According to the policies of the State Administration of Food and Drug Administration, enterprises that have not passed the new GMP certification will temporarily suspend business for rectification. Eventually, they will fail to enter the closure process, and efforts will be made to continue production after passing through.
China's pharmaceutical products are mainly divided into two categories, aseptic and non-sterile preparations, according to the use level and microbial control limit. At present, there are 1,319 aseptic pharmaceutical manufacturers, 796 companies have passed GMP certification, and 523 companies have passed through efforts and are integrated between.
The limit for non-sterile pharmaceutical companies was at the end of 2015. At present, only 778 companies have passed. An insider of the China Pharmaceutical Association stated that at least 1,000 drug companies will be consolidated in this round of the deadline. Then this round of integration of sterile, non-sterile drug companies will be in more than 2,000. A tide of integration is starting.
The batch number and land plot ended on December 31, and the State Administration of Pharmaceutical Supervision announced that there were 796 aseptic drug companies across the country that passed the new GMP certification. Behind the pass rate is the survival of another 523 aseptic companies. What determines the fate of 523 companies is their own "efforts" and "values."
With its own efforts, that is, the State Administration of Pharmaceutical Supervision stipulates that companies that suspend production will try to continue production operations through the new version of the GMP certification after the workshop has been transformed. The failed person enters the merger and closure process. GMP is an international standard that embodies the new concepts of quality management and quality assurance. GMP certification is a compulsory certification that integrates software, hardware, safety, health, and environmental protection.
Value, on the other hand, represents tension and drug approvals in the eyes of most companies, and land plots for pharmaceutical companies. Due to the higher investment in rectification, some companies directly entered the state of being integrated and acquired. In this type of enterprise, the only valuable land in the hands is the approval document.
In recent years, with the tightening of drug approvals, it has been extremely difficult to issue new batches. The batch process of a new drug is probably about 5 years. Too long, there are many applications can not be down, the future in the continuous integration of enterprises, who have the product who is the winner. Therefore, obtaining drug approvals through acquisitions becomes a shortcut.
The more drug approvals, the higher the selling price. In the context of the small number of drug approvals, land is the only valuable thing. In addition to the market instinct, there are actually pressure expansions brought about by GMP reform. Most of the companies that have passed the new GMP certification have almost a commonality and their production capacity has been improved, but their productivity is idle.
According to a person from Shenwei Pharmaceutical, most companies will expand their production capacity when GMP is reformed. After the transformation, the existing product demand will lead to some lack of production capacity. In other words, the rebuilt production line will be idle due to low production demand.
The GMP reform is originally a huge investment, if the production line idle, bank loans, new drug research and development, the company's own liquidity and other aspects are facing tremendous pressure. In this context, expanding capacity as quickly as possible is the best way out of pressure.
According to Zhuang Yichun, director of the Yangzijiang Pharmaceutical News Center, Yang Zijiang’s investment in GMP reform is 500 million yuan. With the transformation, we are currently actively looking for suitable companies that can be acquired, and we hope to see the expansion of product categories.
Thousands of companies or pharmaceutical companies that have been integrated with value are acquired or integrated. The outcome of drug companies with no value can only be bankruptcy. According to the policy of the State Administration of Pharmacy, the date of the new GMP deadline for aseptic manufacturers is the last day of December 2013.
The deadline for non-sterile pharmaceutical companies is the end of 2015, which is less than two years from now. Of the 3,839 non-sterile pharmaceutical manufacturing enterprises, as of October 2013, the State Administration of Food and Drugs revealed that 969 certificates had been issued and 778 had been approved, accounting for 20.3% of the total non-sterile pharmaceutical manufacturing enterprises. This does not include medical oxygen, Chinese herbal medicines and in vitro diagnostic reagents.
The passing rate is clearly bleak. The insiders of the above-mentioned China Pharmaceutical Association believe that there may be more than 1,000 companies that have been consolidated or closed down during this round of the deadline. And this is still on the way. Integration is far from over. During the "12th Five-Year Plan" period, the Ministry of Industry and Information Technology proposed the development of the pharmaceutical conglomeration. By 2015, five companies will have promoted sales revenues exceeding 50 billion yuan.
According to this development strategy, people in the industry interpret that China's pharmaceutical sector will advance towards the oligarchic pattern. After the development of the group, quality, competitiveness, and internationalization will follow, and foreign countries will also be oligopolistic development models.
