Yantai Valliant Pharmaceutical Co., Ltd., founded in 2012, is a wholly-owned subsidiary of CECEP Valiant Co., LTD.(stock code: 002643) and a comprehensive pharmaceutical enterprise integrating development, production and sales of BPC, oral solid preparation and health products with a registered capital of RMB 75 million and a total investment of RMB 200 million.
It is located in Dajijia Industrial Park, Yantai Economic and Technological Development Zone, Yantai—a fantastic city of mountains and sea, near the mountain and by the sea, enjoying pleasant weather, complete infrastructure and plant facilities and smooth logistics network.
Our company covers an area of 56,333 square meters and construction area of 23,954 square meters and has 108 employees. Meanwhile, our company owns a complete organization and a first-rate pharmaceutical R&D and quality inspection team. More than 90% of quality technicians have Bachelor degree or above and can guarantee product quality. In addition, the BPC workshop, Chinese medicine extraction workshop, oral solid preparation workshop and health product workshop have been built according to the new GMP standard (2010 version).
The BPC workshop covers an area of about 1,700 square meters and construction area of about 7,200 square meters. Three 100kg, one kilogram and one gram scale GMP production lines are established according to GMP requirements and can meet the needs of batch production. The four D-level clean areas can meet the needs of production, drying and packaging in a clean environment. The BPC production capacity reaches 100 tons. In 2010, our company submitted the first DMF file to FDA and obtained DMF 24019. Meanwhile, our company was certified to AFM (No.:AG10500451). In addition, BPC products have been certified to MF, passed the field audit of a Japanese famous preparations enterprise and will receive on-site inspection of PMDA.The antifungal BPC has obtained domestic approval number and will receive GMP test.
The oral solid preparation workshop with construction area of 3,000 square meters and clean area of about 1,500 square meters features reasonable process layout and separated flow of people and materials. Our company owns tablet, hard capsule, granule and dry suspension production lines and annually yields 300 million tablets, 300 million hard capsules and 80 million granule pouches and dry suspension pouches. The oral solid preparation workshop has been certified to GMP and provides OEM service.
The health product workshop on the third floor of the preparation building with construction area of 3,000 square meters and clean area of about 1,100 square meters has the pharmaceutical equipment produced by domestic famous manufacturers and boasts high degree of automation and precise control. The health product workshop has been certified to GMP, provides OEM service of tablets, hard capsules, granule, powder and pills and annually yields 100 million tablets, 100 million hard capsules and 50 million granule pouches.
Chinese medicine extraction workshop with construction area of 3,200 square meters and clean area of about 500 square meters has one aqueous extraction production line, one alcohol extraction production line.Our workshop has domestic advanced equipment including extraction tanks with different tonnages, dual-effect concentration equipment, single-effect concentration equipment, spherical concentration equipment, vacuum drier, microwave dryer, pulverizer, etc.
In the basic principle of “Quality First”, our company complies with GMP requirements, introduces GMP concept of ICH and PIC/S, continuously improves GMP management system, strictly carries out the technology and quality standards and meets the requirements of customers and government by virtue of high-quality products.
In addition, our research, quality inspection and analysis center is equipped with advanced instruments including HPLC, LC-MS, GC-MS, GC, TGA, DSC, ICP-OES, XRD, IR, UV, potentiometric titrator, automatic polarimeter, colorimeter, laser particle analyzer, dissolution tester, disintegration tester, hardness tester, atomic absorption spectrophotometer, TOC analyzer, microbial limit test device, conductivity meter, etc. and specializes in R&D and declaration of pharmaceuticals. In the business philosophy of “Market-oriented, Imitation-based” and the development strategy of “Development of Innovative Pharmaceutical Research Field”, our company cooperates with domestic and foreign partners, pays attention to talent introduction and training and boasts a high-quality scientific research team. We have developed a dozen varieties of BPC and related solid preparations including tranexamic acid, celecoxib, ezetimibe, terbinafine hydrochloride, olmesartan medoxomi I, rosuvastatin calcium, vildagliptin, etc., laying a solid product foundation for enterprise development. Nowadays, several patents for invention and provincial technological innovation projects have been applied for.
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