Our exporting business started from 2005, we insisted on the idea of “Best reputation, best service and best quality”. After years of development, we established a strong market net all over the world, and we are evaluated as “the best supplier” by several customers. Our sales is growing year by year, and was rewarded as “Top 5 exporter of API” by China Chamber of Commerce for the Import and Export of Medicines and Health Products (CCCMHPIE) in the year 2010.
Shandong New Time Pharmaceutical Co., Ltd., covering an area of 6 million square meters, is the production base for exported products. Several products have gotten marketing approval in Asia, Europe, America, Africa and etc.
6 APIs such as Clavulanate Potassium, Sevofluranehave have been approved by US FDA.
6 APIs such as Isoflurane have obtained the Certificate of Suitability issued by EDQM.
Our products have been sold over 60 countries and regions.
We started to construct a CGMP formulation plant in 2014 which was put into use in the end of 2016. The plant has 4 units including oral solid formulation &injection workshop, anesthetics workshop, warehouse and QC lab. The annual capacity of oral dosages is 2billion tablets, and for injection is 9million ampoules, and the filling capacity for inhaled anesthetics is 12million bottles per year. Two ANDAs are under review of FDA. And more than ten formulations have applied for marketing authorization in many regulatory markets.
All the internal quality control criteria are more stringent than the National regulatory criteria, quality assurance system is established to meet the requirements of FDA, ICH, EDQM, etc.