Agno Pharmaceuticals LLC
Agno Pharmaceuticals is a US-headquartered end-to-end global CDMO specializing in pharmaceutical innovation. With over 20 years of experience, they offer comprehensive solutions including API development, drug product formulation, and cGMP manufacturing for clinical trials and commercial production. They serve the pharmaceutical, biotech, and generic sectors with a focus on quality, compliance, and innovation, supported by state-of-the-art facilities and a dedicated team of experts.
Industries
Nr. of Employees
medium (51-250)
Services
Contract development and cGMP manufacture of APIs, chemical intermediates, and regulatory starting materials for clinical and commercial supply.
Development and manufacturing services for implantable drug products, including formulation and scale-up to cGMP production.
cGMP production capabilities for sterile active ingredients and sterile excipients used in parenteral formulations.
Analytical services including method development and validation, and stability program execution to support product development and regulatory submissions.
Formulation development and cGMP manufacture of finished drug products, including development for complex formulations and sterile injectables.
Controlled particle size reduction and particle engineering services compatible with aseptic and sterile production environments.
Contract development and cGMP manufacture of APIs, chemical intermediates, and regulatory starting materials for clinical and commercial supply.
Development and manufacturing services for implantable drug products, including formulation and scale-up to cGMP production.
cGMP production capabilities for sterile active ingredients and sterile excipients used in parenteral formulations.
Analytical services including method development and validation, and stability program execution to support product development and regulatory submissions.
Formulation development and cGMP manufacture of finished drug products, including development for complex formulations and sterile injectables.
Controlled particle size reduction and particle engineering services compatible with aseptic and sterile production environments.
Expertise Areas
- Contract development and manufacturing (end-to-end CDMO)
- API process development and scale-up
- Formulation development for complex and poorly soluble molecules
- Sterile and aseptic injectable manufacturing
Key Technologies
- cGMP manufacturing
- Aseptic/sterile filling and suspension processing
- Sterile powder fill processes
- Particle size reduction and milling
News & Updates
March 17-20, 2025. An upcoming industry event in New York.
May 20-22, 2025. Industry event in Philadelphia.
June 16-19, 2025. International biotech event in Boston.
September 8-10, 2025. Industry event with location to be announced.
US FDA Inspection Passes
Successfully passed US FDA inspections in 2014, 2018, 2020, 2021, and 2024, demonstrating high standards of quality and compliance.
March 17-20, 2025. An upcoming industry event in New York.
May 20-22, 2025. Industry event in Philadelphia.
June 16-19, 2025. International biotech event in Boston.
September 8-10, 2025. Industry event with location to be announced.
US FDA Inspection Passes
Successfully passed US FDA inspections in 2014, 2018, 2020, 2021, and 2024, demonstrating high standards of quality and compliance.