The complex drug product sector is evolving rapidly, with rising demand for sterile injectables, long-acting formulations, and challenging molecules requiring specialized development and manufacturing expertise. ForDoz Pharma has emerged as a key player in this space, leveraging advanced drug delivery technologies and robust sterile manufacturing capabilities to bring complex formulations to market efficiently. With a focus on innovation, quality, and scalability, ForDoz supports both proprietary and partnered programs across a range of therapeutic areas. The company’s expertise in microsphere-based injectables and liposomal formulations enables the development of differentiated drug products that enhance patient outcomes. ForDoz Pharma’s CEO, James He, discusses how ForDoz is shaping the future of complex drug manufacturing by combining technical excellence with a commitment to regulatory compliance, with Pharma’s Almanac’s Sophie Lutter, Ph.D.
Sophie Lutter (SL): To start, could you introduce us to the history of ForDoz Pharma, from its genesis through today?
James He (JH): ForDoz was founded in 2014 to continue the goal of developing complex injectables, covering the full process from IND (Investigational New Drug) to commercial manufacturing. Initially, we focused on liposomal formulations, but we have expanded into microspheres, nanosuspensions, emulsions, micelles, and in situ depot formulations for long-acting injectables.
In 2016, we purchased a facility in East Windsor, New Jersey, and by 2018, we had built a cGMP manufacturing facility dedicated to our products. Our first major submission was a liposomal doxorubicin injection product, which we filed under an ANDA (Abbreviated New Drug Application) with the FDA in 2022. The facility underwent a pre-approval inspection in early 2023, which we successfully passed. By July 2024, we received FDA approval, making ForDoz the first U.S.-based company to manufacture and register this product domestically, as previous approvals came from Indian generic manufacturers.
Beyond liposomes, we also focus on microsphere-based products, including generics, such as risperidone and octreotide, etc. We successfully secured FDA confirmation for Q1/Q2/Q3 equivalence, which was critical for advancing our products. Additionally, we are actively developing multiple 505(b)(2) products with our innovative technologies, including partnerships and product co-development, etc.
ForDoz continues to grow, leveraging our expertise in complex injectable product development and manufacturing, both for our own products and through our expanding CDMO (contract development and manufacturing organization) services.
SL: How would you describe ForDoz Pharma’s value proposition today? Having both the CDMO and proprietary product businesses must provide unique advantages.
JH: Our CDMO business and proprietary product development go hand in hand. The expertise we’ve built developing our own complex injectables — whether in liposomal formulations, microspheres, or in situ depot technologies — directly strengthens our CDMO capabilities. Because we’ve had to solve complex formulation, scale-up, and regulatory challenges for our own products, we are uniquely positioned to help clients navigate those same challenges.
At the same time, our CDMO business gives us access to cutting-edge projects, emerging technologies, and new formulation approaches that continually enhance our internal knowledge base. Every successful client project broadens our expertise and strengthens our technical foundation, which in turn benefits future CDMO customers.
The ability to seamlessly transition from development to full-scale manufacturing is another key differentiator. Many CDMOs focus only on early-stage development, but because we have built our own commercial manufacturing capacity, we can offer end-to-end support, ensuring that even the most complex formulations can be successfully scaled up and commercialized. This combination of deep technical expertise, real-world product development experience, and integrated manufacturing capabilities makes ForDoz a uniquely capable partner in the complex injectable space.
SL: What types of products and services do you offer as part of your CDMO business, and what capabilities set ForDoz apart?
JH: Most of the customers who come to us for CDMO services are developing 505(b)(2) products. They typically have a formulation that has been tested at a small scale in the lab but need a partner who can help them scale up for regulatory submission and eventual commercial production.
Our expertise covers the entire development process — from early formulation and process optimization to analytical method development and batch manufacturing. We help clients produce submission batches for regulatory filings and, later, commercial-scale production.
Beyond manufacturing, we also provide regulatory support. Our team has experience with CMC (chemistry, manufacturing, and controls) submissions, FDA communication, and navigating the approval process for complex injectables. With our own complex injectable product already approved in the U.S. and many years’ experience communicating with the FDA, we understand what it takes to bring a product from development to market successfully.
SL: Who is the ideal customer for ForDoz’s CDMO business? What type of company or product would be the perfect fit for your capabilities?
JH: Our ideal customers are companies developing complex injectables — whether they are startups, mid-sized firms, or large pharmaceutical companies. Many of our clients have innovative molecules or 505(b)(2) products but lack the in-house expertise or manufacturing capabilities to develop and scale them.
We specialize in helping companies that are struggling with formulation challenges or need a reliable partner to navigate process development, scale-up, and commercial manufacturing. Whether it’s a startup looking to advance a first-in-class therapy or a large pharma company needing support for a difficult-to-manufacture injectable, we can provide the expertise and infrastructure to bring their product to market.
