Sterile Injectables CDMO Services
US-based expertise, quality, and capacity to advance your program
ForDoz Pharma is focused exclusively on sterile drug products, helping develop and commercialize innovative therapeutics by serving as a contract development and manufacturing organization (CDMO) partner. Based in East Windsor, New Jersey, ForDoz is a fully integrated sterile drug product CDMO with end-to-end capabilities.
Advancing Sterile Drug Products
ForDoz Pharma specializes in conventional formulations and complex sterile drug products:
Conventional aqueous solution products
Lyophilized sterile formulations
Liposomal & nanoparticle-based drug delivery
Microsphere & polymer-based controlled-release systems
in situ depot formulations for long-acting injectables
Along with the ability to work with organic solvents, high-potency compounds, and small or large molecules, our expertise in conventional and complex formulations allows us to address the challenging issues that sterile drug product developers face.
Full Lifecycle CDMO Services
Full Lifecycle CDMO Services
While many CDMOs can handle early-stage development, there aren’t enough CDMOs in the United States with the capacity and expertise to support the end-to-end, full-scale production of sterile drug products. ForDoz Pharma meets this demand by providing full program support from early-phase development to commercial manufacturing, including packaging, labeling, and serialization, for complex and conventional sterile drug products.
ForDoz Pharma’s Services & Facilities Support the Full Product Lifecycle
Preclinical
- Pre-formulation activities
- Early-phase process development
- Toxicology dosing formulation studies
- Analytical method development
- IND-enabling formulation activities
Phase I – Phase III
- Process development & scale-up
- Clinical trial cGMP manufacturing
- ICH-compliant stability testing
- Release testing
- On-site cGMP storage
- Robust CMC and regulatory support
Commercial
- Process optimization
- Commercial cGMP manufacturing
- Release testing
- On-site cGMP storage
- Interval stability testing support
cGMP Facilities
- cGMP sterile manufacturing facility, completed FDA PAI in 2023
- In-house cGMP QC lab
- In-house cGMP microbiology lab
- On-site cGMP finished product inspection
- Packaging, labeling, serialization, and aggregation
- On-site cGMP warehouse
Working to Advance Your Conventional and Complex Injectables Program
Let us put our expertise and capacity to work to support the end-to-end needs of your conventional and complex injectable program, from early development and regulatory approval to commercial manufacturing.