Drug factory · FDA FEI 3002930340
Lonza AG
Lonzastrasse, Visp, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Mar 28, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2010: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bremelanotide | Makes the active ingredient | Cosette Pharmaceuticals, Inc. | 0713-0897 |
| Daratumumab | Tests it | Janssen Biotech, Inc. | 57894-502, 57894-505 |
| Daratumumab and Hyaluronidase (human Recombinant) | Tests it | Janssen Biotech, Inc. | 57894-503 |
| Macitentan | Makes the active ingredient and tests it | Actelion Pharmaceuticals US, Inc. | 66215-501 |
| Macitentan and Tadalafil | Makes the active ingredient and tests it | Actelion Pharmaceuticals US, Inc. | 66215-812, 66215-814 |
| Miglustat | Makes the active ingredient and tests it | Actelion Pharmaceuticals US, Inc., CoTherix, Inc. | 66215-201, 10148-201 |
| Sonidegib | Makes the active ingredient | Caraco Pharmaceutical Laboratories, Ltd. | 47335-303 |
| Vandetanib | Makes the active ingredient and tests it | Genzyme Corporation | 58468-7820, 58468-7840 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 28, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 11, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 29, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 12, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.