg / 500 mg · NDC 0310-6280, 0310-6270, 0310-6225 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dapagliflozin 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.
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc. · 2 recall notices
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.