Bottle

Technology & Platform

Leveraging our novel technologies to support development pipelines

While ForDoz Pharma is adept at the production of conventional injectables, we also have the expertise to produce complex injectable therapeutics, advancing and commercializing novel drug products through three core technology platforms:

Liposomal &
nanoparticle-based delivery
for targeted, controlled release

Microsphere & polymer–based systems to tailor sustained-release profiles

in situ depot
formulations
enabling long-acting injectable therapies

Our development and commercialization begin with crafting high-quality generics of established injectables, then progressing to innovative 505(b)(2) candidates that deliver enhanced clinical outcomes.

Product

FDA-Approved Product

As our first liposome pharmaceutical product to enter the US market, the 2024 FDA approval of our ANDA for doxorubicin HCl liposome injection marked a significant milestone for ForDoz. We are commercially manufacturing this approved liposomal product in our cGMP-compliant commercial manufacturing facility located in East Windsor, New Jersey.

The product is being marketed in the U.S. through our marketing and sales partner, Lupin Pharmaceuticals, Inc.
Please read the complete prescribing information.

  • PRODUCT
  • DOXOrubicin Hydrochloride Liposome Injection
  • SIZE
  • 20 mg/10mL (2mg/mL)
  • (NDC 70748-339-01)
  • 50 mg/25mL (2mg/mL)
  • (NDC 70748-340-01
Pipeline

Our Sterile Injectables Pipeline

PRODUCT
CANDIDATE
REGULATORY PATHWAY INDICATION DEVELOPMENT CLINICAL
STUDY/BE
REGULATORY
SUBMISSION
APPROVED
Doxorubicin ANDA Ovarian Cancer
Amphotericin B ANDA Fungi
MS01 ANDA Acromegaly
MS02 ANDA Schizophrenia
FDL001 505(b)(2) Nausea, Vomiting
FDL002 505(b)(2) Fungi
FDLC001 505(b)(2) Chronic Pain
FDLC002 505(b)(2) Chronic Pain
FDM001 505(b)(2) Women’s Health
FDM002 505(b)(2) Chronic Pain

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.