The startup develops sterile injectable drug products, including prefilled syringes and vials, to address the issue of drug shortages in healthcare settings. By minimizing the resources required for medication preparation and administration, the company enhances operational efficiency for hospitals, outpatient centers, and clinics.
Funding
$19M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
NRFounders
Product
Problem
Drug shortages in healthcare settings can lead to delayed treatments and compromised patient care. Traditional medication preparation and administration can be resource-intensive, impacting operational efficiency for healthcare providers.
Solution
American Injectables is a contract development and manufacturing organization (CDMO) specializing in sterile injectable drug products in vials and prefilled syringes. The company provides end-to-end solutions, from formulation and process engineering to analytical testing, stability studies, and GMP manufacturing. American Injectables helps pharmaceutical companies streamline their manufacturing processes, ensure product quality, and meet regulatory requirements. With flexible batch sizes and state-of-the-art equipment, they support projects from initial formulation to commercial manufacturing.
Target Audience
American Injectables serves pharmaceutical companies, both large and small, seeking a reliable CDMO partner for sterile injectable drug development and manufacturing.
Features
- Manufacturing of sterile injectables in ready-to-use glass or plastic vials (2R to 50R)
- Filling of nested syringes (1 mL long and 1 to 50 mL)
- Formulation development, including optimization and proof-of-concept studies
- Analytical services, including method development, verification, and stability studies (ICH)
- Process engineering, including process flow development, test batches, and validation
- GMP manufacturing with single-use and dedicated reusable systems
- Quality assurance with in-process monitoring and electronic batch reporting
- Packaging services, including small-scale and outsourced large-scale packaging (automated cartoning and syringe assembly planned for 2026)
- Launch and regulatory support, including CMC documentation and GMP warehousing
- FDA-registered fill-finish, laboratory, and packaging/warehouse sites
- Aseptic filling in ISO 5/7 cleanrooms
- Equipment includes Optima syringe filling line, Bosch vial filling line, automated mixing vessels, Fedegari autoclave and dry heat oven, and Girton CIP/SIP and parts washer