Redesigning ANDA or Novel Drug Products at All Stages for the U.S. Market

Post Date: September 19, 2023
Written By: Tedor Pharma Services

The success of both emerging biotech startups with limited resources and budgets and companies developing generic drug products for which cost concerns are critical depends on partnering with contract development and manufacturing organizations (CDMOs) with the right capabilities, expertise, and experience with the development, manufacturing, or regulatory hurdles that must be overcome. With 20 years of experience in the industry, Tedor Pharma Services offers personalized services to biotech startups and generic drug developers, providing small-volume batches for early-phase trials and addressing a range of manufacturing issues.

Tedor’s transparency in quoting projects, experience with controlled substances, and U.S.-based operations are invaluable to clients. The company has experienced steady expansion and planned growth to become a medium-sized CDMO with capabilities in non-sterile liquids, immediate-release (IR) and extended-release (ER) solids, and ultimately biologics.

The Emerging Biotech Landscape: Challenges and Opportunities

Biotech startups form through two main channels: spinouts from academia, where technology developers establish their companies, and organizations created by venture capital (sometimes with involvement from big pharma) using technology licensed from academic groups. Both routes require significant funding, with the latter expected to gain importance due to changes in funding accessibility.1,2 Over 3,000 startup accelerators worldwide support early-stage biotech ventures with high success potential, offering mentorship, training, and investor exposure, leading to successful funding attraction for many companies. Academic biotech spinouts can benefit from the National Institutes of Health (NIH) Innovation Corps (I-Corps), facilitating the launch of over 1,300 startups by providing knowledge about technology validation and commercial potential.1 These startups often need support for R&D, quality management, regulatory compliance, and other drug development and commercialization activities, and they are often located in biotech hubs with top universities, research hospitals, venture capital firms, and government support, offering access to a skilled workforce, potential investors, and a vast network of scientists and researchers for collaboration and R&D assistance.

The Boston–Cambridge, Massachusetts, area is recognized as the top biotech hub, populated not only by many biotech startups but by numerous venture capital firms that invest in the biotech industry.3,4 In mid-2022, it was reported that 135 companies were looking for space in the area.5 San Francisco, California, presently represents the second-most prominent biotech hub, but many other cities are catching up, including San Diego, California; Research Triangle Park, North Carolina; and Philadelphia, Pennsylvania. Biotech hubs are also emerging in a number of other U.S. locations, including Chicago, Illinois, New York City, and Seattle, Washington.3,4,6

A Growing Generics Market, but Developers Face Many Hurdles

Generic drug developers face a different set of challenges than biotech startups, but they also have many opportunities if those challenges can be overcome. The value of the global market for generic drugs is estimated to be expanding at a compound annual growth rate (CAGR) of 5.4% from $439.37 billion in 2022 to $670.82 billion by 2030.7 Key drivers of this growth are continued patent expirations on many successful branded drugs and government initiatives and regulatory agencies focused on increasing the number of available generics. Oral formulations account for two-thirds (65.7%) of the market, followed by injectables (21.2%).

A key challenge for generic drug developers is the lengthy development, review, and approval process, particularly for complex generics, which are a growing segment of the market. Rather than simply a chemically equivalent version of an existing drug formulation, complex generics can have more complex ingredients and thus more complex formulations and may require a more complex delivery system and/or be offered in combination with a medical device.8

The added value — and associated potential greater profitability — offered by complex generics make them increasingly attractive targets.8 The cost and time for development of complex generics are greater, however. Similarly, commercial and regulatory strategies for the development of complex generics often must be established de novo, increasing risk.

To obtain approval of an abbreviated new drug application (ANDA), generic drug developers must demonstrate bioequivalence to the reference listed drug (RLD), and the formulation must share the same active ingredients, condition of use, route of administration, dosage form, strength, and labeling. Complex generics are submitted under the 505(b)(2) pathway, which requires the developer to justify the scientific basis for using the specific RLD and conduct some safety and effectiveness studies beyond what can be inferred on the basis of the characteristics that the new product shares with the RLD.

To control costs, many generic drug companies rely on contract manufacturers. The value of the global generic pharmaceuticals contract manufacturing market was estimated to be $63.7 billion in 2021 and to be expanding at a CAGR of 5.8% to 2030.9

The Ideal Contract Development and Manufacturing Partner

Beyond the obvious need for appropriate facilities, equipment, and technical capabilities, differentiated contract development and manufacturing organizations (CDMOs) have important but less tangible attributes that make them ideal partners.

The biggest factor determining project success for any CDMO is the people doing the work. The best CDMO partners have teams with the highest commitment to quality and customer service, extensive industry experience, and deep process, manufacturing, quality, and regulatory knowledge. Team members collaborate closely, functioning as a small family focused on finding the optimal solutions for each client project.

Treating client concerns with respect is equally important. In addition, completing risk assessments allows the identification of potential issues in advance, enabling the design of manufacturing and control strategies to avoid them. Clients of such CDMOs have confidence that their projects will be completed on time and with the highest quality.

In fact, treating clients well is an inherent aspect of company culture and part of the organization’s DNA at effective CDMOs. Top executives work hard to establish real connections with their clients and ensure that each project is handled as if it were their own. That high level of personal attention is bolstered by an efficient production facility and a highly skilled manufacturing team.

