Serotonin and Norepinephrine Reuptake Inhibitor
Where is Duloxetine made?
25 companies sell it under their own name and 33 repackagers rebottle it. Their labels name 19 factories in India, China, the United States, Spain and Taiwan.
India 14China 2United States 1Spain 1Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.20 mg, 30 mg, 40 mg, 60 mg · NDC 68001-594, 68001-595, 68001-368 +2 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 | |
| Towa Pharmaceutical Europe, S.L.Makes it | Martorelles, Spain | Problems found, fixed voluntarilySep 2022 | |
| Ajanta Pharma USA Inc.20 mg, 30 mg, 40 mg, 60 mg · NDC 27241-097, 27241-098, 27241-164 +1 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 | |
| Caraco Pharmaceutical Laboratories, Ltd. Drizalma Sprinkle20 mg, 30 mg, 40 mg, 60 mg · NDC 47335-381, 47335-616, 47335-382 +4 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Sun Pharmaceutical Industries LimitedMakes it | Mohali, India | Serious problems, FDA actionAug 2022 | |
| Cipla USA., Inc.20 mg, 30 mg, 60 mg · NDC 69097-297, 69097-298, 69097-299 | Inventia Healthcare LimitedMakes it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Zydus Lifesciences LimitedMakes the active ingredient, tests it, packages it and labels it | Ankleshwar, India | No problems foundMar 2025 | |
| Qingdao BAHEAL Pharmaceutical Co., Ltd.20 mg, 30 mg, 60 mg · NDC 70247-012, 70247-013, 70247-014 | Qingdao BAHEAL Pharmaceutical Co.,Ltd.Makes it | Qingdao, China | No problems foundMar 2024 |
| Sci Pharmtech, Inc.Makes the active ingredient | Taoyuan City, Taiwan | Problems found, fixed voluntarilyJun 2025 | |
| Quallent Pharmaceuticals Health LLC20 mg, 30 mg, 40 mg, 60 mg · NDC 82009-029, 82009-170, 82009-030 +5 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Towa Pharmaceutical Europe, S.L.Makes it | Martorelles, Spain | Problems found, fixed voluntarilySep 2022 | |
| ANI Pharmaceuticals, Inc.20 mg, 30 mg, 60 mg · NDC 70954-860, 70954-861, 70954-864 | Inventia Healthcare LimitedMakes it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Alembic Pharmaceuticals Inc.20 mg, 30 mg, 60 mg · NDC 62332-278, 62332-279, 62332-280 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited20 mg, 30 mg, 60 mg · NDC 46708-128, 46708-278, 46708-129 +3 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Almatica Pharma Inc.80 mg, 90 mg, 120 mg · NDC 52427-791, 52427-821, 52427-913 | Norwich Pharmaceuticals, Inc.Makes it and packages it | Norwich, NY, United States | No problems foundMay 2026 |
| Ascend Laboratories, LLC20 mg, 30 mg, 60 mg · NDC 67877-263, 67877-264, 67877-265 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited20 mg, 30 mg, 60 mg · NDC 59651-279, 59651-280, 59651-282 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Breckenridge Pharmaceutical, Inc.20 mg, 30 mg, 40 mg, 60 mg · NDC 51991-746, 51991-747, 51991-750 +1 | Towa Pharmaceutical Europe, S.L.Makes it | Martorelles, Spain | Problems found, fixed voluntarilySep 2022 |
| Cadila Healthcare Limited20 mg, 30 mg, 60 mg · NDC 65841-774, 65841-799, 65841-775 +3 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Camber Pharmaceuticals Inc.20 mg, 30 mg, 60 mg · NDC 31722-168, 31722-169, 31722-170 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Golden State Medical Supply, Inc.20 mg, 30 mg, 60 mg · NDC 51407-817, 51407-818, 51407-819 | Towa Pharmaceutical Europe, S.L.Makes it | Martorelles, Spain | Problems found, fixed voluntarilySep 2022 |
| Inventia Healthcare Limited.20 mg, 30 mg, 60 mg · NDC 49252-007, 49252-008, 49252-009 | Inventia Healthcare LimitedMakes it | Thane, India | Problems found, fixed voluntarilyFeb 2025 |
| Lupin Pharmaceuticals, Inc.20 mg, 30 mg, 40 mg, 60 mg · NDC 68180-294, 68180-295, 68180-297 +1 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Macleods Pharmaceuticals Limited20 mg, 30 mg, 60 mg · NDC 33342-160, 33342-161, 33342-162 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Marksans Pharma Limited20 mg, 30 mg, 60 mg · NDC 25000-608, 25000-609, 25000-610 | Marksans Pharma LimitedMakes it | Verna, India | Problems found, fixed voluntarilyApr 2024 |
