Labeler · US market
CELLTRION USA, Inc.
CELLTRION USA, Inc. is a US drug labeler with US FDA registrations covering 16 drug concepts (16 currently active) across 88 packages. It is currently the only active US supplier of 14 drugs. The company files with FDA under 2 name variants, merged into this profile.
Also files as: CELLTRION, Inc.
ACTIVE - US
openFDA · updated weekly
Labeler codes32228 · 72606
Active drugs16
Registrations34 active / 36
Packages88
Sole supplier of14 drugs
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FDA filings tell us what CELLTRION USA, Inc. registers, not who it is. If you know this company - what it makes, who owns it, where it manufactures - you can add it. Every submission is reviewed before it goes live.
Submit information about this company →Portfolio16 drugs · US
Every drug concept this labeler has US registrations for, by package count.
| Drug | Type | NDCs | Packages | Status |
|---|---|---|---|---|
| Adalimumab-Aaty kit | rx | 5 | 24 | SUPPLYING |
| Infliximab-Dyyb kit | rx | 1 | 12 | SUPPLYING |
| Infliximab-Dyyb injection, powder, lyophilized, for solution | rx | 2 | 6 | SUPPLYING |