Agno Pharmaceuticals LLC
Agno Pharmaceuticals is a US-headquartered end-to-end global CDMO with over 20 years of experience, specializing in API development, drug product formulation, cGMP manufacturing for clinical trials, and commercial production. They serve the pharmaceutical, biotech, and generic sectors with tailored solutions, high-quality standards, and a commitment to excellence across the entire drug development spectrum.
Industries
Nr. of Employees
medium (51-250)
Agno Pharmaceuticals LLC
Piscataway, New Jersey, United States, North America
Products
Drug implants (dosage form)
Development and manufacturing support for subcutaneous and other implantable dosage forms.
Injectable / parenteral dosage forms
Formulation and cGMP manufacture of sterile injectable suspension and finished-dose parenteral products.
Ophthalmic dosage forms
Formulation and development support for ophthalmic drug products.
Oral dosage forms
Formulation and manufacturing support for solid and liquid oral dosage forms.
Topical, mucosal and transdermal dosage forms
Development and manufacturing support for topical, mucosal and transdermal drug delivery systems.
Drug implants (dosage form)
Development and manufacturing support for subcutaneous and other implantable dosage forms.
Injectable / parenteral dosage forms
Formulation and cGMP manufacture of sterile injectable suspension and finished-dose parenteral products.
Ophthalmic dosage forms
Formulation and development support for ophthalmic drug products.
Oral dosage forms
Formulation and manufacturing support for solid and liquid oral dosage forms.
Topical, mucosal and transdermal dosage forms
Development and manufacturing support for topical, mucosal and transdermal drug delivery systems.
Services
API & Intermediates development and cGMP manufacturing
Route scouting, process development, scale-up, and cGMP clinical and commercial manufacturing for APIs, intermediates and regulatory starting materials.
Drug product formulation development and cGMP manufacturing
Formulation R&D and cGMP clinical/commercial manufacturing for complex drug products including injectables, ophthalmics, oral and topical dosage forms.
Long-acting implant development and manufacturing
Design, polymer processing and scale-up for long-acting implants and implantable drug-delivery systems.
Analytical method development, validation and stability programs
Full analytical support from method development and validation through ICH‑compliant stability testing and reporting for global submissions.
Sterile powder fill, aseptic processing and sterile injectable finishing
Aseptic sterile powder filling and sterile injectable finished-dose manufacturing with QA oversight and microbial control.
Particle size reduction and particle engineering services
Micronization, nanomilling and particle engineering for poorly soluble compounds, available under aseptic conditions when required.
API & Intermediates development and cGMP manufacturing
Route scouting, process development, scale-up, and cGMP clinical and commercial manufacturing for APIs, intermediates and regulatory starting materials.
Drug product formulation development and cGMP manufacturing
Formulation R&D and cGMP clinical/commercial manufacturing for complex drug products including injectables, ophthalmics, oral and topical dosage forms.
Long-acting implant development and manufacturing
Design, polymer processing and scale-up for long-acting implants and implantable drug-delivery systems.
Analytical method development, validation and stability programs
Full analytical support from method development and validation through ICH‑compliant stability testing and reporting for global submissions.
Sterile powder fill, aseptic processing and sterile injectable finishing
Aseptic sterile powder filling and sterile injectable finished-dose manufacturing with QA oversight and microbial control.
Particle size reduction and particle engineering services
Micronization, nanomilling and particle engineering for poorly soluble compounds, available under aseptic conditions when required.
Expertise Areas
- End-to-end CDMO services (development to commercial supply)
- API process development and manufacturing
- High-potency API (HPAPI) handling and manufacture
- Sterile injectable and aseptic processing
Key Technologies
- cGMP manufacturing
- GLP testing and GLP batch production
- Lyophilization (freeze-drying)
- Hot-melt extrusion