| Yaopharma Co., Ltd.20 mg, 30 mg, 60 mg · NDC 50771-201, 50771-202, 50771-203 | Yaopharma Co., Ltd.Makes it | Chongqing, China | Problems found, fixed voluntarilyMar 2019 |
| Actavis Pharma, Inc.20 mg, 30 mg, 60 mg · NDC 0228-2890, 0228-2891, 0228-2892 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Asclemed USA, Inc.20 mg, 30 mg, 40 mg · NDC 87063-702, 87063-703, 87063-704 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Coupler LLC30 mg, 60 mg · NDC 67046-1585, 67046-1598 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC20 mg, 30 mg, 60 mg · NDC 43547-379, 43547-380, 43547-381 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Duloxetine 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:
50090-4011,50090-4709,50090-6406,50090-6889+13 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0311,80425-0441,80425-0012,80425-0014+4 - Aidarex Pharmaceuticals LLC:
53217-130 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-401,71610-739,71610-957,43353-303+6 - Asclemed USA, Inc.:
76420-633,76420-236,76420-634,76420-636+1 - Blenheim Pharmacal, Inc.:
62034-029,62034-021 - Bryant Ranch Prepack:
71335-1964,63629-1990,71335-0165,72162-1597+23 - Carilion Materials Management:
68151-4734,68151-4679,68151-4727 - Central Packaging:
80175-0582 - Coupler Enterprises Inc.:
67046-691,67046-679 - Coupler LLC:
67046-1253,67046-1451,67046-1250 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-729 - Direct Rx:
61919-422,61919-636,72189-634,61919-482+4 - Golden State Medical Supply, Inc.:
51407-807,51407-808,51407-809,51407-810 - H.J. Harkins Co., Inc.:
52959-892 - Hawaii Repack, Inc.:
85534-0050,85534-0016,85534-0017,85534-0052+3 - Medsource Pharmaceuticals:
45865-815,45865-813,45865-816 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8494,0615-8495,0615-8496 - Northwestern Memorial HealthCare:
87448-2201 - Northwind Pharmaceuticals:
51655-237 - NuCare Pharmaceuticals.Inc.:
68071-2711,68071-3979,68071-3766,68071-3779+4 - PD-Rx Pharmaceuticals, Inc.:
72789-338 - Physicians Total Care, Inc.:
54868-5215,54868-5315,54868-5192 - Preferred Pharmaceuticals, Inc..:
68788-6380,68788-7897,68788-4128,68788-4025+7 - Proficient Rx LP:
63187-720,71205-005,71205-525,71205-445+7 - QPharma, Inc.:
42708-196 - RPK Pharmaceuticals, Inc.:
53002-1503,53002-1494,53002-1561 - Rebel Distributors Corp..:
21695-657,21695-145,21695-146 - Remedyrepack Inc.:
70518-1139,70518-4440,70518-1054,70518-1765+6 - St. Mary's Medical Park Pharmacy:
60760-759,60760-461,60760-462 - Stat Rx USA:
42549-646 - TYA Pharmaceuticals:
64725-0747,64725-1100,64725-7544 - Unit Dose Services:
50436-2995,50436-0018,50436-2996,50436-0747+7
Recalls
- Jun 22, 2026 · Class II · Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Jun 4, 2026 · Class II · Breckenridge Pharmaceutical, Inc. · 2 recall notices
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - May 14, 2026 · Class II · Asclemed USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. - Apr 29, 2026 · Class II · Ajanta Pharma Ltd. · 3 recall notices
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. - Apr 21, 2026 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Nov 24, 2025 · Class II · Breckenridge Pharmaceutical, Inc. · 2 recall notices
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Oct 9, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. - Aug 8, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. - Jul 25, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Jul 15, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit - Jun 30, 2025 · Class II · Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Apr 14, 2025 · Class II · Breckenridge Pharmaceutical, Inc · 2 recall notices
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.