Pharmaceutical excipients refer to all the ingredients except the main drug. In addition to shaping, acting as a carrier and improving stability, pharmaceutical excipients also have important functions such as solubilization, solubilization, and controlled release. An important ingredient that affects the quality, safety and efficacy of the preparation. The pharmaceutical excipient must meet the medicinal requirements in the production, storage and application.
On November 30, 2017, the State Food and Drug Administration issued the “Announcement of the General Administration of the State Council on Adjusting the Examination and Approval of Raw Material Medicines, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146 of 2017)â€, which clearly The choice of excipients bears the main responsibility, which means that the excipients will fully accept the review of the preparation companies to obtain the approval of the preparation companies. The announcement will promote the development and innovation of excipients, promote the promotion and application of new products, new dosage forms and new processes. The development of the pharmaceutical excipient market is full of unlimited opportunities.
According to relevant statistics, the market size of pharmaceutical excipients in China's pharmaceutical preparations in 2016 was 133.1 billion yuan, a year-on-year increase of 23.2%. At present, China's pharmaceutical excipients industry has made great progress, but due to the late start of China's pharmaceutical excipients, the overall level is still low, so domestic pharmaceutical excipients account for a lower proportion of the entire drug, generally considered at 3%-5 %about.
Nowadays, preparation companies have an urgent need for high-quality medicinal excipients, which has also prompted domestic pharmaceutical excipients and pharmaceutical packaging materials enterprises to actively adjust, improve product quality and ensure drug quality and safety. Some experts said that with the gradual improvement of China's pharmaceutical excipient industry supervision system, the quality of drugs and safety level, especially the development of pharmaceutical industrial production, will inevitably require the technology, process and quality of pharmaceutical excipients to be matched. . The speed of research and development of new drugs is slowing down, and the transformation of drug research and development into new dosage forms will also promote the rapid improvement of the process, quality and variety of pharmaceutical excipients.
For example, Chongqing Steek Reiden Meyer Material Technology Co., Ltd. chose to innovate first, and because innovation has improved the quality of its products, it has attracted famous international companies in the pharmaceutical excipients industry to establish joint ventures and quickly opened up the global market. "We chose to invest at that time, and we also took a fancy to their willingness to take the road of independent research and development, and to meet the international standards, which can improve the level of domestic pharmaceutical accessories enterprises." Chongqing Science and Technology Venture Capital Co., Ltd. said.
Medicinal excipients are a kind of carrier, and at the same time assist in achieving the realization of different functions such as sustained release and controlled release of drugs. In order to promote the better use of pharmaceutical excipients in the production of pharmaceuticals, China needs to continuously improve the level of pharmaceutical excipients. It is understood that in order to promote the upgrading of pharmaceutical accessories, China has issued a number of policies.
According to the National Food Safety Plan of the 13th Five-Year Plan, the state will strengthen supervision over pharmaceutical excipients and pharmaceutical packaging materials, and explore the establishment of pharmaceutical excipients and pharmaceutical packaging materials with key quality risk control as the core and record management as a means. System of review and approval system related to drugs. The 2020 edition of the Chinese Pharmacopoeia will further strengthen the control of the safety of pharmaceutical excipients and pharmaceutical packaging materials, and will be consistent with international relevant requirements. At the same time, increase the standard collection of commonly used pharmaceutical excipients and key pharmaceutical packaging materials, and promote the upgrading and upgrading of pharmaceutical excipients and pharmaceutical packaging materials.
Drugs are indispensable in our lives. Drug safety is more directly related to our health. Although pharmaceutical excipients only serve as a "supporting role", their quality cannot be ignored. With the promotion of policies, the quality of pharmaceutical excipients will be Further improvement. Some experts said that in order to ensure the smooth implementation of the relevant review and approval system for pharmaceutical packaging materials and pharmaceutical excipients, the State Pharmacopoeia Committee will further strengthen the establishment and improvement of the Pharmacopoeia standard system for pharmaceutical excipients and pharmaceutical packaging materials, and strengthen the formulation of relevant pharmacopoeia standards. In the future, the focus of the national standards for the development of pharmaceutical packaging materials and pharmaceutical excipients will be placed on the establishment of the Pharmacopoeia standard system, focusing on the development and improvement of the technical requirements for pharmaceutical packaging materials and pharmaceutical excipients, and the standardization of standard methods. .
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