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In the first year of the "14th Five-Year Plan", China's pharmaceutical industry has entered a new stage of high-quality development
.
The 86th API China Excipients Exhibition joined hands with more than 300 high-quality pharmaceutical excipients companies at home and abroad to display on the same stage.
It also provided high-quality business matching services for exhibitors and visitors, and held precise customized and efficient communication supply-demand conferences on site to boost Chinese medicines Improved quality and efficacy
"What is the impact of a small capsule on drugs? It may speed up the development of drugs, and may also change the stability and dissolution performance of drugs.
Therefore, the participation of excipients is an important part of the development of new drugs
.
" Suzhou Lonza Group Cheng Zhong, general manager of Capsule Co.
Speed up technological innovation
Renewal of pharmaceutical excipient products
Medicinal hollow capsules are an important pharmaceutical excipient whose quality directly affects the safety and stability of the drug
.
For a long time in the past, gelatin has maintained its status as the mainstream capsule material due to its wide range of sources, stable physical and chemical properties and excellent processing properties
Cheng Zhong said that in response to the transformation of China's pharmaceutical industry, the market's functional requirements for capsule excipients are constantly changing, and the original traditional gelatin capsules can no longer fully meet the needs of more diverse technologies
.
"Whether it is technological innovation or the development and manufacturing of new materials, companies hope that more new products can benefit Chinese companies and Chinese patients.
Recently, companies have introduced a new generation of products-the second generation of plant capsules (VcapsRplus), which is continuing On the basis of all the advantages of the previous generation of plant capsules, the appearance and dissolution performance are further optimized, and it is closer to the requirements of the pharmacopoeias of major countries and regions for medicines
High-quality and safe pharmaceutical excipients can not only help pharmaceutical companies solve existing problems, enhance product safety, and enhance product innovation and competitiveness, but also promote the development of China's drug quality to a higher level, and promote more scientific drug supervision in China , Efficient
.
Good medicine must be inseparable from good excipients
.
In 2020, the hydroxypropyl methyl cellulose (HPMC) hollow capsule under Suzhou Capsule was included in the latest edition of the "Chinese Pharmacopoeia" as a new excipient variety, further highlighting the upgrading trend of excipient products
Suzhou Capsules keenly captures the needs of the frontier market, and has planned a very clear product line: from traditional gelatin capsules, to plant capsules with a variety of different functions, to LicapsR liquid-filled capsules that can hold liquids and are widely used in medicines abroad.
Capsules for double-blind clinical trials and full-pigmented capsules have been developed to provide industry chain partners with more abundant functional options
Cheng Zhong said that with the addition of the Chinese drug regulatory authority to the ICH, the continuous acceleration of clinical new drug review and approval, and a series of measures such as the national medical insurance negotiation towards innovative drugs, more and more domestic pharmaceutical innovation companies urgently need to conduct research and development, production, and distribution.
Wait for the entire chain to achieve international standards
.
"China's pharmaceutical innovation vitality is being stimulated, and the development of innovative drugs will inevitably bring about technological innovation in pharmaceutical excipients!"
First full-cycle development
Build a high-quality team in the industry
In April 2012, CCTV broke the chromium-excessive capsule incident, which also exposed the problems in the production and use of pharmaceutical excipients at that time
.
Four months later, the former State Food and Drug Administration issued the "Regulations on Strengthening the Supervision and Management of Pharmaceutical Excipients", which implemented licensing management for pharmaceutical excipient manufacturers and also required pharmaceutical companies to strictly control the quality of pharmaceutical excipients
Cheng Zhong believes that the pharmaceutical industry ecology has undergone earth-shaking changes at the level of standards and laws and regulations
.
"In order to ensure the quality of medicines, the state has formulated a series of laws and regulations on the industry access and production qualifications of pharmaceutical excipients, and the excipient industry is gradually becoming mature
.
The reform idea of related review is to make the industry pay more attention to the quality of excipients and preparations.
The relationship between them highlights the main status of its quality responsibility
.
"
It is not difficult to see that the quality of medicines has become a key factor in the success or failure of pharmaceutical companies, and the importance of specialty pharmaceutical excipients with high quality standards has become increasingly prominent
.
Behind a small capsule is a huge R&D capability and a professional business development team, and this business development team helps the preparation find the most suitable pharmaceutical excipients
.
Cheng Zhong introduced that Suzhou Capsule’s business development team aims to meet the full-cycle development needs of customers, and early intervention, through the understanding of drug performance and market prospects, to provide customers with a full chain of formulation development, prescription issues, regulatory support, etc.
Services to provide support for the production, quality control and promotion of later products
.
"Take capsule color as an example.
Different countries and regions have different management methods and regulations on pigments.
According to the requirements of the market area, it is very important to choose the right ingredients from the beginning
.
The business development team of Suzhou Capsules communicates with customers during the service process.
Close cooperation to facilitate the smooth progress of drug research and development projects
.
"
The "14th Five-Year Plan" will smooth the domestic and international economic cycles.
Facing the international challenges of the pharmaceutical industry in the new era, Chinese pharmaceutical companies are actively accumulating innovation momentum and seizing opportunities for leapfrog development
.
Since its successful holding in 1968, API China Excipients Exhibition has integrated upstream and downstream industries, and has always worked hand in hand with Chinese pharmaceutical companies to create a business exchange and technology sharing platform that links the entire life cycle, entire industry chain, and entire value chain of drugs
.
"The policy is favorable to accelerate the release of market vitality, and the API China accessories exhibition platform is blessed.
I am full of confidence in the future
.
" Cheng Zhong said
.