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HAS Healthcare Advanced Synthesis SA vs Sterling Pharma Solutions

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CategoryHAS Healthcare Advanced Synthesis SASterling Pharma Solutions
Listed sitecdmocdmo
SummaryHAS Healthcare Advanced Synthesis is a Swiss CDMO producing cGMP APIs, HPAPIs and anticancer compounds from clinical to commercial use. Recent Swissmedic milestones include approval of its expanded Reduced Folates unit and inspection of its new ADC suite.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
  • HPAPI Manufacturing (High-Potency)
  • ADC (Antibody-Drug Conjugate) Manufacturing
  • Small Molecule Development & Manufacturing
  • Quality Control Testing
  • 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
  • Peptide
  • Antibody-Drug Conjugate (ADC)
Indications
  • Oncology
Data not yet provided.
Locations
  • Biasca, Biasca, Switzerland
  • 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
CertificationsData not yet provided.
  • 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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