There are more than 470 pharmaceutical excipient production enterprises in China. The main manufacturers of large-scale pharmaceutical excipients include Erkang Pharmaceutical , Shanhe Pharmaceutical, Huangshan Capsule , Weier Pharmaceutical, Huzhou Outlook, Liaocheng Ahua, Liaoning Aoda, and Qufu Tianli, with high technical level and product quality.
Analysis of the development potential and market status of China's pharmaceutical excipients industry
In recent years, the quality management model of pharmaceutical excipients has been continuously running-in and transformed. With the advent of the era of "strict" drug safety supervision, strengthening the quality control of pharmaceutical excipients is no longer just a matter for pharmaceutical excipients manufacturers, but also an important responsibility of preparation manufacturers. However, due to the late start and development of medicinal excipients in my country, the quality levels are uneven. Although the " Drug Administration Law " issued in 2001 and the " Pharmaceutical Excipient Production Quality Management Standards " issued in 2006 put forward relevant requirements for the management of pharmaceutical excipients, they are only guiding principles.
" Relevant Regulations on Strengthening Supervision and Management of Medicinal Excipients " (hereinafter referred to as the "Relevant Regulations") has required local drug supervision and management departments at all levels to strengthen the supervision of production of pharmaceutical excipients. Carry out daily supervision of pharmaceutical excipient production enterprises within the administrative region, or conduct extended inspections of pharmaceutical excipient production enterprises based on problems found during supervision and inspection of pharmaceutical preparation production enterprises.
The pharmaceutical excipient industry stipulates that it is necessary to focus on checking whether the production of pharmaceutical excipients complies with the "Medicinal Excipient Production Quality Management Specifications", whether the quality of raw materials is strictly controlled, whether the production is carried out in accordance with the approved or registered processes, and whether the batch number management system and factory inspection system are established and improved. For those who do not undergo examination, pharmaceutical preparation manufacturers shall not use the pharmaceutical auxiliary materials they produce.
According to the data of the Ministry of Industry and Information Technology and the Provincial Bureau of Statistics, the national pharmaceutical industry above a certain scale achieved operating income of 2796.03 billion yuan, an increase of year-on-year by , and achieved profit of of 412.294 billion yuan, an increase of 19.34% year-on-year by 19.34%. Operating income was the lowest growth rate in the "13th Five-Year Plan", but the total profit reached the highest growth rate in the "13th Five-Year Plan".
The national chemical preparation manufacturing industry achieved operating income of 835.688 billion yuan, a year-on-year decrease of 1.19%, but the operating income of the pharmaceutical excipients and pharmaceutical packaging materials industries was 28.809 billion yuan, a year-on-year increase of 11.54%, significantly higher than the downstream preparation industry, showing that my country's pharmaceutical excipient market is extremely active and has huge potential.
The market size of my country's pharmaceutical excipients is only 3-5% of the output value of the entire pharmaceutical preparation , while foreign pharmaceutical excipients account for 10-20% of the output value of the entire pharmaceutical preparation, indicating that my country's pharmaceutical excipients market still has a big gap compared with foreign countries, but it is developing rapidly at present and has broad prospects in the future.
Without distinguishing the route of administration, the most frequently used pharmaceutical excipients for FDA approved drugs are sodium hydroxide , with 240 uses. sodium chloride and citric acid monohydrate respectively ranked second and third respectively. In the future, the research and development of new green, environmentally friendly, high-end and high-quality medicinal excipients will not only be a high-tech field that the country is focusing on developing, but also have a very broad market prospect, which will surely bring huge economic benefits and industrial value to the whole society.
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