Atypical Antipsychotic
Where is Lurasidone made?
21 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 17 factories in India and the United States.
India 15United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Torrent Pharma, Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 13668-467, 13668-464, 13668-465 +3 | Dr. Reddy's Laboratories LimitedMakes it and packages it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Indrad, India | Problems found, fixed voluntarilyJun 2024 | |
| Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Bharuch, India | No problems foundJan 2026 | |
| Dr. Reddy's Laboratories Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 43598-355, 43598-351, 43598-352 +2 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| Torrent Pharmaceuticals LimitedMakes it and tests it | Indrad, India | Problems found, fixed voluntarilyJun 2024 | |
| Macleods Pharmaceuticals Limited20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 33342-423, 33342-419, 33342-420 +2 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 | |
| Novadoz Pharmaceuticals LLC20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 72205-211, 72205-207, 72205-208 +2 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Accord Healthcare Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 16729-350, 16729-346, 16729-347 +2 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 62332-498, 62332-494, 62332-495 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 46708-498, 46708-494, 46708-495 +2 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 53746-882, 65162-882, 53746-879 +7 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Ascend Laboratories, LLC20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 67877-642, 67877-638, 67877-639 +2 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 65862-957, 65862-953, 65862-954 +2 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 70771-1738, 70771-1734, 70771-1735 +2 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 31722-084, 31722-080, 31722-081 +2 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 47335-579, 47335-578, 47335-684 +2 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Cipla USA., Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 69097-937, 69097-942, 69097-941 +2 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Exelan Pharmaceuticals, Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 76282-525, 76282-522, 76282-523 +2 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Lupin Pharmaceuticals, Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 68180-674, 68180-670, 68180-671 +2 | Lupin LimitedMakes it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Major Pharmaceuticals20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 0904-7425, 0904-7421, 0904-7422 +2 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Northstar Rx LLC.20 mg, 40 mg, 60 mg, 80 mg · NDC 72603-621, 72603-622, 72603-623 +1 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Zydus Pharmaceuticals (USA) Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 68382-968, 68382-965, 68382-966 +2 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 23155-891, 23155-887, 23155-888 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sumitomo Pharma America, Inc. Latuda20 mg, 40 mg, 60 mg, 80 mg, 120 mg · NDC 63402-312, 63402-302, 63402-304 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Lurasidone 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:
50090-6438,50090-7078,50090-7170 - American Health Packaging:
60687-747,60687-758,60687-769,60687-780 - Coupler LLC:
67046-1396,67046-1637,67046-1654,67046-1659 - Direct Rx:
72189-598 - Golden State Medical Supply, Inc.:
51407-838,51407-836,51407-837 - Major Pharmaceuticals:
0904-7359,0904-7355,0904-7356,0904-7357+1 - Proficient Rx LP:
82804-215 - Remedyrepack Inc.:
70518-4563,70518-4260,70518-4241,70518-4173+3
Recalls
- Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc · 2 recall notices
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.