Sterile Drug Products,
Expertly Delivered

US-based sterile drug product CDMO for the full product lifecycle

For over 10 years, ForDoz Pharma has focused exclusively on sterile drug products, developing and commercializing innovative therapeutics and serving as a contract development and manufacturing organization (CDMO) partner. 

Based in East Windsor, New Jersey, ForDoz recognized unmet needs for manufacturing of conventional and complex injectable therapeutics. While the expertise and capacity to develop and manufacture sterile products at commercial scale previously existed at different CDMOs, it was usually not under the same roof at one site. As a fully integrated pharmaceutical CDMO with end-to-end capabilities, ForDoz has worked tirelessly to build and expand U.S. conventional and complex sterile drug expertise, capabilities, and capacity. 

Sterile Drug Product Technology Platforms & Strategy

Our expertise includes conventional sterile injectables and three core advanced technology platforms:

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

This assortment of capabilities allows us to address the challenging issues that sterile drug product developers face, including the need for prolonged circulation times, passive or active targeting, reduced toxicity, improved solubility of poorly soluble drugs, sustained drug release, slow-release, or simply finding a CDMO partner dedicated to conventional injectable quality excellence.

Explore Our Technology-Driven Approach
CDMO Services

CDMO Services for Sterile Drug Products

While many CDMOs can handle early-stage development, there aren’t enough CDMOs with the capacity and expertise to support the end-to-end, full-scale production of conventional to complex sterile drug products. We recognized this gap in U.S. capacity years ago and built a commercial-scale GMP facility to address this unmet need.

ForDoz Pharma founded

2014

Purchased East Windsor, New Jersey facility

2016

Established state-of-the-art cGMP sterile manufacturing facility dedicated to the commercial manufacturing of conventional and complex sterile drug products

2018

Filed our liposomal doxorubicin product with the FDA under an ANDA

2022

FDA approved our liposomal doxorubicin product–the first company to manufacture and register this product in the U.S.

2024

Continuing expansion plans of sterile drug product CDMO services, including packaging, labeling, and serialization

2025

Our Journey

ForDoz Pharma was founded to address the needs of conventional and complex sterile injectable innovators and organizations requiring an end-to-end CDMO partner to develop and manufacture at commercial scale.

Our Team

James He

Co-Founder/CEO

With over 20 years of experience serving in pharmaceutical management positions, he successfully led the development and commercialization of multiple complex injectable products, including the Doxorubicin HCl Liposome injection. Before founding ForDoz Pharma, he was the chairman and CEO of Changzhou Jinyuan Pharmaceutical Manufacturing Co., LTD.

Deepak Tiwari, PhD

Vice President, Business Development & Strategy

Deepak has over 25 years of biopharmaceutical industry experience from the early discovery phase to commercial launches. He has been integral to the success of numerous clinical programs, commercial product launches, and has held senior positions of increasing responsibilities at both small virtual (GPC Biotech and Sucampo) and large bio-pharmaceutical (Bayer and Baxter) companies. His current area of focus includes business development and general corporate strategy.

Haoming Yuan

Head of Operations

With over twenty years of experience in R&D, engineering, project management, and operations management at leading companies, Mr. Yuan has demonstrated strong leadership and crisis management abilities. He effectively managed the construction of a new cGMP sterile manufacturing facility at ForDoz and currently oversees daily operations.

Daniel Bitler

Head of Quality

Mr. Bitler has worked in the pharmaceutical industry for over thirty-five years, including 10 years of experience in manufacturing terminally sterilized and aseptically filled parenteral products, before advancing into the quality area. He led the successful FDA PAI and cGMP inspection for Doxorubicin HCl Liposome injection.

Sydney Ugwu, PhD

Co-Founder/CSO

Dr. Ugwu has over 25 years of experience in complex product development, having held management positions in pharmaceutical R&D at well-known companies across the United States. He has successfully developed a variety of NDA and ANDA complex drug products, including Doxorubicin HCl Liposome injection and Abraxane.

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.