Zhejiang Dade Pharmaceutical Group Co., Ltd.
Zhejiang Dade Pharmaceutical Group Co., Ltd. is a scientific and technological small and medium-sized enterprise in Zhejiang Province, an outstanding enterprise in Jinhua City, and a high-tech research and development center in Jinhua City. . The company has won the Yiwu City Comprehensive Strength Award and the Economic Development Contribution Award for consecutive years, and is a major taxpayer in Yiwu City.
Zhejiang Dade Pharmaceutical Co., Ltd. was formerly known as Yiwu Joint Venture Factory of Hangzhou Hu Qingyutang Pharmaceutical Factory. The joint venture factory was established in 1992. At that time, it rented 200 square meters of the building of Yiwu Refrigeration Factory as a factory building. Employees* ** There are 8 people. The technical level and production equipment are relatively old. Some of the main production equipment such as tea packaging machine, swing granulator, V-shaped mixer, infrared dryer, crusher, etc. are relatively backward. The main products produced include 5 varieties including heat-clearing bag, children's phlegm-resolving powder, lipid-lowering tea bag, infant formula, and Dongfuchun ointment. The annual output value is 300,000 yuan, which is a small-scale production. On December 9, 1997, the Provincial Department of Health and the Provincial Medical Administration Bureau agreed to the following agreement (Zhejiang Medical Zongjingzi [1997] No. 373), agreeing that the joint venture would be decoupled from Hu Qingyutang, and then renamed, restructured, and established in Yiwu Zhejiang Dade Pharmaceutical Co., Ltd. was acquired, and the five drug varieties originally produced were also transferred to the new factory. In early 1998, Zhejiang Dade Pharmaceutical Co., Ltd. was officially established. Yiwu City’s pharmaceutical industry achieved zero breakthroughs. According to the State Council’s Relevant documents issued in 1996 stipulated that a new pharmaceutical factory must have one Category II new drug or two Category III new drugs. A Category II new drug is worth tens of millions of yuan, and a Category III new drug is worth several million. Yuan. At the beginning, the management rights, drug varieties and production equipment of the Yiwu branch of Hu Qingyutang in Hangzhou were purchased with a total legal value of 380,000 yuan.
After 6 years of development and growth, Zhejiang Dade Pharmaceutical Co., Ltd. changed its name to Zhejiang Dade Pharmaceutical Group Co., Ltd. on January 1, 2004. At present, the company is located in Yiwu Economic Development Zone, with very convenient transportation. The roads in the factory area are smooth, the pavement is smooth, the environment is elegant, and the air is fresh. The company officially started construction in September 1998 and completed it in October of the following year. It covers an area of ??more than 33,000 square meters, a new factory building of 10,000 square meters, and a green area of ??18,000 square meters. It has introduced domestically advanced tablets, powders, and capsules. , granules, oral liquids, sachets and traditional Chinese medicine extraction and other production lines. The company has product development department, production department, quality supervision department, engineering department, finance department, office, sales management department, GMP office and other functional departments and sales center. The organizational structure is reasonable and the responsibilities are clear. The company has one general manager and three deputy general managers. The production workshop consists of two major workshops: extraction workshop and preparation workshop. The production workshop all adopts domestic first-class equipment and has strong production capacity. The company has an annual production capacity of 50 million oral liquids, 200 million capsules, 30 million bags of granules, and 200 million tablets. The company has first-class testing equipment and quality management system. The key instruments of the Quality Supervision Department all use international famous brand products. At the same time, the company's internal quality control standards are effectively implemented and quality is strictly controlled. From raw material purchase to after-sales service, strict quality control is carried out in every link, and every employee has a high degree of quality control. Awareness and strong operational capabilities to ensure consistent delivery of quality products and services. In December 1999, the company's five dosage forms of tablets, capsules, powders, granules, and oral liquids all successfully passed the national GMP dynamic certification for pharmaceutical production, becoming the first pharmaceutical company in Zhejiang Province to pass the national GMP dynamic certification for multiple dosage forms at one time. . Facing the impact of SARS in 2003, in order to provide more patients with prevention opportunities, the company added an oral liquid production line. The oral liquid workshop and tea production line passed GMP certification in early 2004. In mid-November 2004, the company's six existing dosage forms, including oral liquid, tablets, granules, capsules, powders and teas, fully passed the national GMP re-certification inspection.