Therefore, through the GMP limit, aseptic preparations and non-sterile preparation companies will first have more than 2,000 pharmaceutical companies entering the ranks of integration and closure. According to the analysis of relevant pharmaceutical companies, in the future, through the development of pharmaceutical grouping in China, about 100 pharmaceutical groups or companies will be formed. In order to achieve this goal, the relevant departments may already have meticulous plans.
According to sources close to the drug administration system, the initial assumption of the drug administration department was that one-third of enterprises passed the new GMP certification, one-third of them passed through some efforts, some were merged, and the other one-third merged. Partly closed down.
In this context, the adequate supply of medicines is the main issue guaranteed by the drug surveillance system. With respect to aseptic companies, all or part of the 796 companies that have passed have passed the newly revised pharmaceutical GMP certification, accounting for 60.3% of the 1,319 sterile drug companies in the country. The varieties of these pharmaceutical companies have covered all varieties of the new edition of the base drug catalog. The coverage rate of aseptic drugs collected in the National Medical Insurance Drug List (2013) also reached 98.7%, and the total production capacity has reached more than 160% of the actual demand of the sterile drug market in 2012.
In other words, under the background of the adoption of 796 companies, the supply of drugs in the aseptic field has been more than enough, then the fate of 523 companies will not have much impact on the pharmaceutical market. As for the failure to pass the new version of GMP, some business people said that the investment is too large. Perhaps because of the high investment and the increase in production costs, most companies are stuck outside the door of the new GMP.
Recently, Tiantan Biology, which was mentioned many times because of the vaccine incident, had previously indicated that the production line had not been transformed in accordance with the requirements of the new GMP due to the huge cost of the transformation of the production line. For 3839 companies that have not passed the non-sterile formulation of the new version of GMP, the State Administration of Food and Drug Administration has given the policy that during the transitional period, it can continue to produce, and if it fails, it will stop production.
At present, the new edition of the base drug bidding in various regions clearly lists the requirements for “restricting bids for companies that have not passed the new GMP certificationâ€, such as Qinghai and Shanghai. Perhaps, this behavior will be a chain reaction from the sterile drug companies to the non-sterile pharmaceutical companies, a wave of big mergers and acquisitions will be opened.
China's pharmaceutical products are mainly divided into two categories, aseptic and non-sterile preparations, according to the use level and microbial control limit. At present, there are 1,319 aseptic pharmaceutical manufacturers, 796 companies have passed GMP certification, and 523 companies have passed through efforts and are integrated between.
The limit for non-sterile pharmaceutical companies was at the end of 2015. At present, only 778 companies have passed. An insider of the China Pharmaceutical Association stated that at least 1,000 drug companies will be consolidated in this round of the deadline. Then this round of integration of sterile, non-sterile drug companies will be in more than 2,000. A tide of integration is starting.
The batch number and land plot ended on December 31, and the State Administration of Pharmaceutical Supervision announced that there were 796 aseptic drug companies across the country that passed the new GMP certification. Behind the pass rate is the survival of another 523 aseptic companies. What determines the fate of 523 companies is their own "efforts" and "values."
With its own efforts, that is, the State Administration of Pharmaceutical Supervision stipulates that companies that suspend production will try to continue production operations through the new version of the GMP certification after the workshop has been transformed. The failed person enters the merger and closure process. GMP is an international standard that embodies the new concepts of quality management and quality assurance. GMP certification is a compulsory certification that integrates software, hardware, safety, health, and environmental protection.
Value, on the other hand, represents tension and drug approvals in the eyes of most companies, and land plots for pharmaceutical companies. Due to the higher investment in rectification, some companies directly entered the state of being integrated and acquired. In this type of enterprise, the only valuable land in the hands is the approval document.
In recent years, with the tightening of drug approvals, it has been extremely difficult to issue new batches. The batch process of a new drug is probably about 5 years. Too long, there are many applications can not be down, the future in the continuous integration of enterprises, who have the product who is the winner. Therefore, obtaining drug approvals through acquisitions becomes a shortcut.
The more drug approvals, the higher the selling price. In the context of the small number of drug approvals, land is the only valuable thing. In addition to the market instinct, there are actually pressure expansions brought about by GMP reform. Most of the companies that have passed the new GMP certification have almost a commonality and their production capacity has been improved, but their productivity is idle.
