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Pharmaceutical production of Zhejiang Dade Pharmaceutical Group
Zhejiang Dade Pharmaceutical Group Co., Ltd.

Zhejiang Dade Pharmaceutical Group Co., Ltd. is a high-tech small and medium-sized enterprise in Zhejiang Province, an excellent enterprise in Jinhua City and a high-tech research and development center in Jinhua City. The company has won the comprehensive strength award and contribution award for economic development in Yiwu year after year, and is a big taxpayer in Yiwu.

Zhejiang Dade Pharmaceutical Co., Ltd. was formerly the Yiwu United Factory of Hangzhou Huqingyutang Pharmaceutical Factory. The joint factory was established in 1992. At that time, a 200-square-meter house of Yiwu Refrigeration Factory was rented as a workshop with 8 employees. The technical level and production equipment are relatively old, and some main production equipment such as tea packaging machine, pendulum granulator, V-mixer, infrared dryer and pulverizer are relatively backward. The main products are five varieties, such as Qingre Bag Bubble, Xiaoer Huatan Powder, Lipid-reducing Tea Bag, Baby Essence and Dongfuchun Cream, with an annual output value of 300,000 yuan, which belongs to small-scale production. 199765438+On February 9th, with the approval of the Provincial Health Department and the Provincial Administration of Medicine (Zhejiang Yaozong Jingzi [1997] No.373), the joint venture factory was decoupled from Hu Qingyutang, and later renamed and restructured, Zhejiang Dade Pharmaceutical Co., Ltd. was established in Yiwu, and the original five drug varieties were formally established by Zhejiang Dade Pharmaceutical Co., Ltd. According to the relevant documents issued by the State Council 1996, a new pharmaceutical factory must have a new class II drug or two new class III drugs, and a new class II drug is worth tens of millions of yuan and a new class III drug is worth several million yuan. At the beginning, I bought the management right, drug varieties and production equipment of Hangzhou Huqingyutang Yiwu Branch, with a total value of 380,000.

After six years of development, Zhejiang Dade Pharmaceutical Co., Ltd. was renamed as Zhejiang Dade Pharmaceutical Group Co., Ltd. on June 65438+ 10/in 2004. At present, the company is located in Yiwu Economic Development Zone with convenient transportation. The roads in the factory area are smooth, the road surface is smooth, the environment is elegant and the air is fresh. The company officially started construction on1September, 1998, and was completed on1October the following year, covering an area of more than 33,000 square meters, with newly built workshop 10000 square meters and green area 18000 square meters. Many domestic advanced production lines, such as tablets, powders, capsules, granules, oral liquids, sachets, and traditional Chinese medicine extraction, have been introduced. 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 centers with reasonable organization and clear responsibilities. There are 1 general manager and 3 deputy general managers in charge of the company. The production workshop has two workshops: extraction workshop and preparation workshop, in which all the production workshops adopt domestic first-class equipment and have strong production capacity. The company has an annual output 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. All the key instruments in the Quality Supervision Department adopt internationally renowned brand products, and at the same time effectively implement the company's internal quality control standards, strictly control the quality, and strictly control every link from raw material procurement to after-sales service. Every employee has a high quality awareness and strong business ability to ensure consistent provision of high-quality products and services. 199965438+February, the company's five dosage forms, including tablets, capsules, powders, granules and oral liquid, all passed the national GMP dynamic certification of pharmaceutical production successfully, becoming the first batch of pharmaceutical enterprises in Zhejiang Province to pass the national GMP dynamic certification of multiple dosage forms at one time. In 2003, in the face of the impact of SARS, in order to provide more patients with preventive opportunities, the company added an oral liquid production line. Oral liquid workshop and tea production line passed GMP certification in early 2004. In mid-October, 2004, the company's existing six dosage forms, such as oral liquid, tablet, granule, capsule, powder and tea, passed the national GMP re-certification inspection.