The company attaches great importance to science and technology, is people-oriented, and actively introduces professional and technical personnel, so that it has strong technical strength in product development, production, inspection, supply and marketing, etc.
The company currently has 200 employees, 132 of whom have college or technical secondary school education, accounting for 66 of the company's total; 19 engineering technicians, accounting for 20 of the total employees; 16 have technical titles; among them, 4 have senior technical titles, accounting for 20 of the total employees 2 of the total; 6 people with intermediate technical titles, accounting for 3 of the total; 18 people with junior technical titles, accounting for 9 of the total number of employees. Among the engineering and technical personnel there are a group of pharmaceutical scholars who have worked in the pharmaceutical industry for many years and have rich theoretical knowledge and practical experience. Wang Jianguo, the general manager of the company, realized the "method of employing people": Recruiting and employing talents is not just a matter of remuneration, but the most fundamental issue is the quality of personnel; as a new company, it is like a blank piece of paper. Drawing the latest and most beautiful pictures depends on the entrepreneurial spirit of all employees, especially the backbone; if you want to enjoy the results, no matter how high a diploma or a high professional title is, it will not help. With this concept in mind, Dade likes to introduce talents who "turn from workers to bosses". At the same time, let the introduced talents participate in the company and become the owners of the company, closely linking their destiny and future with the company. In this way, the introduction of talents is the introduction of entrepreneurs, which can not only retain them, but also encourage them to make their own contributions to the enterprise. Dade also adopts the method of "targeted talent introduction" to recruit talents from medical schools in colleges and universities in Anhui, Jiangxi, Shaanxi, Heilongjiang and other places. Since the establishment of the factory, more than 80 college graduates have been recruited from Anhui and other places. Most of the college graduates introduced in 2000 have taken up key positions and have made great progress in their work. Pharmaceutical production is a high-tech industry that requires top-notch professional and technical personnel across the country. To this end, Dade hired Tu Pengfei, a professor at Peking University, a doctoral supervisor, and a member of the National New Drug Review Committee for Traditional Chinese Medicine, and Leng Fangnan, director of the Beijing Institute of Natural Medicine and leader of the Chinese Patent Medicine Expert Group, as consultants. "Borrowing" high intelligence and high technology has accelerated the introduction, development and research of drugs, and promoted the take-off of enterprises.
Products are the basis for enterprise development and the source of enterprise prosperity and decline. Without marketable and competitive products, an enterprise is like a fish without water or a tree without soil, losing its vitality. In 1999, in the early days of the establishment of the factory, it became even more important for the company to speed up the development of new varieties when the factory was new and the foundation was weak. The company takes advantage of the national GMP certified enterprises' advantages in new drug approval and variety imitation, and actively organizes the development, research and imitation of varieties, so as to "select the right one, develop one, succeed in one, and create profit in one". At the same time, a special leadership group was established to divide responsibilities and step up efforts to improve the production process of fresh motherwort capsules to ensure that the fresh motherwort capsules have mature technology and stable production and are put on the market as the company's flagship product. In 2000, the company invested a lot of manpower and material resources in the development of new products, completed research work on the long-term toxicity, acute toxicity, pharmacological efficacy, and clinical effects of Ginkgo biloba dew, and applied for Ginkgo biloba dew, Xiaoyailing granules, For the traditional Chinese medicine protection of Ruquan Granules, we have obtained the production license number for Lidan Paishi Powder and the clinical approval document for Kangmaixin Oral Liquid. Among them, Fresh Motherwort applied for a national science and technology small and medium-sized enterprise innovation fund project, and received a free grant of 700,000 yuan from the state, injecting new vitality into the enterprise. In June 2000, the company's Saiqi (azithromycin granules) passed the provincial new product identification in Hangzhou. This product was jointly developed by the company and Henan Zhengzhou Pharmaceutical Development Research Institute. It belongs to the National Category Four new chemical drugs. It is a new type of high-efficiency, long-acting macrolide powerful anti-infective drug that has had great influence in recent years. At the appraisal meeting, azithromycin granules won unanimous praise from experts, who believed that its performance indicators were in a leading position among similar domestic products. The production of this dosage form filled a gap in the province. At the same time, the company made full use of the advantages of national GMP certified enterprises in new drug approval, and invited relevant experts to carefully select more than 20 varieties with market development potential to apply. All of them were approved by the State Food and Drug Administration and became the annual national pharmaceutical industry neutral project. An enterprise with the most projects. By the second half of 2002, the application materials for 20 projects had been completed and the production approval number had been obtained from the Food and Drug Administration. We have won financial support from the National Science and Technology Small and Medium-sized Enterprises Technology Innovation Fund for the company's fresh motherwort capsule project.
