Anti-IgE
Where is Omalizumab made?
2 companies sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Genentech, Inc. Xolair PFS, Xolair75 mg per 0.5 mL, 150 mg per 1 mL, 150 mg per 1.2 mL, 300 mg per 2 mL · NDC 50242-215, 50242-040, 50242-227 +1 | Genentech, Inc.Makes the active ingredient and tests it | Oceanside, CA, United States | No problems foundAug 2024 |
| CELLTRION USA, Inc. Omlyclo75 mg per 0.5 mL, 150 mg per 1 mL, 300 mg per 2 mL · NDC 72606-036, 72606-054, 72606-035 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jul 30, 2025 · Class II · Cardinal Health Inc. · 2 recall notices
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. - Jun 9, 2021 · Class II · Genentech Inc
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.