As of January 14, 2014, 796 of the 1,319 aseptic pharmaceutical manufacturers had obtained the newly revised GMP (ie 2010 edition) certification. According to the national "requirements for new GMP requirements before December 31, 2013", it means that there are currently 523 sterile drug manufacturing companies in the state of production suspension, including 67 companies that are in the certification period.
Including Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referred to as “Shenzhen Kangtaiâ€), one of the companies involved in the Hepatitis B Vaccine Incident, the publicity deadline was January 26. Shenzhen Kangtai Deputy General Miao told the reporter in an interview on January 16 that the end of the new GMP certification publicity period is the Spring Festival and it is expected that the production of Hepatitis B vaccine will resume after the Spring Festival.
According to statistics, as of January 14 of this year, of the nearly 40 vaccine companies in the country, 31 vaccine manufacturers have passed the new GMP certification, accounting for about 80% of the total. With regard to the problem of the market structure of sterile drugs, there have been many reports in recent years. The general characteristic is that the market is over-exceeding demand. Therefore, some analysts believe that the implementation of the new version of the GMP certification standard will be conducive to the survival of the fittest, mergers and reorganizations in the industry.
However, experts believe that among the more than 1,000 sterile pharmaceutical companies, the proportion of vaccine companies is relatively small, and the impact of the new GMP certification is not significant. However, the injection market may usher in an adjustment of the industrial structure. Small-scale enterprises with low profits and production of antibiotics have long been affected.
Due to the failure to obtain GMP certification for new drugs, more than 500 sterile drug manufacturers stopped production from January 1, 2014. At the beginning of the new year, this news attracted the attention of the industry. Since January 1, 2014, production companies or production plants for sterile drugs such as blood products, vaccines, and injections that have not passed the newly revised GMP certification have ceased production.
The State Food and Drug Administration stated that its products produced before December 31, 2013 can continue to be sold; final packaging has been completed before December 31, 2013, but products that have not yet completed inspections can continue to be inspected and sold only after being qualified. Before December 31, 2013, a sterile pharmaceutical production company or production workshop that has passed the new revision of GMP certification and has been publicly inspected has continued to produce after January 1, 2014. However, its products should be sold only after obtaining a new "Drug GMP Certificate."
Taking a vaccine company as an example, in 2013, some companies adopted the method of increasing production capacity to carry out the 2014 market reserve to cope with the possible suspension of production, such as Beijing Tiantan Biological. Since its implementation in March 2011, the new version of the GMP certification has been considered as an opportunity for the pharmaceutical industry to reshuffle.
According to the requirements of the State Food and Drug Administration, the certification of the new version of GMP has two time nodes: the production of aseptic products such as blood products, vaccines and injections for drug manufacturers should meet the new GMP requirements for drugs before December 31, 2013; The production of other types of drugs should reach the new version of drug GMP requirements by December 31, 2015. Enterprises (workshops) that do not meet the new GMP requirements for pharmaceuticals may not continue to produce drugs after the above-mentioned deadline.
"In the first half of this year, we expect that many companies will obtain new GMP certification," Shi Lichen, a partner at Beijing University of Medicine and North America, told reporters. According to the reporter's understanding, after January 1, 2014, aseptic pharmaceutical manufacturers or production workshops that have not passed the newly revised pharmaceutical GMP certification can still apply for certification in accordance with relevant regulations; after passing certification, they can resume production.
Although only 60% of aseptic drug companies have passed the new GMP certification, according to the reporter, the varieties produced by these companies cover all aseptic drugs contained in the “National Essential Drugs Catalog†(2012 edition); the National Medical Insurance Drug List (2013) The coverage rate of aseptic drugs collected in the year was also 98.7%.
"The overall production capacity has reached more than 160% of the actual demand of the sterile pharmaceutical market in 2012 and can meet the market supply," said the relevant person in charge of the State Food and Drug Administration. Shi Lichen believes that due to the excessive production capacity of sterile pharmaceutical companies in China for many years, few companies are producing at full capacity. Therefore, it is not clear whether the figure above “160% or more†is calculated according to full load.
Many companies expanded their production in 2013. On the one hand, they responded to the new GMP certification. Another factor was that the low price of medicines led many companies to survive by expanding their production scale.
Including Shenzhen Kangtai Biological Products Co., Ltd. (hereinafter referred to as “Shenzhen Kangtaiâ€), one of the companies involved in the Hepatitis B Vaccine Incident, the publicity deadline was January 26. Shenzhen Kangtai Deputy General Miao told the reporter in an interview on January 16 that the end of the new GMP certification publicity period is the Spring Festival and it is expected that the production of Hepatitis B vaccine will resume after the Spring Festival.
