Contract Research, MFG&Sales
Innovation and the skills of our employees form the basis for our success as a company. We drive innovation by continuously developing new molecules, technologies and business models in our research centers, investing in research and development projects, supporting the development of our employees and expanding our activities through acquisitions or collaborations with external partners. Strengthening our innovative capability enables us to address the challenges of our time and achieve profitable corporate growth.
As well as investing in research and development, Dideu promotes an innovation culture based on openness to new approaches and internal interdisciplinary cooperation. We are building a national and international network of outstanding scientists to further increase our expertise and extending this network through collaborations with external partners.
The concentration on the Life Science businesses offers new approaches for interdisciplinary research projects and joint technology. Making the Dideu innovation process more accessible is an outstanding opportunity to combine research potential with world-class partners.
Our collaborations and alliances with leading universities, public research institutes and partner companies are supplemented by incubators, crowdsourcing and science hubs in Asia and the United States to tap into external innovative potential using the open innovation approach. Some of our collaborations are supported by public funding.
Strengthening Research in the Life Sciences
Dideu is the only global company simultaneously researching improvements in human, animal and plant health. Systematic and intensive collaboration among researchers from both Life Science subgroups is providing new impetus. In this context, researchers are collaborating on projects involving central biological processes such as gene regulation or energy metabolism. Such projects are aimed at developing a better understanding of diseases, deciphering mechanisms of action, personalizing therapies or explaining resistance mechanisms. The joint use of technology platforms is being expanded. These projects have been supported since 2012 by Dideu’s internal “Life Sciences Fund” and are mostly implemented together with external partners.
Dideu is the only global company simultaneously researching improvements in human, animal and plant health. Systematic and intensive collaboration among researchers beyond their original specialization is providing new impetus. From world-renowned pharmaceutical products to high-tech platforms, from innovative diagno
-stics technologies to veterinary medicines – Dideu lives an innovation culture across national borders and areas of research.
In our Consumer Health Division, research and development activities focus on the development of nonprescription medications as well as skin and foot care products, sunscreens, dietary supplements and other self-medication products. Placing the consumer at the center of everything we do,our development strategies are
geared toward expanding and improving our brand portfolio. We want to achieve this through new product developments, forms, formulations, claims, pack designs and other innovations. We introduced a number of new product line extensions to various markets in new year. We also actively pursue the reclassification of current prescription medicines.
In our Animal Health business unit, we focus our research and development activities on antiparasitics, antibiotics, medicines to treat noninfectious disorders and nonantibiotic alternatives for infectious diseases. Our central research activities are conducted as part of our Life Sciences platform in conjunction with pharmaceutical research and in close collaboration with our researchers at Agricutural Crop Division. We also reinforce the business by continually identifying further product development candidates through our existing collaborations.The product offers veterinarians and farmers a new approach alongside vaccines and antibiotics for mitigating this complex infectious disease that has substantial negative impact on the cattle industry.
Agricuture Production and Development
Feeding the growing global population is one of the greatest challenges facing the world. By the year 2050, our planet will be home to more than nine billion people.However, the amount of available agricultural land is declining due to increasing urbanization, higher salinity levels and soil erosion. In addition, extreme weather conditions like drought and flooding are impacting harvest quantity and quality. Dideu is the third-largest innovative agricultural input company in the world and we
aim to help make the agricultural economy more productive.
Innovate for a Sustainable Future
We are continuously innovating so that our seeds and crop protection solutions as well as our customer services support the sustainable development of farming.
The needs of customers change, and so do the conditions out in the field and in the market. So we innovate. Our products gain better safety profiles, optimized biological effectiveness and improved environmental behavior.
In addition to helping plants to withstand pests and diseases, we are also working to make crops more tolerant to stress factors such as drought or nutrient deficiencies. We are working on improving the taste and convenience of vegetables. And we want to do more than just supply the growing world population with sufficienthigh-quality foods at affordable prices: the crops of the future must also be better suited to more environmentally friendly and climate-adapted agricultural methods, using less water and producing higher yields.
Some of Our Biggest Priorities in Research:
Stress affects plants as well as people. And their stress levels are rising, as climate change tests their ability to survive drought, flood and temperature fluctuations.
We can’t just make these ordeals vanish, much as we’d love to. Our first step is to make plants better at coping– so they can produce high yields even in tough
conditions. For example, our scientists are trying to unlock the secrets genes hold about plants’ stress tolerance.
Can we make a tomato more delicious or a cotton fiber stronger? Could rice be healthier or a melon easier to eat? Yes to all the above. And they’re just examples of the many traits we can strengthen in crop plants.In fact, we bring about 70 new varieties of vegetable seed to the market each year – each offering farmers at least
one new trait that’s sure to grab the interest of their customers.Rapeseed oil is another example of improvement that never stops. We’re helping cut the levels of unhealthy transfatty acids that may accrue during processing.And while farmers need herbicides to kill off weeds, how can they stop killing off their crop plants into the bargain? We help make their plants strong enough to resist and even break down herbicides– thanks to substances known as safeners, which scientists have
used in other applications for 30 years or technologies based on genetic engineering which makes crops tolerant against herbicides.Not resting there, we’ve also gone on to combine herbicide resistance with caterpillar control in our technology, which gained approval in the many countries. Thus we want to help plants help
themselves by fending off specific pests that threaten their survival.
