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On February 18, the CFDA announced the latest phase of the GMP certification for pharmaceuticals. 65 pharmaceutical manufacturing companies such as Shandong New Times Pharmaceutical Co., Ltd. passed GMP on-site inspections, and the number of GMP certified companies in China increased to 861.
According to the CFDA's previous announcement, as of December 31, 2013, all or part of the 796 sterile pharmaceutical manufacturing companies had passed the new GMP certification. There were a total of 1,319 aseptic pharmaceutical manufacturers across the country, and 60.3% of the companies had passed certification. According to the needs of China's pharmaceutical market in 2012, the total production capacity of the four main dosage forms of aseptic drugs that have passed the new GMP certification in China has reached 160%, and it can fully meet the market demand.
From the variety analysis, the National Essential Drugs Catalogue (2012 edition) contained 171 aseptic drugs, all of which had been certified by the companies producing. The National Medicare Drugs Catalogue (2013 edition) and commonly used clinical drugs contained 629 and 563 aseptic drugs, respectively, of which 621 and 556 have been certified, accounting for 98.7% of the total. Individual species that have not yet been covered have also completed product reserves. Overall, it can effectively ensure the pharmaceutical market supply.
At present, some enterprises that have not passed certification are still applying for certification because of production arrangements and construction renovations. Another part is preparing to sell assets. The industry expects that companies that need to be certified in the second half of 2014 will be basically completed.
Liu Shulin, deputy general manager of China National Pharmaceutical Group Huamin Co., Ltd., said in an interview with the Pharmaceutical Economics News that the new GMP requirements for injections have increased. It is indeed a comparison for enterprises that have not had sufficient production tasks, are behind production equipment, and have insufficient strength. Big challenge. (Bio Valley Bioon.com)
The opportunity for rejection and expansion is the opportunity for new GMP reforms. At present, some domestic companies are busy making large-scale mergers and acquisitions. Another part of the company hastened to dispose of non-core assets and light vehicles.
For example, in recent years, Dazhong Pharmaceutical Co., Ltd. has sneezed around the globe and its GPIC Group, which has always focused on internal reforms, has finally expressed its expansion ambitions. It said that it will use the opportunity for the expiration of the new GMP certification to acquire 20 to 30 companies in 3 to 4 years. Pharmaceutical companies, with injections and biopharmaceuticals as their main targets, will concentrate their efforts on production approvals and mergers and acquisitions of industrial companies. Currently, they are negotiating with more than a dozen companies; Yabao Pharmaceuticals has announced that it will not pass new GMP standards. Company Yabao North Zhongda Company sells.
WANG Weibing, an expert member of the GMP design team and the deputy general manager of Zhejiang Hisun Pharmaceutical, told reporters that corporate acquisitions are mainly related to the company's development strategy. At present, product approvals are still targeted, and the original production is not full, transformation and new investment and The products with disproportionate output ratio have little significance in continuing to reinvest huge sums of money in an environment with relative capacity surplus, or the product area is not the product of the company's strategic development, and will take this opportunity to make adjustments.
At present, a large number of aseptic production enterprises that have not passed GMP are collectively discontinued, and mergers and acquisitions in the pharmaceutical industry again set off a climax. According to the relevant announcement of the State Food and Drug Administration (CFDA), enterprises that have already passed certification can basically guarantee the market demand for sterile drugs in China.