Fresh motherwort capsules are a new generation of gynecological medicine jointly developed by the company and Zhejiang Institute of Traditional Chinese Medicine. This project has applied for two national patent protections. In order to cooperate with the production of this project, the company has also established two fresh motherwort planting bases in the Yiwu Mountains ( This project has been included in the Provincial Torch Plan Project by the Science and Technology System and has passed acceptance). In 2001, the company's ginkgo dew was officially listed as a national protected traditional Chinese medicine variety by the China Insurance Office. At the same time, in the first half of the year, the company also completed the application for multiple generic drugs such as Yiqi Yangxue Oral Liquid, Tongmai Oral Liquid, Siji Sanhuang Tablets, Maiweidihuang Oral Liquid, Yangchun Yuye, Tangnuiling Tablets, etc. The data supplementation work for Kangmaixin Oral Liquid, a Class III new Chinese medicine, and Fresh Motherwort Capsules, a Class IV new Chinese medicine, has now obtained the production approval certificate and new drug certificate issued by the State Food and Drug Administration. In addition, the phase III clinical trials of antiviral oral liquid and Xiaoyailing granules were applied for national protected traditional Chinese medicines. These have laid a solid foundation for ensuring the sustainable and healthy development of the enterprise. In the second half of 2001, the process improvement of Ganoderma lucidum granules was completed. Ganoderma lucidum granules with high sucrose content were improved into lactose-type Ganoderma lucidum granules to expand the applicable consumer group and improve compliance. In 2002, the Class 1 and Class III new drug Kangmaixin Oral Liquid was applied for production based on the completion of clinical research work, and the production approval was obtained in 2003. Four new drugs, hepatocyte growth-promoting hormone capsules, have obtained clinical approval and entered the clinical trial stage. 2. Obtained approval numbers for more than ten generic products, including Yiqi Yangxue Oral Liquid, Yangchun Yuye, Siji Sanhuang Tablets, Weikangling Capsules, Maiwei Dihuang Oral Liquid, and Tongmai Oral Liquid. Tangnuiling Tablets, Fengshiding Capsules, and Tongbianling Capsules will also obtain production approval. 3. Completed the registration application work for the generic products Nioseitong Tablets, Gankang Granules, and Azithromycin Capsules. Among them, Azithromycin Capsules cooperated with Jiangxi Medical College to conduct bioequivalence tests. 4. Completed the clinical pharmacological efficacy research of Geng Nian Chun Tablets and Gui Lu Jiannao Anshen Tablets, and have now applied for registration and listing of these two products in Hong Kong. 5. Complete the process improvement work for azithromycin granules, and carry out the patent application for its process (accepted). The modified process application materials have been reported to the registration office of the State Food and Drug Administration. 6. Two products, Motherwort Capsules and Xiaoyailing Granules, passed the provincial new product identification. 7. Efforts have been made to protect traditional Chinese medicine varieties, and have obtained traditional Chinese medicine variety protection certificates for antiviral oral liquid, Ginkgo biloba, and Xiaoyailing granules. The protection work of Ruquan Granules is also in progress. The preliminary preparation work (clinical trial) for traditional Chinese medicine protection of sugar-free Ganoderma lucidum granules was completed. 8. "A preparation method of pharmaceutical preparation hepatocyte growth-promoting hormone capsules", "a preparation method and preparation method of pharmaceutical preparation Geng Nian Chun Tablets", "a preparation method and preparation method of pharmaceutical preparation Guilu Jiannao Anshen Tablets" , "The formula and preparation method of a pharmaceutical preparation Kangmaixin Oral Liquid", "The formula and preparation method of a pharmaceutical preparation (azithromycin granules)" have all been accepted. 9. Complete the classification and approval of prescription drugs and over-the-counter drugs, the application for drug replacement approval numbers, the rectification of Dongfuchun ointment health products, and the approval of landmark upgrades. In 2004, we completed 8 product R&D registration applications, 34 product R&D supplementary applications in 7 categories, 5 patent applications, 9 project applications, 2 applications for protected Chinese medicine varieties, 6 OTC declaration and registration filing of varieties, 13 registered trademarks and trademark objections.
