ScinoPharm Taiwan Ltd., Taiwan

ScinoPharm Taiwan - an exclusive partner for Active Pharmaceutical Ingredients and Intermediates.

The company:
Founded in 1997, with initial on-site operations beginning in November 1999, ScinoPharm Taiwan offers a wide array of process R&D services and API manufacturing capabilities. With its strict adherence to industrial confidentiality and intellectual property protection, coupled with its rigorous QA and QC compliance, ScinoPharm has been entrusted by many major pharmaceutical companies to produce advanced drug intermediates as well as finished API's. With the research teams in Taiwan and China, in conjunction with its FDA approved state-of-the-art cGMP facilities in Taiwan, ScinoPharm Taiwan can assure on-time development of non-infringing patent processes and timely delivery of high quality, price competitive APIs to its downstream customers.

Specific Strengths:

US cGMP Manufacturing Facilities and Quality Compliance Skills
ScinoPharm adheres to the latest ICH cGMP guidelines. ScinoPharm's multi-purpose, multi-product facility, located in the Tainan Science Park, Taiwan, was inspected by US FDA and given a "suitable" facility rating in 2001. To date, the facility has been successfully audited by more than 15 major international pharmaceutical companies, and found to meet their quality and other key supplier requirements. The production facilities consist of 7 units (9 cGMP lines) for production ranging from kilograms to multiple tons.
Cost Advantages
The FTE rate for R&D scientist with advanced academic degree in Taiwan is about 45 % of Western countries. Compared to the competitors in China or India, ScinoPharm Taiwan might not be the API supplier with lowest cost but it certainly is the most favorable in terms of intellectual property compliance with Western standard, issues of quality as well as reliability of supply.
Broadening Product Portfolio
ScinoPharm is building up a broaden product portfolio which includes the niche high potency products such as steroidal or cytotoxic molecules. In addition, ScinoPharm Taiwan has installed five sets of ultra pure water systems that allow the development and production of low endotoxin product for injectable. ScinoPharm is capable of supplying more than 20 generic products. Another 10 APIs will be ready in 2004, and 10-12 new generic products are planned in development each year.
Integration of R&D Work Force
Depending on customer requirements and the market potential, ScinoPharm can develop new synthetic routes from the beginning or modify and optimize proccesses revealed in public domain. The development timeframe can be shortened to meet customers' need as the first-to-filer by integrating ScinoPharm R&D work force which combines over 80 scientists in Taiwan and over 60 employees in a satellite research facility located in Kunshan, Jiangshu, China. Additionally, ScinoPharm Kunshan's cost effective process R&D allows ScinoPharm to have a very broad scope of key intermediates and integration of API development at the lowest price.

Further Valuable Information:
In anticipation that biogenerics will soon become a reality, ScinoPharm has successfully developed the ability to produce a number of biopharmaceuticals whose patents will soon expire. ScinoPharm, through contract, has access to a newly constructed cGMP biotech facility and it has the capability to develop several selected biogeneric products. ScinoPharm intends to construct its own cGMP production facility for biogeneric products in the near future.