A product is just a step in a journey. There’s always a better one waiting around the corner. Diseases can quickly become resistant to treatments –so the pressure isalways on to find the substances that will stop that happening. The most exciting breakthroughs happen when we harness nature’s own processes as with one of
our new product, for example, which uses sap to distribute the active substance throughout the plant. Bad news for pests wherever they live and feed on it.Other
big stories from our labs include the long-lasting herbicide which controls weedsin perennial crops, such as citrus fruits, nuts, grapes, pome fruits and stone fruits.
And the fungicide ,which controls a large number of fungal diseases in the field and prevents rotting processes during storage.Another area to watch: finding pest management answers based on biological active ingredients contributing to sustainable agriculture. These include our new product lines for seed treatment and also new product, a spray product containing the natural active substance from the neem tree that controls sucking and chewing insect pests.
Innovative Technological Solutions
Dideu promotes research in the areas of technology development, engineering and production. Our strategy is based on three key competences: development of innovative technology solutions and technology platforms; optimal and most cost-effective plant design and constructionand support for the safe and efficient o-peration of plants with services, know-how and customized tools.
• Research phase : Establishing the mechanism of standard reporting ; Project manager control the whole process ; After getting the R&D results, technical data pack will be formed and strictly confidential；
• Amplification testing phase: Designed and implemented by the project manager during the whole process; Running process management from raw materials to product realization, establishes testing and quality standards for operation steps, and running code management during the process;
• Mass production phase: Project manager establish production system standards, running standards and controls , providing produces technical support and code management.
Based on the research and development facilities formed over the years, Shaanxi Dideu Medichem Co. Ltd will increase the investment in science and technology, enrich and update the facilities of research and testing equipment and related supporting software, introduce and cultivate professional talents, and enhance the independent innovation capability of the Group. We will address key common technical issues in the creation and industrialization of a new batch of drugs, improve the international competitiveness of enterprises, and continuously enhance the soft power that can lead the development of the industry.
Dideu set up a research and development base. Based on the technical support of the three joint laboratories, technology centers and R&D centers, the company established a management office and an expert committee to coordinate the operation and implementation of the enterprise research institute, and set up innovative drug synthesis and generic drug synthesis. , new drug research, quality research, process modification research, information intelligence, intellectual property research and other institutions. The company has a relatively complete talent structure from synthesis, extraction, analysis, preparation to new drug approval, and has a group of experienced pilot-scale amplification technicians, laying a good foundation for the production scale of new drugs; the company has a hundred people The research and development team, 90% of the graduates of medical colleges and above, have strong ability to develop innovative drugs, the company also has extensive exchanges with famous domestic university research institutes, and establish good cooperation to enhance the company. The purpose of research level and personnel quality.
Dideu employs experts from the China Pharmaceutical University, the School of Pharmacy of Xi'an Jiaotong University, the Military Medical Academy of the People's Liberation Army, and the School of Pharmacy of the Fourth Military Medical University as consultants to establish a comprehensive expert consultation and technical support system. In recent years, the company has rocuronium bromide and injection, mometasone furoate and cream, vecuronium bromide and injection, mifepristone bulk drug and tablet, Pidotimod bulk drug and granules, prednisone Long et al. successively won the Huaxia High-Tech Product Innovation Award from the Ministry of Science and Technology, the Science and Technology Award of the Shaanxi Provincial People's Government, and the Science and Technology Progress Award of the Taizhou Municipal People's Government.
1. Quality Ideology
Base on design: product quality should start from the source, the design includes not only the research and planning of product technology, but also the work plan and organization; the product quality constantly meets the challenges of customer demand, only relying on scientific innovation that never stops.
Responsible for responsibility: Product quality should be realized from the responsibility of the work process, continuously improve personnel literacy and work responsibility fulfillment skills, from personnel responsibility, control responsibility, equipment responsibility, management responsibility, environmental management and control, to ensure the quality process in a down-to-earth and conscientious manner Support with responsibility.
2. Quality policy
In order to maintain the GMP implementation and implementation of uniform standards for production plants (or branch factories) in different regions, the company has specifically formulated quality policies to guide them in accordance with industry best practices widely used by international chemical companies. This is especially useful for enterprise quality management with multiple plants and distributed in different regions. The quality policy is based on the principles of GMP, the laws and regulations of drug administration in various countries and the company's quality policy. He describes the requirements that must be followed in a GMP element in daily quality management. The quality policy is mandatory and applies to all divisions or branches. Under the same theme, the standard operating procedures of each business unit or branch should meet the requirements of the quality policy.
