Taiwan has long been a hub for low-cost manufacturing. Today, however, the country is looking to lose its factory stereotype and serve as an attractive destination for foreign companies looking not so much at low-cost API, but rather at a high-tech industrial land that boasts many successful companies and an excellent reputation for intellectual property rights.

Meanwhile, facing competition from China, two Taiwanese API manufacturers have differentiated themselves by following strategies of specialisation and leveraging outside resources.

Speciality strategy

Chirogate was founded in 1999 by a group of organic chemists and biochemists with more than 20 years’ experience in prostaglandin (PG) synthesis. With a strong technology background, Chirogate has been able to work on niche-market molecules such as PGs. This group of products has long been considered difficult for artificial synthesis in terms of the long reaction steps required and challenges in controlling the multi-chirality of the compound.

Chirogate has developed a revolutionary approach that has not only significantly reduced the steps of total synthesis, but has also efficiently lowered the levels of impurities, particularly stereo-isomers, in the final products. Due to this proprietary technology, Chirogate has been able to expand the product spectrum and capacity easily, yet has maintained a high product quality comparable to that of the product’s originators.

More excitingly, hundreds of novel PG intermediates, explored along with the novel approach, offer more possibilities for convenient synthesis of new PG entities and facilitate the screening of new PG drugs, which may not be achievable when using conventional approaches.

A recent plant expansion, expected to be completed by late 2007, will further increase the capacities of currently produced PG products, by up to hundreds of kilograms a year. Recent successful inspection by the US FDA has shown the company’s quality system to be in compliance with cGMP as well as international drug manufacturing codes. Chirogate’s continued dedication to developing proprietary technology and to improving product quality has initiated a new era for PG production.

External resources

With 75% of its business in North America and Europe, Chunghwa Chemical Synthesis & Biotech (CCSB) has been collaborating on API and advanced intermediate development and production with leading branded and generic drug companies for years. Founded in 1964, CCSB’s successful track record includes commercialising several APIs of statin, immunosuppressant, muscle relaxant and ACE inhibitor with complete DMFs.

Instead of developing niche technology, CCSB’s business model is to focus on robust and economic API manufacturing by integrating Taiwanese quality assurance systems and cost-effective raw materials from China. Meanwhile, CCSB’s subsidiary in the US, Pharmaports LLC, approaches and serves customers in regulated markets. This leveraging of different cost structures across different geographies can be integrated into the whole life cycle manufacturing strategy of pharmaceutical partners.

In addition to cost control, added value comes from many areas beyond simply manufacturing capacity and being the lowest-cost provider in a given technology. As partnership is crucial for contract manufacturing projects, CCSB has achieved customer satisfaction by its devotion to communication; trust-building and risk-taking.

Taiwan has been dealing with the West for many decades and is more accepting of general business rules, with integrity as the most important factor. So if a Western buyer is planning to enter the seemingly random world of partnerships in China, a partner in Taiwan such as CCSB may be the best way in. CCSB has a clear working model by which it can tackle challenges in a collaborative way.

From low cost to high value

Pharma buyers have seen and continue to see the transformation towards a high-end, value-based Taiwanese API industry. CCSB and Chirogate are possibly the finest examples of the efforts made to compete with low-cost and labour-intensive areas. Taiwan’s emphasis on sustainable development has given Taiwanese companies an understanding of corporate responsibility to create unique values.

Company profile

CCSB is a member company of China Chemical Pharmaceutical Group. Chirogate is a professional prostaglandin manufacturer with great enthusiasm in developing chiral technology.