Formosa Laboratories, Inc.
The API and Injection Product Development and Manufacturing Leaders

With a long history of API development and manufacturing experiences, Formosa Laboratories possesses the production capability with GMP compliance and analytical development ability. That’s why the company is able to provide clients with a comprehensive solution through its well-managed CDMO service. “With capabilities inherited from our professionalism and experiences of API development, we offer contract research and development services from APIs to liquid or lyophilized and specialty injectables,” says Dr C. Y. Cheng, the president of Formosa Laboratories. Accompanied by its analytical expertise, Formosa Laboratories streamlines the timeline of the formulation development to manufacturing for drug submission by achieving parallel active pharmaceutical ingredient and finished product development. The company, with its sister company, EirGenix Biotech, offers one-stop CDMO service in the development and manufacture of ADCs, including antibody development and production, synthesis of linker and payload, bio-conjugation, downstream purification, and the final fill-finish. “Knowing end market prices of generic drug products is always a challenge for our clients in APAC regions. We are dedicated to develop cost-effective manufacturing process and carrying out highly efficient procurement management to supply quality products that support our clients to maintain their market presence or commence new market entries,” mentions Dr Cheng.

The process control that is implemented in Formosa’s state-of-the-art injectable facility is advantageous in many aspects.

One commercial high-speed line aseptically fills liquid for non-cytotoxic products can reach 18,000 vials per hour with a 100 percent weight check for IPC. The auto-loading and unloading system (ALUS) for lyophilizer enables the manufacture in a more efficient state when handling complex process. Quick VHP cycle and low hydrogen peroxide residual concentration makes the advantage in handling biologic drugs. And the disposable (single-use system) provides options to reduce risks of contamination and streamline process operations for the manufacturing of biologic products. With the strengths of the facilities’ capacity and versatility, Formosa can offer process under full cGMP conditions with speed, efficiency and exceptional quality, plus flexibility to adapt to changes in clients’ market and goals.

We are dedicated to develop cost-effective manufacturing process and carrying out highly efficient procurement management to supply quality products

Further, to supply quality products with GMP compliance and on-time delivery, Formosa participates in supporting development and manufacturing role for new drugs or specialty drugs that can address medical needs and support patients and healthcare providers. “We have also been a good choice of API partner for generic companies who desire early entry into the market by P4 challenge thanks to our capability and history of supplying non-infringing APIs,” states Dr Cheng.

For the future, Formosa Labs will continue to maintain its position as a major supplier of APIs to generic companies around the world. “With our strong R&D capability, abundant experience in GMP production, and the inception of our modern injectable facilities, we aim to become a first-rate CDMO service provider for difficult-to-make cytotoxic and non-cytotoxic unique APIs, and their injectable formulation products,” says Dr. Cheng. To expand its business from small molecules to include large molecules, Formosa Labs is growing its CDMO service in ADC development through collaboration with EirGenix. The company also expects to become a major provider of fill/finish service for antibody and other protein drugs. In terms of geographic expansion, Formosa Labs has set up a sales and BD subsidiary in Japan, Formosa Laboratories Japan. It also evaluating other potential M&A opportunities.