The State Food and Drug Administration announced that: “As of December 31, 2013, all or part of the 796 sterile pharmaceutical manufacturing companies had passed the newly revised GMP certification.â€
The first batch of 1,319 aseptic products such as vaccines and blood products (sterile drugs refer to the preparations and raw materials for sterility test items, including aseptic raw materials, injections, vaccines, powder injections, and blood products. Only 60.3% of production companies passed the clearance smoothly, and the rest 523 pharmaceutical companies were suspended in 2014.
In the remaining two years before the deadline for the second round of certification on December 31, 2015, the rest of the country's nearly 4,700 pharmaceutical companies will also face a cruel "test of life and death".
The new standard has spawned technological changes. In this situation, domestic pharmaceutical companies that have not passed certification will face two options, stop production or make modifications. If you choose to reform, then companies will invest a lot of money to upgrade equipment, which will have higher standards for the production of pharmaceuticals for the production of sterile pharmaceuticals. Therefore, this has also led to changes in the pharmaceutical machine industry. For pharmaceutical machinery companies, meeting the market test and meeting new requirements are both opportunities and challenges.
According to a research fellow from the China Merchants Securities pharmaceutical industry, the new GMP requirements for sterility have increased, which has led to higher requirements for the isolation and automation of pharmaceutical equipment. According to statistics, for the 1000-1200 stock lyophilization production lines in current domestic operations, more than 90% of domestic freeze-dried products of pharmaceutical companies still use manual feed and discharge materials. In the next few years, the market share of automatic discharge systems and aseptic isolation devices will increase. In other words, freeze-drying system equipment consisting of three major devices, freeze dryers, sterile isolation systems, and automatic access and discharge systems, will emerge in the future. A substantial increase.
Intense market competition Strong demand in the downstream industry According to relevant statistics from the China Pharmaceutical Equipment Industry Association, currently, 20% of China's chemical preparations are freeze-dried, and the proportion of freeze-dried drugs in biological products reaches 30%, and the proportion is still constantly improving. The domestic manufacturers of freeze-dried drugs have grown from the six major biological products research institutes directly subordinate to the Ministry of Health at the beginning to provincial and municipal or regional biopharmaceutical plants and veterinary drug biological product factories. The rapid growth of the pharmaceutical industry will drive the rapid development of the freeze-drying system industry.
In addition, with the gradual shift of the production of APIs in developed countries in Europe and America to emerging market countries such as China and India, pharmaceutical companies in emerging markets need not only to expand the scale of freeze-dried production lines, but also to upgrade the technical level of lyophilization system equipment to meet the requirements of international GMP regulations. , Which also stimulated the demand for freeze-drying systems.
The first batch of 1,319 aseptic products such as vaccines and blood products (sterile drugs refer to the preparations and raw materials for sterility test items, including aseptic raw materials, injections, vaccines, powder injections, and blood products. Only 60.3% of production companies passed the clearance smoothly, and the rest 523 pharmaceutical companies were suspended in 2014.
In the remaining two years before the deadline for the second round of certification on December 31, 2015, the rest of the country's nearly 4,700 pharmaceutical companies will also face a cruel "test of life and death".
The new standard has spawned technological changes. In this situation, domestic pharmaceutical companies that have not passed certification will face two options, stop production or make modifications. If you choose to reform, then companies will invest a lot of money to upgrade equipment, which will have higher standards for the production of pharmaceuticals for the production of sterile pharmaceuticals. Therefore, this has also led to changes in the pharmaceutical machine industry. For pharmaceutical machinery companies, meeting the market test and meeting new requirements are both opportunities and challenges.
According to a research fellow from the China Merchants Securities pharmaceutical industry, the new GMP requirements for sterility have increased, which has led to higher requirements for the isolation and automation of pharmaceutical equipment. According to statistics, for the 1000-1200 stock lyophilization production lines in current domestic operations, more than 90% of domestic freeze-dried products of pharmaceutical companies still use manual feed and discharge materials. In the next few years, the market share of automatic discharge systems and aseptic isolation devices will increase. In other words, freeze-drying system equipment consisting of three major devices, freeze dryers, sterile isolation systems, and automatic access and discharge systems, will emerge in the future. A substantial increase.
Intense market competition Strong demand in the downstream industry According to relevant statistics from the China Pharmaceutical Equipment Industry Association, currently, 20% of China's chemical preparations are freeze-dried, and the proportion of freeze-dried drugs in biological products reaches 30%, and the proportion is still constantly improving. The domestic manufacturers of freeze-dried drugs have grown from the six major biological products research institutes directly subordinate to the Ministry of Health at the beginning to provincial and municipal or regional biopharmaceutical plants and veterinary drug biological product factories. The rapid growth of the pharmaceutical industry will drive the rapid development of the freeze-drying system industry.
In addition, with the gradual shift of the production of APIs in developed countries in Europe and America to emerging market countries such as China and India, pharmaceutical companies in emerging markets need not only to expand the scale of freeze-dried production lines, but also to upgrade the technical level of lyophilization system equipment to meet the requirements of international GMP regulations. , Which also stimulated the demand for freeze-drying systems.
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