Marketing is the leader of an enterprise and the key to its development. Under the conditions of market economy, if an enterprise wants to survive and develop, it must actively adapt to the market economy, be market-oriented, strive to expand the market share of products, and improve the economic benefits of the enterprise, otherwise it will be eliminated by fierce market competition. . At the beginning of the company's establishment in 1998, the company established a sales department, hired capable people with high salaries as marketing managers and market promoters from all over the country, recommended a regional agency system, and established a stable and reliable sales network and channels.
In 2000, the company improved its product marketing system. The sales department is directly under the leadership of the general manager and is fully responsible for the sales of the company's products. The company has established offices in major cities in Zhejiang Province, such as Hangzhou, Ningbo, Jiaxing, Shaoxing, Quzhou, Taizhou and other places. Offices have been established outside the province, and offices or agents have been set up in Beijing, Nanjing, Shandong, Tianjin, Chengdu, Wuhan, Jiangxi, Fujian, Guangxi and other regions, and a set of dynamic marketing management systems have been formed. The company also focuses on exploring future overseas markets and actively contacts with institutions such as Thailand's Huanya Pharmaceutical Company to prepare to sell Xiaoluiling Granules and other varieties to Southeast Asia and other regions. At the same time, a sales company (Hong Kong International Dade Pharmaceutical Co., Ltd.) was registered in Hong Kong, laying the foundation for the products to enter the international market in the future. At the same time, the company invested a large amount of advertising expenses from 1998 to 2000. In 2001 and 2002, the company gradually increased its investment in advertising expenses. In 2001, it invested 5 million yuan in advertising expenses, and in 2002, it invested 12 million yuan. Yuan advertising expenses, advertising expenses have been increasing year after year. Product advertisements have been broadcast on Zhejiang Satellite TV, Zhejiang Entertainment Channel, Zhejiang Education Channel, Jinhua TV Station, and Yiwu TV Station. The company firmly grasps the market dynamics, conducts market research and market analysis, and continuously collects information, thereby formulating corresponding marketing strategies to adapt to market requirements and better serve the market, thus making the Dade brand deeply rooted in the hearts of the people and shaping the corporate image. overall image.
In terms of enterprise production and operation, in the past six years, the enterprise's total industrial output value (current price), industrial added value, sales output value, profits and taxes, profits, export delivery value, technological innovation investment and other data have increased year by year, and profits have increased. 6 times, and profits and taxes increased by 109 times. Made a significant contribution to local fiscal revenue.
Yiwu Dade Medicinal Material Cultivation Co., Ltd.
Yiwu Dade Medicinal Material Cultivation Co., Ltd. was established at the end of December 2003. It is located on Jiangbin West Road, Yiwu City and is mainly engaged in medicinal material cultivation. Technical research and development, consulting services and medicinal material planting. The company has built a fresh motherwort planting base, implemented GAP planting, and provided fresh motherwort raw materials for Dade Pharmaceutical. The company has two standardized planting plots, both located in Yiwu City, where the company is located.
