More Than 30% Sterile Drug Producers In China Fail To Meet GMP Deadline
This article was originally published in PharmAsia News
Executive Summary
China FDA’s recent statistical data show that by the end of 2013, only 796 sterile drug producers among 1,319 had passed good manufacturing practices standards.
China FDA’s recent statistical data show that by the end of 2013, only 796 sterile drug producers among 1,319 had passed good manufacturing practices standards, newly revised in 2010. The remaining 40% did not receive the new drug GMP certificate and were asked to stop manufacturing from the start of 2014. At the end of 2013, about 34% sterile drug producers had not applied for the new drug GMP certificate. Large-scale infusion manufacturers have all passed and received the new certificate to date; the supply of infusion products will not be greatly affected in 2014 and future market share is not expected to change dramatically. (Click Here For More - Chinese Language
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"Over 30% Sterile Drug Producers In China Haven’t Applied The New Drug GMP Certificate" - chinamsr.com (1/3/2014)