State-of-the-Art cGMP Sterile Drug Product Manufacturing Facilities
Expanding US sterile drug product capacity
ForDoz Pharma’s East Windsor, New Jersey, US facility focuses exclusively on developing and commercializing sterile drug products throughout their full product lifecycle.
Our purpose-built, state-of-the-art cGMP sterile drug product manufacturing facility empowers innovators developing conventional and complex aqueous solutions and lyophilized sterile formulations, for small or large molecules, including high-potency compounds. Additionally, we leverage our proprietary particle-based drug delivery technologies and long-acting injectable (LAI) platforms for complex products with challenging drug delivery requirements.
Key advantages of our facility include:
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Key advantages
Full cGMP compliance for conventional and complex sterile drug products
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Key advantages
Seamless integration from early development to Phase 1 and then scale-up from Phase II clinical batches through late phase and commercial runs
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Key advantages
End-to-end support under one roof, from formulation development and analytical testing to regulatory filing and commercial release
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Facility I
cGMP Sterile Drug Product Manufacturing Facility I
Our current cGMP sterile manufacturing facility is dedicated to producing conventional and complex sterile drug products, including aqueous solution products, lyophilized sterile formulations, liposomes, suspensions, and long-acting Injectable products (LAIs).
- Fully isolator-based and automatic solution vial filling line
- Lyophilization machines equipped with vial auto-loading and auto-unloading
- Dedicated suite for the manufacturing of high-potency products
- Complies with both US and EU cGMP standards
- Successfully completed FDA inspection in 2023
- In-house cGMP QC lab and microbiology lab
- On-site inspection, labeling, serialization, and aggregation
- On-site cGMP warehouse
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Facility II – Under Construction
Under Construction: cGMP Sterile Manufacturing Facility II
Currently in strategic planning, our second manufacturing facility will also be dedicated to cGMP manufacturing of sterile drug products. Featuring a state-of-the-art, fully isolator-based automatic filling line, this expansion will support the production of long-acting injectable products (LAIs) as well as other sterile drug products.
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.