Drug
Who makes metformin hydrochloride?
69 companies list metformin hydrochloride as a human prescription drug, including under the names Glumetza, Riomet. Forms: solution; tablet; tablet, coated; tablet, extended release; tablet, film coated; tablet, film coated, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing metformin hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet; tablet, coated; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA090564, ANDA201991 | 44 | 3 |
| Bryant Ranch PrepackUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA076756, ANDA077078, ANDA077095 | 29 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA077336, ANDA078321 | 23 | 0 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA078321, ANDA090564 | 16 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA078321, ANDA090295 | 16 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077880, ANDA078321, ANDA090295 | 15 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA078321, ANDA090564 | 15 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, coated; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA090295, ANDA090564 | 13 | 1 |
| Northwind Health Company, LLCUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA078321, ANDA090295 | 9 | 1 |
| ASCEND Therapeutics US, LLC | tablet, extended release; tablet, film coated | ANDAANDA091184, ANDA201991, ANDA206145 | 9 | 0 |
| Westminster Pharmaceuticals, LLC | tablet, coated; tablet, film coated; tablet, film coated, extended release | ANDAANDA203769, ANDA203832, ANDA205096 | 8 | 0 |
| Granules Pharmaceuticals Inc.India | tablet; tablet, extended release | ANDAANDA090564, ANDA213344 | 6 | 8 |
| Macleods Pharmaceuticals LimitedIndia | tablet, extended release; tablet, film coated | ANDAANDA205330, ANDA206955, ANDA211163 | 6 | 5 |
| Coupler LLCUnited States | tablet; tablet, coated; tablet, extended release; tablet, film coated | ANDAANDA090564, ANDA205096, ANDA209882 | 6 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | solution; tablet, extended release; tablet, film coated, extended release | ANDA, NDAANDA077336, ANDA202917, NDA021591 | 5 | 13 |
| Zydus Lifesciences LimitedIndia | tablet, extended release; tablet, film coated | ANDAANDA077060, ANDA077078, ANDA203686 | 5 | 12 |
| LAURUS LABS LIMITEDIndia | tablet, extended release; tablet, film coated | ANDAANDA209882, ANDA217631 | 5 | 5 |
| Epic Laboratories, LLCUnited States | tablet, extended release; tablet, film coated | ANDAANDA090564, ANDA211052 | 5 | 3 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet | ANDAANDA203769 | 5 | 3 |
| MARKSANS PHARMA LIMITEDIndia | tablet, extended release; tablet, film coated | ANDAANDA090295, ANDA090888 | 5 | 2 |
| Direct RxUnited States | tablet; tablet, extended release | ANDAANDA078321, ANDA090295, ANDA203769 | 5 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA201991 | 5 | 1 |
| Precision Dose Inc.United States | tablet, coated; tablet, extended release | ANDAANDA078321, ANDA205096 | 5 | 1 |
| Chartwell RX, LLC. | tablet | ANDAANDA075972 | 5 | 0 |
| Lupin LimitedIndia | tablet, extended release | ANDAANDA090692, ANDA091664 | 4 | 14 |
| Unichem Laboratories Limited, IndiaIndia | tablet, extended release | ANDAANDA207427, ANDA213359 | 4 | 5 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA213651, ANDA213962 | 4 | 2 |
| Amneal Ireland LimitedIreland | tablet, extended release | ANDAANDA078596 | 4 | 1 |
| Golden State Medical Supply Inc.United States | tablet; tablet, film coated, extended release | ANDAANDA203769, ANDA203832 | 4 | 1 |
| Quallent Pharmaceuticals Health, LLC | tablet, extended release; tablet, film coated | ANDAANDA203686, ANDA206145 | 4 | 0 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA077880 | 3 | 14 |
| Aurobindo Pharma LimitedIndia | tablet, extended release; tablet, film coated | ANDAANDA077095, ANDA209694 | 3 | 6 |
| Micro Labs LimitedIndia | solution; tablet, film coated, extended release | ANDAANDA211309, ANDA212448 | 3 | 5 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet, film coated | ANDAANDA203686 | 3 | 5 |
