Companies
Catalent
global GMP capacity (Lonza Visp/US, Catalent, Thermo Fisher Patheon) that lets a sponsor manufacture in-region without owning a plant.
- Country
- United States
Commercial
Global CDMO
Coverage
| CN | EU | IN | US | |
|---|---|---|---|---|
| market-access-commercial | ✓ | ✓ | ✓ | ✓ |
| therapeutics-platforms | ✓ | ✓ | — | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | $1.15 billion in total funding | intuitionlabs.ai |
| Capacity | Single-use bioreactors up to 2,000 L; 16 GMP suites at Harmans/BWI; Madison site has multiple 2,000 L reactors | intuitionlabs.ai · catalent.com |
| Certification | FDA CGMP, EMA, PMDA, ANVISA, Russian Ministry of Health, ISO 14001, ISO 45001, Ecovadis GOLD, HPRA GMP certified | catalent.com |
| Regulatory approval | Supported multiple regulatory approvals including FDA CBER, EMA, PMDA, ANVISA, and Russian Ministry of Health | catalent.com |
| Production site | More than 40 global sites, including major hubs in Madison, WI and Harmans/BWI, MD | catalent.com |
| Revenue | $4.38 billion (FY2024) | intuitionlabs.ai · sec.gov |
Independent sources: intuitionlabs.ai · sec.gov
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Bioproduction CDMO/CMO (biologics/ATMP/mRNA) | therapeutics-platforms | Low | → |
| Local manufacturing for market access | market-access-commercial | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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