GMP is the basic principle for drug production and quality management, and it has been implemented in China since the 1980s. The revised version of 2010, which was formally implemented in March 2011, is called the new version of GMP. The hardware of this version refers to the relevant EU standards. The software part refers to the relevant FDA standards and is formed according to the actual situation in China. And the requirements are very strict.
According to the data released by the Food and Drug Administration, as of December 31, 2013, 60% of drug manufacturers had passed the certification, among which there was no shortage of pharmaceutical listed companies. Peking University Pharmaceuticals, Yisheng Pharmaceutical, Qianhong Pharmaceutical, Northeast Pharmaceutical, Kelun Pharmaceutical, and Lingrui Pharmaceutical have listed dozens of pharmaceutical listed companies that have passed the new GMP certification.
The requirements of the new version of the GMP certification rules are higher According to Guo Fanli, research director of China Investment Consulting, the new GMP certification rules put higher requirements on the production, transportation, and clinical use of the products, and the company will invest heavily in the new GMP requirements. The new factory building, or the transformation of the existing pharmaceutical production plant and the air-conditioning system, will also require higher costs. This means that the new version of the GMP reform is also a test of the drug manufacturers' own economic strength and financing capacity.
According to the "Investment Announcement on GMP Reform Phase I Project Investment" released by Yi Zhe Pharmaceutical in March 2012, the company is responding to the new version of GMP. The proposed preparation plant, extraction plant, quality assurance building layer, boiler room, sewage treatment station And so on, the investment amounted to 271 million yuan. Then in February 2013, the company issued a non-public offering plan, and plans to issue no more than 58.18 million shares at a reserve price of 19.94 yuan/share, and the total amount of funds raised shall not exceed 1.16 billion yuan for the second phase of the GMP transformation project. Two subsidiaries GMP transformation business.
Little impact on large companies Although some companies fail to pass GMP certification, some in the industry believe that this will have little impact on the performance of large companies and will only affect those companies with weak capital strength, which will promote The merger and acquisition started.
According to industry sources, for the blood product industry, due to the fact that most varieties of domestic blood products have been in short supply, the discontinuation of production on the 1st will intensify the contradiction between the supply and demand of blood products. The price of the main blood products is controlled by the highest retail price. There is little impact on the performance of GMP companies.
Promoting industrial mergers and acquisitions, upgrades According to the requirements of the new GMP, before December 31, 2013, the existing drug manufacturers must produce new products such as blood products, vaccines, and injections, which must reach the new version of GMP. All production workshops will stop production. Therefore, the new version of GMP certification is no different from the "test of death and death" of domestic pharmaceutical manufacturers, and it is also a "big reshuffle" of the pharmaceutical industry.
According to the data released by the Food and Drug Administration, as of December 31, 2013, 60% of drug manufacturers had passed the certification, among which there was no shortage of pharmaceutical listed companies. Peking University Pharmaceuticals, Yisheng Pharmaceutical, Qianhong Pharmaceutical, Northeast Pharmaceutical, Kelun Pharmaceutical, and Lingrui Pharmaceutical have listed dozens of pharmaceutical listed companies that have passed the new GMP certification.
The requirements of the new version of the GMP certification rules are higher According to Guo Fanli, research director of China Investment Consulting, the new GMP certification rules put higher requirements on the production, transportation, and clinical use of the products, and the company will invest heavily in the new GMP requirements. The new factory building, or the transformation of the existing pharmaceutical production plant and the air-conditioning system, will also require higher costs. This means that the new version of the GMP reform is also a test of the drug manufacturers' own economic strength and financing capacity.
According to the "Investment Announcement on GMP Reform Phase I Project Investment" released by Yi Zhe Pharmaceutical in March 2012, the company is responding to the new version of GMP. The proposed preparation plant, extraction plant, quality assurance building layer, boiler room, sewage treatment station And so on, the investment amounted to 271 million yuan. Then in February 2013, the company issued a non-public offering plan, and plans to issue no more than 58.18 million shares at a reserve price of 19.94 yuan/share, and the total amount of funds raised shall not exceed 1.16 billion yuan for the second phase of the GMP transformation project. Two subsidiaries GMP transformation business.
Little impact on large companies Although some companies fail to pass GMP certification, some in the industry believe that this will have little impact on the performance of large companies and will only affect those companies with weak capital strength, which will promote The merger and acquisition started.
According to industry sources, for the blood product industry, due to the fact that most varieties of domestic blood products have been in short supply, the discontinuation of production on the 1st will intensify the contradiction between the supply and demand of blood products. The price of the main blood products is controlled by the highest retail price. There is little impact on the performance of GMP companies.
Promoting industrial mergers and acquisitions, upgrades According to the requirements of the new GMP, before December 31, 2013, the existing drug manufacturers must produce new products such as blood products, vaccines, and injections, which must reach the new version of GMP. All production workshops will stop production. Therefore, the new version of GMP certification is no different from the "test of death and death" of domestic pharmaceutical manufacturers, and it is also a "big reshuffle" of the pharmaceutical industry.
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