Formosa Laboratories
Strategic One-Stop CDMO Partner

Formosa Laboratories, a Taiwan-based contract research organization (CRO), is a global leader in active pharmaceutical ingredients (API) process development, impurity identification and synthesis services. With its 30th anniversary approaching in 2025, the company has consistently excelled in producing the highest-quality APIs and injectables that comply with global regulatory standards.

The genesis of Formosa Laboratories can be traced back to a small team of five researchers at National Taiwan University’s pharmacy school, where Dr. C.Y. Cheng, a professor who eventually became the company’s president and chairman. Dr. Cheng, alongside his first hire as a research chemist, Jessica Liou, who would rise to become the SVP of the marketing department, initially focused on API process development. This small team leveraged their profound expertise from previous experiences at Siegfried Chemicals to set the foundation in pharmaceutical manufacturing in 1995.

The company gained traction in 1998 when it provided API synthesis services to local pharmaceutical companies. This demand spurred Formosa Laboratories to leverage its comprehensive custom synthesis services and develop API processes and impurity profiles essential for regulatory filings.

Over the years, Formosa Laboratories has significantly expanded its capabilities. Early on, the company recognized the need for a dedicated good manufacturing practice (GMP) facility, which they established by renting space that another company formerly occupied. This move paid dividends in 2004 when Formosa Laboratories received its first US FDA approval for the GMP facility, a significant milestone that demonstrated its commitment to quality and compliance.

The strategic decision to focus on high-value, niche markets like vitamin D derivatives and polymer products for pharmaceutical applications also distinguished Formosa Laboratories from its competitors. These product’s development and commercialization solidified the company’s market position, showcasing its ability to navigate complex product landscapes. In one particular instance, a U.S. company requested Formosa Laboratories to develop a polymer product API that was successfully launched in 2005. This led to approvals of various polymer APIs for new drug development companies.

“Polymer products and vitamin D derivatives now account for more than 40 percent of our sales revenue,” says Dr. Cheng.

With a wholly-owned subsidiary in the U.S., Formosa Laboratories has strengthened its ties with U.S. clients. This acquisition will also open up more business opportunities because the company, which operates as a CRO and research lab, can revert scale-up and commercial GMP manufacturing back to Taiwan.

The strategic move allows the firm to reclaim the contract development and manufacturing organizations (CDMO) that Chinese companies previously dominated, positioning them to advance further in the CDMO space.

“In the past 30 years, we have developed over 200 compounds and around 50 APIs, supporting global customer launches in the U.S., EU, LATAM, MENA, and Japan,” says Liou. Such a track record speaks volumes about Formosa Laboratories' expertise, which allowed it to further establish a high-potency facility in 2009 to handle toxic APIs.

Over a decade ago, a European antibody–drug conjugates (ADC) drug development company approached Formosa Laboratories for payload assistance. The firm successfully prepared small scale samples for the client, who was pleased with the results and subsequently extended their collaboration to encompass everything, from the production of highly toxic payloads to the final drug product for clinical trials.

Since 2019, Formosa Laboratories has expanded its production capabilities to include injectables. This was highlighted when a client chose to consolidate both stages under the company after initially working with different CDMOs for drug substance and drug product stages. Such integration proved beneficial in reducing costs and time while increasing the availability of resources for clinical trials.

Formosa Laboratories, with a rich history started as a compound manufacturer for clients, effectively operating as a CDMO. Over time, the firm began producing its own APIs for clients, gaining significant experience in chemical sourcing—a crucial aspect of CDMO. Its team of highly skilled chemists plays a vital role in drug development, particularly in developing analytical methods. Today, regulatory expertise is an important aspect of its service offering. Formosa Laboratories has considerable experience in handling drug master files (DMF) and providing the necessary data for clients’ final drug products. In addition, the company has ventured into the ADC field, recognizing its significance for big pharma.

Formosa Laboratories leverages its extensive knowledge of R&D, ARD, QC, quality systems, GMP facilities and regulatory compliance to provide one-stop, comprehensive solutions to its clients. The company uses conventional technologies and explores innovative approaches, including unique nanotechnology capabilities within its subsidiary.

The success of Formosa Laboratories in the CDMO sector is attributed to its experienced team, advanced facilities and robust quality systems, all of which have been inspected and certified by various regulatory authorities. Clients rely on the company to develop and manufacture

materials for their clinical studies. When customers approach it with underdeveloped processes, Formosa Laboratories’ experience and creativity allow them to effectively enhance these processes. The company is steering ahead as a trusted partner and is committed to helping its clients grow and succeed.