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On October 21, CDE issued a Notice on Matters Related to Supplemental Information on Injection Consistency Evaluation, which decided to further improve the efficiency of injection consistency evaluation and optimize the review and approval process.
100 billion injection market is about to change, pharmaceutical companies or benefit (photo source: pharmaceutical network) to this, industry insiders believe that in the context of the consistent evaluation of the decision to the competitive landscape of generic drug companies, improve the evaluation of injection consistency, will further "disturb" the domestic drug injection market of hundreds of billions.
background, it is urgent for pharmaceutical companies to improve product quality and development level.
, pharmaceutical companies to improve product quality and development level, can not be separated from the help of pharmaceutical equipment.
, industry insiders predict that the pharmaceutical equipment industry will benefit from the transformation of the injectables market.
it is understood that injection machinery and equipment is one of the important components of the pharmaceutical equipment industry.
Usually, the equipment used for the production of injections includes bottle washing machine, bottler, cap mill, screw cap machine, displuenter, ampoule fuse (filling) machine, water transfer machine, bag-making machine, water injection machine, sterilization oven and washing, baking, irrigation, sealing linkage production line.
these devices have always played a vital role in the safe production and cost-effectiveness of injections.
by domestic injection enterprises to improve product quality requirements, related equipment and enterprises will be further upgraded products to meet the needs of pharmaceutical companies.
meet the demand, the market of related pharmaceutical equipment companies will also usher in more new development opportunities.
the author learned that the current multi-functional bottle washing machine in the pharmaceutical industry has been widely used.
according to the relevant technical personnel, multi-functional bottle washing machine is xilin bottles or other similar bottles in the mechanical continuous transport of internal and external cleaning equipment.
because of its simple structure, stable performance, simple operation, low maintenance costs and other advantages, in the pharmaceutical factory production process has also been continuously improved.
But in order to continue to meet the needs of different enterprises, in the rapid development of science and technology and automation technology, many domestic pharmaceutical equipment enterprises or through continuous innovation, breaking the bottle washing machine in the past simply by manual operation mode, whether in the quality of bottle washing or work efficiency, have reached a more mature level.
Such as a multi-functional bottle washing machine produced by an enterprise will use 304 stainless steel and flexible module combination design new concept, adapt to a variety of specifications of the bottle inside and outside cleaning blow-drying, just simple adjustment, easy to operate, simple maintenance.
addition, injections are known to be more safe and risky to use than oral solids.
, the country has always had clear technical requirements for quality control of injectable products.
such as the Injection Consistency Evaluation Technical Requirements (Draft for Comments) there are clear package requirements, from "low boronicilic/sodium calcium is not recommended" to "not inferior to the evaluation preparation."
these standards, in the better protection of drug quality, but also means that injection consistency evaluation officially started, only those compliance, and excellent quality, better performance of equipment manufacturers, can get the favor of injection pharmaceutical companies.
industry expects that production companies such as upstream medicinal glass, especially Xilin bottles (mold-resistant bottles), may see further improvements in future performance.
currently on the domestic layout of neutral boron silicon pharmaceutical glass enterprises, leading enterprises in the future market position is stable, is expected to become the beneficiaries of the upgrading of the pharmaceutical glass industry.
, for example, shandong drug glass neutral boron-silicon molded bottle development space is very large.
, for pharmaceutical equipment enterprises, combined with pharmaceutical technology, technology research and development equipment, and constantly meet the production needs of enterprises is the long-term development of the way.
But it is worth noting that China's pharmaceutical equipment enterprises in accordance with the pharmaceutical process innovation equipment still has a great shortage, so the future also need pharmaceutical equipment enterprises to increase innovation investment, accelerate the upgrading of technology, improve product services.