Website: www.lotuspharm.com.tw Company Name: Shi Mei Chemical Pharmaceutical Co., Ltd.
English name: meishih pharmaceutical co, Ltd.
English address: No.30, 540, Chenggong 1st Road, Li Xinxing, Nantou.
English address: No.30 Chenggong 1 Road. Nangong industry. Area. Nantou City, Nantou County, Taiwan Province, Republic of China
Tel: (049)22504 1 1, 2250048
Fax: (049)2258-403
Person in charge: Lin Donghe
& lt Produced by Taiwan Province Pharmaceutical Industry Association >
Based on Taiwan Province Province, look around the world.
Pharmaceutical factory oriented to new drug research and development
Create background
A group of pharmaceutical professionals with pharmaceutical background founded Yourui Company in Taipei on 1988 for lack of local R&D and professional marketing. At the beginning of its establishment, Yourui focused on professional marketing and its performance grew rapidly. 1996, yourui merged with Shi Mei chemical pharmaceutical co., ltd to become a surviving company. In 2004, Shi Mei Pharmaceutical Factory passed the third phase verification operation of cGMP of the Ministry of Health.
Over the years, Shi Mei Pharmaceutical has been adhering to the business philosophy of "research and innovation for the benefit of the people", constantly researching and developing innovative models to provide safe and healthy modern life for Chinese people and create a new pattern of pharmaceutical industry in Taiwan Province.
Shi Mei visual sense
Based on Taiwan Province Province, with a broad view of the world, we are guided by the research and development of new drugs.
Shi Mei Pharmaceutical adheres to the vision of new drug research and development, and has been creating new business strategies and models.
The business strategy of Shi Mei Pharmaceutical Co., Ltd. is to carry out clinical trials of new drugs, accumulate experience, enter the research and development of new dosage forms, and gradually develop into the development of new indications and new ingredients. Shi Mei focuses on this R&D innovation-oriented strategy, and its annual investment in R&D accounts for about 65,438+05% of its turnover.
The market strategy has gradually crossed the export market from the local market.
Shi Mei Pharmaceutical has developed products in many fields, including drugs for treating cardiovascular diseases, pain, nervous system diseases, skin diseases, metabolic diseases, respiratory diseases, etc., and has shown brilliant transcripts in the domestic sales market.
At present, it is exported to Chinese mainland, Southeast Asian countries, and has been distributed in the American market of the European Bureau.
America's competitive advantage is based on the implementation of several unique strategies:
1? Carry out clinical trials of new drugs in line with GCP, accumulate core knowledge of pharmaceutical industry, and provide basis for R&D and marketing;
In line with the policy of "July 7th Announcement" of the government's new drug regulations, Shi Mei Pharmaceutical Co., Ltd. was approved by the Ministry of Health for monitoring new drugs with its excellent human trial quality from 199 1, which opened the era for Shi Mei Pharmaceutical Co., Ltd. to develop new drugs through clinical trials.
In 2002, the implementation of "Apano Tab" clinical trial was audited by the Department of Health, which became the first case for local pharmaceutical companies to comply with the Good Practice for Clinical Trials (GCP), which promoted domestic clinical trials and brought them into line with international standards.
In this way, Shi Mei Pharmaceutical Co., Ltd. took the lead in introducing drugs that have been listed abroad, and announced new drugs approved by the Ministry of Health.
Such as: Apano (mifepristone), Arheuma (leflunomide), Bensau (benzoate), Basazyde (Balshazite), Butaro (butorphanol), desloratadine (desloratadine), Ichdem (doxepin), Mesyrel (trazodone), Musgud (Nimed bessarin).
At present, Shi Mei Pharmaceutical has been authorized by Edmund Pharmaceutical to sell its respiratory system product Erdostein in Taiwan Province Province and Chinese mainland. This is another advantage. With its expertise in clinical trials and marketing, Shi Mei Pharmaceutical can strive for the authorization of potential new products in China.
Through this strategy, Shi Mei Pharmaceutical Co., Ltd. has launched new products to meet the health needs of domestic people, so that people can obtain more beneficial drugs and improve the health and well-being of people in China.
At present, there are 15 clinical research projects that have been implemented and passed the audit of GCP Health Department.
2? Improve added value and establish advantages by developing new dosage forms;
Shi Mei Pharmaceutical Co., Ltd. continues to develop controlled release dosage forms, and related technologies have applied for domestic patents. At present, Forflow S.R (pentoxifylline), Milix M.R (indomethacin), Mezidm.R (Gliclazide), Muactions R. (Tramadol) and Fedsensr (pseudoephedrine) have been listed.
In addition, Shi Mei Pharmaceutical and Fisherman Pharmaceutical formed a strategic alliance to develop special dosage forms such as soft capsules and external patches.
3? Enter the development of new ingredients and new indications, improve the research and development capabilities of pharmaceutical companies, and lay out global operations;
The formula of external multivitamin developed by our company has been patented, and many animal and large-scale human experiments have been carried out, which will develop into a global brand for adjuvant treatment of acne patients.
In addition, the company transferred the technology of "New Drugs for Cardiovascular Diseases (LS-NTU- 106)" from Taiwan Province Provincial University, and actively participated in preclinical research, and planned to apply for IND (Investigational New Drug) in the United States to develop a case and challenge the field of new ingredient development.
Shi Mei Pharmaceutical has transferred LT085 from the National Institutes of Health, and is planning to carry out the clinical application of the drug in hepatitis C, which is a case of developing new indications for listed products. This is another milestone for Shi Mei pharmaceutical industry to enter new drug development.
4? Cross the export market and open up business opportunities;
At present, the business opportunities for OEM in the generic drug market in Europe and America have gradually emerged, and Japan's pharmaceutical industry policy is also more open to imported generic drugs. The United States is also focusing on this global market, and is actively involved in the export field, and plans to attract local sales channels to cooperate and lay out the global pharmaceutical market through the research and development of different generic drugs.
Shi Mei Pharmaceuticals has planned factory inspections by the FDA and other European health authorities. When the global pharmaceutical industry gradually reduces circulation obstacles through the ICH framework, Shi Mei Pharmaceutical will gradually sow seeds and bear fruit in the global market by strengthening its core R&D capabilities and unique market vision.
Download the PDF file of the organization chart of Shi Mei Chemical Pharmaceutical Co., Ltd.
1955.06
1955 Shi Mei was established.
1986.09
1986 became a GMP pharmaceutical factory.
1987.09
1987 court. S was approved by NTU Hospital.
1988.09
1988 yourui company was established with a capital of 5 million yuan.
199 1.09
199 1 year was approved for clinical trial.
1994.09
1994 meishuyu is exported to the mainland.
1996.09
1996 merger of Shi Mei chemical industry and yourui company.
2004.08
In August 2004, it passed the three-stage verification of cGMP.
2004. 1 1
2004. 1 1 was awarded the industrial sustainable elite award by the Ministry of Economic Affairs.
2005.0 1
On October, 2005, KLOC-0 was awarded the "1993 Medical Science and Technology Research and Development Award" by the Ministry of Health.
2004. 1 1
2004. 1 1 The "First Taipei Biotechnology Award" sponsored by the North City Government won the prize.
2005.02
In February, 2005, the cGMP pharmaceutical factory, which meets international standards, started construction.