Nanwangdian planting base is located in the mountainous area of ??Fotang Town in the south of Yiwu City, adjacent to Shuanglin Scenic Area. It has beautiful mountains and clear waters, convenient transportation, sufficient land and water conservancy resources, and has carried out standard farmland transformation and water conservancy measures. It is good, and wild motherwort grows in the area all year round, so it is suitable for planting fresh motherwort. The planting base has fresh air, no air pollution around it, no chemical plants, cement plants and other polluting enterprises, no harmful gases, smoke and dust. The base is located upstream of the water source, so there is no pollution from production water or domestic water, and the water quality is pure. The soil is loam to sandy loam, slightly acidic to neutral, and has a rich soil layer, which meets the requirements for growing fresh motherwort. The planting area is about 100 acres.
Dumen Planting Base is located in the mountainous area of ??Dachen Town in the north of Yiwu City, at the foot of Efeng Mountain, the highest peak in Yiwu City. It has convenient transportation, sufficient land and water resources, and wild motherwort grows all year round, so it is suitable for fresh motherwort cultivation. Planting. The planting base has fresh air, no air pollution around it, no chemical plants, cement plants and other polluting enterprises, no harmful gas emissions, no smoke and dust. The base is located upstream of the water source, so there is no pollution from production water or domestic water, and the water quality is pure. The soil is loam to sandy loam, slightly acidic to neutral, and has a rich soil layer, which meets the requirements for growing fresh motherwort. The planting area is about 50 acres.
Fresh motherwort capsules are the key products of Zhejiang Dade Pharmaceutical Group Co., Ltd. Compared with traditional motherwort preparations, fresh motherwort capsules have wider functions, more accurate curative effects, and are more convenient to use, catering to modern society. The demand for green natural environmentally friendly drugs can replace traditional motherwort preparations. It has strong market competitiveness and the ability to earn foreign exchange through export. It is the only green drug in the country. The company's annual output of fresh motherwort exceeds 800 tons. After processing, it can provide medicines with accurate curative effects to a large number of patients.
Yiwu Dade Traditional Chinese Medicine Pieces Co., Ltd.
Yiwu Dade Traditional Chinese Medicine Pieces Co., Ltd. produces Chinese patent medicines for Dade Pharmaceuticals, performs pre-processing of Chinese medicinal materials, and provides the required extraction of Chinese medicines. The company covers an area of ??3,000 square meters and a building area of ??2,500 square meters. Among them, the production area is 1050 square meters and the storage area is 1080 square meters. The green area is 500 square meters. There are 21 employees***, 15 of whom have technical secondary school education or above.
The surrounding environment of the decoction piece workshop is clean and tidy, the layout is reasonable, and the roads in the factory area are smooth. The production workshop is designed according to the requirements of the processing flow of decoction pieces. The flow of people and logistics are separated. Drug processing workshops are strictly separated from other processing and processing operations. Strict quality assurance measures are taken during the production process. The storage conditions are in good condition and each functional area is separated according to regulations. To prevent mistakes. The workshop currently produces 421 varieties. The annual output is more than 500 tons of decoction pieces.
The company has 14 employees, including 4 technicians. All personnel have undergone comprehensive production technology training. The production workshop of the decoction piece company has one deputy workshop director (in charge of the work), one technician, one QA person, one QC person, and one administrator. The production workshop of decoction pieces is directly under the production department of the company. Personnel engaged in production management and quality management of decoction pieces meet the requirements of the acceptance standards. Personnel engaged in production operations and quality inspection of decoction pieces will take up their posts after receiving professional technical training. Employees undergo physical examinations every year, and all those suffering from infectious diseases, skin diseases, and trauma are removed from work positions that come into direct contact with the decoction pieces.
