China: CDE Rejected 542 Drug Applications Last Year
Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons…
Address: Guilinyang Develops Area, Haikou, Hainan province, P.R.China 571127
Tel: +86 898 6571 8261
Hainan Yishun Pharmaceutical Co,. Ltd is a modern large pharmaceutical enterprise, which is established in Jun 6, 2003, with a registered capital of 50 million RMB (about 7.8 million dollars) and fixed asserts of 100 million RMB (about 15.7 million dollars). Company is located in Guilinyang Develops Area, Haikou, Hainan province, P.R.China. The plant area is more than 12,000 square meters, with a staff of more than 200. There are several production lines: powder for injection, new-type solid dosage form, APIs, small capacity injection and lyophilized powder for injection. All the production lines, staff and facility are organized and built strictly by GMP standard, and pass through and obtain new version SFDA-GMP certificate. On the aspect of quality control and quality assurance, we start with a high standard to build new plants, to introduce advanced production equipments, to be equipped with state-level drug quality testing instruments. All the efforts we make are to establish a comprehensive quality control and quality assurance system to supervise every link of drug production, sale and recall to ensure product quality. The whole process is in strict accordance with GMP requirements to implement and manage.
For overseas market, we will focus on promoting products of lyophilized powder for injection and sterile powder for injection. There is a products catalog available for international registration and sale. The overseas target markets of the company are Southeast Asia, Africa and Latin America. The company is looking for long-term partners and agents to create business opportunities and to achieve a win-win situation.
Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons…
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