Calcineurin Inhibitor Immunosuppressant
Where is Cyclosporine made?
23 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 9 factories in India, France, China, the Czech Republic, Turkey and South Korea.
India 2France 2China 2Czech Republic 1Turkey 1South Korea 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd. Cequa0.0009 g per 1 mL, 0.0009 mg per 1 mL · NDC 47335-506, 47335-507 | Laboratoire UnitherMakes it | Coutances, France | Problems found, fixed voluntarilyOct 2021 |
| TAPI Czech Industries s.r.oMakes the active ingredient | Opava, Czech Republic | Not inspected on record | |
| Aurobindo Pharma Limited25 mg, 50 mg, 100 mg · NDC 59651-929, 59651-927, 59651-928 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cipla USA., Inc.0.5 mg per 1 mL · NDC 69097-292 | Jiangsu Anbison Pharmaceutical Co., Ltd.Makes it | Taizhou, China | Not inspected on record |
| Devatis, Inc.0.5 mg per 1 mL · NDC 73043-005 | Deva Holding A S-Kartepe Uretim TesisleriMakes it | Kocaeli, Turkey | No problems foundDec 2023 |
| Harrow Eye, LLC Vevye, Verkazia1 mg per 1 mL · NDC 82667-900, 82667-014 | ExcelvisionMakes it | Annonay, France | Serious problems, FDA actionJan 2026 |
| Qilu Pharmaceutical Co., Ltd.25 mg, 100 mg · NDC 67184-0585, 67184-0584 | Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)Makes it and tests it | Jinan, China | Problems found, fixed voluntarilyJan 2025 |
| Saptalis Pharmaceuticals, LLC.0.5 mg per 1 mL · NDC 71656-012 | Taejoon Pharmaceutical Co., Ltd.Makes it | Yongin-si, South Korea | Problems found, fixed voluntarilyOct 2022 |
| Strides Pharma Science Limited25 mg, 50 mg, 100 mg · NDC 64380-129, 64380-127, 64380-128 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Upsher-Smith Laboratories, Inc.0.5 mg per 1 mL · NDC 24979-126 | Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)Makes it, tests it and packages it | Jinan, China | Problems found, fixed voluntarilyJan 2025 |
| AbbVie Inc.25 mg, 50 mg, 100 mg · NDC 0074-6479, 0074-3109, 0074-6463 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Allergan, Inc. Restasis, Restasis MultiDose0.5 mg per 1 mL · NDC 0023-9163, 0023-5301 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.0.5 mg per 1 mL, 25 mg, 50 mg, 100 mg · NDC 60505-6202, 60505-0134, 60505-4632 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.25 mg, 100 mg · NDC 75907-048, 75907-047 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.25 mg, 50 mg, 100 mg · NDC 23155-839, 23155-837, 23155-838 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Imprimis NJOF, LLC1 mg per 1 mL · NDC 71384-514 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ImprimisRx NJ1 mg per 1 mL · NDC 70261-514 | The label doesn't name the factory. Plants this company names for other drugs | ||
| KVK-TECH, Inc.0.5 mg per 1 mL · NDC 10702-808 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc.0.5 mg per 1 mL · NDC 68180-214 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.5 mg per 1 mL · NDC 0378-8760 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Sandimmune, Neoral25 mg, 50 mg per 1 mL, 100 mg, 100 mg per 1 mL · NDC 0078-0241, 0078-0248, 0078-0274 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Santen Incorporated Verkazia1 mg per 1 mL · NDC 65086-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.25 mg, 50 mg, 100 mg, 100 mg per 1 mL · NDC 0093-9020, 0172-7313, 0093-9018 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.0.5 mg per 1 mL · NDC 0480-4076 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cyclosporine 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:
50090-1242,50090-4476 - American Health Packaging:
68084-921,68084-879 - Physicians Total Care, Inc.:
54868-4793,54868-6232,54868-5522
Recalls
- Oct 20, 2025 · Class III · Imprimis NJOF, LLC
Subpotent Drug - May 14, 2024 · Class II · Imprimis NJOF, LLC
Lack of Assurance of Sterility - Sep 7, 2023 · Class III · Sun Pharmaceutical Industries Inc
Subpotent: Out of Specification result observed for low assay - Sep 16, 2022 · Class II · Novartis Pharmaceuticals Corporation
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. - Apr 1, 2022 · Class III · Sun Pharmaceutical Industries Inc
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. - May 7, 2021 · Class III · Sun Pharmaceutical Industries Inc
Subpotent and Presence of Particulates . - Feb 22, 2021 · Class III · Sun Pharmaceutical Industries Inc
Subpotent - Feb 8, 2017 · Class II · Amerisource Health Services
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities - Feb 3, 2017 · Class II · Apotex Inc.
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.