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Axplora vs Sterling Pharma Solutions

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CategoryAxploraSterling Pharma Solutions
Listed sitecdmocdmo
SummaryGlobal CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.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
  • ADC Payload & Linker Synthesis
  • ADC (Antibody-Drug Conjugate) Manufacturing
  • HPAPI Manufacturing (High-Potency)
  • API Synthesis & Manufacturing
  • Process Development
  • CMC Analytical Development
  • Formulation Development
  • Technology Transfer
  • Flow Chemistry & Continuous Manufacturing
  • Solid-State Chemistry & Polymorph Screening
  • CMC Regulatory Submission Support
  • Quality Control Testing
  • Small Molecule Development & Manufacturing
  • 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
  • Antibody-Drug Conjugate (ADC)
  • Small Molecule
  • Small Molecule
  • Antibody-Drug Conjugate (ADC)
  • Peptide
Indications
  • Oncology
  • Immunology
  • Metabolic
  • Infectious Disease
  • Respiratory
  • Women's Health
Data not yet provided.
Locations
  • Headquarters, Raubling, Bavaria, Germany
  • Chasse-sur-Rhône, Chasse-sur-Rhône, Auvergne-Rhône-Alpes, France
  • Gropello Cairoli, Gropello Cairoli, Lombardy, Italy
  • Leverkusen, Leverkusen, North Rhine-Westphalia, Germany
  • Le Mans, Le Mans, Pays de la Loire, France
  • Mourenx, Mourenx, Nouvelle-Aquitaine, France
  • Pompey, Pompey, Grand-Est, France
  • Chennai, Chennai, Tamil Nadu, India
  • Vizag, Visakhapatnam, Andhra Pradesh, India
  • R&D Center, Wilmington, Delaware, United States
  • 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
  • FDA · Identifier: US FDA
  • EMA · Identifier: EU
  • PMDA · Identifier: PMDA
  • ANVISA · Identifier: ANVISA
  • ISO · Identifier: ISO 9001
  • ISO · Identifier: ISO 50001
  • CDSCO · Identifier: CDSCO
  • 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.