Companies attach importance to science and technology, people-oriented, and actively introduce professional and technical personnel, so that product development, production, inspection, supply and marketing and other links have a strong technical force. The company has 200 employees, with college degree or above 132, accounting for 66% of the total number of the company. Engineering and technical personnel 19, accounting for 20% of the total number of employees; With technical titles accounted for16%; Among them, there are 4 senior technical titles, accounting for 2% of the total number of employees; There are 6 intermediate technical titles, accounting for 3% of the total; Junior technical titles 18, accounting for 9% of the total number of employees. 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 way of employing people: recruiting talents and attracting talents is not only a matter of treatment, but also the quality of personnel; As a new enterprise, just like a blank sheet of paper, it depends on the entrepreneurial spirit of all employees, especially the backbone, to draw the latest and most beautiful pictures; If you want to enjoy success, no matter how high your diploma is or how high your title is. With this concept, Dade likes to introduce talents from migrant workers to bosses. At the same time, let the introduced talents participate in the company, become the owners of the enterprise, and closely link their own destiny and future with the enterprise. In this way, introducing talents means introducing entrepreneurs, which can not only keep him, but also encourage him to make his own contribution to the enterprise. Dade also adopts the way of "directed talent introduction" to recruit talents from medical schools in colleges and universities in Anhui, Jiangxi, Shaanxi and Heilongjiang. 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 took up key positions and their jobs were greatly improved. Pharmaceutical production is a high-tech, which needs first-class professional and technical personnel in China. To this end, Dade hired Professor Peking University, doctoral supervisor, Tu Pengfei, member of the National New Drug Evaluation Committee of Traditional Chinese Medicine, Leng Fangnan, director of the Beijing Institute of Natural Medicine and head of the China Chinese patent medicine expert group, as consultants. "Borrowing" has gained high wisdom and high technology, which has accelerated the introduction, development and research of drugs and promoted the take-off of enterprises.

Products are the foundation of enterprise development and the source of enterprise rise and fall. Without marketable and competitive products, enterprises are like fish without water and wood without soil, losing their vitality. 1999, in the initial stage of the factory, the company should pay more attention to the development of new varieties under the condition of new factory and weak foundation. Taking advantage of the advantages of national GMP certification enterprises in new drug approval and variety imitation, the company actively organizes the development, research and imitation of varieties, so as to achieve "selecting one, researching one, succeeding one and creating one profit". At the same time, a special leading group will be set up, which will be responsible for the division of labor, and the production technology of fresh motherwort capsule will be improved to ensure that fresh motherwort capsule is mature in technology and stable in production, and will be put on the market as the company's fist product. In 2000, the company invested a lot of manpower and material resources to develop new products, completed the research work on chronic toxicity, acute toxicity, pharmacological action and clinical aspects of Yinxing Lu, declared the protection of traditional Chinese medicine for Yinxing Lu, Xiaozhengting Granule and Ruquan Granule, and obtained the production batch number of Lidan Paishi Powder and the clinical approval of Kangmaixin Oral Liquid. Among them, fresh Leonurus japonicus applied for the national innovation fund project for small and medium-sized scientific and technological enterprises, and won 700,000 yuan from the state for free, which injected new vitality into the enterprise. In June 2000, Saiqi (Azithromycin Granule) produced by the company passed the provincial new product appraisal in Hangzhou. This product is developed by our company in cooperation with Zhengzhou Institute of Medicine Development in Henan Province. Belonging to the fourth category of national new chemical drugs, it is an effective and long-acting macrolide anti-infective drug with great influence in recent years. At the appraisal meeting, azithromycin granules won unanimous praise from experts, and considered that its performance index was in a leading position among similar products in China, and 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 certification enterprises in the examination and approval of new drugs, invited relevant experts to carefully select more than 20 varieties with market development potential for declaration, and all of them were approved by the State Pharmaceutical Products Administration, becoming the enterprise with the most approved projects in the national pharmaceutical industry that year. By the second half of 2002, the data declaration of 20 approved projects had been completed, and the production approval number of the drug administration had been obtained. The company's fresh motherwort capsule project was supported by the National Technology Innovation Fund for Small and Medium-sized Science and Technology Enterprises. Fresh motherwort capsule is a new generation of gynecological drugs jointly developed by the company and Zhejiang Institute of Traditional Chinese Medicine. The project has applied for two national patent protection. In order to cooperate with the production of this project, the company has also established two fresh motherwort planting bases in Yiwu mountainous area (this project has been included in the provincial torch plan project by the science and technology system and passed the acceptance). In 200 1 year, the company's ginkgo dew was officially listed as a national protected variety of traditional Chinese medicine by China Insurance Office. At the same time, in the first half of the year, the company also completed the declaration of several generic drugs such as Yiqi Yangxue Oral Liquid, Tongmai Oral Liquid, Siji Sanhuang Tablet, Maiwei Dihuang Oral Liquid, Yangchun Yu Ye and Tangniaoling Tablet. The data supplement of Kangmaixin Oral Liquid, a third class of new Chinese medicine, and Xian motherwort capsule, a fourth class of new Chinese medicine, have obtained the production approval certificate and new medicine certificate issued by the State Administration of Pharmaceutical Products. In addition, the third-phase clinical trial of antiviral oral liquid and Xiaoziling granule, which were declared as national protected varieties of traditional Chinese medicine, was completed. All these have laid a solid foundation for ensuring the sustained and healthy development of enterprises. In the second half of 200/kloc-0, the technological improvement of ganoderma lucidum granules was completed, and the ganoderma lucidum granules with high sucrose content were improved into lactose ganoderma lucidum granules, which expanded the applicable population of consumers and improved the compliance. In 2002, 1, Kangmaixin oral liquid, a new class III drug, was declared for production on the basis of clinical research, and was approved for production in 2003. Four new drugs of hepatocyte growth-promoting factor capsules obtained clinical approval and entered the clinical trial stage. 2. Obtained the approval numbers of more than ten imitation products such as Yiqi Yangxue Oral Liquid, Yangchun Yu Ye, Siji Sanhuang Tablet, Weikangling Capsule, Maiwei Dihuang Oral Liquid and Tongmai Oral Liquid. Tangniaoling tablets, Fengshiding capsules and Tongbianling capsules will also receive production approval. 3. Complete the registration declaration of imitation products Niaoseitong Tablet, Gankang Granule and Azithromycin Capsule, among which Azithromycin Capsule cooperated with Jiangxi Medical College to conduct bioequivalence test. 4. The clinical pharmacological and pharmacodynamic studies of Gengnianchun Tablet and Guilu Jiannao Anshen Tablet have been completed, and they have been registered and listed in Hong Kong. 5. Complete the process improvement of azithromycin granules and apply for process patent (accepted). The application materials for modifying the process have been submitted to the registration office of the State Administration of Pharmaceutical Products. 6. Two products, motherwort capsule and Mojieting Granule, passed the provincial new product appraisal. 7. Efforts have been made to protect the varieties of traditional Chinese medicines, and we have obtained protection certificates for varieties of traditional Chinese medicines, such as antiviral oral liquid, ginkgo dew and Xiaoweiling granules. The protection of Ruquan granules is also in progress. Completed the preparation of traditional Chinese medicine protection for sugar-free Ganoderma lucidum granules (clinical trial). 8. Preparation method of hepatocyte growth-promoting capsule pharmaceutical preparation, formula and preparation method of Gengnianchun tablet pharmaceutical preparation, formula and preparation method of Guilu Jiannao Anshen tablet pharmaceutical preparation, formula and preparation method of Kangmaixin oral liquid pharmaceutical preparation and formula and preparation method of a drug (azithromycin granules) have all been accepted. 9. Complete the classification approval of prescription drugs and over-the-counter drugs, the declaration of drug renewal approval number, the rectification of Dongfuchun cream and health care products and the landmark approval. In 2004, 8 applications for product R&D registration, 7 categories and 34 varieties of product R&D supplements, 5 varieties of patent applications, 9 project applications, 2 varieties of traditional Chinese medicine protection applications, 6 varieties of OTC registration, 13 registered trademarks and trademark objections were completed.

