Drug factory · FDA FEI 3012403297
Quagen Pharmaceuticals LLC
34 Fairfield Place, West Caldwell, NJ, United States
No problems found at FDA's last inspection, Apr 17, 2026.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2020: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Acetaminophen and Butalbital | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-147, 70752-148 |
| Acetaminophen and Butalbital and Caffeine | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-144 |
| Albuterol | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-102 |
| Aripiprazole | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-114 |
| Clobetasol | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-153 |
| Codeine and Promethazine | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-139 |
| Cyproheptadine | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-101, 70752-107, 70752-185 |
| Fluocinolone Acetonide | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-156, 70752-158, 70752-159 |
| Fluocinonide | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-154 |
| Glycopyrronium | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-175 |
| Halobetasol | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-119 |
| Hydrocortisone | Makes it and packages it |
Major Pharmaceuticals, Quagen Pharmaceuticals LLC, Rising Pharma Holdings, Inc. |
0904-7340, 70752-169, 16571-164 +1 |
| Lidocaine | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-113 |
| Methylphenidate | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-131, 70752-132 |
| Oxycodone | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-136, 70752-137 |
| Phenobarbital | Makes it and packages it |
Quagen Pharmaceuticals LLC, Rising Pharma Holdings, Inc. |
70752-157, 70752-161, 70752-162 +15 |
| Potassium Cation | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-150, 70752-151 |
| Promethazine | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-138 |
| Propylthiouracil | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-171 |
| Triamcinolone Acetonide | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-129, 70752-130, 70752-140 |
| Valproic Acid | Makes it and packages it |
Quagen Pharmaceuticals LLC |
70752-202 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Apr 17, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2026 | No problems found | Drug Quality Assurance | — |
| May 9, 2023 | No problems found | Drug Quality Assurance | — |
| May 9, 2023 | No problems found | Drug Quality Assurance | — |
| Oct 26, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 26, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture; pack.