We currently have 230 R&D staff including two distinguished experts of national “One Thousand Talents Program”， one expert of Hubei “One Hundred Talents Program”， one expert of Wuhan “Yellow Crane Talents”， 8 external senior experts and overseas returnees, 10 internal distinguished experts, 130 PhDs and post-graduates. For constantly improving the competitiveness of our team, we provide training courses more than 100 times per year including GMP, SOP, QA, QC, pharmaceutical regulations, generic drugs development and innovation drugs development. Furthermore, we select excellent employees and send them to Beijing University to study for “International Pharmaceutical Engineering Management Master Degree”， attend “QR-Renmin University of China MBA Training Class” etc.
Comprehensive R&D system
Scientific and technological achievements came with our continuously improvement in the R&D system. In 2004 and 2007, we established joint laboratories with Shanghai Institute of Pharmaceutical Industry and Tongji Collegeof Pharmacy, Huazhong University of Science and Technology and gradually strengthened our own R&D capability.We have established an overallR&D system from small scale, pilot scaleto commercial production, with currently three R&D centers, a national innovation drug developing base, a nation-local jointed engineering research center, a national post-doctoral work station, five provincial research platforms, and four industrial-academic-research integrated research centers,which fully realized the resources integration and key products technology breakthrough, and greatly improved our innovation capability.
We have undertaken 7 projects of national “The 12th Five-year Plan - Major New Drug Development”， over 20 provincial projects. In 2012, QR has gainedproduction approvalsfor four products and submitted 10 applications for production approval by CFDA; in2013, four projects have passed site inspectionsby CFDA, 3 projects under registration for clinical trial approvals, andfurther 40 projects under development; 56 patent applications have been submitted, and 26 patents have been authorized.
QR has accomplished many API innovative technology research in the fields of cardiovascular, digestion, anti-fungal, and respiratory diseases, etc. QR targets to gain 10-15 exclusive innovative dug licenses, 2-3 innovative drugs clinical licenses, progressively achieve transformation of productivity.
Well-established Production and Quality System
We have a complete set of production system, and API & formulation production base with an area of 466,666 square meters.
Formulation production base was GMP certified by CFDA in 2006. In phase I, we have GMP certified workshops for APIs with 200 tons annual capacity, finished dosage of solid oral and injectable with 20 million vials annual capacity, and a multi-functional pilot scale base, fully capable of scale-up and commercial production, which are to be compliant with cGMP standards and FDA accreditation. We are about to finish Phase II facility construction, with international first class equipment installed, to be compliant with US FDA and EU cGMP guidelines.
Our pharmaceutical raw materials production base has introduced in international first class automatic production equipment, automatic wastewater treatment and environmental monitoring facilities. We also employed highly-competent talents for making the base to be an export-oriented API production base which meets EHS requirements and to be cGMP compliant so as to pass US FDA inspection. The base has successfully started exportation for our API products.
Innovative Products with Best Quality
Our mainly development products cover fields of cardiovascular, anti-cancer, digestion and psychotropic, which are urgently needed in the market. Our main products are L-Ornithine L-Aspartate series products, Sofalcone Dry Suspension, and Fasudil Mesylate for Injection. L-Ornithine L-Aspartate series products（brand name “Ruigan”）is the national Class 4 drug and we are the only manufacturer of L-Ornithine L-Aspartate lyophilized powder for injection in and out of China. Meanwhile, L-Ornithine L-Aspartate series products have been included in national medicine insurance catalog, with IMS sales data ranked No.1 among all hepatic supplementary medicines in the last 7 years. Fasudil Mesylate for Injection（brand name “Langlai”）is the only Fasudil Mesylate lyophilized powder for injection （national Class 4 drug）approved by CFDA, with little stimulation to blood vessel, high safety and reliable curative effects.