Marketing is the leader of an enterprise and the key to its development. Under the condition of market economy, if enterprises want to survive and develop, they must actively adapt to the market economy, take the market as the guide, strive to expand the market share of products and improve the economic benefits of enterprises, otherwise they will be eliminated by fierce market competition. 1998 Company set up a sales department at the beginning of its establishment, openly recruited talented people from all over the country as marketing managers and promoters, elected regional agency system, and established a stable and reliable sales network and channels. In 2000, the company improved the product marketing system, and the sales department was directly under the leadership of the general manager and was fully responsible for the sales of the company's products. The company has set up offices in major cities in Zhejiang Province such as Hangzhou, Ningbo, Jiaxing, Shaoxing, Quzhou and Taizhou, and also set up offices or agents in Beijing, Nanjing, Shandong, Tianjin, Chengdu, Wuhan, Jiangxi, Fujian and Guangxi outside the province, forming a set of agents. In the future, the company will also focus on exploring overseas markets, actively contact with Thailand Huanya Pharmaceutical Company and other institutions, and prepare to sell Xiaoshi tablets and other varieties to Southeast Asia and other regions. At the same time, we also registered a sales company in Hong Kong (Hong Kong International Dade Pharmaceutical Co., Ltd.), which laid the foundation for our products to enter the international market in the future. At the same time, from 1998 to 2000, the company invested a lot of advertising expenses. In 200 1 and 2002, the company gradually increased advertising expenses. In 200 1 year, the advertising fee was 5 million yuan, and in 2002, the advertising fee was120 thousand yuan. So far, advertising expenses have increased year by year. The products have been advertised in Zhejiang Satellite TV, Zhejiang Entertainment TV, Zhejiang Education TV, Jinhua TV and Yiwu TV. Companies firmly grasp the market dynamics, conduct market research and analysis, and constantly collect information, so as to formulate corresponding marketing strategies to meet market requirements and better serve the market, so as to make Dade brand deeply rooted in the hearts of the people and shape the overall image of the enterprise.

