American Injectables
American Injectables is a nimble, industry veteran-built CDMO committed to bringing quality injectable manufacturing back to U.S. soil, emphasizing transparency, collaboration, and regulatory excellence. Established in 2020, it specializes in sterile injectables with a focus on vials and syringes, offering end-to-end solutions supported by state-of-the-art facilities and a strong quality system. The company values teamwork, integrity, and service, aiming to be the CDMO of choice for sterile pharmaceutical injectables.
Industries
Nr. of Employees
small (1-50)
American Injectables
Tampa, Florida, United States, North America
Services
Formulation optimization, proof-of-concept development, and production of clinical trial material for sterile injectables.
Analytical method development and verification, stability study design and execution to support product release and regulatory submissions.
Process flow development, test batch execution, process optimization, and support for validation and registration batches.
Sterile fill–finish manufacturing for vials and syringes with capacity for small-to-mid production runs, including GMP-compliant operations and packaging support.
In-process monitoring, electronic batch records, shop-floor supervision, change control, deviation management, and CAPA processes.
Small-scale packaging operations with partner outsourcing options and plans for larger-scale packaging capacity.
Formulation optimization, proof-of-concept development, and production of clinical trial material for sterile injectables.
Analytical method development and verification, stability study design and execution to support product release and regulatory submissions.
Process flow development, test batch execution, process optimization, and support for validation and registration batches.
Sterile fill–finish manufacturing for vials and syringes with capacity for small-to-mid production runs, including GMP-compliant operations and packaging support.
In-process monitoring, electronic batch records, shop-floor supervision, change control, deviation management, and CAPA processes.
Small-scale packaging operations with partner outsourcing options and plans for larger-scale packaging capacity.
Expertise Areas
- Sterile injectable CDMO services
- Fill–finish manufacturing
- Parenteral formulation development
- Process engineering and scale-up
Key Technologies
- Peristaltic filling systems
- Direct displacement filling
- Nitrogen blanketing/flushing
- Single-use manufacturing systems
News & Updates
American Injectables, a leading CDMO specializing in sterile injectables, recently announced key leadership appointments to support its growth.
As of January 2025, American Injectables is an FDA-approved CDMO, reflecting its commitment to regulatory standards.
An overview of market trends and business insights related to injectable solutions.
Discussion on the importance of data integrity in pharmaceutical manufacturing.
Insights into developing potent and fast-acting parenteral formulations.
Exploring how formulation impacts the pharmaceutical supply chain.
American Injectables, a leading CDMO specializing in sterile injectables, recently announced key leadership appointments to support its growth.
As of January 2025, American Injectables is an FDA-approved CDMO, reflecting its commitment to regulatory standards.
An overview of market trends and business insights related to injectable solutions.
Discussion on the importance of data integrity in pharmaceutical manufacturing.
Insights into developing potent and fast-acting parenteral formulations.
Exploring how formulation impacts the pharmaceutical supply chain.