Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Catalent Anagni S.R.L. | Anagni (fontana Del Ceraso), Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 23, 2024 · 7 inspections |
| ModernaTX, Inc. | Norwood, MA, United States | Makes the active ingredient and tests it | Not inspected on record |
| ROVI Pharma Industrial Services S.A. | Madrid, Spain | Makes it and tests it | Problems found, fixed voluntarilyMar 14, 2024 · 6 inspections |
| Rovi Pharma Industrial Services S.a. | San Sebastián de los Reyes, Spain | Makes it | Problems found, fixed voluntarilyJun 3, 2021 · 1 inspection |
| Associates of Cape Cod, Inc. | East Falmouth, MA, United States | Tests it | No problems foundJul 16, 2025 · 6 inspections |
| Eurofins Biopharma Product Testing Ireland Limited | Ireland | Tests it | Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| Moderna Biotech Spain Sl. | Madrid, Spain | Tests it | Not inspected on record |
| Rovi Pharma Industrial Services SA | Alcala de Henares, Spain | Tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2024 · 5 inspections |
Product details
- Generic drug
- Cx-055611: every company that makes it
- Form
- injection, suspension, intramuscular
- Strength
- 50 ug per 0.5 mL
- Approval
- BLA BLA125752
- On the market since
- Aug 17, 2026
- Package NDCs
80777-114-0180777-114-96- Official label
- DailyMed (National Library of Medicine), updated Aug 17, 2026
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