In the production and operation of enterprises, the data of total industrial output value (current price), industrial added value, sales output value, profits, taxes, export delivery value, technical transformation investment and so on have increased year by year in the past six years, with profits increasing 6 times and profits and taxes increasing 109 times. It has made great contributions to local fiscal revenue.

Yiwu Dade medicine planting co., ltd

Yiwu Dade Medicinal Plants Co., Ltd. was established at the end of June, 2003, 5438+February, located in Jiang Bin West Road, Yiwu, and mainly engaged in research and development of medicinal plants, consulting services and cultivation of medicinal plants. The company established a fresh motherwort planting base, implemented GAP planting, and provided fresh motherwort raw materials for Dade Pharmaceutical. The two plots planted by the company are located in Yiwu, 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 Sara Scenic Area, with beautiful scenery, convenient transportation, abundant water and soil resources, standardized farmland transformation and good water conservancy measures. Wild Leonurus japonicus grows all year round in this area, which is suitable for planting fresh Leonurus japonicus. The air in the planting base is fresh, there is no air pollution around it, no polluting enterprises such as chemical plants and cement plants, no harmful gas emission and no smoke. The base is located in the upper reaches of the water source, and there is no pollution of production water and domestic water, and the water quality is pure. The soil is loam to sandy loam, weakly acidic to neutral, and the soil layer is thick, which meets the planting requirements of fresh motherwort. The planting area is about 100 mu.

Dumen planting base is located in the mountainous area of Chen Da Town, northern Yiwu, at the foot of Emei Mountain, the northern peak, with convenient transportation and rich water and soil resources. Wild motherwort grows all year round and is suitable for planting fresh motherwort. The air in the planting base is fresh, there is no air pollution around it, no polluting enterprises such as chemical plants and cement plants, no harmful gas emission and no smoke. The base is located in the upper reaches of the water source, and there is no pollution of production water and domestic water, and the water quality is pure. The soil is loam to sandy loam, weakly acidic to neutral, and the soil layer is thick, which meets the planting requirements of fresh motherwort. The planting area is about 50 mu.

Fresh motherwort capsule is the key product of Zhejiang Dade Pharmaceutical Group Co., Ltd. Compared with the traditional motherwort preparation, it has wider functions, more definite curative effect and more convenient use, which caters to the demand of modern society for green natural and environmental protection drugs, can replace the traditional motherwort preparation, has strong market competitiveness and export earning capacity, and is the only green drug in China. The company has an annual output of more than 800 tons of fresh motherwort, which can provide effective drugs for patients after processing.

Yiwu Dade traditional Chinese medicine co., ltd

Yiwu Dade Chinese Herbal Pieces Co., Ltd. preprocesses Chinese herbal medicines for Dade Pharmaceutical to produce Chinese patent medicines, and provides Chinese herbal pieces needed for the extraction of Chinese herbal medicines. The company covers an area of 3,000 square meters, with a building area of 2,500 square meters. In which the production area1050m2 and the storage area1080m2. The green area is 500 square meters. Employees 2 1 person, technical secondary school education or above 15 people.

The surrounding environment of the decoction pieces 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. Separation of people flow and logistics. The pharmaceutical processing workshop is strictly separated from other processing operations. Strict quality assurance measures have been taken in the production process. The storage conditions are good and the functional areas are separated according to regulations. In case of mistakes. Workshop has 42 1 production varieties. The annual output of decoction pieces is more than 500 tons.

◆ The company currently has 14 employees, including 4 technicians. All employees have received comprehensive production technical training. The production workshop of Yinpian Company is provided with workshop deputy director (presiding) 1 name, technician 1 name, QA member 1 name, QC member 1 name and administrator 1 name. ◆ The production workshop is directly under the production department of the company. Personnel engaged in the production management and quality management of decoction pieces meet the requirements of acceptance standards. Personnel engaged in the production, operation and quality inspection of decoction pieces shall take up their posts after professional and technical training. Employees shall have an annual physical examination, and those who suffer from infectious diseases, skin diseases and trauma shall be transferred from their jobs where they are in direct contact with decoction pieces.

