Biguanide, Dipeptidyl Peptidase 4 Inhibitor

Where is Metformin and Sitagliptin made?

7 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 2 factories in India.

India 2
India: 2

Companies and their factories

Company on the labelFactoryWhereLast FDA inspection
Cadila Healthcare Limited Zituvimet XR, Zituvimet50 mg / 1000 mg, 50 mg / 500 mg, 100 mg / 1000 mg · NDC 70771-1888, 70771-1881, 70771-1886 +7 Zydus Lifesciences LimitedMakes it and tests it Ahmedabad, IndiaProblems found, fixed voluntarilyAug 2022
Zydus Lifesciences LimitedMakes it and tests it Ahmedabad, IndiaProblems found, fixed voluntarilyMar 2023
Zydus Pharmaceuticals (USA) Inc. Zituvimet XR, Zituvimet50 mg / 1000 mg, 50 mg / 500 mg, 100 mg / 1000 mg · NDC 70710-2038, 70710-1806, 70710-2037 +7 Zydus Lifesciences LimitedMakes it and tests it Ahmedabad, IndiaProblems found, fixed voluntarilyMar 2023
Apotex Corp.50 mg / 1000 mg, 50 mg / 500 mg · NDC 60505-3659, 60505-3658The label doesn't name the factory. Plants this company names for other drugs
ENDO USA, Inc.50 mg / 1000 mg, 50 mg / 500 mg, 100 mg / 1000 mg · NDC 10370-351, 10370-318, 10370-317The label doesn't name the factory. Plants this company names for other drugs
Merck Sharp & Dohme LLC Janumet XR, Janumet50 mg / 1000 mg, 50 mg / 500 mg, 100 mg / 1000 mg · NDC 0006-0081, 0006-0577, 0006-0080 +2The label doesn't name the factory. Plants this company names for other drugs
Sandoz Inc.50 mg / 1000 mg, 50 mg / 500 mg · NDC 0781-5802, 0781-5801The label doesn't name the factory. Plants this company names for other drugs
Truemed Group LLC50 mg / 850 mg · NDC 82922-100The label doesn't name the factory. Plants this company names for other drugs

Repackaged by

These companies buy Metformin and Sitagliptin 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

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.