Chunghwa Chemical Synthesis & Biotech Co (Taiwan, China)

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB), founded in 1964, is one of the largest API manufacturer in Taiwan. It has evolved into a biotechnology company from 2003 and is located in the suburb of Taipei with a manufacturing site of 8.7 acres. CCSB is principally engaged in the manufacture and distribution of chemical synthetic products and biotechnology products. The Company provides pravastatin, rapamycin, tacrolimus, mycophenolate mofetil, mycophenolic acid sodium, methocarbamol, metaxalone, alpreazolam, glipizide, guaifenesin, erythromycin estolate, dexbrompheniramine maleate, fluconazole, trandolapril, perindopril, sodium starch glycolate and bucetin among others. Its products are applied in the manufacture of drugs for treatment of fever, diabetes, cardiovascular diseases, diarrhea and immune system diseases, among others. In 1984, CCSB was the first API manufacturer in Taiwan inspected and approved by FDA for cGMP compliance. CCSB has filed DMF's for 18 products with the FDA. In April 2002 and December 2005, CCSB passed again the FDA inspection of their cGMP plant to produce synthesis and biotechnology products. CCSB has filed DMF, EDMF and COS for several products. In 1999 CCSB established a sales office, Pharmaports LLC in Exton, Pennsylvania, to promote its products and provide better services to the North American region. With 75% of business in North America and Europe, CCSB has been collaborating on API and advanced intermediate development and production with leading branded and generic drug companies for years.