1. BACKGROUND Zhejiang Xinhua Pharmaceutical Co., Ltd., holded by SINOCHEM NINGBO LTD., is a comprehensive manufacturer of pharmaceuticals, including: APIs, Pharmaceutical Intermediates, and finished preparations. Established in 1986, formerly as Xinhua Pharma Chemical Co., Ltd. Huangyan Zhejiang, Zhejiang Xinhua Pharmaceutical Co., Ltd. is one of main manufacturers of Fluoroquinolones APIs and intermediates, of which Ciprofloxacin HCl accounted for 30% of the market in China. It is located in Zhejiang provincial Chemical and Medical Materials Base Linhai zone, registered capital: RMB 50 million, covering an area of 220,000 square meters. There are around 500 employees, of whom 140 people got the college education, with the percentage of 28%. In 2003, the company was awarded the certificate of ISO9000; In 2005, the company was entitled as the HI-Tech manufacturer of the National Torch Plan; In 2006, the company get the GMP certificates for the main workshops. With a promising future, the company is on the highway of development.2. The main products manufacturedThe main products manufactured in Zhejiang Xinhua Pharmaceutical Co., Ltd. include Fluoroquinolones (Ciprofloxacin, etc.), veterinary antibiotics (Enrofloxacin,
enrofloxacin HCL, etc.), antipyretic analgesic drugs (Salsalate, etc.), penicillins (Sodium Sulbactam for injection, Sultamicillin, etc.), β-lactam antibiotics (Tazobactam, etc.), Cardiovascular drugs ( Spironolactone, Carenone, Lacidipine, valsartan, etc.) and antipsychotic drugs (Bupropion, Sulpiride, Olanzapine, etc. ).3. QUALITY MANAGEMENTQuality Unit which is independent of production is established for managing quality. The whole procedures, processes, resources, as well as activities to ensure confidence that the APIs/ intermediates will meet its intended specifications for quality and purity are encompassed in the system. Quality Unit has 3 departments, Quality Assurance (QA), Quality Control (QC) and Registration Office.QA department, as the supervising role, is involved in all quality-related matters, reviewing and approving all appropriate quality-related documents. It makes sure that all the quality concerns can be traced from the resources to the after sale services.QC department is in charge of all the testing items, including raw materials, intermediates, packaging and labeling materials. For the time being, the following tests can be made in the laboratory: HPLC, GC, UV, IR, Stability, and Particle Size Distribution.Registration Office takes care of the all the registration work in the world together with the agents. For instance, Sipronolactone has got the COS certificate for European market, Ciprofloxacin HCl and
sulbactam sodium have been registered in India through Trichem (Mumbai). And some documents are submitted to US agent for the registration in FDA.The current specifications include the latest USP version, CP version, and EP/BP version. Meanwhile the special requirements from the customer can be complied with.4. RESEARCH & DEVELOPMENTWith the tenet of rofits and Markets are from the Technology? the company paid great importance on the R&D, established and fulfilled a system to work for the creativity. A vice general manager is responsible for the R&D center, which collects the hi-tech information, discusses the hi-tech transfer, searches the promising products and offers medical study services. Apart from the R&D center in the plant, the co-operated laboratories are set up in Shanghai Institute of Pharmaceutical Industry, Shanghai Institute of Organic Chemistry Chinese Academy of Sciences, Zhejiang University and Zhejiang University of Technology, which are the reliable fountains of the development.5. ENVIRONMENT PROTECTION AND SOCIAL RESPONSIBILITIESLiving in harmony with the Nature is the traditional culture of Chinese people, not to mention the XinHua people who are in the pursuit of fortune for the society, either through pharmaceuticals or the environment protection. Over 10 million RMB were invested in the facilities and utilities for the treatment of the waste gases, solids and liquids. The wastes are treated and recycled before they are properly drained. The harmonious cooperation among the company, society and environment is achieved6. PROMISING FUTUREAfter decades of hardworking, the company is on the highway of progress. In the following 5-10 years, the company will catch the opportunities and become the most pharmaceutical manufacturer in China.
