Kinase Inhibitor
Where is Larotrectinib made?
2 companies sell it under their own name. Their labels name 2 factories in the United Kingdom and the United States.
United Kingdom 1United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Loxo Oncology, Inc. Vitrakvi20 mg per 1 mL, 25 mg, 100 mg · NDC 71777-391, 71777-392, 71777-390 | Penn Pharmaceutical Services LimitedMakes it | Tredegar, United Kingdom | Problems found, fixed voluntarilyApr 2022 |
| W. R. Grace & Co.-Conn.Makes the active ingredient | South Haven, MI, United States | No problems foundMar 2026 | |
| Bayer HealthCare Pharmaceuticals Inc. Vitrakvi20 mg per 1 mL, 25 mg, 100 mg · NDC 50419-391, 50419-392, 50419-393 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 6, 2023 · Class I · Bayer Healthcare Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.