ForDoz Pharma
US-based contract development and manufacturing organization (CDMO) focused exclusively on conventional and complex sterile injectable drug products. Operates a purpose-built cGMP sterile manufacturing facility in East Windsor, New Jersey, offering end-to-end services from preclinical development and analytical method development to clinical and commercial cGMP manufacturing, packaging, and regulatory support. Technology platforms include liposomal and nanoparticle delivery, microsphere/polymer controlled-release systems, and in situ depot long-acting injectable (LAI) technologies.
Industries
Nr. of Employees
small (1-50)
ForDoz Pharma
69 Princeton Hightstown Rd, East Windsor, New Jersey 08520, USA
Patents
Injectable sustained-release formulations for treatment of joint pain and inflammation
US-12589102-B2
View DetailsOral liquid formulations of lipid-lowering and blood pressure-lowering drugs
US-12377045-B2
View Details
Injectable sustained-release formulations for treatment of joint pain and inflammation
US-12589102-B2
View DetailsOral liquid formulations of lipid-lowering and blood pressure-lowering drugs
US-12377045-B2
View DetailsProducts
Doxorubicin hydrochloride liposome injection (ANDA-approved product)
FDA-approved liposomal doxorubicin injectable product manufactured commercially at the company's cGMP facility; available in 20 mg/10 mL and 50 mg/25 mL vial sizes (2 mg/mL).
Doxorubicin hydrochloride liposome injection (ANDA-approved product)
FDA-approved liposomal doxorubicin injectable product manufactured commercially at the company's cGMP facility; available in 20 mg/10 mL and 50 mg/25 mL vial sizes (2 mg/mL).
Services
End-to-end services from preclinical formulation and IND-enabling activities through Phase I–III clinical manufacturing to commercial cGMP production, including process development, scale-up, and regulatory support.
Analytical method development, validation, and release testing for APIs and finished sterile products with in-house cGMP QC and microbiology labs.
Isolator-based automated vial filling lines, high-throughput liquid filling, and automated lyophilization services for sterile liquid and lyophilized products.
Commercial packaging, labeling, serialization, aggregation, and on-site cGMP warehousing integrated with manufacturing operations.
End-to-end services from preclinical formulation and IND-enabling activities through Phase I–III clinical manufacturing to commercial cGMP production, including process development, scale-up, and regulatory support.
Analytical method development, validation, and release testing for APIs and finished sterile products with in-house cGMP QC and microbiology labs.
Isolator-based automated vial filling lines, high-throughput liquid filling, and automated lyophilization services for sterile liquid and lyophilized products.
Commercial packaging, labeling, serialization, aggregation, and on-site cGMP warehousing integrated with manufacturing operations.
Expertise Areas
- Sterile injectable CDMO services (end-to-end)
- Liposomal and nanoparticle drug delivery
- Microsphere and polymer-controlled release systems
- Long-acting injectable (LAI) formulation development
Key Technologies
- Liposomal nanoparticle delivery
- Nanosuspensions (submicron suspensions)
- Polymeric microspheres (PLGA/PLA based)
- Micelles
News & Updates
Announcement of FDA ANDA approval for doxorubicin hydrochloride liposome injection (first liposomal injectable product approved and manufactured domestically by the company).
Article discussing challenges and strategies for translating complex injectable formulations from R&D to commercial manufacture, with commentary on facility and platform needs.
Interview and article describing the company’s history, technology platforms, CDMO value proposition, and plans for capacity expansion.
Overview of complex injectable technologies (liposomes, microspheres, micelles, submicron crystals) and the specialized manufacturing and analytical requirements to support them.
Received US FDA approval for a doxorubicin hydrochloride liposome injection ANDA; product entered the US market and is commercially manufactured in the company's cGMP facility.
Facility completed a pre-approval inspection by the US FDA in 2023.
Announcement of FDA ANDA approval for doxorubicin hydrochloride liposome injection (first liposomal injectable product approved and manufactured domestically by the company).
Article discussing challenges and strategies for translating complex injectable formulations from R&D to commercial manufacture, with commentary on facility and platform needs.
Interview and article describing the company’s history, technology platforms, CDMO value proposition, and plans for capacity expansion.
Overview of complex injectable technologies (liposomes, microspheres, micelles, submicron crystals) and the specialized manufacturing and analytical requirements to support them.
Received US FDA approval for a doxorubicin hydrochloride liposome injection ANDA; product entered the US market and is commercially manufactured in the company's cGMP facility.
Facility completed a pre-approval inspection by the US FDA in 2023.