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Pharmaceutical machinery has high industry barriers

The pharmaceutical equipment industry, especially the formulation equipment industry, is a typical technology-intensive industry. Its R&D, design, and manufacturing involve related technologies in various fields such as pharmaceutical technology, machinery manufacturing, automation control, and computer application. Our country implements the GMP certification for pharmaceutical production enterprises. Only those companies that meet the GMP certification of pharmaceuticals can engage in the production of pharmaceuticals. The entry of drugs into the EU and US markets must also pass the EU's EUGMP certification or the US FDA's pharmaceutical cGMPs certification. Pharmaceutical equipment companies can only gain a place in the competition of the industry if their technical level, quality stability, and process adaptability meet the requirements of GMP. The design and research and development of pharmaceutical equipment products need to be based on the investment scale, product type, production scale, and the specific conditions of the workshops of pharmaceutical production companies, with a low degree of standardization. The peculiarities of pharmaceuticals require that pharmaceutical equipments have high reliability, high stability, repeatability, and traceability, and require high levels of automation in the manufacturing technology, manufacturing processes, and equipment. For new varieties of drug production, multiple simulation tests are required to carry out scale production. This further requires that pharmaceutical equipment manufacturers have a high level of R&D production capacity. The dominant companies in the industry have accumulated considerable experience in R&D and manufacturing, and possess more intellectual property rights. New entrants not only lack design, development, and manufacturing capabilities, but are also hindered by intellectual property barriers built by the first entrants. Therefore, the industry has high technical barriers.