| ACI Healthcare USA, Inc.United States | tablet | ANDAANDA203769 | 3 | 2 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | tablet | ANDAANDA213320 | 3 | 1 |
| QPharma IncUnited States | tablet, extended release; tablet, film coated | ANDAANDA201991, ANDA213320 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA203686 | 3 | 1 |
| Legacy Pharmaceutical Packaging, LLC | tablet | ANDAANDA090564 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA090564 | 3 | 0 |
| Metcure Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA090564 | 3 | 0 |
| Mullan Pharmaceutical Inc. | tablet, coated | ANDAANDA205096 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA075973 | 3 | 0 |
| PuraCap Laboratories LLC dba Blu Pharmaceuticals | tablet, film coated | ANDAANDA075965 | 3 | 0 |
| Santarus, Inc.. | tablet, film coated, extended release | NDANDA021748 | 3 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated, extended release | ANDAANDA212969 | 2 | 9 |
| Lifsa Drugs LLCUnited States | tablet | ANDAANDA075972 | 2 | 1 |
| Marlex Pharmaceuticals, IncUnited States | tablet, extended release | ANDAANDA202306 | 2 | 1 |
| RedPharm DrugUnited States | tablet, extended release | ANDAANDA078321, ANDA217631 | 2 | 1 |
| Time Cap Laboratories, Inc.United States | tablet, extended release | ANDAANDA090295 | 2 | 1 |
| AvKARE | tablet, extended release | ANDAANDA207427 | 2 | 0 |
| AvPAK | tablet, extended release | ANDAANDA078321 | 2 | 0 |
| Method Pharmaceuticals, LLC. | tablet | ANDAANDA203769 | 2 | 0 |
| Oceanside Pharmaceuticals. | tablet, film coated, extended release | NDA AUTHORIZED GENERICNDA021748 | 2 | 0 |
| Solco healthcare U.S., LLC | tablet, extended release | ANDAANDA212681 | 2 | 0 |
| TAGI Pharma, Inc. | tablet, extended release | ANDAANDA078321 | 2 | 0 |
| TruPharma LLC. | solution | ANDAANDA211309 | 2 | 0 |
| VGYAAN Pharmaceuticals LLC | tablet, extended release | ANDAANDA215629 | 2 | 0 |
| Viona Pharmaceuticals Inc. | tablet, extended release | ANDAANDA077060, ANDA077078 | 2 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA090564 | 1 | 34 |
| Bionpharma Inc.India | solution | ANDAANDA219151 | 1 | 1 |
| Calvin Scott & Co., Inc.United States | tablet, extended release | ANDAANDA078321 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA215008 | 1 | 1 |
| Leading Pharma, LLCUnited States | tablet, extended release | ANDAANDA201991 | 1 | 1 |
| Saptalis Pharmaceuticals, LLCUnited States | solution | ANDAANDA211309 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA090564 | 1 | 1 |
| Advanced Rx of Tennessee, LLC | tablet, film coated | ANDAANDA075973 | 1 | 0 |
| NuCare Pharmaceuticcals,Inc. | tablet, film coated | ANDAANDA213320 | 1 | 0 |
| VistaPharm, LLC | solution | ANDAANDA212677 | 1 | 0 |
Bulk ingredient listings
- USV Private LimitedIndia · 5 NDC
- Granules Pharmaceuticals Inc.India · 3 NDC
- Farmhispania S.A.Spain · 2 NDC
- LAURUS LABS LIMITEDIndia · 2 NDC
- Vistin Pharma ASNorway · 2 NDC
- Wanbury LimitedIndia · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- HARMAN FINOCHEM LIMITEDIndia · 1 NDC
- Holiday Labs Mexico, S.A. de C.V.Mexico · 1 NDC
- IOL Chemicals and Pharmaceuticals Ltd.India · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Ningxia Hengkang Technology Co LtdChina · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Shouguang Fukang Pharmaceutical Co LtdChina · 1 NDC
- Sinbiotik SA de CVMexico · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists metformin hydrochloride as the active ingredient, expiring between May 2035 and May 2035. Application holder: SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes metformin hydrochloride?
- 69 companies list metformin hydrochloride as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, Preferred Pharmaceuticals Inc., Proficient Rx LP. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Glumetza?
- 67 companies list metformin hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies metformin hydrochloride active ingredient?
- 19 companies list metformin hydrochloride as a bulk ingredient, including USV Private Limited, Granules Pharmaceuticals Inc., Farmhispania S.A., LAURUS LABS LIMITED.