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API Contract Research and Development
Chunghwa Chemical Synthesis & Biotech Co. Ltd., (CCSB) Development of innovative and cost-effective manufacturing processes for high value metabolites, recombinant proteins and。 Key technologies :
‧Genetic engineering, strain improvement, microbial fermentation, cell culture.
‧ Protein purification, enzyme immobilization, bio-conversion, and impurity analysis.
‧Pilot lab equipped with three 20-liter and one 600-liter fermentors for scale-up study and process validation.
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Contract Research and Development for Human Use Drugs & Animal Health Products
Ever since China Chemical & Pharmaceutical Co., Ltd. (CCPC) was established in 1952, we have placed a great deal of importance on drug research and development (R&D). The R&D section was first established in 1960. In order to incorporate the R&D teams of CCPC and CCSB, the R&D center was established at Shulin. The Pharmaceutical Research Center was completed in 2011. CCPC has never stopped enhancing the research and development ability. The leadership in R&D has accumulated more than 30 years of experience in the pharmaceutical industry. There is not only the professionalism in generic drug development but also in domestic and international regulations.

Over the years, we have developed various types of drug delivery technologies and we have signed technological transfer and co-operation agreements with major pharmaceutical corporations in Europe, the United States and Japan. We have adopted numerous new technologies and concepts in drug development, which in turn have formed a solid foundation for the research of many critical drug manufacturing technologies and enriched our knowledge, abilities and international foundation.

The future expectation of our own is able to develop the new drug through 505(b)(2) approval pathway which is a fast way to enter the new drug market in the advanced countries.

Our research and development team also participate in government-sponsored industry/academia projects to establish independent, autonomous technological know-how and technological platforms.

There are now over 56 specialized and professional researchers in our research and development team. We value every outstanding personnel and devote to give more opportunities for passing down high-grade legacy in the field of pharmaceutical industry. Over 194 drug products have met the BA/BE (Biological availability/Bioequivalence) limits and clinical test and been approved to launch by Food and Drug Administration, Ministry of Health and Welfare (FDA). Six extended release products and two oral disintegration products were awarded golden, silver and bronze medals for the Manufacturing Technology of Drug Research and Development Science and Technology Award from FDA. Based on our unique and leading technology, we have established many distinctive dosage model and controlled-release drug manufacturing platforms that have brought us many pharmaceutical technology research and development awards.

In the future, the well-developed unique technological platform will integrate many distinctive dosage forms and drug controlled-release technologies and expand the new drug market.

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