Plant and facilities: The production environment of the plant is clean, the flow of people and materials is separated, the road surface is smooth, and the overall layout of the plant is reasonable. The production workshop is 50 meters away from the main road, and the production workshop has a decoction piece workshop, a power system, a sewage treatment system and an administrative office area. According to the reasonable layout of process flow, the workshop can prevent insects, rats and flies from entering. The inner surface of the factory building is smooth and easy to clean and disinfect. The transportation pipelines and water and electricity pipelines in the plant area are concealed pipelines; The lighting of the main operating room shall not be less than 300 lux. Yiwu Dade Traditional Chinese Medicine Pieces Co., Ltd. manages the internal packaging post according to the clean area. People in the factory are separated, and facilities such as changing shoes, clothes, washing hands, disinfection and cleaning are installed in the factory, which can effectively prevent pollution. There is a security door in the factory building. The storage area is equipped with a Chinese herbal medicine area, a decoction piece area, a pending inspection area, a qualified product area, an unqualified product area, a delivery area, a drug warehouse, a fumigation room and the like. , in line with the requirements of acceptance criteria. The quality management department has a laboratory for biological test, chemical test, instrument analysis, bacterial test and sample observation. There is a workshop laboratory in the workshop.

Equipment: the company's production equipment, public engineering equipment and instruments and equipment used for quality inspection meet the needs of existing production products, and meet the requirements of acceptance standards in terms of materials, capabilities, cleaning, disinfection, operation and maintenance. Dust removal devices and ventilation facilities shall be installed in posts with large dust production such as crushing and cleaning. The accuracy of instruments, meters, measuring instruments and weighing instruments used in production and inspection has been verified by legal technical supervision departments, and there are clear status marks. The installation layout of the equipment is suitable for the technological process, and the pipeline paint conforms to the relevant regulations, with contents 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 the different materials, the warehouse of decoction pieces workshop is divided into original medicinal materials area, auxiliary materials area, finished products area, medicine warehouse and packaging material warehouse. In order to ensure the quality of decoction pieces, the procurement and use of raw materials, auxiliary materials, packaging materials and other materials have a management system, which meets the national drug standards. The positions of raw materials and packaging materials to be inspected, qualified and unqualified are strictly separated, and there are obvious state identification marks. Unqualified raw 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 the quality standards will not leave the factory. Toxic medicinal materials are stored in a special warehouse, which is managed by two people and two locks. The processed pure medicinal materials are stored in a clean container. The original medicinal materials, auxiliary materials and finished products all have a shelf life and re-inspection system. Unqualified materials and wastes shall be treated separately according to the prescribed procedures.

Production management and quality management: according to the actual situation of decoction pieces production, a set of production management and quality management documents has been established and improved. The production process runs in an orderly manner according to the requirements of the acceptance standard, each batch of products is fed according to the prescription amount 100%, and the key working procedures are set up for review and QA supervision and inspection. Formulate and modify process regulations and post operation methods, and implement drafting, review and approval procedures. Each product is produced in accordance with the established technological procedures and post operation methods. Personal hygiene, clean production plant equipment, strict implementation of various health management systems, inner packaging room according to the management of clean areas. Each batch of products has batch production records that reflect the actual production situation and meet the requirements of acceptance standards. Batch records shall be filed for three years, and batch records of toxic varieties shall be filed for five years. Different products are not produced in the same operation room at the same time, and each production operation room, production equipment and container has the status mark of the product being processed. Rinse the medicinal materials with tap water, and drain the used water in time. Different medicinal materials are not washed in the same moistening pool at the same time. The production workshop and main production equipment are marked with status. After each production stage of each batch of products is completed, clean up the site and fill in the clearing record. Under the direct leadership of the general manager, the quality supervision department is responsible for the quality supervision of the whole process of drug production. Each variety has formulated the quality standards and inspection procedures for the original medicinal materials, auxiliary materials, packaging materials and decoction pieces. The quality inspection equipment is complete and advanced, and it has the ability to comprehensively inspect Chinese herbal medicines, intermediate products and finished products. All ex-factory decoction pieces have ex-factory inspection reports.

Yiwu Dade Chinese Herbal Pieces Co., Ltd. will spare no effort to continuously improve and strive to improve its work level, produce high-quality herbal pieces and serve patients and society.