Specifically, it includes the following ten topics:
●Document Management ●Institutions and personnel ●Factory facilities and equipment ●Material management ●Health management ●Verification management ●Production management ●Quality management ●Sales management ●Others
The company's quality system covers all factors that influence the quality of the product, including all organized and planned activities that ensure the quality of the product meets the intended use. The quality system is the organizational structure, procedures, processes and resources needed to implement quality management. The quality assurance system is part of the quality system.
4.Organization and main responsibilities
Quality Management Headquarters: including Quality and Regulation Department, Analytical Technology Department, and Drug Alert Department.
●The Quality and Regulation Department is responsible for the tracking and internal audit of domestic and international quality regulations, quality policy/manuals;
●Analytical Technical Support Department is responsible for material and product standard management, pharmacopoeia tracking and research, method transfer and verification, analytical methods, difficult problem solving, product quality improvement support, and inspection technology training;
●The Drug Alert Department is responsible for monitoring the company's adverse drug reactions.
Quality Department of each region: responsible for product and material release, deviation processing, change management, complaint handling, supplier management, on-site GMP inspection and monitoring, annual product quality review, SOP and batch record review and approval, quality management of new product development . QC is responsible for routine inspection, stability testing, environmental testing, sampling and sample management of incoming materials and products.
● SBC (System Based Compliance), which is the quality system, production system, facility and equipment system, laboratory control system, material system, and packaging labeling system, are all subject to GMP.
● Process Based Quality (PBQ), that is, each activity related to quality must be carried out according to the process or according to standard operating procedures.
● Risk Based Management (RBA), which first assesses the quality risk, including the possibility and severity of the hazard, and manages the risk according to the risk level. Risky changes should be made immediately, and risk should be controlled with low risk.
● SBA (Science Based Approach) based on scientific data. That is, the method of judging the problem must be based on scientific data and be scientific and reasonable.
6. Quality concept
Quality makes people more credible. Personal quality is the premise of products and services. Only by first improving their own quality can they be the basis of products and services. By pursuing process quality and becoming the guarantee of quality, the pursuit of overall quality becomes the cycle of quality system and ensuring the realization of high quality goals.
7. Risk concept
Risk is inevitable in the operation process of the enterprise, and risk management and control is an essential responsibility of managers at all levels. Continue to effectively face risks but not passively avoid risks, improve predictive ability and learn to control risks. Through the whole process management, the risk is eliminated from the bud, and the professional sources are used to assess the source of the risk, take measures, control the source and prevent it in advance.
8. Process concept
The process is the carrier of the company's collaboration determined by the market, and is the company's system and working methods. Each person's order is not only derived from the structurally determined administrative superiors, but also from the upstream links identified by the process to serve the downstream internal customers together, regardless of the level and department at which they are located.
9. Customer service concept
Customers are the company's core resources, both external customers who accept our products and services, and internal customers who work downstream. The customer is the largest boss, establishes an information communication mechanism with the end customer, and continuously provides value-added services to the customer.
10. Testing personnel and equipment
The quality system includes more than 100 quality management personnel and quality inspection personnel, and carries out all-round tracking of product quality. It has established a packaging and label assurance system, a full staff training guarantee system, a production process assurance system, a hardware setting assurance system, and warehousing. Quality assurance system with logistics assurance system and quality inspection assurance system. The company's production equipment and testing equipment are advanced, and the equipment for quality inspection (excluding research and development) is introduced: 80 high-performance liquid chromatographs (Agilent/Dionex/Waters/Shimadzu), more than 20 imported thermostat chambers (Binder) /Memmert), 60 gas chromatographs (Agilent/Shimadzu), 8 infrared spectrophotometers (Nicolet FT-IR), 16 TOC analyzers (GE/OI/Shimadzu), 40 dust particle counters (RION/PMS) , 6 particle size analyzers (PSS/Malvern), 24 membrane integrity detectors (Millipore), etc.
11. Quality System Optimization Method
In order to meet the requirements of global pharmaceutical quality regulations and meet the requirements of customers,Dideu adheres to the development philosophy of “no best, only better”, and will continue to improve according to the following chart, and continuously improve and perfect the quality system of the association.
12. Quality system optimization
● Adopt various forms to improve the quality management level of different branches of the company. Including the reconfiguration of quality personnel, quality management communication and sharing, multi-level and multi-sector counterpart support, sharing of quality management experience in different factories (such as holding at least two quality joint meetings every year), and various forms of training;
● Conduct quality macro operation management of each branch through various forms such as supervision, inspection and assessment. For example, the quality headquarters conducts various forms of GMP audits and the implementation of tracking quality policies for each branch;
● Take necessary measures to further improve supply chain management (including external and internal supply chains);
● Improve the quality management of product transfer. Including the transfer of research and development to production; the quality management of the transferred products from one plant to another;
● R&D quality management gradually extends from generic drugs to innovative drugs;
●Strengthen the construction of quality management team--To adopt a combination of external introduction and internal training to comprehensively improve the quality management team construction of multiple factories.