According to statistics, as of January 14 of this year, of the nearly 40 vaccine companies in the country, 31 vaccine manufacturers have passed the new GMP certification, accounting for about 80% of the total. With regard to the problem of the market structure of sterile drugs, there have been many reports in recent years. The general characteristic is that the market is over-exceeding demand. Therefore, some analysts believe that the implementation of the new version of the GMP certification standard will be conducive to the survival of the fittest, mergers and reorganizations in the industry.
However, experts believe that among the more than 1,000 sterile pharmaceutical companies, the proportion of vaccine companies is relatively small, and the impact of the new GMP certification is not significant. However, the injection market may usher in an adjustment of the industrial structure. Small-scale enterprises with low profits and production of antibiotics have long been affected.
Due to the failure to obtain GMP certification for new drugs, more than 500 sterile drug manufacturers stopped production from January 1, 2014. At the beginning of the new year, this news attracted the attention of the industry. Since January 1, 2014, production companies or production plants for sterile drugs such as blood products, vaccines, and injections that have not passed the newly revised GMP certification have ceased production.
The State Food and Drug Administration stated that its products produced before December 31, 2013 can continue to be sold; final packaging has been completed before December 31, 2013, but products that have not yet completed inspections can continue to be inspected and sold only after being qualified. Before December 31, 2013, a sterile pharmaceutical production company or production workshop that has passed the new revision of GMP certification and has been publicly inspected has continued to produce after January 1, 2014. However, its products should be sold only after obtaining a new "Drug GMP Certificate."
Taking a vaccine company as an example, in 2013, some companies adopted the method of increasing production capacity to carry out the 2014 market reserve to cope with the possible suspension of production, such as Beijing Tiantan Biological. Since its implementation in March 2011, the new version of the GMP certification has been considered as an opportunity for the pharmaceutical industry to reshuffle.
According to the requirements of the State Food and Drug Administration, the certification of the new version of GMP has two time nodes: the production of aseptic products such as blood products, vaccines and injections for drug manufacturers should meet the new GMP requirements for drugs before December 31, 2013; The production of other types of drugs should reach the new version of drug GMP requirements by December 31, 2015. Enterprises (workshops) that do not meet the new GMP requirements for pharmaceuticals may not continue to produce drugs after the above-mentioned deadline.
"In the first half of this year, we expect that many companies will obtain new GMP certification," Shi Lichen, a partner at Beijing University of Medicine and North America, told reporters. According to the reporter's understanding, after January 1, 2014, aseptic pharmaceutical manufacturers or production workshops that have not passed the newly revised pharmaceutical GMP certification can still apply for certification in accordance with relevant regulations; after passing certification, they can resume production.
Although only 60% of aseptic drug companies have passed the new GMP certification, according to the reporter, the varieties produced by these companies cover all aseptic drugs contained in the “National Essential Drugs Catalog†(2012 edition); the National Medical Insurance Drug List (2013) The coverage rate of aseptic drugs collected in the year was also 98.7%.
"The overall production capacity has reached more than 160% of the actual demand of the sterile pharmaceutical market in 2012 and can meet the market supply," said the relevant person in charge of the State Food and Drug Administration. Shi Lichen believes that due to the excessive production capacity of sterile pharmaceutical companies in China for many years, few companies are producing at full capacity. Therefore, it is not clear whether the figure above “160% or more†is calculated according to full load.
Many companies expanded their production in 2013. On the one hand, they responded to the new GMP certification. Another factor was that the low price of medicines led many companies to survive by expanding their production scale.
Stamping (also known as pressing) is the process of placing flat sheet metal in either blank or coil form into a stamping press where a tool and die surface forms the metal into a net shape. Stamping includes a variety of sheet-metal forming manufacturing processes, such as punching using a machine press or stamping press, blanking, embossing, bending, flanging, and coining.This could be a single stage operation where every stroke of the press produces the desired form on the sheet metal part, or could occur through a series of stages. The process is usually carried out on sheet metal, but can also be used on other materials, such as polystyrene. Progressive dies are commonly feed from a coil of steel, coil reel for unwinding of coil to a straightener to level the coil and then into a feeder which advances the material into the press and die at a predetermined feed length.
Stamping is usually done on cold metal sheet. See Forging for hot metal forming operations.
NINGBO RUICAN MACHINERY COMPANY can offer the stamping parts per the drawings or samples.
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