Atypical Antipsychotic
Where is Clozapine made?
7 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 4 factories in India and the United States.
India 3United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 59651-262, 65862-846, 59651-260 +6 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Northstar Rx LLC.25 mg, 50 mg, 100 mg, 200 mg · NDC 72603-913, 72603-914, 72603-911 +1 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Accord Healthcare Inc.25 mg, 100 mg · NDC 16729-142, 16729-141 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| TruPharma LLC. Versacloz50 mg per 1 mL · NDC 52817-601 | Pharmaceutics International, Inc.Makes it and packages it | Hunt Valley, MD, United States | Problems found, fixed voluntarilyDec 2024 |
| HLS Therapeutics (USA), Inc. Clozaril25 mg, 100 mg · NDC 69809-0127, 69809-0126 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.25 mg, 50 mg, 100 mg, 150 mg, 200 mg · NDC 0378-3815, 0378-0860, 0378-3816 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.12.5 mg, 25 mg, 100 mg, 150 mg, 200 mg · NDC 0093-5419, 0093-5416, 0093-5376 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Clozapine 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.
- American Health Packaging:
60687-415,60687-426,60687-404,60687-548 - Cardinal Health 107, LLC:
55154-3568 - Major Pharmaceuticals:
0904-7087,0904-7088,0904-7089,0904-7406 - Mylan Institutional Inc.:
51079-288,51079-922,51079-749,51079-921 - Safecor Health, LLC:
48433-024,48433-022,48433-025,48433-023 - TYA Pharmaceuticals:
64725-1260
Recalls
- Jun 12, 2020 · Class II · Aurobindo Pharma USA Inc.
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. - Sep 21, 2018 · Class II · Teva Pharmaceuticals USA
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.