beta3-Adrenergic Agonist
Where is Mirabegron made?
8 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 8 factories in India, Japan, Ireland and China.
India 3Japan 3Ireland 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Astellas Pharma US, Inc. Myrbetriq8 mg per 1 mL, 25 mg, 50 mg · NDC 0469-2601, 0469-2602, 0469-5020 | Astellas Ireland Co., LimitedMakes the active ingredient and tests it | Dublin, Ireland | Problems found, fixed voluntarilyJun 2022 |
| Astellas Pharma Inc.Makes the active ingredient and tests it | Takahagi, Japan | Problems found, fixed voluntarilyJun 2025 | |
| Astellas Pharma Inc.Makes it and tests it | Yaizu, Japan | Problems found, fixed voluntarilyOct 2023 | |
| Sumitomo Chemical Company, LimitedMakes the active ingredient | Kurashiki, Japan | No problems foundNov 2023 | |
| Ascend Laboratories, LLC8 mg per 1 mL · NDC 67877-890 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Cadila Healthcare Limited25 mg, 50 mg · NDC 70771-1752, 70771-1753 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Lupin Pharmaceuticals, Inc.25 mg, 50 mg · NDC 68180-151, 68180-152 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Qilu Pharmaceutical Co., Ltd.25 mg, 50 mg · NDC 67184-0571, 67184-0572 | Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)Makes it and tests it | Jinan, China | Problems found, fixed voluntarilyMay 2026 |
| Zydus Pharmaceuticals (USA) Inc.25 mg, 50 mg · NDC 70710-1159, 70710-1160 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Amneal Pharmaceuticals25 mg, 50 mg · NDC 69238-2860, 69238-2861 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.25 mg, 50 mg · NDC 73190-115, 73190-116 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Mirabegron 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.
- Bryant Ranch Prepack:
71335-2809,71335-2807,71335-2808,71335-2810 - Cardinal Health 107, LLC:
55154-8712,55154-8713 - Remedyrepack Inc.:
70518-4631,70518-4665,70518-4304
Recalls
- Aug 5, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.