SL: How does ForDoz approach product development — both for its own pipeline and for CDMO clients? What factors guide your selection of new products and formulation strategies?
JH: Our product development strategy is built around three core complex injectable technology platforms: liposomal and nanoparticle-based drug delivery, microsphere and polymer-based controlled-release systems, and in situ depot formulations for long-acting injectables. We intentionally focus on these areas rather than branching into technologies that cannot be scaled up and manufactured. Even when developing 505(b)(2) products, we ensure they align with one of these platforms.
One of the criteria for selecting new products is whether we can manufacture them in our manufacturing facility. We prioritize products that we can take all the way from formulation to commercial production without relying on external manufacturing partners. This allows us to maintain full control over quality, scale-up, and regulatory compliance—ensuring efficiency and long-term success.
The same scientific and technical expertise we apply to our own pipeline is what makes us a valuable CDMO partner. Selecting the right formulation and delivery technology for any given drug product requires a combination of experience, technical knowledge, and an understanding of clinical needs. When we evaluate a new molecule—whether for our own development or for a CDMO client—we assess whether it is best suited for a liposomal formulation, a microsphere-based system, or another advanced delivery method.
However, clinical requirements also play a major role. Not every drug needs a liposomal formulation or a long-acting injectable—sometimes, a simpler approach is sufficient. But when a drug has solubility, stability, or toxicity challenges, we explore different formulation strategies to optimize its safety, efficacy, and manufacturability.
For example, a company approached us with a highly potent new drug they had been trying to formulate as a liposome for years. Due to its high toxicity and low bioavailability, they struggled to find a U.S.-based partner who could make it work. Within two months, we successfully developed a formulation and conducted an animal study, reducing the toxicity by a factor of ten. We don’t just rely on one technology—we explore multiple options, such as microspheres or albumin-based formulations, to compare their effectiveness and find the best solution.
Whether for our own pipeline or for CDMO clients, our goal is always the same: to balance reducing toxicity, improving bioavailability, and ensuring manufacturability—selecting the best technology to meet both clinical and commercial needs.
SL: I understand that ForDoz is currently expanding its manufacturing capacity with a new facility. Can you explain that scope and what it means for both businesses?
JH: Our current facility can accommodate the production of our own products, as well as several CDMO projects. However, we’ve been receiving more inquiries from potential partners asking whether we have the capacity to handle commercial manufacturing once their products are approved. That demand made it clear that we needed to expand.
The new facility will be an extension of our existing site, allowing for a seamless transition and efficient operations. Based on our prior experience — having built one facility in China and our current one in the U.S. — we anticipate that construction will take about 18–24 months. We already have the necessary vendor relationships and general contractors in place, which will help us move quickly.
There is significant demand for complex injectables, and many customers require dedicated suites or filling lines for their products. This is particularly true for high-potency drugs, which often need specialized containment and handling capabilities. We’ve even had potential clients tell us that if they had known about our facility earlier, they would have partnered with us sooner. Our FDA-approved cGMP site is already well-positioned to support our CDMO clients, and this expansion will ensure we can meet the growing need for specialized manufacturing.
SL: How do you ensure a clear distinction between client-owned IP and innovations that ForDoz can integrate into its own platforms?
JH: From the very beginning of any client partnership, we sign strict confidentiality agreements to ensure that their technology remains completely protected. Our role is to help them develop and manufacture their product, but their proprietary technology, IP, know-how, etc. remain entirely their own.
In most cases, our clients aren’t bringing highly novel technologies — our expertise in complex injectables often exceeds what they have internally. However, when we do make new discoveries during a project, we typically share those innovations with the client, ensuring they have full access to make patentable improvements or file new patents that arise from our collaboration. Our goal is not to take ownership of their ideas but to support their success by applying our knowledge and experience to their product development.
SL: Given how critical experience and expertise are to your work, how challenging is recruiting talent to scale the business?
JH: Finding experienced talent in this field is extremely difficult. Even if someone has worked with liposomes or other complex formulations in a research setting, that doesn’t necessarily mean they have the expertise needed for full-scale development and manufacturing.
Because of this, we take a hands-on approach to training. When we hire new scientists, we don’t just rely on their resumes — we work with them directly, teaching them every step of the development and manufacturing process. Many of our employees have been with us for years, and we continuously train them not just in technical skills but also in regulatory filing, process development, and even customer interactions.
In this industry, expertise isn’t something you can acquire overnight. That’s why we invest heavily in developing our internal team, ensuring that they gain real, practical experience and can grow into leadership roles over time.
Our reputation has grown because of our expertise. Clients come to us after struggling elsewhere, and once we solve their formulation or manufacturing challenges, they share their experiences with others. Many companies realize that we have the knowledge and capabilities they need, especially when they have complex injectable projects that require specialized solutions.
Our experience — 20 years focused exclusively on complex injectables—positions us as a top choice for companies looking for a reliable CDMO partner.