Experienced Yet Cutting-Edge CDMO Supporting Biotech Startups and Generic Drug Developers

Tedor meets all of the above qualifications. We are a small, cutting-edge CDMO with 20 years of experience helping clients meet their solid dosage manufacturing needs in a very personalized manner. With operations, business development, and quality support from long-term industry experts, Tedor has built upon its two decades of experience and is rapidly establishing a reputation as a reliable and competitive outsourcing partner.

Knowledge, capability, and caring comprise the fundamental aspects of Tedor. Customer care at Tedor is backed by a unique knowledge base and strong work ethic. The Tedor team possesses the critical information to help clients get differentiated products to market and is able to evaluate problems differently than other CDMOs. We collaborate closely with clients to help them identify their needs and address them. Our goal is to help clients get to where they want to be by serving as an extension of their business and making sure their products are produced with the highest quality when they need them.

For biotech startups and emerging pharmaceutical companies with limited resources, budget, and/or capacity, Tedor Pharma has the necessary agility and flexibility combined with deep industry knowledge and the perfect organizational fit. We can rapidly provide small-volume, highly specific batches for early-phase trials, a service that many larger CDMOs are not able or willing to support.

For generics developers, Tedor is also well positioned to address a wide variety of manufacturing issues — from simple tablet sticking problems to more complex reformulation issues associated with old ANDAs — leveraging the knowledge and expertise gained when previously operating as a generics drug developer. Indeed, today Tedor is a CDMO offering a unique set of capabilities and knowledge around the redesign of drug product formulations across all development cycles. As a result, we can effectively shepherd client projects from the very start of the conversation.

A key differentiator for Tedor is our transparent quoting process, which provides clients with excellent value. Our history in the generics space has made us hyperaware of the need to bring down costs and accurately quote projects.

Another benefit to working with Tedor is access to extensive experience working with controlled substances under a DEA license. Projects involving controlled substances require special care, particularly around the quota requirements. There are often four-month or longer lead times. With the team’s knowledge and experience in the field, Tedor can guide client decision-making with respect to the timely provision of necessary documentation, order placements, and other critical concerns.

Our OSD facility is located just outside Boston — readily accessible by the numerous biotech and pharma companies in the Boston biotech hub — and we welcome inspections by existing and potential clients. We can help with everything from upfront analytical work all the way through the development of data packages for regulatory submission and clinical and commercial manufacturing, including the tech transfer and scale-up of ANDA products with established production processes.

Solid, U.S.-Based Alternative

A further important advantage of Tedor is its ability to provide cost-competitive services from a U.S.-based organization. When shipping and the additional hurdles associated with working on projects in China or India are taken into consideration, Tedor provides a solid alternative for U.S. companies serving the domestic market. Tedor welcomes site visits, does not typically face shipping issues, and has a reliable raw material supply that mitigates supply chain issues. For companies located outside the United States, using Tedor is an effective way to access products that are made in America.

Steady Expansion and Planned Growth

The experience and customer service offered by Tedor are earning the company a highly respected reputation as a reliable, high-quality CDMO. Tedor’s customer base has expanded significantly in the last 18 months. Several new projects were brought on board in 2022, and additional signings in the first half of 2023 have doubled that number. Tedor is producing commercial products and tech transferring in additional ANDAs. The company has also diversified from formulation development and commercialization to include clinical supply activities.

To meet the needs of this growing customer base, Tedor has expanded its staff, adding a director of quality control and several additional manufacturing and support personnel, and solidifying key critical roles to further ensure client success.

Further expansion of Tedor’s capabilities and capacities is planned with the goal of becoming a medium-sized CDMO within approximately five years. We are looking to expand into non-sterile liquids, IR, and ER solids, and ultimately biologics. Packaging support will also be added, which will make the company even more competitive with an end-to-end offering. On the front end, Tedor is partnering with formulations groups that do not have commercial manufacturing capacity to become their go-to for small-lot manufacturing and tech transfers.

  1. References:

    1. Marrus, Stephanie K. and John A. Blaho. “Increasing the success potential of promising biotech companies.” Nature Biotechnology. 41: 154–155 (2023).1
    2. Friedman, Jared. “How Biotech Startup Funding Will Change in the Next 10 Years.” Y Combinator Blog, Accessed 19 Jul. 2023.
    3. Thomas, Megan. “Where are the hottest drug discovery hubs in the US?” Drug Discovery World, 7 Apr. 2023.
    4. Waddick, Karissa, Shaun Lucas, and Julia Himmel. “The next era of Greater Boston’s biotech boom.” Pharma Voice. 22 Nov. 2022.
    5. Armstrong, Ammalee. “The Top Biotech Hubs in 2022.” Fierce Biotech 5 Jul. 2022.
    6. Top Cities for Biotech.” Excedr, 28 Feb. 2022.
    7. Precedence Research, “Generic Drugs Market … – Global Industry Analysis, Market Size, Share, Growth, Trends, Region Outlook, And Segment Forecasts, 2022 – 2030,
    8. Duncan, Ann et al. “Complex Generics: Charting a new path.” QunitilesIMS White Paper. 2016.
    9. Generic Pharmaceuticals Contract Manufacturing Market Size, Share & Trends Analysis Report By Drug Type (Branded, Unbranded), By Product (API, Drug Product), By Route Of Administration, By Application, And Segment Forecasts, 2022 – 2030. Grand View Research. Accessed 19 Jul. 2023.