Drug factory · FDA FEI 3002806294
ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo Reszvenytarsasag
Kabay Janos u. 29., Tiszavasvari, Hungary
Problems found, fixed voluntarily at FDA's last inspection, Mar 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Albuterol | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
53489-176, 53489-177 |
| Allopurinol | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
53489-156, 53489-157 |
| Amitriptyline | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-687, 57664-688, 57664-689 +3 |
| Carbidopa and Levodopa | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
47335-186, 47335-187, 47335-188 |
| Doxycycline | Makes it, tests it and packages it |
Caraco Pharmaceutical Laboratories, Ltd. |
53489-118, 53489-119, 53489-120 +1 |
| Hydroxychloroquine | Makes it, tests it and packages it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-761 |
| Mirtazapine | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-499, 57664-500, 57664-501 +1 |
| Phentermine | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
53489-676 |
| Pindolol | Makes it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-655, 57664-656 |
| Sulfamethoxazole and Trimethoprim | Makes it, tests it and packages it |
Caraco Pharmaceutical Laboratories, Ltd. |
49708-145, 49708-146, 53489-145 +1 |
| Tizanidine | Makes it, tests it and packages it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-502, 57664-503 |
| Venlafaxine | Makes it, tests it and packages it |
Caraco Pharmaceutical Laboratories, Ltd. |
57664-392, 57664-393, 57664-394 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Mar 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | No problems found | Drug Quality Assurance | — |
| Mar 10, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 4, 2015 | No problems found | Drug Quality Assurance | — |
| May 22, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 27, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; pack.