In terms of factory buildings and facilities: the production environment of the factory area is clean and tidy, with people and logistics separated, the road surface is smooth, and the overall layout of the factory area is reasonable. The production plant is 50 meters away from the main traffic road. The production workshop has a slice workshop, a power system, a sewage treatment system, an administrative office area, etc. The reasonable layout of the factory building according to the process flow can prevent the entry of insects, rats, flies, etc. The inner surface of the factory is flat and smooth, making it easy to clean and disinfect. The transmission pipelines, water, electricity and other pipelines in the factory are all concealed; the main operating room lighting should not be less than 300 lux. The inner packaging positions of Yiwu Dade Traditional Chinese Medicine Pieces Co., Ltd. are managed as clean areas. People and materials are separated in the factory, and facilities such as changing shoes, changing clothes, hand washing, disinfection, and cleaning are provided to effectively prevent contamination. There is a safety door in the factory. The storage area is equipped with Chinese herbal medicine area, prepared pieces area, area to be inspected, qualified product area, unqualified product area, shipping area, drug warehouse, fumigation room, etc., which are consistent with the requirements of acceptance standards. The quality management department has laboratories for biological testing, chemical testing, instrument analysis, bacterial testing, and sample observation. The workshop has a workshop laboratory.
In terms of equipment: the company's production equipment, public engineering equipment and quality inspection instruments and equipment are adapted to the needs of existing production products and meet the acceptance standards in terms of materials, capabilities, cleaning, disinfection, operation and maintenance. requirements. Posts that generate large amounts of dust, such as crushing and cleaning, are equipped with dust removal devices and ventilation and exhaust facilities. The precision of instruments, meters, measuring instruments, scales, etc. used for production and inspection has been verified by the statutory technical supervision department, and has clear status marks. The equipment installation layout is consistent with the process flow, the pipelines are painted in compliance with relevant regulations, and there are content and flow direction signs. The company is equipped with fire extinguishing devices and safety doors in strict accordance with national requirements.
Material management: According to different materials, the warehouse of the decoction piece workshop is divided into raw medicinal material area, excipient material area, finished product area, drug warehouse, packaging material warehouse, etc. In order to ensure the quality of the decoction pieces, a management system has been established for the purchase and use of raw materials, excipients, packaging materials and other materials, and they comply with national drug standards. The cargo locations of raw materials, auxiliary materials, and packaging materials to be inspected, qualified, and unqualified are strictly separated, and there are obvious status identification marks. Unqualified raw and auxiliary materials and packaging materials are guaranteed not to be put into use; unqualified semi-finished products and intermediates are guaranteed not to flow into the next process; finished products that do not meet quality standards are not allowed to leave the factory. Toxic medicinal materials are stored in a special warehouse and managed by two people and double locks. The processed medicinal materials should be stored in clean containers. There are storage periods and re-inspection systems for raw medicinal materials, excipients and finished products. Unqualified materials and waste shall be disposed of according to prescribed procedures.
In terms of production management and quality management: a complete set of production management and quality management documents has been established and improved according to the actual situation of the production of decoction pieces.
The production process operates in an orderly manner in accordance with the requirements of acceptance standards. Each batch of products is fed according to 100 prescriptions, and key processes are set up for review and QA supervision and inspection. Formulate and revise process procedures and job operating methods, and implement drafting, review and approval procedures. Each product is produced according to established process procedures and job operation methods. Personal hygiene, production plants and equipment are clean, and various hygiene management systems are strictly implemented. The inner packaging room is managed as a clean area. Each batch of products has a batch production record that reflects the actual production situation and meets the requirements of the acceptance standards. The batch records are archived for three years, and the batch records of toxic varieties are archived for five years. Different products are not produced in the same operating room at the same time. Each production operating room, production equipment, and containers have status signs indicating that the products are being processed. Use flowing water for washing of medicinal materials, and the used water should be discharged and cleared in a timely manner. Different medicinal materials should not be washed in the same moisturizing tank at the same time. Production workshops and major production equipment have status signs. After each production stage of each batch of products is completed, the site is cleared and the clearance record is filled in. The Quality Supervision Department is responsible for quality supervision of the entire pharmaceutical production process and is directly under the leadership of the General Manager. Quality standards and inspection procedures for raw medicinal materials, excipients, packaging materials, and slices have been formulated for each variety. It has complete quality inspection instruments and advanced equipment, and has the ability to fully inspect Chinese medicinal materials, intermediate products and finished products. All pieces shipped from the factory have factory inspection reports.
Yiwu Dade Traditional Chinese Medicine Pieces Co., Ltd. will spare no effort to continuously improve, strive to improve the standard of work, produce high-quality pieces, and serve patients and society.