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Carbogen Amcis vs Sterling Pharma Solutions

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CategoryCarbogen AmcisSterling Pharma Solutions
Listed sitecdmocdmo
SummaryFull-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.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.
Services
  • API Synthesis & Manufacturing
  • Process Development
  • CMC Analytical Development
  • Formulation Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Lyophilization (Freeze Drying)
  • Flow Chemistry & Continuous Manufacturing
  • HPAPI Manufacturing (High-Potency)
  • ADC Payload & Linker Synthesis
  • Bioconjugation Services
  • Vial Filling
  • Sterile Fill-Finish & Aseptic Manufacturing
  • ADC (Antibody-Drug Conjugate) Manufacturing
  • Small Molecule Development & Manufacturing
  • Solid-State Chemistry & Polymorph Screening
  • API Synthesis & Manufacturing
  • HPAPI Manufacturing (High-Potency)
  • Controlled Substance Manufacturing
  • Peptide Manufacturing
  • ADC (Antibody-Drug Conjugate) Manufacturing
  • ADC Payload & Linker Synthesis
  • Flow Chemistry & Continuous Manufacturing
  • Solid-State Chemistry & Polymorph Screening
  • CMC Analytical Development
  • Process Development
  • CMC Regulatory Submission Support
  • Bioconjugation Services
  • Small Molecule Development & Manufacturing
  • Quality Control Testing
  • Technology Transfer
Modalities
  • Small Molecule
  • Antibody-Drug Conjugate (ADC)
  • Small Molecule
  • Antibody-Drug Conjugate (ADC)
  • Peptide
IndicationsData not yet provided.Data not yet provided.
Locations
  • Bubendorf (Headquarters), Bubendorf, Basel-Landschaft, Switzerland
  • Aarau, Aarau, Aargau, Switzerland
  • Neuland, Hunzenschwil, Aargau, Switzerland
  • Vionnaz, Vionnaz, Valais, Switzerland
  • France, France, France
  • United Kingdom, United Kingdom, United Kingdom
  • Netherlands, Netherlands, Netherlands
  • China, China, China
  • Headquarters, Bubendorf, Basel-Landschaft, Switzerland
  • Switzerland, Switzerland, Switzerland
  • UK, UK, United Kingdom
  • France, France, France
  • Netherlands, Netherlands, Netherlands
  • Shanghai, Shanghai, 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
Certifications
  • NMPA · Identifier: GMP
  • NMPA · Identifier: GMP Compliance
  • NMPA · Identifier: GMP compliant
  • NMPA · Identifier: GMP Compliance (Shanghai site, unannounced inspection, no observations)
  • CIA · Identifier: Chemical Industries Association Recognition
  • 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
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.