According to a person from Shenwei Pharmaceutical, most companies will expand their production capacity when GMP is reformed. After the transformation, the existing product demand will lead to some lack of production capacity. In other words, the rebuilt production line will be idle due to low production demand.
The GMP reform is originally a huge investment, if the production line idle, bank loans, new drug research and development, the company's own liquidity and other aspects are facing tremendous pressure. In this context, expanding capacity as quickly as possible is the best way out of pressure.
According to Zhuang Yichun, director of the Yangzijiang Pharmaceutical News Center, Yang Zijiang’s investment in GMP reform is 500 million yuan. With the transformation, we are currently actively looking for suitable companies that can be acquired, and we hope to see the expansion of product categories.
Thousands of companies or pharmaceutical companies that have been integrated with value are acquired or integrated. The outcome of drug companies with no value can only be bankruptcy. According to the policy of the State Administration of Pharmacy, the date of the new GMP deadline for aseptic manufacturers is the last day of December 2013.
The deadline for non-sterile pharmaceutical companies is the end of 2015, which is less than two years from now. Of the 3,839 non-sterile pharmaceutical manufacturing enterprises, as of October 2013, the State Administration of Food and Drugs revealed that 969 certificates had been issued and 778 had been approved, accounting for 20.3% of the total non-sterile pharmaceutical manufacturing enterprises. This does not include medical oxygen, Chinese herbal medicines and in vitro diagnostic reagents.
The passing rate is clearly bleak. The insiders of the above-mentioned China Pharmaceutical Association believe that there may be more than 1,000 companies that have been consolidated or closed down during this round of the deadline. And this is still on the way. Integration is far from over. During the "12th Five-Year Plan" period, the Ministry of Industry and Information Technology proposed the development of the pharmaceutical conglomeration. By 2015, five companies will have promoted sales revenues exceeding 50 billion yuan.
According to this development strategy, people in the industry interpret that China's pharmaceutical sector will advance towards the oligarchic pattern. After the development of the group, quality, competitiveness, and internationalization will follow, and foreign countries will also be oligopolistic development models.
Therefore, through the GMP limit, aseptic preparations and non-sterile preparation companies will first have more than 2,000 pharmaceutical companies entering the ranks of integration and closure. According to the analysis of relevant pharmaceutical companies, in the future, through the development of pharmaceutical grouping in China, about 100 pharmaceutical groups or companies will be formed. In order to achieve this goal, the relevant departments may already have meticulous plans.
According to sources close to the drug administration system, the initial assumption of the drug administration department was that one-third of enterprises passed the new GMP certification, one-third of them passed through some efforts, some were merged, and the other one-third merged. Partly closed down.
In this context, the adequate supply of medicines is the main issue guaranteed by the drug surveillance system. With respect to aseptic companies, all or part of the 796 companies that have passed have passed the newly revised pharmaceutical GMP certification, accounting for 60.3% of the 1,319 sterile drug companies in the country. The varieties of these pharmaceutical companies have covered all varieties of the new edition of the base drug catalog. The coverage rate of aseptic drugs collected in the National Medical Insurance Drug List (2013) also reached 98.7%, and the total production capacity has reached more than 160% of the actual demand of the sterile drug market in 2012.
In other words, under the background of the adoption of 796 companies, the supply of drugs in the aseptic field has been more than enough, then the fate of 523 companies will not have much impact on the pharmaceutical market. As for the failure to pass the new version of GMP, some business people said that the investment is too large. Perhaps because of the high investment and the increase in production costs, most companies are stuck outside the door of the new GMP.
Recently, Tiantan Biology, which was mentioned many times because of the vaccine incident, had previously indicated that the production line had not been transformed in accordance with the requirements of the new GMP due to the huge cost of the transformation of the production line. For 3839 companies that have not passed the non-sterile formulation of the new version of GMP, the State Administration of Food and Drug Administration has given the policy that during the transitional period, it can continue to produce, and if it fails, it will stop production.
At present, the new edition of the base drug bidding in various regions clearly lists the requirements for “restricting bids for companies that have not passed the new GMP certificationâ€, such as Qinghai and Shanghai. Perhaps, this behavior will be a chain reaction from the sterile drug companies to the non-sterile pharmaceutical companies, a wave of big mergers and acquisitions will be opened.
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