The drug substance and the device are in cooperation with each other to resist the new storm.

Looking back on 2017, with the introduction and implementation of a series of heavy-duty policies, China's pharmaceutical industry is showing signs of vigor and vitality. Many pharmaceutical companies are enjoying a bumper harvest. What kind of vision is there for raw materials used in the production of various preparations? What is the future development trend, and how should the upstream APIs be transformed and upgraded to promote the development of the API industry?

原料药与设备唇齿相依 双方通力合作抵抗新风暴

With the increase in environmental protection in 2017, the API industry has entered a reshuffle period, many small and medium-sized manufacturers may be eliminated, and the high-end market share and profits of APIs will achieve rapid growth. For example, the relevant person in charge of Zhejiang Guobang Pharmaceutical Co., Ltd. introduced that in 2017, the international high-end market share and profit of the company's APIs increased rapidly. At the same time, raw materials are required to move toward the high-end market, and the threshold for entry is also improved. According to the relevant person in charge of Guobang Pharmaceutical, the two international high-end markets that the current state-owned drug owners are playing are the EU and the US market, and the entry threshold is also notoriously high. One of them is the entire production process of the drug substance. The requirements are very strict.

Faced with such demanding requirements, many API companies are daunting. Some small enterprises are gradually withdrawing from the market because of various pressures. The ultimate survival will be some truly powerful brand enterprises with high-end routes, and some Although traditional enterprises have increased environmental inspections and infrastructure investment, transformation and upgrading are also a matter of course. The so-called lip-tooth cold, facing the new storm of raw materials, the raw material medicine equipment industry in the upstream drug industry is also facing tremendous pressure and challenges, and related companies have to consider looking for new development directions.

Adopting new technology, reducing production links and reducing pollution... Some experts said that in the face of the new situation, raw material pharmaceutical companies will inevitably carry out strict checks on the entire production process and process. Safety and environmental protection will inevitably be the focus of competition in the API market. This API equipment company should naturally follow the rules of the API market, carry out green environmental protection upgrades, research and develop high-end, high-tech equipment to promote the safe production of APIs and transform into a green and high-end market.

It is understood that the raw material medicine equipment in some developed countries pay more attention to environmental protection, energy conservation, safety and stability, and the automation design is more practical. Compared with the advanced equipment in developed countries, China's raw material medicine equipment has more irrational industrial structure, low research and development level, and circulation. The use of low-function, high energy consumption and many other issues. In 2018, a new storm of API is coming. In order to ensure that the quality of raw materials produced is not affected by the processing process, China's APIs should continuously introduce advanced technology and innovative equipment functions to ensure that the drugs will not be used in the processing. Come to impurities and pollution. According to industry insiders, these raw material medicine equipments must not only prevent external microorganisms and other bacteria from being mixed into the reaction materials, but also have functions such as in-situ cleaning and in-situ sterilization.

China is a big exporter of raw materials, but it is not a strong country. With the promotion of supervision and consistency evaluation, China's API industry is accelerating the concentration of production through the survival of the fittest, forcing enterprises to improve their core competitiveness. As the "engine" of APIs, equipment companies should continue to promote technological innovation and upgrading. For example, further strengthen the online corrosion controllable technology, the modular technology combined with the process, the dehydration technology combined with the hydraulic and inflatable diaphragm, and the simulation virtual technology in the development and application of the raw material medicine equipment.

According to the relevant technical personnel, the hydraulic and inflatable diaphragms are combined to maximize the separation force, so as to obtain more effective solid-liquid separation effect with minimum energy consumption; and the application of simulation and virtual technology can make the project design modification fast. The whole process is faster, clear and controllable, generally reducing project investment costs by 30%, project design costs by 40%, and design speed by 30%.

Strengthen the upgrading of raw material medicine equipment, promote the application of new technology in raw material medicine equipment, realize the recycling of raw material medicine equipment, green energy conservation and environmental protection, and ensure the safe and reliable production of raw material medicine without pollution. This is the development direction of raw material medicine equipment. In the face of the storm of raw materials, the raw material medicine equipment can only gain a new place in the fierce competition if it only introduces new products and abandons the traditional drawbacks and products with independent intellectual property rights. For example, the CWL-M series centrifugal extractor developed by Zhengzhou Tianyi Extraction Co., Ltd. for the drawbacks of the current conventional centrifugal extractor consumes only 10% to 30% of the traditional annular-gap model (with the same amount of processing), thus receiving more Multi-enterprise choice.

In order to improve the right to speak of raw materials, China needs to continue to increase the inspection of API manufacturers, pay attention to various risk signals and clues, and ensure the quality and safety of APIs. According to the relevant public information, China's raw material drug export enterprises received 12 warning letters from the EU and 21 copies from the FDA due to insufficient laboratory data integrity, confusion in the use of factories and equipment, inconsistent actual production areas of drugs, and poor management of documents. Export ban and 15 warning letters. Faced with this phenomenon, China's APIs should improve quality and enhance their competitiveness. Raw material medicine equipment, as a raw material medicine production equipment, should lead by example and continuously improve the technical level and quality of equipment to ensure the safe and standardized green production of raw materials and improve raw materials. The right to speak.

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