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The pharmaceutical industry to rewrite

2014.02.14   09:16

         The new GMP certification was finished finally,523 drug firm  failed to pass certification and all were asked to stop prodution.
         Why did these more than 500 sterile drug firms would rather bear the risk of stopping production than reforming the prodution line?Firstly,one of the reasons for low pass rate of new GMP certification is that the firms' intiative are not enough.Although the state is imperative to promoting new GMP certification,but the firms' attitude are different and some firms still have fluke mind beacause of limited development and economic strength.However,the State Food Drug Administration insist on primary certification standard and asked the sterile firms that didn't through certification to stop prodution.
         Secondly,the improvement cost is too high for firms.The standards of production hardware and software are improved highly by comparing the 2010 revised GMP to 1998 old GMP.The new GMP standard is close to the international standard.
         However,the drug firms are facing the multiple pressures,but apparently the pharmaceutical industry is also in the "golden years",which is a process of survival of the fittest.The State Food and Drug Administration issued that the varieties that producted by firms that passed the certification covers the entire production of sterile drug "National Essential Drugs List" (2012 edition) contained.Even there are nearly half firms have been stopped production,the materials still can meet the market supply.
         The reshuffle of pharmaceutical industry has come,if companies still have the fluke mind,they will be the object of merger,the future drug market structure will be rewritten.

By Ann

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