Tricyclic Antidepressant
Where is Clomipramine made?
14 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 11 factories in India, Israel, the United States and Canada.
India 8Israel 1United States 1Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ajanta Pharma USA Inc.25 mg, 50 mg, 75 mg · NDC 27241-210, 27241-211, 27241-212 | Ajanta Pharma LimitedMakes it | Bharuch, India | No problems foundJun 2023 |
| Alembic Pharmaceuticals Inc.25 mg, 50 mg, 75 mg · NDC 62332-407, 62332-408, 62332-409 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited25 mg, 50 mg, 75 mg · NDC 46708-407, 46708-408, 46708-409 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited25 mg, 50 mg, 75 mg · NDC 59651-381, 59651-382, 59651-383 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 75 mg · NDC 51672-4011, 51672-4012, 51672-4013 | Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 |
| Leading Pharma, LLC25 mg, 50 mg, 75 mg · NDC 69315-167, 69315-166, 69315-165 | Leading Pharma, LLCMakes it | Fairfield, NJ, United States | Problems found, fixed voluntarilyOct 2024 |
| Lifestar Pharma LLC.25 mg, 50 mg, 75 mg · NDC 70756-405, 70756-406, 70756-407 | Mankind Pharma LimitedMakes it, tests it and packages it | Sirmaur, India | Problems found, fixed voluntarilyFeb 2022 |
| Lupin Pharmaceuticals, Inc.25 mg, 50 mg, 75 mg · NDC 68180-492, 68180-493, 68180-494 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Micro Labs Limited25 mg, 50 mg, 75 mg · NDC 42571-342, 42571-343, 42571-344 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.25 mg, 50 mg, 75 mg · NDC 16714-849, 16714-850, 16714-851 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Rising Pharma Holdings, Inc.25 mg, 50 mg, 75 mg · NDC 16571-683, 16571-684, 16571-685 | Unique Pharmaceutical LaboratoriesMakes it and tests it | Bharuch, India | Problems found, fixed voluntarilyOct 2022 |
| SpecGx LLC Clomipramine Hydrochloride, Anafranil25 mg, 50 mg, 75 mg · NDC 0406-8806, 0406-9906, 0406-8807 +3 | Patheon Inc.Makes it | Whitby, Canada | Problems found, fixed voluntarilyFeb 2023 |
| Marlex Pharmaceuticals, Inc.25 mg, 50 mg, 75 mg · NDC 10135-698, 10135-699, 10135-700 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VGYAAN Pharmaceuticals LLC25 mg, 50 mg, 75 mg · NDC 72664-214, 72664-215, 72664-216 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Clomipramine 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:
68084-790,68084-818 - Bryant Ranch Prepack:
63629-1111,72162-1977 - Carilion Materials Management:
68151-3048 - Golden State Medical Supply, Inc.:
51407-757,51407-758,51407-759 - Major Pharmaceuticals:
0904-7038,0904-7039 - Physicians Total Care, Inc.:
54868-4023 - Proficient Rx LP:
71205-910,71205-911,71205-912
Recalls
- Oct 22, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc · 3 recall notices
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. - Jun 27, 2025 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. - Apr 10, 2025 · Class II · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. - Aug 23, 2022 · Class III · Leading Pharma, LLC
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.