| Summary | CDMO specializing in HPAPIs, ADCs, peptides, vaccines, and biologics with 4,700+ team members across 15 global sites and 500+ customers. Offers integrated development and manufacturing with backward integration capabilities and global program management. | Small molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation. |
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| Locations | - Grangemouth, Grangemouth, Scotland, United Kingdom
- Shanghai, Shanghai, China
- Sourcing Office, Shanghai, China
| - Cork, Cork, Munster, Ireland
- Cramlington, Cramlington, Northumberland, United Kingdom
- Deeside, Deeside, Wales, United Kingdom
- Newcastle Biosphere, Newcastle, Tyne and Wear, United Kingdom
- North Carolina, North Carolina, North Carolina, United States
- Wisconsin, Wisconsin, Wisconsin, United States
- North Carolina, North Carolina, North Carolina, US
- Wisconsin, Wisconsin, Wisconsin, US
- Newcastle Biosphere, Newcastle, England, UK
- North Carolina, North Carolina, US
- Wisconsin, Wisconsin, US
- Cramlington, Cramlington, England, UK
- North Carolina, North Carolina, North Carolina, USA
- Wisconsin, Wisconsin, Wisconsin, USA
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| Certifications | - MHRA · Identifier: GMP Certificate
- GMP · Identifier: GMP
- ISO · Identifier: ISO 9001, 14001, 45001
- FAMI-QS · Identifier: FAMI-QS
- ISO · Identifier: ISO 9001
- ISO · Identifier: ISO 14001
- ISO · Identifier: ISO 45001
| - FDA · Identifier: cGMP inspection
- HPRA · Identifier: cGMP inspection (mutually recognised by FDA)
- PMDA · Identifier: Project specific inspection
- ANVISA · Identifier: Project specific inspection
- MHRA · Identifier: cGMP inspection
- DEA · Identifier: Schedule I-V controlled substances approval
- ISO · Identifier: ISO/IEC 27001:2022, ISO/IEC 9001:2015, ISO 45001:2018, ISO 14001:2015
- FDA · Identifier: cGMP inspection January 2017
- PMDA · Identifier: project specific inspection June 2022
- HPRA · Identifier: cGMP inspection March 2022
- ANVISA · Identifier: project specific inspection 2021
- MHRA · Identifier: cGMP inspection June 2021
- FDA · Identifier: cGMP inspection May 2018
- MHRA · Identifier: cGMP inspection April 2023
- FDA · Identifier: Registered as bulk API manufacturer
- DEA · Identifier: Approved to import, store, manufacture and export Schedule I-V controlled substances
- FDA · Identifier: cGMP inspection March 2024
- cGMP · Identifier: cGMP accreditation
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