Sulfonylurea
Where is Glimepiride made?
11 companies sell it under their own name and 27 repackagers rebottle it. Their labels name 9 factories in India and the United States.
India 7United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Accord Healthcare Inc.1 mg, 2 mg, 4 mg · NDC 16729-001, 16729-002, 16729-003 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 | |
| Dr.Reddy's Laboratories Ltd.1 mg, 2 mg, 4 mg · NDC 55111-320, 55111-321, 55111-322 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 | |
| Aurobindo Pharma Limited1 mg, 2 mg, 4 mg · NDC 65862-579, 65862-580, 65862-581 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| BluePoint Laboratories.1 mg, 2 mg, 4 mg · NDC 68001-584, 68001-585, 68001-586 | Micro Labs LimitedMakes it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Carlsbad Technology, Inc.1 mg, 2 mg, 4 mg · NDC 61442-115, 61442-116, 61442-117 | Carlsbad Technology, Inc.Makes it and tests it | Carlsbad, CA, United States | Problems found, fixed voluntarilyJun 2026 |
| Florida Pharmaceutical Products, LLC.1 mg, 2 mg, 4 mg · NDC 71921-214, 71921-215, 71921-216 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Problems found, fixed voluntarilyJan 2023 |
| International Laboratories, LLC1 mg, 2 mg, 4 mg · NDC 54458-968, 54458-967, 54458-966 | Dr. Reddy's Laboratories LimitedMakes it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Lifsa Drugs LLC3 mg · NDC 72336-641 | Micro Labs LimitedMakes it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Micro Labs Limited1 mg, 2 mg, 3 mg, 4 mg, 6 mg, 8 mg · NDC 42571-100, 42571-101, 42571-102 +3 | Micro Labs LimitedMakes it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Rising Pharma Holdings, Inc.1 mg, 2 mg, 4 mg · NDC 16571-773, 16571-774, 16571-775 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Solco Healthcare U.S., LLC1 mg, 2 mg, 4 mg · NDC 43547-394, 43547-395, 43547-396 | Generics Bidco II LLC d/b/a Prinston LaboratoriesMakes it | Charlotte, NC, United States | Problems found, fixed voluntarilySep 2025 |
Repackaged by
These companies buy Glimepiride 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.
- A-S Medication Solutions:
50090-3547,50090-6394,50090-7187,50090-6415+11 - Aidarex Pharmaceuticals LLC:
33261-961,33261-831,53217-250,53217-323+3 - American Health Packaging:
68084-788,68084-326,68084-327 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-236 - AvPAK:
50268-358,50268-359,50268-360 - Blenheim Pharmacal, Inc.:
10544-217,10544-219 - Bryant Ranch Prepack:
71335-1848,63629-5650,71335-2561,71335-1885+8 - Cardinal Health 107, LLC:
55154-8175 - Coupler LLC:
67046-1114,67046-1608 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-232,70934-167,70934-173,70934-323 - Direct Rx:
61919-723,61919-448,72189-485,61919-720+2 - Golden State Medical Supply, Inc.:
60429-918,60429-919,60429-920 - Liberty Pharmaceuticals, Inc.:
0440-6564,0440-6565,0440-6566 - MedVantx, Inc.:
66116-432 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8332,0615-8333,0615-8334 - Northwind Pharmaceuticals:
51655-381,82868-042,51655-565,51655-383+2 - NuCare Pharmaceuticals.Inc.:
68071-3639,68071-2385,68071-2228 - PD-Rx Pharmaceuticals, Inc.:
43063-121,43063-697,72789-370,43063-630+6 - Physicians Total Care, Inc.:
54868-3327,54868-5457,54868-3377 - Preferred Pharmaceuticals, Inc..:
68788-8728,68788-8432,68788-4191 - Proficient Rx LP:
63187-698,82804-140,71205-779,63187-641+3 - Rebel Distributors Corp..:
21695-993,21695-746,21695-747 - RedPharm Drug. Inc.:
67296-1246,67296-1247 - Remedyrepack Inc.:
70518-4774,70518-4486,70518-4485 - St. Mary's Medical Park Pharmacy:
60760-845,60760-800 - Stat Rx USA:
42549-499,42549-498 - Unit Dose Services:
50436-7073
Recalls
- Jan 18, 2024 · Class III · Dr. Reddy's Laboratories, Inc. · 2 recall notices
Misprint on tablet - Mar 16, 2023 · Class II · Northwind Pharmaceuticals LLC · 2 recall notices
CGMP Deviations - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 3 recall notices
CGMP Deviations: recalling drug products following an FDA inspection. - Oct 9, 2014 · Class II · Micro Labs Usa, Inc S
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.