Nonergot Dopamine Agonist
Where is Ropinirole made?
12 companies sell it under their own name and 23 repackagers rebottle it. Their labels name 9 factories in India, the United States and China.
India 7United States 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 62332-030, 62332-031, 62332-032 +9 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Alembic Pharmaceuticals Limited0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 46708-030, 46708-031, 46708-032 +9 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyNov 2024 | |
| Bionpharma Inc.0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 69452-356, 69452-357, 69452-358 +4 | Optimus Pharma Private LimitedMakes it, tests it and labels it | Hyderabad, India | Problems found, fixed voluntarilyOct 2025 |
| OrBion Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Kancheepuram, India | No problems foundOct 2025 | |
| Accord Healthcare Inc.0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 16729-232, 16729-233, 16729-234 +4 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Dr.Reddy's Laboratories Ltd.2 mg, 4 mg, 6 mg, 8 mg, 12 mg · NDC 55111-728, 55111-659, 55111-661 +2 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Elite Laboratories, Inc.2 mg, 4 mg, 6 mg, 8 mg, 12 mg · NDC 64850-254, 64850-250, 64850-251 +2 | Elite Laboratories, Inc.Makes it and labels it | Northvale, NJ, United States | Problems found, fixed voluntarilyAug 2025 |
| Glenmark Pharmaceuticals Inc., USA0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 68462-253, 68462-254, 68462-255 +4 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Solco Healthcare U.S., LLC0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 43547-595, 43547-268, 43547-596 +16 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| Wockhardt Limited0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 55648-154, 55648-155, 55648-171 +9 | Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Actavis Pharma, Inc.2 mg, 4 mg, 6 mg, 8 mg, 12 mg · NDC 0228-3661, 0228-3658, 0228-3659 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 10135-673, 10135-674, 10135-675 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Zhejiang Huahai Pharmaceutical Co., Ltd.0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg · NDC 64220-420, 64220-421, 64220-422 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ropinirole 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:
50090-4804,50090-1330,50090-4803,50090-1822+7 - Aidarex Pharmaceuticals LLC:
53217-166 - American Health Packaging:
60687-577,60687-588 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-920,43353-194,43353-195,43353-912+3 - Asclemed USA, Inc.:
87063-198,87063-199,87063-200,87063-201 - AvKARE, Inc.:
42291-717,42291-713,42291-714,42291-715+1 - AvPAK:
50268-741,50268-742,50268-743,50268-744 - Bryant Ranch Prepack:
71335-0587,71335-1231,71335-2793,63629-4798+19 - Cardinal Health 107, LLC:
55154-7888,55154-7633 - Carilion Materials Management:
68151-4071,68151-4072,68151-4073 - Coupler LLC:
67046-1489,67046-1490 - Direct Rx:
72189-364,72189-416,72189-222,72189-494 - Dispensing Solutions Inc.:
68258-7162,68258-7163 - Major Pharmaceuticals:
0904-6373,0904-6374 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8188,0615-8189,0615-8190,0615-8191 - Northwind Pharmaceuticals:
51655-360 - Physicians Total Care, Inc.:
54868-5952,54868-5953,54868-5897,54868-6093+3 - Preferred Pharmaceuticals, Inc..:
68788-4138 - Proficient Rx LP:
71205-825 - Rebel Distributors Corp..:
21695-792,21695-793,21695-794,21695-798 - Remedyrepack Inc.:
70518-3478,70518-4318,70518-3482,70518-3618 - Stat Rx USA:
16590-643,16590-734 - Unit Dose Services:
50436-0255
Recalls
- Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 7 recall notices
CGMP Deviations: recalling drug products following an FDA inspection.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.